Medical equipment

maintenance programme
overview
WHO Medical device technical series

Medical equipment
maintenance programme
overview
WHO Medical device technical series

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3 Scheduling maintenance 27 5.4.2 Setting IPM frequency 26 5.3 Operational management 26 5.1 Inventory 14 4.2 Training 25 5.3.5 Performance improvement 33 WHO Medical device technical series 1 .8 Communication 30 5.3.7 Tags and labels 30 5.2 Methodology 15 4.3 IPM yield 32 5.4 Performance monitoring 32 5.5 CM performance measures 33 5.9 Managing use and user error 31 5.3.2 Physical resources 17 4.4.3.4 IPM productivity 33 5.3 Human resources 20 5 Management 23 5.1 Developing or changing IPM procedures 26 5.3.3.4.3.2 Personnel management 23 5.3.4.1 Completion rate of assigned IPM 32 5.1 Financial resources 16 4.3 Resources 15 4.4 Prioritization of work 27 5.3.3.1 Service vendors 24 5.3.10 Travel 31 5.6 Computerized maintenance management systems 29 5.2.2.1 Financial management 23 5.3.5 Keeping records 28 5.Contents Preface 4 Maintenance series and external guidance 5 Methodology 5 Definitions 6 Acknowledgements 7 Declarations of interests 7 Acronyms and abbreviations 8 Executive summary 9 1 Introduction 10 2 Purpose 11 3 Maintenance related definitions 12 4 Maintenance programme planning 14 4.3.2 Equipment location rate 32 5.4.

infusion 63 Appendix B.6 Infection control 56 Appendix B Examples of inspection and preventive maintenance procedures 58 Appendix B.2 Factors affecting equipment failures 36 6.3 Reporting 37 6.6 X-ray system.1 Troubleshooting and repair 35 6.1 Inspection and preventive maintenance 35 6.1 Record of inspection 74 Appendix E.1. mobile 64 Appendix C Calculating IPM workload 65 Appendix D Examples of inventory and inspection forms 68 Appendix D. 6 Implementation 35 6.3 Work order form 72 Appendix E Samples of inspection labels 73 Appendix E.3 Inspection and return to service 37 6.5 Pump.4 Work order system for corrective maintenance 52 Appendix A.5 Corrective actions identified during preventive maintenance 54 Appendix A.1 Procedure template 59 Appendix B.2.2 Corrective maintenance 35 6.3 Inspection and preventive maintenance procedure 50 Appendix A.2 Equipment inspection forms 70 Appendix D.1 Risk-based biomedical equipment management programme 44 Appendix A.1 IPM procedures 35 6.2 Problem identification 35 6.2 Anaesthesia/analgesia unit (gas machine) 60 Appendix B. table top 61 Appendix B.3 Centrifuge.3 Notification of defect 76 Appendix F Test equipment per medical device category 77 2 Medical equipment maintenance programme overview .2.2.1 New equipment received form 69 Appendix D.2 Initial testing and evaluation 48 Appendix A.2 Record of inspection (test) results 75 Appendix E.4 Safety 37 7 Concluding remarks 39 References 40 Useful resources 41 Appendix A Sample policies and procedures 43 Appendix A.4 Monitor. ECG 62 Appendix B.1.

Service agreement types 25 WHO Medical device technical series 3 . Components of a maintenance programme 10 Figure 2.2 Biomedical equipment technician .3 Planning a maintenance programme within a regional health system 86 Appendix H.senior-level 81 Appendix G. Financial resources required for a maintenance programme 16 Table 2.entry-level 79 Appendix G.3 Biomedical equipment technician . Critical factors in planning a maintenance programme 14 Table 1.4 Managing a maintenance programme within a regional health system 87 Figures and tables Figure 1.1 Biomedical equipment technician .2 Managing a maintenance programme at a district hospital 85 Appendix H.4 Clinical engineering supervisor/manager 82 Appendix H Examples of actions performed when developing maintenance programmes at the facility level 83 Appendix H. Management aspects of a maintenance programme 23 Table 3.1 Planning a maintenance programme at a district hospital 84 Appendix H.Appendix G Examples of job descriptions 78 Appendix G.mid-level 80 Appendix G. Classification and roles of technical personnel 21 Figure 3.

To meet these objectives. WHO and partners have been working towards devising an agenda. diagnosis. One of WHO’s strategic objectives is to “ensure improved access. Preface Health technologies are essential for a functioning health system. 4 Medical equipment maintenance programme overview . Recognizing this important role of health technologies. This document is part of a series of reference documents being developed for use at the country level. It has two specific objectives: • to challenge the international community to establish a framework for the development of national essential health technology programmes that will have a positive impact on the burden of disease and ensure effective use of resources. tools and guidelines to increase access to appropriate medical devices. as well as patient rehabilitation. By adopting this resolution. The resolution covers issues arising from the inappropriate deployment and use of health technologies. The series will include the following subject areas: • policy framework for health technology • medical device regulations • health technology assessment • health technology management › needs assessment of medical devices › medical device procurement › medical equipment donations › medical equipment inventory management › medical equipment maintenance › computerized maintenance management systems • medical device data › medical device nomenclature › medical devices by health-care setting › medical devices by clinical procedures • medical device innovation. research and development. the World Health Assembly adopted resolution WHA60. delegations from Member States acknowledged the importance of health technologies for achieving health-related development goals. GIHT aims to make core health technologies available at an affordable price. and the need to establish priorities in the selection and management of health technologies. and requested that the World Health Organization (WHO) take specific actions to support Member States. urged expansion of expertise in the field of health technologies. with funding from the Bill & Melinda Gates Foundation. and treatment of illness and disease. • to challenge the business and scientific communities to identify and adapt innovative technologies that can have a significant impact on public health. specifically medical devices. particularly to communities in resource-limited settings. quality and use of medical products and technologies. to effectively control important health problems. in particular medical devices.” This objective. Medical devices in particular are crucial in the prevention. formed the basis for establishing the Global Initiative on Health Technologies (GIHT). an action plan.29 in May 2007. together with the World Health Assembly resolution.

outcomes. health service provider organizations in developing countries and are publicly available. regional or global levels. exists for people who work for. The documents address medical equipment inventory management. The first meeting was held in Geneva in April 2009 to prioritize which tools and topics most required updating or developing. maintenance. nongovernmental organizations and academic institutions involved in health technology at the district. experts and advisers have collaborated through an online community to provide feedback on the development of the documents.int/medical_devices/gfmd_report_final. Stakeholders from 106 countries made recommendations on how to implement the information covered in this series of documents at the country level. Furthermore.These documents are intended for use by biomedical engineers. A second meeting was held in Rio de Janeiro in November 2009 to share progress on the health technology management tools under development since April 2009.html 2 First WHO Global Forum on Medical Devices: context. known as the ‘How To Manage’ series. national. and future actions is available at: http://www. and to hold an interactive session for the group to present proposals for new tools.1 Methodology The documents in this series were written by international experts in their respective fields. based on information gathered from the earlier presentations and discussions. or assist. and no conflicts were identified.pdf (accessed March 2011) WHO Medical device technical series 5 .healthpartners-int. Each of these documents can be used as a stand-alone document. to review the current challenges and strategies facing the pilot countries. a six-volume comprehensive series of manuals for the management of healthcare technology. and computerized maintenance management systems. donors.uk/our_expertise/how_to_manage_series. The last meeting was held in Cairo in June 2010 to finalize the documents and to help countries develop action plans for their implementation. and reviewed by members of the Technical Advisory Group on Health Technology (TAGHT). 1 Available at http://www. In addition to these meetings.co.2 All meeting participants and people involved in the development of these documents were asked to complete a declaration of interest form. The group has met on three occasions. The TAGHT was established in 2009 to provide a forum for both experienced professionals and country representatives to develop and implement the appropriate tools and documents to meet the objectives of the GIHT. but together they present all of the factors to consider when developing a medical equipment maintenance programme. health managers.who. Maintenance series and external guidance Three documents in this technical series have been developed specifically to aid a health facility or a national ministry of health to establish or improve a medical equipment maintenance programme. The concepts were discussed further during the First WHO Global Forum on Medical Devices in September 2010.

Typically. 3 World Health Assembly resolution WHA60. it can be used either alone or in combination with any accessory. disposable or single-use medical devices. Health technology: The application of organized knowledge and skills in the form of devices. repair. apparatus or machine that is used in the prevention. consumable.ghtf. diagnosis or treatment of illness or disease. Medical device: An article.who. instrument. the purpose of a medical device is not achieved by pharmacological. and decommissioning − activities usually managed by clinical engineers. Global Harmonization Task Force. restoring. immunological or metabolic means. 6 Medical equipment maintenance programme overview . accessed March 2011).org/documents/sg1/sg1n29r162005. medicines. Medical equipment excludes implantable. May 2007 (http://www.29. maintenance.4 Medical equipment: Medical devices requiring calibration. correcting or modifying the structure or function of the body for some health purpose. procedures and systems developed to solve a health problem and improve quality of life. Definitions Recognizing that there are multiple interpretations for the terms listed below.pdf. measuring.int/medical_devices/resolution_wha60_29-en1. or other piece of medical equipment. vaccines. or for detecting. user training. they are defined as follows for the purposes of this technical series. 2005 (http://www. accessed March 2011). Medical equipment is used for the specific purposes of diagnosis and treatment of disease or rehabilitation following disease or injury.3 It is used interchangeably with health-care technology. pdf. 4 Information document concerning the definition of the term “medical device”.

We would like to thank Aditi A Sharma for assistance in proofreading and Karina Reyes- Moya and Gudrun Ingolfsdottir for administrative support throughout the development of this document. United States of America. Fort Collins. Colorado. The draft was reviewed by Jennifer Barragan (WHO). Baretich Engineering. Iyad Mobarek (WHO).Acknowledgements Medical equipment maintenance programme overview was developed under the primary authorship of Frank R. WHO Medical device technical series 7 . Adham Ismail (WHO). Switzerland as part of the Global Initiative on Health Technologies project funded by the Bill & Melinda Gates Foundation. Hartford. Declarations of interests Conflict of interest statements were collected from all contributors and reviewers to the document development. and Matthew F. Lisa Stroux (WHO). Rob Parsons (consultant). Jorge Calil (Universidade Estadual de Campinas). Baretich. Geneva. No conflicts of interest were declared. and edited by Inis Communication. Jennifer Jackson (Sapienza University). WHO. Billy Teninty (Engineering World Health). Connecticut. University of Connecticut. Painter. USA and under the overall direction of Adriana Velazquez-Berumen.

Acronyms and abbreviations AAMI Association for Advancement of Medical Instrumentation ACCE American College of Clinical Engineering BMET biomedical equipment technician CIMV conventional intermittent mandatory ventilation CM corrective maintenance CMMS computerized maintenance management system ECG electrocardiograph EM equipment management FDA Food and Drug Administration GIHT Global Initiative on Health Technologies HEPA high efficiency particulate air HTM health/health-care technology management IPM inspection and preventive maintenance ISO independent service organization MRI magnetic resonance imaging NFPA National Fire Protection Association PM preventive maintenance PPE personal protective equipment SIMV synchronized intermittent mandatory ventilation TAGHT Technical Advisory Group on Health Technology UPS uninterruptable power supply WHO World Health Organization 8 Medical equipment maintenance programme overview .

In addition. treatments and monitoring of patients. safety inspections ensure the equipment is safe for both patients and operators. Ultimately. safe and available for use when it is needed for diagnostic procedures. such a programme prolongs the useful life of the equipment and minimizes the cost of equipment ownership. performing inspections of equipment only ensures that the device is in good operating condition at the time of inspection and cannot eliminate the possibility of failure during future use. Additionally. It is important. Performance inspections ensure that equipment is operating correctly. the nature of most electrical and mechanical components is that they can potentially fail at any time. as well as preventive and corrective maintenance. proper implementation of the programme is key to ensuring optimal equipment functionality.Executive summary Medical devices are assets that directly affect human lives. A maintenance strategy includes procedures for inspection. management and implementation. personnel and operational aspects are continually examined and managed to ensure the programme continues uninterrupted and improves as necessary. Once the programme has been defined. Corrective maintenance (CM) restores the function of a failed device and allows it to be put back into service. some hidden problems may be discovered during a scheduled inspection. However. An effective medical equipment maintenance programme consists of adequate planning. therapy. and preventive maintenance (PM) aims to extend the life of the equipment and reduce failure rates. Planning considers the financial. therefore. physical and human resources required to adequately implement the maintenance activities. to have a well planned and managed maintenance programme that is able to keep the medical equipment in a health-care institution reliable. They are considerable investments and in many cases have high maintenance costs. financial. WHO Medical device technical series 9 .

maintenance Inspection Preventive maintenance 10 Medical equipment maintenance programme overview . cleaned (IPM). this is be divided into two major categories: important as PM can be fairly invasive in inspection and preventive maintenance that components are removed. Components of a maintenance programme Maintenance IPM Corrective . IPM includes all scheduled activities that ensure equipment It is essential for any health-care facility. to implement a or failures. Performance and safety maintenance programme for medical inspections are straightforward procedures equipment. stand-alone activity and in conjunction Figure 1. the same if it is in an urban area in a part replacement. the principles of a performed to extend the life of a device good maintenance programme will be and prevent failure (i. functionality and prevent breakdowns regardless of its size.e. Inspection can be conducted as a a low. cleaning. The complexity of the that verify proper functionality and safe programme depends on the size and type use of a device. (CM) (see Figure 1). high-income country or a rural setting in etc). and the resources (PM) refers to scheduled activities required. However. and corrective maintenance or replaced. by calibration. lubrication. its location. Preventive maintenance of facility. 1 Introduction Medical equipment maintenance can with PM to ensure functionality.to middle-income country.

managing and implementing the such services may not yet be fully maintenance of medical equipment. responsible for planning. The document is intended for those vide information regarding the compo. local. with plan. so that each country or institution can design an ap- propriate programme to meet their own specific requirements. in resource-constrained countries where ning. WHO Medical device technical series 11 . particularly those in developing countries. especially regional and national levels. health-care organizations. It may also be of value to intended to be concise and flexible. It focuses on general principles rather than being a rigid model. It can assist management services at the facility. and engineers and technicians responsible may be adapted to various settings and for carrying out the many tasks described. It is established. levels of technical resources as required. managing nents of an effective medical equipment and implementing health technology maintenance programme.2 Purpose The objective of this document is to pro.

g. and/or a breach of physical integrity. etc. we refer most often to clinical engineering department. inspection times. Although manufacturers have specific names for devices. 3 Maintenance related definitions Key terms used in the discussion of medical equipment maintenance are defined below. safety and/or performance of a device after a failure. Corrective A process used to restore the physical integrity. While a clinical engineer is a specialized biomedical engineer.aspx) 12 Medical equipment maintenance programme overview .com/) and the Universal Medical Device Nomenclature System (https:// www.g. Depending on the context and country.gmdnagency. Clinical engineer A professional who supports and advances patient care by applying engineering and managerial skills to health-care technology (American College of Clinical Engineering). service costs and other important maintenance management information from facility to facility. nomenclature name: electrosurgical system.g.ecri. corrective maintenance. physical therapy stimulators. or calibration but can also be completed as a stand-alone activity scheduled at specific intervals. Common descriptive The terminology used to describe a device. Inspection and IPM refers to all the scheduled activity necessary to ensure a piece of medical equipment is functioning preventive correctly and is well maintained.org/Products/Pages/UMDNS. Some alternative names include: ‘biomedical engineering department’. Inspection Inspection refers to scheduled activities necessary to ensure a piece of medical equipment is functioning correctly. It includes both performance inspections and safety inspections. electrosurgical units. this department or team may be referred to by a wide variety of names. Failure The condition of not meeting intended performance or safety requirements. This document uses these terms interchangeably. In this document. ‘medical equipment management unit’. IPM therefore includes inspection and preventive maintenance (PM). the terms are often used interchangeably. ‘medical equipment maintenance department’. etc.) also require periodic calibration to ensure accuracy compared to known standards. When the device first arrives in the health-care facility. etc. Calibration Some medical equipment. it is functioning as specified. needs to be calibrated periodically. vendor name for the device: electrosurgical generator. patient scales. pulmonary function analysers. monopolar/bipolar. particularly those with therapeutic energy output (e. adjustments must be made until the device functions within specifications. Devices that take measurements (e. electrocardiographs. the training for users has been arranged and it is installed correctly. it is registered into the CMMS. laboratory equipment. it is checked to ensure it matches the purchase order. This means that energy levels are to be measured and if there is a discrepancy from the indicated levels. maintenance (CM) Corrective maintenance and unscheduled maintenance are regarded as equivalent to the term repair. defibrillators. failure rates. maintenance (IPM) 1 Two common nomenclatures are the Global Medical Device Nomenclature (http://www. Term Definition Acceptance testing The initial inspection performed on a piece of medical equipment prior to it being put into service. Clinical engineering Engineer/technician or team of engineers/technicians responsible for the management and department/group maintenance of medical equipment. Using common universal descriptive names from a single nomenclature internationally accepted source1 is key to comparing inspection procedures. vendor model name: Radiolase).). it is important to store the common name of the device as listed in the nomenclature system (e. These occur in conjunction with preventive maintenance. A failure is corrected by repair and/or calibration. If a computerized maintenance management system (CMMS) is available.

Safety inspections These are performed to ensure the device is electrically and mechanically safe. Tests compare the inspections performance of the device to technical specifications established by the manufacturer in their maintenance or service manual. Used interchangeably with corrective maintenance.g. This document uses these terms interchangeably. These inspections are not meant to extend the life of equipment. seals). The procedures and intervals are usually established by the manufacturer. and/or performance of a device after a failure. Preventive PM involves maintenance performed to extend the life of the device and prevent failure. cleaning (e. Repair A process used to restore the physical integrity. WHO Medical device technical series 13 . the results are compared to country or regional standards as well as to manufacturer’s specifications. The frequency of safety inspections may be different than planned maintenance and performance inspections. Performance inspections are sometimes referred to as ‘performance assurance inspections’. PM is usually maintenance (PM) scheduled at specific intervals and includes specific maintenance activities such as lubrication. and are usually based on regulatory requirements. In health care this is primarily done in a facility that has a large number of medical devices from a single manufacturer or model. In special cases the user may change the frequency to accommodate local environmental conditions.g. filters) or replacing parts that are expected to wear (e. The maintenance interval is then set so components are replaced before they fail. When these inspections are done. valves. safety. ensuring the equipment continues to operate reliably. pumps.g.Performance These activities are designed to test the operating status of a medical device. Preventive maintenance is sometimes referred to as ‘planned maintenance’ or ‘scheduled maintenance’. batteries. Predictive This activity involves a forecasting technique to determine the rate of failure of certain types of maintenance replaceable components (e. tubing).g. These inspections may also include checks for radiation safety or dangerous gas or chemical pollutants. bearings) or which have a finite life (e. but merely to assess its current condition.

At the other extreme are not all equipment needs to be tracked in advanced imaging and laboratory devices. 4. and hundreds of other types care technology management (HTM). ECG (electrocardiograph) comprehensive programme for health. For example.1 Inventory The clinical engineering department Medical devices range from relatively should identify and select the devices to simple to highly complex. and the range of devices in those facilities. organizations have the manpower to physical and human resources. Repair of a magnetic resonance imaging and very few hospitals or health-care system requires extensive financial. Critical factors in planning a maintenance programme Critical factors Inventory Methodology Resources The types and numbers of Identification of the method The financial. inspected or maintained. and medical devices to be tracked by which maintenance will be human resources available to by the hospital and those that provided to the items included the programme. are specifically included in the in the programme. covered by the programme. calibration (and some government agencies may instruments and basic hand tools are require this). an inventory. Between accomplish this level of effort. and which manual devices to measure blood of those to include in the maintenance pressure (sphygmomanometers) have programme. Approaches Figure 2. as shown in Figure 2. maintenance programme. part of a broader effort to establish a defibrillators. This programme that is appropriate and cost. of medical devices of varying complexity. it is essential to The challenge for planners is to balance determine the types of devices that need these factors to design a maintenance to be included in the programme. ranging from primary care clinics to tertiary hospitals. While some may prefer only few components and are easily to record all equipment in the facility repaired. physical. assuming that parts. will depend on the types of facilities to be effective for their situation. maintenance programme. 14 Medical equipment maintenance programme overview . 4 Maintenance programme planning Planning a maintenance programme is these extremes are infusion pumps. studies have shown that available. machines. be included in the inventory. This planning process includes a review Early in the process of planning a of critical factors.

Some for inclusion in an inventory. They are management activities is to decide which responsible for routinely checking that services should be provided by which all the equipment being tracked within combination of internal and external a health-care facility is in the inventory service providers.4 discusses approach is to establish some level of methods for prioritizing work. or a combination of both. based on the capacity and that all the equipment listed in the of the facility and its staff. it is important to independent service organizations consider in advance the financial. care organization. when new a given context.2 outlines a policy for initial 4. Furthermore. equipment arrives it should be inspected and then added to the inventory. it is possible for a health.1 outlines one specific method in conducted by employees of the health- greater detail. Maintenance also requires appropriate staff skills. A maintenance programme can be implemented in any number of ways so Maintenance requires access to it is important to consider the variety equipment parts which may be difficult of methodologies that are available. the typical are important. To prepare contracts with device manufacturers.3. In such physical and human resources necessary cases it is essential for the health-care to properly execute the intended activities. which are management and technical capability also helpful in the selection of equipment within the health-care organization. Appendix A. organization to have personnel to monitor WHO Medical device technical series 15 . to obtain due to budget limitations and For example. calculations of inventory management in this technical the staff requirement and knowledge of series for further information. while Appendix D.3 Resources testing and evaluation. education and experience. Further details inventory can be located. procurement difficulties. when a piece of equipment might fail. Section 5. which help in while carrying out routine inspections or designing an appropriate methodology for PM activities. 4. One of the most important maintaining the inventory. This requires a to Introduction to medical equipment maintenance history. for such challenges.to selecting equipment to record in an and manage the activities of these service inventory and a maintenance programme contractors. In practice. Please also refer are difficult to project. particularly care organization to establish service when purchasing from abroad. (ISOs).2 Methodology Outside vendors are necessary for the maintenance of complex equipment. Other maintenance activities may be conducted by service The clinical engineering department contractors or other external service is responsible for developing and providers.1 provides a sample form for new Resources needed for maintenance equipment received. The team may on management and implementation are find it convenient to perform an inventory found in sections 5 and 6. Appendix of the maintenance activities may also be A.

to estimate initially. time The financial resources required for to obtain the equipment to be inspected a maintenance programme (as one (either bringing it to a central work area component of a comprehensive HTM or going to the location of the equipment). Table 1 summarizes the major items within each Direct maintenance costs can be difficult category. Initial costs are re-order PM parts used. maintenance. this measure may be much workload required by the programme. For the IPM component For planning purposes in developing specifically.1 vehicles. or region. and only after an extended using the applicable rates in the country period of performance improvement. 4. The initial and when substantial supporting resources operating costs are then calculated are available. An example can be found in are ongoing expenses required to keep Appendix C. turnover. Administrative time to make additional investments in the to create the IPM forms. it is possible to determine an estimated total workload for Over time there will be opportunities the IPM programme. but will improve with time and experience. especially for new programmes This is a relatively straightforward process in resource-constrained environments. These types of services can be acquired on a time and materials basis Initial costs Operating costs or by contracting over a set period at a fixed rate. Operating costs calculation. cost of service ratio is between 5% and and on the level and type of maintenance 10% (1). The cost of service ratio is a useful Direct (not applicable) Service contracts. 16 Medical equipment maintenance programme overview . initial Salaries. based on the number and types In the United States. Financial resources required for a by negotiation with external service maintenance programme providers. utilities. resources training. programme. measure in determining the financial maintenance parts and materials. benefits. for example. effectiveness of a maintenance travel. Service contract costs. continuing education. the cost of service ratio. the programme in operation. however. if the estimated time for inspections However. Section 5. programme) fall into two categories: initial time to document the work done and costs and operating costs. can be determined Table 1.1 Financial resources in getting ready to do inspections. For example.3. resources test equipment. needed. by the estimated time. Operation. This ratio is calculated by dividing the total annual cost of operating a medical equipment maintenance The first step in calculating costs is to programme by the value (initial cost) specify the physical and human resources of medical equipment in the inventory. preparation time maintenance programme. the of medical equipment in the inventory. discusses further the issues surrounding Human Recruiting. be planned in advance and included computer resources. engagement of service vendors. higher. in related budgets. This ratio is achievable only methodology selected. the cost must Physical Space. In either case. shipping. it is helpful to estimate the countries. tools.2. By counting the number of be monitored over time and be used as devices of each type (each common a guide for performance improvement nomenclature type) and multiplying it efforts. should is known. calibration. are all activities investments that must be made before that should be added to the total workload the programme begins.

This may be a without appropriate tools and test time consuming process. This decision-making process Inclusion of computer resources in for new investments is particularly the workspace is also important to effective when it is informed by actual consider. situation and the new proposal can be compared. a simple business plan repair. where internet communication resides. replacement parts.3. or computerized A maintenance programme relies on a maintenance management system number of physical resources. planning to take essential typically found within the facility itself. it can be a valuable planning a maintenance programme each resource. repair parts rather than outsourcing the work. tools and test equipment to the work but if the programme includes multiple site or equipping a space closer to the facilities it may be more economical to equipment is necessary.the programme may consider providing and medical gases. and access to whatever Then the costs and benefits of the current computer resources are required. The clinical engineering workshop is In this case. service and operator initial and operating costs of the proposal. For some types of equipment is unreliable. At each and supplies. establish a centralized repair depot. when internet needed to perform maintenance. supplies. Basic documentation may data from the programme.2 Physical resources database programme. laboratory phone can be an effective alternative. include the workspace.edu/medtech/index. and surgical lights. 4. be maintained with paper records but the use of a computer spreadsheet. A good workspace is clean and well-organized. but the clinical equipment. When access is available. analysers. It provides 1 An example of an online educational opportunity is the series of courses developed good lighting and access to utility systems by the University of Vermont in USA (http://its. improvement (see section 5. for example). manuals.3.6 for more and operation and service manuals information). It service for a particular type of equipment includes work benches and storage space by using internal resources and staffing for tools and test equipment.html). The location in which maintenance will inexpensive voice communication and take place should be considered when e-mail communication enable effective planning the programme.1 Furthermore. Additionally. and as follows. As purchases are planned. It also includes space for records should be drawn up that includes the and documentation. These (CMMS) supports good record-keeping.uvm. online educational programmes may be an option to further technical knowledge Workspace and facilitate training. going to the equipment is the only option. Many technical resources are of these should be considered individually available online at little or no cost. and equipment awaiting such opportunity. The second option is to transport the Tools and test equipment equipment to the clinical engineering The productivity of biomedical equipment department’s repair shop to have the technicians (BMETs) will be limited IPM or CM performed. tools and test performance monitoring and performance equipment. WHO Medical device technical series 17 . One option is in collaboration across wide distances. sterilizers. keeping in touch by mobile such as X-ray systems. the location where the equipment usually However. Spanish language versions of the courses are offered through Universidad CES required by the equipment (electricity (Colombia) and Pontifica Universidad Católica de Peru. engineering department may be the it should be noted that investment in only location where some maintenance tools and test equipment results in can be performed.

They should be kept in the accuracy of the calibrations. calibrate and may be necessary. such as troubleshooting software and laptop computers to connect Replacement parts to computer-based laboratory or imaging When planning an IPM programme. Medical instrumentation (e. maintained. but so too is providing additional more advanced tools and test equipment ongoing funding to purchase. Tools and. specialized items. (e. by referring to the manufacturer’s 18 Medical equipment maintenance programme overview . it may not be Supplies appropriate to take responsibility for the These primarily consist of cleaning and maintenance of the associated device. may have a shorter useful is possible to forecast in advance what lifespan because the laboratory and parts need to be replaced and how of- imaging technology changes so quickly. Typically. Purchasing programme. in particular. is not possible to procure and maintain certain test equipment. calibrated at margin of safety for the patients and staff. Where resources are constrained. In addition. Facilities with few equipment in service. The The life of tools and test equipment may manufacturers’ service manuals give exceed ten years if they are carefully cautions about using the wrong cleaning maintained. creativ- Various tools and test equipment are ity is required. appropriate intervals. which can damage labelling and be used for about seven years. resistance a minimum set of tools and test equip- and capacitance substitution boxes. necessary. establishing a network of required to perform IPM and/or CM technicians and engineers may mean that procedures. and need to be acquired in sufficient quantities. and the good physical condition. the maintenance. more advanced tools and test equipment will enable clinical engineering technical A detailed list of test equipment and the staff to calibrate. in a large service test equipment for new medical hospital with more than a few operating equipment the hospital may acquire in rooms and modern electrosurgery the future. For example. These electrical safety meter). an electrosurgical analyser to expand the scope of the maintenance may be a prudent purchase. an ment for low-resource settings (2). test equipment can agents. Highly the plastic surfaces of some equipment. reduced maintenance costs. ten.g. lubricating supplies. and repaired as as well as the efficiency of the staff doing required. a physiological simulator. It is possible to financial resources can consider rent- perform a large proportion of IPM and CM ing or sharing expensive test equipment procedures satisfactorily with a basic set of and tools with other hospitals in the sur- electronic service tools and test equipment rounding area. depending on the type of tools can be shared. In larger Initial funding to start a programme is facilities with more complex equipment. temperature meter. in the developing world recommends force gauge. Small hospitals or recommendations represent the most clinics with a limited amount of medical basic level of investment in tools and test equipment can run their programme with equipment that can enable meaningful just several pieces of basic test equipment service for medical devices. volt meter. oscilloscope.g. test equipment having the right equipment will greatly must themselves be appropriately increase the reliability of the readings. If it in Appendix F. safety analyser and some basic tools). maintain and repair a devices they are required for is provided wider variety of medical equipment. it equipment. or for test equipment needed equipment.

with equipment specifications that leads Even if the hospital staff does not plan to device failure) must be carefully to do maintenance on a particular piece considered beforehand. preventive maintenance. of equipment. based on the number Unfortunately. These manufacturer’s parts is an option if the procedures are usually written very clearly quality and characteristics of each part and in many cases with illustrations for is carefully analysed. non-compliance them to do so at the time of purchase. batteries. analysis and guarantee the parts they maintenance and service manuals.g. it is important that and the associated costs will help in these manuals are included as part of the planning maintenance and informing purchase agreement. For existing minimizing shipping costs. knowing what will be needed For new equipment. Manuals or advice may be found among the wider health technology In many countries the problem of obtaining management community. loss of schematics unless the owner requires manufacturer guarantee. sell – is a reasonable solution in many troubleshooting guidelines. the manuals may be borrowed tantly. parts (or parts kits) to be used during or may be in a language not spoken by preventive maintenance (e. Clinical engineering department improve reliability and availability of the managers should. However. the replacement service manuals are not always available. This practice will online.2 and in a timely manner can be substantial. this purpose. valves. The operation manual is valuable not only for equipment users For donated equipment. parts lists and cases. equipment. Purchasing generic performing complete and appropriate parts from specialty medical equipment IPM. the instincts and know-how of the The service manual is essential for staff will be the primary resource. manufacturers may parts suppliers – who do the engineering not provide specific IPM procedures. Most impor.) can is important that a clinical engineering be ordered many months in advance. Therefore. the replacement parts will be on from other local hospitals or obtained hand when needed. This may lead who sell equipment are required to to funds being redirected to critical areas. equipment technicians. Thus. net/?page_id=38 WHO Medical device technical series 19 . having maintenance and service manuals enables the hospital Operation and service manuals to provide the manuals to external Ideally. it filters. seals. inspection. equipment. department take steps that allow them optimizing any volume discounts and access to such manuals. such as the replacement parts at a reasonable cost Infratech mailing list. the maintenance programme will maintenance providers or do the repairs have an operation (user) manual and a themselves in the future if circumstances service manual for each model of medical change. have equipment and increase the productivity access to high-speed Internet service for of the staff performing the maintenance.guidelines.g. provide detailed IPM procedures for use The use of generic parts instead of the by those who buy their equipment. However. etc. 2 Instructions on how to join the Infratech listserv are found at http://infratechonline. However. operation manuals and of devices at the facility. but associated risks (e. access. if possible. and calibration. when manuals but also for equipment technicians who have not been provided and due to the need to understand in detail how the age or type of equipment are impossible to equipment is used in clinical practice. repair. tubing. All manufacturers management in advance.

they must number of technical and management receive the relevant higher education and personnel.3. however. but will need more single technician who provides services supervision and training to effectively for a small inventory of relatively simple accomplish their work. Table 2 provides a classification ticular technologies. In general. Biomedical infrastructure so that qualified technical or clinical engineers. it is important to discuss engineering or electrical technology) with the supplier if manuals are available. Overtime and equipment. technicians may become cal engineering department serving a qualified to take a position as a biomedical large number of health-care facilities. the country or region. there their typical duties. On the other hand. are educated in personnel can be created within the general engineering principles. appropriate guidelines. The first step is to identify the have adverse consequences on human number and type staff that a facility (or life. this additional training because medical essary to operate an effective mainte. and have taken certificate courses. It may be a good idea physical and biological sciences and to include universities within the country their application to medical technology. or can be made available.3 Human resources Engineers or technicians must have Developing the human resources nec. In many countries there is a shortage of qualified clinical engineers and biomedical Technical Personnel equipment technicians. with experience. for especially when those facilities include engineers to become qualified as a higher level hospitals. A long-term Within the category of technical personnel solution is to develop the educational are engineers and technicians. However. Developing countries post-graduate training and a degree or should work with responsible donor certificate in biomedical electronics or agencies and insist on adherence to biomedical equipment technology. degree. Biomedical or education for technical personnel. engineers and technicians may be trained in a related field (such as industrial In all cases. equipment technician. This type of engineer or technician group of facilities) requires. while and emphasizing the importance of biomedical equipment technicians often including operation and service manuals come into the position with two year’s with every donation. technical series for more information. particularly in countries with for solicitation and provision in this fewer specialized training programmes. including specialists in par. perhaps at an additional cost. is usually easier to find in the employment a small health-care facility may have a marketplace. For example. In clinical engineers come into the position the short-term it is necessary to recruit 20 Medical equipment maintenance programme overview . 4. or region in human resource planning Similarly. with multiple levels of the types of technical personnel and of supervision. technicians receive technical as they can develop formal degree training with a primary focus on medical programmes and provide continuing equipment maintenance. the clinical engineering department should after completion of a four to five year consider developing their own guidelines bachelor’s degree progamme. are two categories of clinical engineering personnel: technical and management. will have a large biomedical or clinical engineer. apprenticeship enabling them to work in the area of medical equipment. equipment is highly specialized and if nance programme is a slow and steady improperly maintained or repaired may process. Please refer to Medical device donations: considerations Alternatively. in the local received training or completed an language. a clini.

but most of the maintenance will find it necessary to complement staff will need to have electronics training the internal staff with external and an understanding of the functioning service providers (either the vendor/ of test equipment. supervision of external service provider. the technicians for the purpose of service number and type of medical equipment management. investing and CM for equipment that internal staff in higher level technicians may allow are not able to complete. Other related fields Require a training course and certificates to work (e. the Pan American Health Organization has conducted overall cost of maintaining the hospital’s numerous workshops on clinical engineering and HTM in countries throughout Latin America and the Caribbean. as outlined above. planning. technicians. Service provider Engineer or technician Provide maintenance that cannot be performed in house. In general. Technician Biomedical equipment technicians Primary focus on specialized medical equipment repair and maintenance. electrical or medical Preventive maintenance and repair of less complex technologist. and the familiar with other equipment. engineers and technicians from other by highly trained specialists who focus disciplines. ORBIS International conducts similar programmes in Bangladesh. These outside vendors medical technology. in cooperation with ACCE (www. India. polyvalent technician) equipment. electrical engineer. to undertake less technical work is Almost all maintenance programmes acceptable.ewh. specialized maintenance. It is important that they receive specialized training for high-risk medical devices. Peru and Viet Nam. needs assessment. Ethiopia. surgical and imaging equipment. Hiring well trained org). who can assume more WHO Medical device technical series 21 . China. and user training. Other related fields (e. Engineering World Health (www. Primary focus is on the maintenance of medical equipment and sometimes managerial positions.accenet.org) also conducts technical training and qualified biomedical equipment programmes in Costa Rica and Kenya. They are product-oriented and specialized in a certain field. In addition. mechanical engineer) in the medical device field. etc.3 should operate under the supervision of in-house biomedical equipment The size of a health-care organization. cost control and the in the maintenance programme. concepts of electronic manufacturer’s service representatives calibrations and the operating principles or third-party service representatives). as well as in various African and in-house technical staff helps to limit the Baltic nations. Furthermore. the clinical engineering department to repair work on the most sophisticated eventually provide in-house service on medical equipment is only accomplished even the highest level laboratory. the skills opportunity to become increasingly found in the local marketplace. and to on a single technology or small group provide them with training related to of technologies. Classification and roles of technical personnel Personnel Title Role Engineer Biomedical engineer or clinical engineer Management. financial capacity of the organization will be the basis for identifying the correct Having some lower level general staff blend of engineers and technicians. of the medical equipment in order to do Such providers may perform the IPM the job effectively.g. medical equipment..Table 2.g. the more the work that can be undertaken by 3 In addition to numerous workshops conducted by the World Health Organization (WHO) in Nepal and the Russian Federation.

arrange for maintaining a hospital’s equipment. This is especially true in the Management personnel can also have a early stages of implementing a health combination of business and technical technology management programme. they set department policies. They may be engineers or Over time. of several hundred medical devices. performance improvement technicians who have additional training efforts will increase the productivity of and experience in management and individual personnel. Care should be supervision. the number of devices degree and familiarity with the health-care per technical person must be greatly environment and health-care technology. training. responsibility. reduced. In concert with hospital admin. positions outlined above are provided in provide budget recommendations. The background of those to support technical personnel. it is in this position may include a technical typical that one technical person may degree (two years) with many years of be responsible for the maintenance experience in medical equipment service. 22 Medical equipment maintenance programme overview . to avoid overburdening personnel required in a clinical technical personnel at the outset of new engineering group depends on the size programmes. in countries without such someone with a four-year engineering support resources. Sample job descriptions for the istration. training. and structure of the group and is based primarily on maintaining an appropriate Management Personnel ‘span of control’ for each supervisor and Engineering management staff provide manager. will reduce the cost of supervise technical staff. set priorities for the department activities and administer the overall Where substantial resources are available programme. leadership for the maintenance pro- gramme. The number of management taken. Appendix G. however. but a preferable combination would be However.

Costs are monitored by accurately documenting all of the time and expenses associated with maintenance activities. Budget- ing can be problematic with regard to CM costs because such costs are un- Personnel Operational predictable. Programme section 4.5 Management Once established. it is essential to This information may be used to calculate manage the programme in an effective the cost of service ratio described in and economical manner. Actual costs are compared to the budget. This will allow for accurate cost 5. one or the other types of maintenance WHO Medical device technical series 23 . if available. assignments should be made to match the contract costs (or the itemized costs the skills of the technical personnel and for service) are recorded on the work to promote efficiency. The result is that personnel will be assigned a combination for each medical device in the inventory of IPM and CM responsibilities. Management aspects of a maintenance sents the target or benchmark for the programme programme. over time. Any difference between Financial actual and budget data triggers a review management of the reasons for the variance. Work performed by external service providers. the average level of CM expenses remains within the target bud- get. technical order. However. However.1.3. Financial management for a maintenance Additionally. Specifically for work programme objectives are achieved. 5. The established budget repre- Figure 3.1 Financial management accounting and future budgeting for IPM and more accurate repair accounting. expenses of this type Performance Performance must be anticipated as much as possible improvement monitoring so that.2 Personnel management For work performed by technical personnel. there is a history of all time and expenses there may be cases where emphasis on associated with maintaining that device. of existing equipment as this affects costs associated with both IPM and CM. followed by entry into the programme’s human resources so that CMMS. unlike managing any other organizational budget. Typically. it is important to consider programme focuses primarily on two adjusting the maintenance budget after tasks: monitoring costs and managing acquisition of new equipment or removal the budget. this is typically accomplished The purpose of personnel management by recording this information on a work is to provide support to the maintenance order document. An unexpected and expen- management management sive repair required for a critical medical device can cause a substantial budget variance. management has several aspects that are typically addressed concurrently. or into the CMMS. It is a good idea to allocate the cost of repair to a separate account from the IPM work. as Managing the maintenance budget is not seen in Figure 3.

it may be adequate training. Additionally it is advisable to check the references of any outside There are generally two categories of vendor prior to hiring them. it is service organizations. However.5. in remote areas with small inventories effectiveness of the programme.3. is necessary better justification for the external service to ensure that technical staff are capable providers to enter the local market. it is often not possible two. Service discusses training in further detail. Section 5.2.2 agreements as outlined in Table 3.2. as well as routine refresher health-care facilities in order to provide training on existing hardware. which offer the to individual in-house technicians. More of equipment. in specifically discusses the various aspects some cases extending to all the medical of scheduling maintenance activities. agreement.1 Service vendors maintenance. limited.4 to negotiate a contract that covers a and 5. agreements can include various levels of scheduled maintenance. clinical engineering department manager productivity monitoring can identify a wide variety of options. Many equipment essential to monitor the performance of manufacturers offer scheduled and the service provider. When applied to the external service providers is much more maintenance programme as a whole. In some cases. Independent service organizations range Personnel management also includes in size. Training on new reasonable to consider liaising with other equipment. activities is appropriate. It is important to variety of equipment types. but necessary to make use of external service care must be taken to fully understand providers for a significant portion of the those terms before entering into a formal maintenance activities. of properly maintaining and repairing the medical equipment included within the There are several types of service scope of the programme. equipment in a health-care organization. some specialize in a particular monitoring service vendors when type of medical equipment and others maintenance must be outsourced offer maintenance services for a wide (see 5.3 equipment from other manufacturers. especially if that inventory has a reasonable level of The most important aspect of personnel standardization in terms of manufacturer management is the ability to ensure and model. This is necessary to unscheduled maintenance services make sure that the terms of the agreement for the equipment they manufacture. When applied external service providers. external service providers: equipment manufacturers and independent After a service agreement is in place. agreements is valuable to the clinical house. in those technicians needing additional other parts of the world the number of support or training. it may be engineering department manager. They are more likely to details on performance monitoring and expand their service areas if it possible improvement are found in sections 5.1 below).2. In some cases these companies productivity monitoring can identify find it uneconomical to offer services opportunities to improve the cost. unscheduled 5. are being met and that the health-care Some also offer maintenance services for organization is receiving the services it 24 Medical equipment maintenance programme overview . monitor the productivity of internal and outsourced technical personnel In some parts of the world there are many on a regular basis. large inventory of equipment. Flexibility in the terms of service to provide all maintenance services in. Section 5. or a combination of the As mentioned. In such circumstances.

3. in a CMMS. The most sophisticated equipment in • One-to-one training provided by hospital settings consists of computer- a more experienced person from based multi-component systems. Training of technical personnel can local availability of information sources be provided inside the health-care and the ability to coordinate with other organization through: hospitals who might have technicians to train as well. Service agreement types inside the organization. process. WHO Medical device technical series 25 . • The clinical engineering department 5. for example. expensive options. This section describes the training of The methods of training suggested technical personnel and section 5. and success in future problem solving. for nurses or other clinical users External staff follows up as and when required. Enabling staff to see that • Manufacturer’s training programmes learning is important and a constant specifically designed for equipment feature of their job will improve reliability technicians. The technical staff tenance and operation. service parts • The biomedical equipment techni- Shared Internal staff provides cian taking part in a education class responsibility initial response and repair. to the most expensive to implement. the hospital can choose • Self-study: a methodology that best matches their › reading the equipment service and resources.2 Training bringing in one of the manufactur- For the safety of the patient and the user. trained and versed on their specific • Third-party training programmes responsibilities. er’s trainers to present to biomedical proper training is critical for both the user equipment technicians about main- and the technical staff. progress from the least expensive briefly discusses user training. › using materials provided by a third party. if available) nance of a particular piece or type and reviewed on a regular basis. of equipment.e. for sophisticated equipment are the more als provided by the manufacturer.Table 3. or a all times technician who is familiar with Time and Varying response time Hourly charge the device guiding others about material available as needed plus cost of maintenance and operation. and the clinical engineering department manager have dual responsibility for Or training can take place outside the ensuring that the technical personnel as organization at: well as the clinical users are informed. that the most effective training methods › using additional self-study materi. This may be a clinician teaching biomedical Type Description Rates (cost) equipment technicians how the Full service Quick response available at Fixed device works. It should be noted however training manuals. So depending on hospital resources. to learn about the operation of the equipment.9 above. Training and education designed to explain several models is not a one-time activity but a continual of a specific technology. • The clinical engineering department needs. All maintenance activities they bringing in a specialized outside perform and associated costs should also trainer to teach staff about mainte- be recorded (i.2.

in some cases. and the relevant model of equipment. Then. performed by software-based inspection • Provide recommended forms to be systems built into the equipment itself. However. The process of selecting or writing make sure the conditions leading to the must begin with a good understanding of change persist. the department provided by the manufacturer or vendor will then have to consider if this is for a fee. microscope) can owner should expect IPM procedures be used. oto/ophthalmoscope. In cases • Show how to replace parts. in the maintenance manual. the device.g.3.g. equipment may only come with training If this is not possible. IPM procedure should be thoroughly procedures are either selected or written documented for future reference.3 Operational management equipment (or industry recommendations). used for the IPM procedure. IPM procedures can be changed. Obtaining access to the computer codes • Be provided in the predominant and understanding how to maintain this major language of the region/country.2 Setting IPM frequency limits for measurements the The frequency of IPM is specified by biomedical equipment technician the manufacturer of the equipment will take. manual as a baseline. While using available generic from the manufacturer to: procedures may be very convenient. The so they provide sufficient testing and decision to make this change should also maintenance for specific devices and their be reviewed periodically (e. it is best to model. If this 5.1 Developing or changing IPM is done. • Explain what the upper and lower 5. Most of the performance inspection • Explain the required frequency of and verification of this equipment is specific steps. the justification for deviating procedures from the manufacturer’s suggested For IPM to be conducted properly. it must be done with understanding and • Be well designed and easy to discernment as some are written with understand. the unique characteristics and features of devices require unique When developing new procedures for inspection steps for each different either old or new equipment. a take the most conservative approach and generic procedure for all manufacturers use the manufacturer’s IPM procedure and models (e. required. where there is sufficient familiarity with 26 Medical equipment maintenance programme overview . If the hospital has developed a the best purchase for them or if they competent staff of biomedical equipment can afford to translate the manuals technicians. In most cases. The equipment fibre optic light source. Appendix B procedure. the technology in general. service training by the vendor themselves.3. is a good investment as it enables the hospital to eliminate vendor-related costs Procedures should not be changed until and may also lead to the hospital being the owner has some experience with able to assume repair responsibilities. contains a procedure template and a few • Explain what test equipment is sample generic procedures. the intention of providing only the most • Clearly explain every step in the basic steps in an inspection. based on inputs from biomedical equipment technicians and/ or other organizations who also own the 5. annually) to features.

the workload is best sched- safety committee (if available) or uled over the calendar year so that the hospital management. Because of a medical device. using rules established overall expenses.the equipment or because of resource scheduled by hours of usage (e. See section 5. CM activities will consider the regulatory environment. Measuring the workload and adjust the procedures and frequency created by scheduled IPM helps identify only after familiarity increases. rather than plan a programme with dar dates depending on the manufac.3 Scheduling maintenance Work can be assigned manually by Efficient use of technician time will reduce management personnel or automatically down-time of equipment and minimize by the CMMS. (thus leaving some WHO Medical device technical series 27 .8 for more Before changing the inspection frequency on effective communication.g. For preventive maintenance. staff available. for constraints. the clinical engineering volume ventilators). In this way. In this case. how nicate the device’s elapsed usage time often maintenance should be performed to the clinical engineering department and what parts should be replaced. once every equipment and then not completing the 3 months etc. creat- department manager may prefer to ing a method for the users to commu- modify what equipment to inspect. Alternatively. the level of user Therefore it is important to have a pri- training. during vacation or responsibility is spread to a broader group holiday periods where staffing levels in of interested parties. When the clinical the department may be reduced. 5. Ap- a level less than the manufacturer’s pendix C explains how the IPM workload specification is determined. the equipment in the hospital and the taneously. oritization scheme in place so that CM the frequency of use. one approach at hand without interruption. However. This works very well for be unrelated to IPM work. equipment that does not move from the department. Another approach would be 5.g.3. This will is to plan for the equipment in a given require sufficient staff to be able to clinical department to be inspected at handle repairs or service calls that may the same time. staff available to do the work are rare. the reliability of the equipment. critical needs (see section 5. this should can be calculated and related to staff be noted in the equipment’s maintenance time so they can be matched as closely record. the increase or decrease with demand. The most appropriate by management. equipment may be scheduled by calen. the decision-making be aligned. Greater efficiency can method for scheduling maintenance in a be gained by creating a system where particular health-care facility should be IPM technicians can focus on the work chosen. physical environment.3. This information could then be presented to a multidisciplinary For IPM. the goal to inspect and maintain all the turer’s recommendation (e.3. consid- engineering department is unfamiliar with eration can be given to reduce the IPM the equipment. how much wear the resources are directed toward the most equipment receives during normal use.g. it is best to simply follow workload by moving IPM inspections to the manufacturer’s recommendations another time. to make the final work schedule and staff capacity can decision. defibrillators) simul.4 for more and the number and types of technical information on prioritization). For inspections. it can be scheduled work.4 Prioritization of work to schedule inspection of equipment of Exact matches between workload for a given type (e. So. Where where adjustments may be needed. the manager should they are unscheduled. is important. as possible.).3.

These data are typically used in this type of care would become contained in work order records that pro- the priority. It is of our patient care? For example. This methodology is based on the and location (see Introduction to medical question: Which devices are most equipment inventory management in this important to us in providing the majority technical series for more details). those devices with the highest risk (as the inventory database will contain the described by the method listed in the entire technical and financial history for previous section). model. Risk-based prioritization most important to the work of the hospital One method used to prioritize medical or that are maintenance critical would equipment IPM is based on assigning be maintained first. in order to be prioritized. where the most adequate level of IPM. define maintenance priorities. the equipment for the device. of the critical. injury if it fails. serial number.5 Keeping records Appendix A. for example). The second priority after vide documentation of every maintenance this work is completed would then be task performed on the device. gives the manager more control over both in combination with knowledge about the work and the outcome. The record for each device should include identifying data such as a brief descrip- Mission-based prioritization (4) tion. that they benefit from scheduled IPM. the devices with the highest risk. This methodology uses any of the Managing the process in this manner three prioritization models (see above). Categorizing devices by maintenance priority. An example of how this risk-based technique is implemented is shown in 5. The same is true years the Joint Commission for the when the non-availability of equipment Accreditation of Healthcare Organizations incurs higher costs for the organization has required a risk-based approach to (due to the costs of temporary rental of prioritizing IPM of medical equipment replacement equipment.1.3. and identifying In addition to these methods. In this way. requires that generates revenue for the health- a systematic approach. and and have a significant potential to function schedule this work as a priority. priority may those that are of such a low risk that be given to IPM and CM of equipment maintenance is not necessary. Appendix 28 Medical equipment maintenance programme overview . Devices excluded important equipment is dealt with first. For over 20 care organization. When additional staff is added and their training completed. As a result. (3). it is better This methodology analyses which devices to carefully identify the equipment in have a significant potential to harm a the health-care facility that is the most patient if they do not function properly important to inspect and maintain. The following the staffing and resource levels of the are examples of how maintenance may particular facility or region. each device in the inventory. if the helpful to also include data regarding the hospital’s priorities were caring for people time and expense of providing scheduled living with HIV and caring for pregnant and unscheduled maintenance services women and their children. manufacturer. and other devices the highest priority to equipment with with a lower prioritization rank would be the highest likelihood of causing patient maintained if resources permitted. Creating improperly if they are not provided with an such a ‘tiered process’ . high risk or life support Maintenance-based prioritization (5) equipment not serviced). the next lower tier of Resource-based prioritization equipment can be added to the schedule. are those for which there is no evidence is a better use of limited resources.

equipment requiring maintenance as well • Store IPM procedures and related as an accurate accounting of the specific information. work that run on a stand-alone computer.3. but simply having the information information. the past few analysis purposes). maintenance management system (CMMS). Using an organized • Schedule IPM procedures. work done and the list of parts used. the pletion times. › IPM that failed and required repair 5. Keeping database the repair process.3 provides an example of an actual computer system. available in a paper format is still useful. keeping accurate records of locations of • Record and store the results of equipment to facilitate quick location of the IPM inspection procedures equipment for procedures. Thus. are good methods to service events (for reference). it is helpful to see what previous work was In an effort to effectively manage a good done and what the measurement values programme. Additionally. time spent in different department. put in storage or was moved to a problem with the device. disposed • Record the CM activity including the of. Another important aspect the expected IPM completion date/ of equipment control and tracking is time.) and retrieve or print for accurate records of both the total list of them if needed. problem with a piece of equipment occurs. management systems › IPM actual versus expected com- In most modern health-care facilities. a CMMS system may provide were. • Keep track of past service events (e. including the ability to this in a CMMS for electronic retrieval is easily add or change the equipment ideal. and keep records. CM. the measurements taken and information. when a equipment maintenance programme. a computerized work order form. it is invaluable to have the following capabilities: thorough documentation of all service events which have taken place over the • Keep an inventory of each device in life of the equipment. change CMMS system to print appropriate the schedule of IPM procedures and procedures for each scheduled activity. which is well worth the effort when striving • Produce summary reports of: for good programme management. › IPM completion rates. recently removed from service. many hours can be saved the acceptable range of measured in trying to locate equipment that was values. Therefore. a software tool that is able to From a regulatory point of view.g.6 Computerized maintenance work. number of pieces of medical equipment › Inventory lists of equipment by WHO Medical device technical series 29 . a description of the information updated is an ongoing task. Being able to keep the facility. recalls. coding to record the results of the IPM • Print individual IPM forms with the (for quality control and productivity appropriate procedure. print a summary list of what has been and a good system of annotations and scheduled. software The maintenance programme must strive updates etc. If attention is – including tasks that passed or given to keeping accurate records and failed. work completed. IPM.4 provides a sample policy outlining and the number of service events are how to manage a work order system for so large that keeping and organizing corrective maintenance and Appendix this information can only be done by a D. can be was not documented is work that was very useful in managing the medical never performed.A.

This number will effective dispatch communication system be used by the users to communicate in place will ensure that repair requests with the medical equipment maintenance from users are promptly relayed to department so there is no confusion technical personnel for timely response. yellow – this year. a label personnel. This helps readily identify which resource when ready to implement such equipment is next due for inspection. preferably in person. health centre. system in this technical series is a good etc).g. to inquire indicating the date the work was done about any equipment-related problems and the procedure that was performed they are experiencing. a system. the paper Some hospitals use coloured inspection records can be phased out. The active development sticker which is placed on the equipment of an inventory may also function as an for future reference. In some countries where there is a • To identify to IPM technicians which shortage of staff. the process of which are still due for IPM.2 and Appendix E for examples of inventory is established. about which specific piece of equipment Many maintenance programmes have is being reported. stickers to indicate when the device was last inspected in (e.8 Communication where a CMMS may not be possible Keeping in mind that the ultimate or is not necessary (e.3. and staff measurements are recorded on the can be confident that there is a form of inspection form but many hospitals also record keeping available with which they choose to record these readings on a feel comfortable. In this way the 30 Medical equipment maintenance programme overview . owner or device type. Furthermore. objective of a maintenance programme small hospital). location. and particularly of devices have been completed and adequately trained staff. Respect is shown to the user for their role in helping to complete the 5. as it provides details on the key elements of an effective CMMS. on getting started with tracking current The user will know what to expect from inventory and equipment maintenance the clinical engineering department and in a paper-based way. pink – two years ago. Introduction to medical is to improve patient care. In cases 5. others that the device was recently inspected or maintained. › List of parts used to repair equip. also found it helpful for technical personnel to regularly contact clinical When doing IPM procedures. Computerized maintenance management blue – last year. The initial inventory is When taking power measurements on taken on computer but also on paper. • To communicate with clinicians and ment over a certain time period. more comfortable with computers and with the inventory system. it is essential to equipment inventory management in develop strong working relationships with this technical series is a good resource clinicians and to understand their needs. vice versa.3. Once the initial D. the that there is a back-up option. and staff are inspection forms and labels.g. implementing a CMMS may begin as a dual system. so equipment that have an output. should be applied to the equipment for › Repairs completed in a certain time two reasons: period. resulting in appreciation for It is good practice to label each piece the work and responsibilities of the clinical of medical equipment with a unique engineering unit.7 Tags and labels maintenance. having an identification number. See Appendix extended training period.

For related to the use of a medical device. elapsed usage time for the determi- nation of PM frequency. appropriate) on the operation of a device • The clinical engineering department and working with the users to identify being kept well informed of a device’s factors leading to use error. 5. or safety inspections are done. The overall result Providing clinical users with a list of the will be a user who feels ownership for scheduled IPM work a few weeks in the equipment. the it may be also reasonable to develop and patient. Therefore. the environment and support user maintenance where it may be WHO Medical device technical series 31 . This example. is responsible for training them on the correct procedures.9 Managing use and user error 5. Investigation of use error planning maintenance activities. However. it may take a is distinct from the term ‘user error’. including the use Travel is an important component of of health technology. a series of activities intended to achieve If extensive travel between facilities is a particular clinical objective: diagnosis. settings and adjustments before using it • Devices in storage being brought out with patients once again. for inspection. etc.3. a problem vehicle and other travel expenses. includes consideration of the user. implies that the user of the device caused travel time should be considered when the problem. the settings such problems are detected. However. and inform been changed and they should check the technical personnel of location. this objective due to ‘use error’. productivity standards.3. A well-trained user is aware that when • The clinical users being alert to preventive maintenance. The root cause of user error is typically easier Ultimately.technical personnel become accepted as other systemic factors that may block the part of the clinical team. solved or remain well. the device. can be viewed as an effective maintenance programme. monitoring or life support. takes good care of the advance. that the user may be used to having left • The clinical staff being able to locate untouched on their equipment will have all essential equipment. performance changes or issues with the equip. are just a few examples the clinical engineering department and of good communication practice. difficult.10 Travel The work of clinicians. provide basic. Thus. there will be significant effects on However. achievement of a clinical objective. the clinical engineering department with the clinical department. in remote areas. a copy of IPM results. routine maintenance on a • An improved working relationship device. • Minimal time being spent in the Additionally. the ment and immediately contacting the equipment is adjusted to test its various clinical engineering department when modes of operation. or a list equipment. leading to a reduced workload for to be addressed. which day or more to travel to a local clinic. effective communication with to identify. operates (and maintains) it of problems identified. required or the accessibility of facilities is treatment. if users are expected to department. behind inspecting and maintaining They are responsible for providing them equipment and the benefits of such with adequate training (or retraining if a programme. improved lifespan for the equipment. in both cases clinical the clinical users leads to: engineers and biomedical equipment technician can be instrumental in working • Clinical staff understanding the reason with clinicians to resolve these issues. a user may be unable to meet work assignments.

equipment location rate. priority devices should have the highest and technician to the site.1 Completion rate of assigned were found that affected equipment IPM operation or safety (note: cosmetic The completion rate is percentage problems which do not affect function or of procedures completed. The highest of the effectiveness of the maintenance programme. any significant trends. This indicator measured at the end of an assignment measures the general reliability of the period (e.1 effectiveness of the policies to keep the inventory accurate. so the technician is not performance over time. IPM 32 Medical equipment maintenance programme overview . However it when equipment is moved. and identify opportunities for improvement. service that will support detailed It also provides an indication of the performance monitoring. which provides detected by the user. loaned or put is important to conduct some sort of into storage. IPM completion rates for each measures do not have a standard or technician must take into consideration benchmark to compare with. In such the expected time it takes to complete an cases the manager should monitor IPM procedure.3 IPM yield for improvement. be higher than anticipated. maintenance programme. By comparing performance period but not located before the end data.ecri.4 Performance monitoring This indicator is used to measure the productivity and effectiveness of the IPM For effective management of the staff.2 Equipment location rate important to communicate regularly with The proportion of equipment scheduled colleagues who are managing similar to be inspected in the assignment programmes. including detailed benchmarking capabilities for medical equipment maintenance activities. with lower priority groups having lower goals. equipment..g. investigate overloaded. but note that without clinicians and the medical equipment a CMMS it is very difficult to calculate maintenance department. the percentage will several valuable tools for medical technology management. When quarterly). This measure could also analysed it can be useful to compare be calculated to evaluate the completion the reliability of one model against rate of each priority group. if problems are discovered engineering (www. It supports performance monitoring. the ability of the technical personnel. Furthermore. difficult to transport the tools. which is a online self-assessment tool for clinical Alternatively. particularly some of these measures. Benchmarking Solution. It can be safety are not included). starting with another.4. completion rate goal. Most performance levels. monthly. 5. As such.org/abs). IPM yield is the percent of scheduled IPM procedures performed where problems 5. if equipment is being well- 1 The Association for the Advancement of Medical Instrumentation offers AAMI’s maintained the percentage will be low.aami. upon inspection that should have been ECRI Institute (www. e.4. it is important to and the adequacy of the staffing measure performance.4. or underloaded. it is a measure the highest priority group.g. This indicator Those with the financial resources may primarily measures the accuracy of the consider subscribing to a benchmarking inventory database in the CMMS system.org) offers Biomedical Benchmark. assessment of best practices. over 95%. managers can identify and take of the inspection period is known as the advantage of improvement opportunities. bi-monthly or medical equipment at the facility. A good completion rate goal is individual models of equipment are to be above 90%. It is also 5. as well as measuring Several important performance measures the quality of communications between are described below. with work. and performance improvement. performance monitoring on a regular basis in order to to identify opportunities 5.

IPM productivity. By modifying department poli. provements in individual or group pro- ductivity can be achieved. tion time is initially obtained from out. The number for all to improved performance. test equipment. The several years of experience and collecting aspect of performance selected accurate data. Improve performance. with professional colleagues. • Delinquent work orders. monitoring as described above. with the IPM productivity is an expression of the ultimate objective of improving patient actual time it takes an individual to com. within the profession as leading ly productivity levels. Performance side sources such as the manufacturer’s improvement projects should maintenance manual. The performance improvement plete a single scheduled IPM procedure process has the following steps: divided by the time the IPM procedure is expected to take.5 Performance improvement are measured. failures within a specified period of If the new procedures demonstrate time. The time between report problems they find with equipment.yield may also indicate how well clinicians • Response time. The most important IPM productivity measurement in use today is For a maintenance programme. The actual time taken 1. a request for service and the start of repair. great im. However. this can be managed only if targeted activities 5.4. there are certain measures systematically to determine if the changes that may be recorded to specifically improve performance and quality. positive improvements then the change WHO Medical device technical series 33 . They technicians can be added to calculate are found in clinical engineering the results for an entire maintenance literature and through collaboration programme. weekly or month. care. that a device is out of service. The for several measurement periods (months average time elapsed between or quarters). Identify opportunities for improve- does not include preparation or set-up ment. performance improvement applies to every aspect of the programme. For example: can be done by: a) carefully measuring the performance and quality indicators • Mean time between failures. b) making a change in the failures. way things are done. This monitor CM performance. The time between the The productivity and effectiveness of the start and finish of repair. IPM staff is an important management • Downtime. 5. Identify best practices. for improvement should be closely ence to guide expected completion times. monitored until the desired level of performance is achieved. not completed within 30 days. 3. and c) continuing • Repeated failures. cedure on each device. These are individual inspections can then be added actions that have been recognized up to measure the daily. after be based on best practices. 5. merely the actual time it takes the careful and thorough performance technician to perform the individual pro. Eventually. This is one of the outcomes of time.4 IPM productivity • Repair time. you can use past experi. The expected IPM comple. cies. The number of to measure the performance and quality.5 CM performance measures In addition to the measures already Specific changes should be measured mentioned.4. The percentage of time measure. The results from 2. Work orders and/or forms or procedures. levels of training.

the cost of these changes improvement can have a very positive can be justified. upgrade to a CMMS of managing programme performance system etc. was an effective one. revisit the original performance the technicians operate (e. install a analysis. ment in performance and quality after 34 Medical equipment maintenance programme overview . If indicators do not making changes to the system in which improve.g. This systematic approach test equipment. the changes will be impact over a period of several years. adjust accordingly and repeat remote workshop. purchase automated the process. well accepted by the staff. and further systemic changes can continue to be Additionally by measuring the improve. made.).

The type In order to return equipment to of inspection the user might perform service as quickly as possible. replaceable the IPM work can continue on schedule.5 presents a sample section 5. daily testing of defibrillators device itself has failed and must be or checking the standard calibration repaired. Component-level When IPM identifies a problem. and for discreet WHO Medical device technical series 35 .3. or the repair can be completed as part of mechanical devices. Appendix A. so the failure to a single. This corrective inspection and preventive maintenance maintenance may be accomplished at procedure.1 Troubleshooting and repair Most IPM procedures are completed Identification of a device failure occurs by technical personnel from the clinical when a device user has reported a engineering department. efficient would be pre-use or daily checks. Examples of this might be daily failure and determine its origin.2 Corrective maintenance model). The technician then determines of laboratory equipment. through a careful review of each type of equipment (or 6. where troubleshooting is required to verify the required. If the IPM activities or maintenance related repairs are not accomplished in a certain pre-defined period. It is the what steps are necessary to correct the responsibility of the clinical engineering problem and return the device to full department to train the user to perform functionality.3 provides a sample policy on providers when necessary. As mentioned however.2 Problem identification • Component level.3.6 Implementation 6. the work order 6.1 Inspection and preventive the IPM process. The technician initiates these tasks. routine and easy to perform earlier.1. In some cases. performing information on user interaction. critical tasks and also provides the user with a sense of ownership.1 IPM procedures should be left open and the staff should Using the correct and appropriate inspect or repair the device as soon procedures for equipment maintenance as reasonably possible. See section 5. Higher priority can make the difference between devices not inspected in previous IPM having reliable and properly functioning periods should be located and inspected equipment and not. some steps themselves and making use of in-house expertise or external service Appendix A.1. component. it may also occur when a tasks are completed by the user. This technician in the clinical engineering saves time for technical personnel to department finds that a device is not perform more technically complex and performing as expected during IPM. various levels: 6. the procedures used in policy regarding corrective actions performing IPM activities should be identified during preventive maintenance. defined prior to execution of the inspection or maintenance work. the device troubleshooting and repair isolates can either be set aside for later repair. In electrical devices. As discussed in first. In some calibration of portable blood glucose cases the technician will find that the monitors. problem with the device. 6.1.9 for further the corrective maintenance.2.

installing uninterruptable for example. For high-priority cases.2. In such cases it can be be reliable.2 on factors affecting equipment circuit boards (digital circuit failure for further information. When considering acquiring reclaimed from non-functional or obsolete new equipment. Modern electronic 6. be taken into due consideration. Technical personnel should It is important to choose an appropriate collaborate with those responsible for the level of maintenance for each situation.3. such as and repair is too difficult or time. For it is common to isolate failures to a example. In those cases board-level or failures even system-level repair need to be When investigating an unexplained considered. that the device performs within its 36 Medical equipment maintenance programme overview . For electronic devices. of supporting it. these ideal characteristics entire device or subsystem. more cost-effective to replace the Unfortunately. regulators. the technician will find and more robust equipment. component-level did not function as expected.2 Factors affecting equipment level. as well as on the urgency of a particular This may include purchasing voltage repair request.2. physical and human resources function as effectively as possible. In relation to electronic environment to determine why the device devices.8 on managing use error and section and difficult. technical personnel should is proposed.or component-level repair may extension leads/plug boards in series. failure. in place and that the switch to auxiliary The replacement can be made with power is made in under 10 seconds. given electronic component. voltage spikes. When more time is available. the technical personnel to ensure that assessment and permission of the clinical the electrical power system is capable engineering manager). specialized parts from the manufacturer. as defined by (such as resistors or capacitors in the manufacturer. and consuming. an electronic circuit. protectors. surges or dropouts. boards. do not always exist in many developing countries. part replacement may be work with the facility personnel to ensure necessary. with only rare loss of power. fuses). and avoiding connecting board. electrical power should have a steady • Device or system level. For this approach. be even board-level troubleshooting free of transient distortions. In such instances. be feasible. environmental factors should • Board level. device-level repairs may be power supplies (UPS). medical devices that require particular circuit board and to replace electrical power may be adversely the entire circuit board rather than a affected by power issues. Another alternative may be to select with generic parts of the same or higher and purchase equipment that is battery specifications (e. however. If component-level repair Furthermore. or fuses) this it is necessary to communicate with is often the most effective repair the device user and examine the work approach. See section repair may be time-consuming 5. using surge preferred. it is also important for equipment (only after thorough risk. it often makes sense to opt for less sophisticated In some cases. especially) are frequently not repairable at the component 6. electrical power system in the health-care This is dependent on the availability of organization to help make the system financial. Ideally. there are that a functional back-up generator is a few options from which to choose. or with spares operated. In some cases voltage (of the appropriate value). When it cannot.g. components of electronic devices design specifications.

2. personnel is fundamental.html). and necessary to return the equipment to full general infection control. For example. for ate climates or controlled environments. they should collaborate with thus helps avoid skipping or overlooking others in the organization to optimize the specific steps. medical For IPM activities. standards. 6.Similarly. Additionally.3 Reporting aware of how medical devices interact with other utility systems (e. etc. functioning appropriately. including the time infrastructure rather than to assume it is and the cost of those actions. overloaded and/or outdated. the technician records what it is often necessary to test the utility actions were taken. inspection form helps identify potential problems. utilities were last replaced helps identify if or systems will degrade and may become when the parts should be replaced again.1 as ‘pass/fail’ or numeric values) aids in the execution of future maintenance work.eia. can adversely affect medical during maintenance is extremely helpful equipment designed for use in temper. Unique aspects of the physical environ. Recording measurements ability of the utility systems to support and documenting the final results (either medical equipment.4 Safety service After completion of repair. information technology and a checklist also serves as a reminder communication infrastructure. including repairs.). technical personnel should be 6. Therefore. And. such as high temperature and of IPM checklists on-hand for reference humidity. water order to record the results. facility may also play a role in medical knowing when routine maintenance parts equipment failure. the device may be returned to use in patient The safety of equipment maintenance care.co/numeros/4/index. as equipment energy levels The age and condition of the health-care may slowly drift over time. safety the device and allow for any adjustments of the user following maintenance.g. For CM. This policy ensures that provides an overview of these topics can be found in Issue 4 of Revista Ingeniería Biomédica (Colombia) (http://revistabme. calibration may be required. temperature has a detailed checklist to follow in control and ventilation systems. Over time. Therefore. Older and helps explain the condition of the facilities will have been built to older parts during the current inspection. and effective maintenance programme. for decision-making. These such as the safety of technical personnel activities will measure the performance of while performing maintenance. Even new facilities may not meet all applicable standards. it is essential There are various safety aspects to to conduct a performance and safety consider when implementing a successful inspection. the technician typically gas and vacuum systems.3 Inspection and return to 6.edu. Once this is complete. including the energy readings country or region may need to be ad. equipment with therapeutic energy Maintenance procedures in a particular output. when working on electrical equipment WHO Medical device technical series 37 . of each step in the IPM process and once again. functionality. Having the last few sets ment. it is important to have a lock out/tag out policy to protect personnel from unexpected 1 It is important for clinical engineers and biomedical equipment technicians to have activation of equipment and release of a working knowledge of utility systems and facility infrastructure. and in some cases a re. Having such supply. An article that stored energy. from the last few inspections on the next justed based on these local factors.

When it to using the device with patients. especially after patients. from radiation-generating equipment for example) and. etc. when given to electrical safety for medical in doubt. radiation hazards airborne infections such a tuberculosis. as premature infants) can be severely technical personnel should verify that affected by moulds and spores disturbed the device is safe to use. See Appendix A. if there is any doubt. of Lastly. hazardous maintenance. prior to performing maintenance work. equipment maintainers should devices such that ground resistance and communicate with clinicians about leakage currents are measured to ensure potential risks and ways to manage those that they are within applicable limits. who will and techniques that will allow technical have knowledge regarding the potential personnel to work safely in hazardous contaminants and their associated conditions are critical. risks. Furthermore. equipment. mechanically and dispersed by maintenance activities and electrically. One or more simple electrical tests to verify device physical locks may be applied to keep the integrity). it is essential to disconnect it from the rely on careful repair techniques and electrical power source. hazards from device that appears to be contaminated. and radiopharmaceuticals. technical personnel must 38 Medical equipment maintenance programme overview . patients with AIDS. technical personnel to have PPE readily available within should be aware of infection hazards the clinical engineering department for that their work might create for patients. Again. Training they should request assistance in cleaning in personal protective equipment (PPE) the device from the clinical user. personnel should be aware. In field hazards from magnetic resonance particular. When is not possible to physically lock out the direct communication is not possible. For example. magnetic they should ask clinicians in the area. compressed gas cylinders. Additionally. device so that it is not used without being checked by the clinician. a power source. technical personnel should present special hazards such as chemical be aware of infection control risks that hazards from chemotherapeutic agents they might encounter (patients with and from other sources. It is preferable hazards. if asked to work on a medical imaging (MRI) equipment. patients with compromised immune systems (certain organ transplant Following maintenance. prominent signage should prominent note should be placed on the be posted (‘tag out’). and others) procedures that may have affected the or otherwise susceptible to infection (such safety features of a medical device. when working in the clinical particular medical technologies that may environment.6 for a sample (In the absence of electrical safety test infection control policy. Particular attention is in the clinical environment. Clinicians should be advised power source disconnected (‘lock out’) so to check the settings of the device and to that it is not inadvertently reconnected perform basic operational checks prior before the repair is completed.

WHO Medical device technical series 39 . physical and fulfil the tasks outlined by the programme. human resource aspects are carefully Only in this way will patients have access examined. effective suits the needs of a particular context treatment or appropriate rehabilitation. even with certain resource to the medical equipment that can provide constraints. activities maximize the value of health the programme must be considered an technology resources. However. a successful programme that them with an accurate diagnosis. minimum set of resources designated to When the various financial. which is especially integral part of health-care delivery with a important when resources are limited.7 Concluding remarks Timely and economical maintenance can be designed and executed.

2001. 35(3):167-176. Malkin R. Biomedical Instrumentation & Technology. 2002. Fennigkoh. Biomedical Instrumentation and Technology. Engineering World Health. Classifying medical devices according to their maintenance sensitivity: a practical. 4. Memphis. Oakbrook Terrace. 5. Clinical equipment management. volume I . Accreditation manual for hospitals. Equipment inclusion criteria – a new interpretation of JCAHO’s medical equipment management standard. Joint Commission on Accreditation of Healthcare Organizations. 2010. Medical instrumentation in the developing world. Wang B. 2006. 2. Joint Commission on Accreditation of Healthcare Organizations Plant Technology and Safety Management Series. Levenson A. Smith B. 40 Medical equipment maintenance programme overview . 2:3−12. L. 6. 25:26–35. Journal of Clinical Engineering. 3. 4(4):346-349. AAMI’s Benchmarking solution: analysis of cost of service ratio and other metrics. 2000. 1989. Ridgeway M. risk-based approach to PM program management. Cohen T. References 1.Standards.

Burlington.aami.aspx) Joint Commission/Joint Commission International: • Accreditation standards.aha.aami. How to organize the maintenance of your healthcare technology. Practicum for biomedical engineering and technology management issues.24x7mag.ecri.html) ECRI Institute (www.aami.org) • American Hospital Association (www.org/publications/books/esm.org) National Fire Protection Association (www. St Alban’s.html) • Computerized maintenance management systems (www.elhospital.org/publications/ books/cmms.org): • Health devices system (www. Elsevier Academic Press.org/abs) • Electrical safety manual (www. Ziken International (Health Partners International).org): • AAMI benchmarking solution (www.aspx) • Biomedical benchmark (www. Kendall-Hunt Publishing.org/publications/books/mem.org/Products/Pages/BiomedicalBenchmark.com) • Engineering World Health (www. 2008. 2004.com) • American College of Clinical Engineering (www. html) • Medical electrical equipment standard 60601-1 (www.org): • Standard for health care facilities (NFPA 99) • National electrical code (NFPA 70) Other online resources: • 24×7 (www.ecri. Clinical engineering handbook.com/jcejournal) Online discussion groups: • Infratech (infratechonline.net) • Biomedtalk (www.lww.jointcommission.iec.html) • Medical equipment management manual (www.org/Products/Pages/Health_Devices_System.ch) • Journal of Clinical Engineering (journals.org) • Biomedical Instrumentation and Technology (www.accenet.ecri. • Temple-Bird C et al.ecri. Dubuque.jointcommissioninternational.ewh.aami.aami.aami.org/publications/ standards/60601. United States (www. ‘How to Manage’ series of health care technology guides no.nfpa.org) • International Electrotechnical Commission (www.org/publications/BIT/) • El Hospital (www.org) • Accreditation standards. • Atles LR. WHO Medical device technical series 41 . 2005.Useful resources All URLs accessed 29th April 2011 Association for the Advancement of Medical Instrumentation (www.org/biomedtalk) Books and articles: • Dyro J. international (www. 5.aami.

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42 Medical equipment maintenance programme overview

Appendix A
Sample policies and procedures
The following samples are provided to support the development of medical equipment
maintenance policies and procedures in a hospital, health centre or other health facilities.
The samples should be adapted and modified according to the specific needs and
circumstances of any given institution, the relevant resource context and local environment.

A.1 Risk-based biomedical equipment management programme

A.2 Initial testing and evaluation

A.3 Inspection and preventive maintenance procedure

A.4 Work order system for corrective maintenance

A.5 Corrective actions identified during preventive maintenance

A.6 Infection control

WHO Medical device technical series 43

SAMPLE Appendix A.1
Risk-based biomedical equipment management programme
Equipment inclusion criteria have been developed to evaluate each piece of equipment
in use at a hospital or health facility. The following details a modified version of the
Fennigkoh and Smith model (see reference 6) where a numerical value has been
assigned to each device type by classifying its equipment function, clinical application
and required maintenance. Adding the number from each subgroup and adding
or subtracting a factor based on equipment failure history yields an equipment
management (EM) number.

EM number equation:
EM # = Function # + Application # + Maintenance # + History #

Equipment function

Includes various areas in which therapeutic, diagnostic, analytical and miscellaneous
equipment is used.

Category Function description Point score
Therapeutic Life support 10
Surgical and intensive care 9
Physical therapy and treatment 8
Diagnostic Surgical and intensive care monitoring 7
Additional physiological monitoring and diagnostic 6
Analytical Analytical laboratory 5
Laboratory accessories 4
Computers and related 3
Miscellaneous Patient related and other 2

Physical risk associated with clinical application

Lists the potential patient or equipment risk during use.

Description of use risk Point score
Potential patient death 5
Potential patient or operator injury 4
Inappropriate therapy or misdiagnosis 3
Equipment damage 2
No significant identified risk 1

44 Medical equipment maintenance programme overview

any new device will be included in the programme if the device has been previously evaluated and classified for inclusion. It will be evaluated according to the outlined procedure to produce an EM number and will be included in the programme if appropriate. During the acceptance testing. WHO Medical device technical series 45 . Average equipment failures Factor Significant: more than one every 6 months +2 Moderate: one every 6–9 months +1 Average: one every 9–18 months 0 Minimal: one every 18–30 months -1 Insignificant: less than one in the past 30 months -2 Included devices All devices with a total EM number of 12 or more will be included in the programme and scheduled for inspections and preventive maintenance. a performance assurance inspection and preventive maintenance procedure will be written for the new device. If included. a new device classification will be created. Maintenance requirement Point score Extensive: routine calibration and part replacement required 5 Above-average 4 Average: performance verification and safety testing 3 Below-average 2 Minimal: visual inspection 1 Equipment incident history Any information available regarding service history that can be considered when evaluating the device type to determine an EM number. If the device has not been previously evaluated. SAMPLE Maintenance requirements Describes the level and frequency of maintenance required as noted by the manufacturer or through experience.

46 Medical equipment maintenance programme overview . • Devices with average or minimal requirements (values of 3. may still be included in the hospital’s biomedical equipment inventory and be covered on a repair-only basis. 2 or 1) are scheduled for preventive maintenance annually. • All devices classified as extensive (characteristic value of 4 or 5) are given a preventive maintenance interval of six months. • Devices with an EM number of 15 or above will be scheduled for inspection at least every six months. Devices not included in the programme All patient care-related equipment including therapeutic. • Devices with an EM number of 19 or 20 will be given an inspection interval of four months.SAMPLE Maintenance interval The maintenance requirement values are also used to determine the interval between each inspection and maintenance procedure for each device type. monitoring. because it did not receive an EM number of 12 or above. diagnostic or analytical equipment not included in the programme.

mobile 8 5 4 -1 16 I S Blood warmer 9 4 3 -1 15 I S Bone saw 9 4 2 -2 3 I A Blood pressure module 7 3 2 0 12 I A Camera. 3-channel 6 3 5 2 16 I S Endoscopic video system 6 3 3 0 12 I A Electrosurgical unit 9 4 3 0 16 I S Fetal monitor 7 3 3 0 13 I A Humidifier. surgical portable 2 4 3 -1 8 N - Light source. SAMPLE Equipment classification examples Equipment Clinical Maintenance Incident Inspection Device description function application requirement history EM # Class frequency Anaesthesia machine 10 5 5 0 20 I T Anaesthesia vaporizer 9 5 3 -2 15 I S (enflurane/ethrane) Arthroscopic surgical unit 9 4 2 -2 13 I A Breast pump 3 4 3 -2 8 N - Aspirator. micro (pc) 3 3 1 -2 5 N - Cryosurgical unit 9 4 3 -1 15 I S Defibrillator/monitor 9 5 4 0 18 I S Electrocardiograph. medical 6 3 3 0 12 I A Cast cutter 2 4 3 -2 7 N - Cast cutter vacuum 2 2 3 -2 5 N - Cardiac output computer 7 3 2 0 12 I A Computer. heated 8 3 3 1 15 I S Hypo/hyperthermia machine 9 4 5 0 18 I S Light. video. fibre optic 7 3 3 -2 11 N - Microscope. ophthalmic slit lamp 6 3 3 -2 10 N - Class Inspection frequency I = Included A = Annual T = Three-yearly N = Not included S = Semi-annual WHO Medical device technical series 47 .

Clinical alarm functionality and audibility. e. Examples of ownership categories are: • Rental/leased equipment • Physician-owned equipment • Donated/loaned equipment • Hospital-owned equipment Procedures A. the technician will affix a clinical equipment maintenance inspection sticker. f. and schematics. if applicable. evaluations and inventories are documented.2 Initial testing and evaluation Purpose To assure that all clinical equipment is inspected prior to its initial use. in a visible location on the device. All clinical equipment falling under the responsibility of the clinical engineering department is covered by this policy. Inclusion into. The clinical engineering department will ensure that the new equipment is inspected for: a. 48 Medical equipment maintenance programme overview . b. These tests. Compliance on labelling of equipment. Hospital-owned equipment: 1. d. Presence of operators’ manuals and technical service manuals. Passage of electrical safety requirements. 3. Proper operation of the equipment. the equipment management programme. Policy All clinical equipment coming into the hospital is tested before initial use and appropriately added to an inventory. if applicable. Performance specifications in the manufacturer’s service literature should be used if available. and must pass the incoming inspection before it will be allowed into the hospital. or exclusion from. if applicable. or other means of identification. If equipment passes all required inspections. c. the clinical engineering department will initiate a work order. 2. to ensure that the equipment has been evaluated for safety and suitability for intended use by a nationally or internationally recognized testing laboratory. regardless of ownership.SAMPLE Appendix A. g. Presence of all accessories required for proper operation. When notified that new clinical equipment is received in the hospital.

the technician will make a recommendation to the hospital education department or the department manager. B. and is safe for use in the hospital. Testing of devices brought in for demonstration or trial evaluation The hospital is responsible for the safety of all patients. 1. If the technician determines that an in-service orientation/training would be beneficial. evaluation or demonstration is tested prior to its use in the hospital. the technician will assist in coordinating this effort with the hospital education department. Hospital technical staff is not responsible for the maintenance of this equipment. In this instance. WHO Medical device technical series 49 . unless an emergency dictates otherwise. it must be safety tested by the clinical engineering department. will also receive a “PM Exempt” sticker). equipment for loan. SAMPLE 4. the user should ensure with reasonable certainty that the equipment is in safe working condition before operating. and visitors. staff. but that do not require regular preventive maintenance. C. The clinical engineering technician who performs the inspection is responsible for ensuring the completion of the initial inspection documentation. Should a manufacturer in-service demonstration be required. If the equipment is to remain in the hospital subsequent to its emergency use. Equipment intended for use in a clinical laboratory application Vendor provided equipment in exchange for the purchase of reagents or consumables must be approved by hospital management. Devices included in the programme. All electrical equipment that passes the clinical engineering safety inspection will have a clinical equipment maintenance sticker affixed in a visible location. or pathology department manager and safety tested prior to being placed into service. indicating that it has been inspected. (Certain battery-operated devices may be excluded from the preventive maintenance programme. 2. the clinical laboratory. and will not have a sticker affixed. or equivalent. Such equipment/device will be prohibited from being used in the facility until it has been repaired and satisfactorily passes the safety inspection. Any equipment that fails the clinical engineering safety inspection will be returned to its originating source with a description of the failure.

10. When the IPM and documentation is completed. equipment cannot be located).SAMPLE Appendix A. the work order will be updated in the records and/or the CMMS. equipment is in use. 4. When the IPM is completed successfully. These IPM procedures will be based on manufacturer’s recommendations. equipment required to be maintained by regulations. If scheduled work cannot be completed (i. 9. the equipment will receive an IPM sticker or other identification denoting its maintenance status. 50 Medical equipment maintenance programme overview . The assigned technician will document on the work order the inspections and maintenance performed and any other important observations. industry recommendations and facility experience. imaging equipment. 8. equipment which could cause patient injury or death if it fails. if in place. equipment under lease where maintenance is part of the lease. 3. The inspection and preventive maintenance (IPM) tasks will be assigned to specific biomedical technicians. the biomedical engineering department will notify the vendor and schedule the maintenance service. The list of maintenance tasks can be generated automatically by a computerized maintenance management system (CMMS).e. 5. laboratory equipment. the reason is documented on a work order. When scheduled maintenance is performed by an outside vendor. 2. 6. Parts required for preventive maintenance are ordered and made available for the equipment in this period. Maintenance will be performed in accordance with the established IPM procedure. and equipment under warranty. Procedure 1.3 Inspection and preventive maintenance procedure Equipment to be covered by the programme will typically include: life support equipment. When maintenance and documentation is completed. equipment on an outside vendor maintenance programme. 7. the work order is subsequently updated in the records and/or the CMMS. This work will be followed up at a later date. surgical and critical care equipment. Work orders will be generated and distributed to the assigned technicians. parts are needed. All equipment due for maintenance needs to be identified one month prior to the maintenance date.

WHO Medical device technical series 51 . procedures and practices need to be evaluated by clinical engineering management. it will be removed from service and deleted from the records. Life support equipment due for maintenance but still in use by patients will be scheduled for maintenance after it is removed from the patient. lists of equipment unable to be located. relevant safety information and other service history records. Longer or shorter preventive maintenance intervals are adopted after documented justification based on previous PM yield data. 13. If the equipment has not been located for two consecutive maintenance cycles. the equipment owners have made every attempt to locate it and the biomedical engineering supervisor/manager has approved the device to be marked in this way. 12. SAMPLE 11. 14. can be identified as “could not locate” only after a concerted effort to locate the device has been made. 15. To assure IPM quality technician competency and the correct execution of IPM. Maintenance completion rates. The technician will work closely with the clinical department to schedule the maintenance as soon as possible. PM yield rates and other quality or performance related statistics will be reported to the relevant safety committee and the clinical engineering department staff at least quarterly. and/or deactivated in the CMMS. Equipment scheduled for IPM but which cannot be located.

only an emergency request will pre-empt this work order. Procedure 1. Upon receipt of the request.4 Work order system for corrective maintenance The clinical engineering department has adopted a standard work order system for all departments requesting maintenance on clinical equipment. When a malfunction occurs with a piece of clinical equipment that is encompassed within the programme of the clinical engineering department. The priority categories are as follows: I. Routine • This describes an action that needs to be taken. on-line/web request. visitors or staff. • Under such circumstances. • Emergency requests are accepted by phone or verbally and will be addressed by the chief biomedical engineer. 52 Medical equipment maintenance programme overview . The lack of immediate action could lead to severe consequences for the hospital and/or potential loss of life or disability. II. documentation will be completed at the earliest possible opportunity. prior to being taken into service. • Should an outside vendor be required to rectify the problem. Urgent • This category is used for failures that require immediate attention because the operation of the hospital/facility is compromised. a work order will be initiated. Input from users is encouraged with regard to priority assignment. but the situation does not compromise the primary function of the hospital/facility. Purpose To provide guidelines for the receipt and processing of clinical engineering service requests. interdepartmental mail or bringing the device to the clinical engineering office. Both will normally be determined by the appropriate clinical engineering manager. the user department shall notify clinical engineering by telephone. the chief biomedical engineer will test and evaluate the equipment upon return.SAMPLE Appendix A. Emergency urgent • This describes situations of dire need and severe safety concerns for patients. III. This includes priority designation and delegation of the work order to a technician for completion. • A work order can be hand-carried to the clinical engineering department. The response to the request will be as soon as possible.

2. Description of the problem Upon completion of the work. It is the responsibility of each clinical engineering technician to follow-up on such situations as needed and personally contact the request originator or department manager if necessary. and provide them with an estimated time of repair. Location of equipment g. including all information relating to the service request. Equipment description d. IV. or by the technician. All work orders are dated and logged for record keeping. the respective department and to describe the problem should be provided on the work request. In the event that a work order cannot be completed in the requested time. Telephone number e. This may include the following: a. the technician will notify the request originator or department manager and inform them of the reasons that the equipment repair will be delayed. • The requesting department will be notified once the order has been received and the work has been scheduled. by the person originating the request for service. Information to identify the equipment. the technician will complete the work order within one day. Cost center (usually the user department) c. SAMPLE • Routine work orders can be sent through the hospital/facility interdepartmental mail system. Name of contact f. WHO Medical device technical series 53 . Deferred • Routine requests may be deferred based on workload or priority. Inventory identification number b. or within twelve business days. No work order may be deferred for more than 10 normal working days without the approval of the clinical engineering manager.

a hose bracket for an anaesthesia machine is broken or a cosmetic label has fallen off). Affix an updated sticker on the device.g. Perform the preventive maintenance procedure. Procedure A. affix a label to the device indicating it is out of service and inform the user department of the delay in return to service of the device. B. No problem found during preventive maintenance of a medical device 1. 3. b. Once the preventive maintenance procedure is performed. or other record of inspection. If a problem is determined to be minor. Purpose To ensure corrective actions are performed and documented appropriately when found during preventive maintenance procedures. Perform the preventive maintenance procedure. on the device. the technician will date the sticker to correspond with the month the work request was completed. a power cord has a cut in the covering). The due date should reflect the next due date based upon the last due month and the appropriate interval for the device. the preventive maintenance procedure can be completed and the device cannot be returned to service (e. Note: if the PM work request is completed in a month after the scheduled month. 2. the technician will complete the preventive maintenance work order form.5 Corrective actions identified during preventive maintenance The clinical engineering department performs preventive maintenance procedures on a timely basis as part of the hospital’s equipment management plan. c. Initiate a corrective work order request. the technician will date the sticker to correspond with the month the work request was completed. Complete the PM work order form. d. If a problem is determined to be minor. the technician should follow these steps: a. 54 Medical equipment maintenance programme overview . Problem found during preventive maintenance of a medical device 1. Note: if the PM work request is completed in a month later than the scheduled month. the technician should follow these steps: a. The technician will affix an updated maintenance sticker. the preventive maintenance procedure can be completed and the device can be returned to service (e.g. The technician will return the device to service. Corrective actions arising during preventive maintenance procedures will be documented appropriately.SAMPLE Appendix A. 2.

Return the unit to service. Upon completion of the corrective action. Initiate a corrective work order referencing the preventive work request number. Complete the preventive maintenance work order and must reference the corrective work order number. Note: if the PM work request is completed in a month after the scheduled month. WHO Medical device technical series 55 . The due date should reflect the next due date based upon the last due month and the appropriate interval for the device. The technician will complete the CM work order and document the date the CM work was done.g. Note: the completion date will be the date the PM work request documentation is completed in the work order system. Affix an updated maintenance sticker on the device. the technician will date the sticker to correspond with the month the work request was completed. a PM work request was completed in October and the CM work request was opened and carried over into November. Affix an updated maintenance sticker on the device. b. For example. The due date should reflect the next due date based upon the last due month and the appropriate interval for the device. 3. c. the technician should follow these steps: a. d. The PM sticker should reflect the October date coinciding with the PM work order. Return the device to service. Initiate a corrective work order for eventual follow-up action when the device is available and take appropriate actions to complete the request. resume the preventive maintenance procedure. Complete the PM work order form. SAMPLE b. the flow control module on a mechanical ventilator is damaged). affix a label to the device indicating it is out of service and inform the user department of the delay in return to service of the device. e.. If a problem is determined to be more than minor and the preventive maintenance procedure cannot be completed (e. e. c. document that a preventive maintenance procedure was completed and then complete the corrective work request. d.

SAMPLE Appendix A. to protect clinical engineering technicians from contaminated equipment. applying cosmetics and handling contact lenses are prohibited in areas where there is a risk of occupational exposure to blood or body fluids. d. 2. for all workers at risk of exposure for use at their discretion or as required. All clinical engineering technicians will observe isolation guidelines as well as the dress and scrub procedures for the area in which they are working. Procedure General precautions 1. clean working environment. drinking. b. Between patient contacts. Visibly contaminated equipment will not be accepted for repair until adequately cleaned by the appropriate department. Hand-washing is required whenever: a. Purpose To provide all employees with a safe. Disposable gloves are available. 3. Employees will not knowingly expose themselves or others to any types of infectious waste. 2. 56 Medical equipment maintenance programme overview . Clinical engineering technicians should not enter ‘isolation rooms’ or ‘restricted areas’ without obtaining permission from the charge nurse. All clinical engineering employees will attend annual infection control education. Eating. Protective gloves are removed. c. Eye protection and/or a facemask will be worn whenever handling equipment that puts the employee at risk of occupational exposure to blood or body fluids through splashing. Appropriate personal protective equipment is worn to handle equipment.6 Infection control All clinical engineering employees will be aware of current hospital policies regarding infection control. within the clinical engineering department. Personal protective equipment (PPE) 1. Hands become contaminated with blood or body fluids. This training will be documented in the employees’ personal training record in the clinical engineering department. 4.

These filters will be disposed of as infectious waste. plastic bags and tightly closed for appropriate disposal. (i. All replaced filters from the clinical laboratory should be considered contaminated and disposed of as infectious waste. masks and absorbent towels) are to be placed in sturdy. Equipment that can be carried or rolled easily will be removed to the clinical engineering workshop for cleaning. and protective eyewear are worn. gowns. 3.e. particulate respirator. (i. Any equipment containing a HEPA filter requires that gloves. Personal protective equipment. All equipment that needs to be opened and vacuumed or blown clean will be done away from patient care or employee work areas whenever possible. Appropriate PPE will be worn. gown. SAMPLE 3. All equipment that cannot be moved from the employee work area will be vacuumed (as opposed to blown clean). Contaminated supplies. WHO Medical device technical series 57 . 4. Clinical engineering personnel will wear masks to eliminate the risk of breathing the dust from any machine. masks and goggles) will be supplied by the user department whenever needed. gloves. gloves. 5. 2. so as not to contaminate the work environment. Gloves will be worn during non-HEPA (high-efficiency particulate air) filter changes.e. These filters will be placed in normal waste. 4. gowns. Equipment precautions 1. All equipment containing serviced filters will have the filters cleaned or replaced according to manufacturer recommendations.

Appendix B Examples of inspection and preventive maintenance procedures B.5 Pump. infusion B. mobile 58 Medical equipment maintenance programme overview .1 Procedure template B. ECG B. table top B.3 Centrifuge.4 Monitor.6 X-ray system.2 Anaesthesia/analgesia unit (gas machine) B.

1 Procedure template Equipment type Name and/or type of equipment Risk score Available from the national Safety inspections/year Refer to manufacturer's regulatory agency.1 to PM checks/year Refer to manufacturer's function category) determine category service manual Procedures: List the steps to be taken to perform inspection and preventive maintenance.Appendix B.1 to Performance inspections/year Refer to manufacturer's determine risk EM number service manual Risk group (equipment Refer to Appendix A. or consult service manual the United States Food and Drug Administration (FDA) Programme risk (EM number) Refer to Appendix A. WHO Medical device technical series 59 .

Inspect interior for signs of corrosion or missing hardware. 18. controls and displays. 14. Inspect all external quick disconnect O-rings.: 12 Risk group: Life support PM checks/yr. Verify correct flow meter calibration. Inspect exterior of equipment for damage or missing hardware./yr. flow). 9. 2. Inspect the power cord. strain relief and plug/s for any signs of damage. insp. 15. 6. Verify correct vaporizer calibration. Appendix B. Inspect condition of all tubing. 3. 8.2 Anaesthesia/analgesia unit (gas machine) FDA risk: 2 Safety insp. cables. 17. Clean exterior of unit including all accessories. Verify correct operation of gas scavenger systems. 16. Inspect all cables for excessive wear. 7. 11. Verify correct operation of unit in all functional modalities. open user-accessible covers and inspect unit for damage. controls. 5.: 2 Programme risk score: Perf. 13. replace if necessary. 12. volume. 60 Medical equipment maintenance programme overview ./yr. 4. Verify correct operation of all buttons. Clean unit interior components and exterior with vacuum or compressed air. Turn unit off.: 12 Procedure 1. Verify correct operation of ventilator (rate. Repair as required. Inspect internal circuits by leak testing. Inspect electrical components for signs of excessive heat or deterioration. 10. Inspect inspiratory and expiratory flow valves. displays and/or indicators.

/yr. 6.: 4 Procedure 1. Verify correct operation of tachometer if applicable. Clean unit interior components and exterior with vacuum or compressed air. 7. 14. Verify correct operation of refrigeration and thermostat if applicable. Repair as required. Verify correct operation of unit in all functional modalities. 13. 18. Inspect motor brushes and armature for wear. table top FDA risk: 1 Safety insp. open user-accessible covers and inspect unit for damage. 16. Inspect lid gasket. controls. Check brushes if applicable. 3. insp. Lubricate motor and mechanical parts where applicable. Clean exterior of unit including all accessories. strain relief and plug/s for any signs of damage. Clean out carbon build-up. displays and indicators. Verify correct operation of all buttons. Clean motor with compressed air. Verify smooth operation of the timer and correct operation of braking. 2. 8. 15. 12. 17. cables./yr.: 1 Programme risk score: Perf. Verify correct operation of lid and safety mechanism. 9. controls and displays. Inspect interior for signs of corrosion or missing hardware. Check for vibrations and excess noise. 10. Turn unit off.: 4 Risk group: Diagnostic PM checks/yr. Inspect the power cord.Appendix B. 11.3 Centrifuge. Verify speed setting using a test photo-tachometer. Verify head balance. WHO Medical device technical series 61 . 4. Inspect exterior of equipment for damage or missing hardware. Inspect electrical components for signs of excessive heat or deterioration. 5.

Verify vertical gain and calibration pulse. strain relief and plug/s for any signs of damage. Verify correct amplifier frequency response and common mode rejection. 7. Verify correct operation of freeze and cascade controls if applicable. Inspect electrical components for signs of excessive heat or deterioration. cables. 17. Verify correct brightness and focus of trace. Verify accuracy of heart rate meter at 3 points for ±3% accuracy. 14. 62 Medical equipment maintenance programme overview . Turn unit off. 2. 15. Verify correct operation of unit in all functional modalities. Verify correct operation of all buttons.4 Monitor. Inspect interior for signs of corrosion or missing hardware. Verify correct detenting and lead shorting of lead selector switch. ECG FDA risk: 2 Safety insp. Repair as required. Cycle alarms and verify correct operation of audio and visual indicators. 3. linearity. insp. Inspect exterior of equipment for damage or missing hardware. 16. 8. centring. 19. 5. 12. Inspect monitor/diagnostic switch. controls. displays and/or indicators. 6.: 2 Programme risk score: Perf. 9. 13. 4./yr.: 2 Risk group: Diagnostic PM checks/yr. 18.: 2 Procedure 1. Verify operation of high and low alarms for correct trigger and response time. open user-accessible covers and inspect unit for damage. Clean exterior of unit including all accessories. controls and displays. Verify correct sweep size. 11./yr. speed and vertical spacing. Clean unit interior components and exterior with vacuum or compressed air. Inspect patient cable and connectors for mechanical or electrical damage. 10. Inspect the power cord. Appendix B.

WHO Medical device technical series 63 . Turn unit off. 7. 5.5 Pump. Inspect the power cord. Clean unit interior components and exterior with vacuum or compressed air. 4. Verify pressure calibration. Inspect exterior of equipment for damage or missing hardware.: 2 Programme risk score: Perf. 3. Inspect electrical components for signs of excessive heat or deterioration. 9./yr. Test instrument service/test mode. 10.: 2 Risk group: Patient support PM checks/yr. 12. 2.Appendix B. Inspect interior for signs of corrosion or missing hardware. displays and/or indicators. Verify correct operation of all buttons. Verify correct operation of unit in all functional modalities. Perform auto pinch-off test./yr. 13. 6. Perform battery operation test. strain relief and plug/s for any signs of damage. Verify rate accuracy. 8. infusion FDA risk: 2 Safety insp. insp. controls. open user-accessible covers and inspect unit for damage. Repair as required. 11.: 2 Procedure 1.

Inspect batteries if applicable. open user-accessible covers and inspect unit for damage. 9. Clean unit interior components and exterior with vacuum or compressed air. Verify correct support and travel of stationary and movable rails. 16. mobile FDA risk: 11 Safety insp. 13. 2. 10. service as required.6 X-ray system. strain relief and plug/s for any signs of damage. displays and/or indicators. 11. Verify correct operation of unit in all functional modalities.: 2 Risk group: Diagnostic PM checks/yr. controls and displays. Verify accuracy of kVp. Inspect interior for signs of corrosion or missing hardware. 8. controls. mA-time. 6. Verify correct operation of all buttons. 3. Appendix B. Verify correct operation within specifications of collimators (auto and manual). 15. Verify correct operation of display devices if applicable. Inspect exterior of equipment for damage or missing hardware. Verify correct operation of electrical locks (tube and table). Turn unit off./yr. 5. 18. Clean exterior of unit including all accessories. 64 Medical equipment maintenance programme overview . per manufacturer’s specifications. 7. 12. cables.: 2 Procedure 1. Inspect the power cord. Verify smooth operation of the drive system. Verify correct operation of other electrical functions. Verify correct calibration using manufacturer’s specifications. Repair as required.: 1 Programme risk score: Perf. 14. insp. Inspect electrical components for signs of excessive heat or deterioration. 17. 4./yr.

5 Centrifuge 2 0.6 Computer monitor 1 0.5 1 1. Record time it takes a technician to perform the inspection procedure. a whole facility).3 0 0 0.75 2.0 1 4.75 1 1. detailed method Minor IPM Major IPM frequency Minor IPM time frequency Major IPM time Total time Medical equipment (per year) (hours) (per year) (hours) (hours/year) Laboratory chemistry department Laboratory blood refrigerator 11 0.8 Laboratory mixer 2 0.7 Laboratory specimen refrigerator 1 0.25 Bilirubin analyser 2 0.Appendix C Calculating IPM workload The following procedure and charts are used to calculate IPM workload. Each piece of equipment should be analysed.0 19.3 0 0 0. a new wing. Create a complete inventory of each item to be covered for IPM.25 0 0 0.0 WHO Medical device technical series 65 .2 1 0. a department. If the clinical engineering department calculates the actual work needed to accomplish this task and acquires the staff to do this work. The steps are as follows: 1. This mathe- matical methodology is used by service companies to calculate the IPM workload of the accounts they bid on.25 0 0 0.5 1 Heating block 2 0. An example of this is provided in Chart A.25 Chemistry analyser 3 4.5 0.3 1 0.5 1 1. the more likely the work will be accomplished and the goals achieved.0 Laboratory freezer 1 0. the inspection frequency and times entered into a spreadsheet and the total annual time for inspection and preventive maintenance calculated for the list of equipment to be covered.6 Computer printer 2 0.5 0.5 Microscope 1 0.5 2.5 1 0.0 2.25 0 0 0. 2.5 Chemistry analyser 3 3.5 1 0.0 2. Chart A: Calculating IPM workload.0 13.0 Printer module 2 0. Identify the areas to be covered for IPM (a group of equipment. 3.5 1 6.5 Spectrophotometer 3 0.

3 1 0.0 Physiological monitor 1 0.9 hrs.0 Fetal blood gas monitor 2 1.0 13.0 1 5. some PM may be required.0 Water purification system 1 1.5 1 1.0 1. This method requires some familiarity with the equipment and maintenance procedures.0 1 5.0 1 1.0 14.75 1 1.0 5. 66 Medical equipment maintenance programme overview .0 Video monitor 1 0. Labour and delivery department Fetal monitor 4 0.5 Infant radiant warmer 2 0.0 5.0 Total 76.0 1 4.0 2.5 1 2.5 1 0.0 2.4 0.3 0 0 0.75 0 0 3.5 0 0 0.3 1 0. Advanced systems – inspected 2–4 times per year.7 Chemistry analyser 3 3.4 0. An alternate.75 Doppler blood flow probe 2 0.5 Infant radiant warmer 2 0.25 Electrosurgical unit 1 1.5 Fetal monitor 4 0.0 Fetal monitor 4 0.0 3.3 hrs.75 0 0 3.0 2.7 Warming blanket 1 0. 3. Chemistry analyser 3 3.75 0 0 3. 2.0 Fetal blood gas monitor 2 1.0 Fetal monitor 4 0.0 Ultrasound scanner 1 3.0 1. An example of this method is found in Chart B.6 Syringe pump 1 0. The approximate inspection times and frequencies for each class of equipment is entered into the chart and the calculations are done to yield the total IPM work time.75 0 0 3. Intermediate devices – inspected once or twice per year.0 8.75 1 1. Simple device – inspected once per year with no PM required.0 1 2.75 1 1. extensive PM required.0 Total 43. simplified method to do this is to generally categorize each device into one of three classifications: 1.0 Refrigerator 1 0.75 1.5 Pulse oximeter 1 0.5 1 2.

Chart B: Determining workload

(This example uses the chemistry and delivery room inventory above)

Equipment type Simple devices Intermediate devices Advanced systems
Number of devices 5 Chemistry 8 Chemistry 4 Chemistry
1 Delivery 14 Delivery 3 Delivery
Total number of devices 6.0 22.0 7.0
Hours/inspection 0.3 0.5 1.0
Inspections/year 1.0 1.5 4.0
Total hours inspecting equipment 1.8 16.5 28.0
Total Workload = 46.3

This method yields the total time needed to provide complete inspection and preventive
maintenance on this inventory. This example did not take into account the time needed to
travel to the clinical site to perform the work, the time to get ready for work in a particular
area (gather correct paperwork, test equipment, tools and PM parts) or the time it takes
to complete the paperwork after the work is done. These tasks are variable depending
where the department is located with respect to the clinical areas, where the work
takes place and what type of equipment will be maintained. Additionally time should
be taken out of the normal work day for lunch, short breaks and short conversations
with the clinical staff to build rapport and to learn about how the equipment has been
functioning. All things considered, this example yields about two weeks of work for a
single technician to accomplish this work in a careful and thorough manner.

WHO Medical device technical series 67

Appendix D
Examples of inventory and inspection forms
D.1 New equipment received form

D.2 Equipment inspection forms

D.3 Work order form

68 Medical equipment maintenance programme overview

Appendix D.1

SAMPLE
New equipment received form
Date:

Tech name:

Equipment Category

Floor Unit Dept.

Details Purchase Info
Note: Arrival date / /
Asset # Installation date / /
Model # Warranty date / /
Serial # Purchase price $
Vendor # Replacement cost $

Manufacturer

Functional units
Life expectancy yrs
Function score
Risk score PM schedule
(monthly, annual, etc.)
Maintenance score

Work order #

Purchase order #

Incoming #

Comments

WHO Medical device technical series 69

2008 70 Medical equipment maintenance programme overview .2 Equipment inspection forms Adapted from Medi-Therm III hyper/hypothermia service manual.SAMPLE Appendix D.

1998 WHO Medical device technical series 71 . ventilator service report. SAMPLE Adapted from MEDIQ/PRN quality assurance programme form.

.) Note: Keep this form in the active file for at least 15 days after the completion of final repairs.3 Work order form Request for service Department: Date: Clinician/technician reporting problem: Location of device: Problem description: Date/time: Service record Service engineer name: Date/time responded: Action taken: Has the problem been corrected? Is follow-up work necessary? When will follow-up work be performed? Follow-up action Service engineer name: Date/time responded: Action taken: Has the problem been corrected? Is futher follow-up work necessary? (If so. Reference# 1004 Biomedical Engineering 72 Medical equipment maintenance programme overview . Adapted from: Medical Consultants Network Inc. describe on reverse side of this form.SAMPLE Appendix D.

1 Record of inspection E.Appendix E Samples of inspection labels E.3 Notification of defect WHO Medical device technical series 73 .2 Record of inspection (test) results E.

This tag may be covered with plastic adhesive/cover to protect it from being defaced during the cleaning process. Appendix E.1 Record of inspection This type of label indicates the date the device was serviced or inspected and may indicate when the next service is due. 74 Medical equipment maintenance programme overview . one for each year or inspection cycle so that it is easier to identify devices that are due for inspection. These tags are sometimes printed in different colours.

nerve stimulators. These can be used to record outputs on many energy-producing devices including ultrasound therapy equipment. WHO Medical device technical series 75 .2 Record of inspection (test) results This label provides space to record the output readings taken during the performance assurance inspection.Appendix E. lasers. electrocurrent therapy devices. defibrillators. etc.

76 Medical equipment maintenance programme overview . Appendix E. It is printed on very brightly coloured paper to attract the clinician’s visual attention and prevent inadvertent use of the device.3 Notification of defect This label is placed on medical equipment that has been inspected by the clinical engineering staff and found to be defective.

Physiological simulators defibrillators. EKG machines ICU monitors. vacuum Gas flow meters regulators. ultrasound. pneumatic flow meter Medical gas systems. insufflators. intra-aortic balloon pumps. suction regulators Incubators. CO2 insufflators. infant warmers. floor scale. MR Phantoms Air-O2 blenders. medical gas systems Oxygen analyser Pacemakers Pacemaker analyser Scales. weights Ventilators. laboratory ovens Temperature probe/thermometers Infusion pumps. ventilators. traction units Stop watch/timers Centrifuges Photo or contact tachometer Electrical outlets Receptacle testers Isolated power systems Isolated power tester Non-invasive blood pressure monitors Non-invasive blood pressure simulator Dialysis machine pH/conductivity meter Various Variable resistance box. spring scale. traction units Scales. surgical irrigation pump Graduated cylinder Radiographic and fluoroscopic equipment Ionization chamber/radiation analyser/kVp meter Surgical and ophthalmic lasers Laser power meter/laser thermal imaging plates Most electronic equipment Multimeter/oscilloscope/function generator Radiographic. anaesthesia machines. dialysis machines Anaesthesia machines. warming Fluid flow meter pad pumps. ventilators Test lung Anaesthesia machines. heart-lung machine. EKG machines Arrhythmia simulators IV pump. EEG machines. variable capacitance box WHO Medical device technical series 77 . lasers Physiological monitors. ventilators Ventilation analyser Heart lung machines. air-O2 blenders.Appendix F Test equipment per medical device category Medical device category Test equipment required Electrosurgical units Radio frequency electrosurgical analyser Defibrillators Defibrillator analyser All electrical equipment Electrical safety analyser Anaesthesia machines. anaesthesia machine Pneumatic tester. mammography. hyper/hypothermia machines. haemodialysis Pressure meter machines. lasers. balance. CT.

4 Clinical engineering supervisor/manager 78 Medical equipment maintenance programme overview . Appendix G Examples of job descriptions G.2 Biomedical equipment technician – mid-level G.3 Biomedical equipment technician – senior-level G.1 Biomedical equipment technician – entry-level G.

14. diagnostic and monitoring medical equipment.and work-safety issues. Maintaining a professional appearance and approach to work. Following all departmental policies and procedures. Making suggestions to improve department productivity when appropriate. 13.Appendix G. 15. Education: Two-year degree or equivalent training in electronics.1 SAMPLE Biomedical equipment technician – entry-level Job description: Performs tasks involving the installation and maintenance of therapeutic. 5. maintenance and repair of a diverse range of medical equipment. Meeting the needs of clinical departments and obtaining loaner or replacement equipment as required. corrective and preventive maintenance and special requests as required. Maintaining documentation in an accurate and timely manner. Installation. 10. Acceptance testing on new clinical equipment per department policy. Being aware of patient. Maintaining a clean and safe work place. 4. 2. clinical staff and other hospital workers. 11. Assisting hospital clinical and technical staff in the proper operation and maintenance of clinical equipment. Assisting in the systematic preventive maintenance programme of medical equipment. Maintaining good relationships with fellow workers. has an extensive repair history. Communication with users regarding status of repairs. Documenting all work performed including new equipment inspections. Providing good customer service. reports problems found and assists with correction of issues as required. Performing electrical safety inspections on medical equipment using specialized test equipment. no longer has service support from the manufacturer or has identified safety problems. upon request. One-year experience as a biomedical equipment technician in a health-care setting preferred. WHO Medical device technical series 79 . Identifying and recommending medical equipment that is obsolete. 6. answering phones in a pleasant manner. 3. biomedical equipment technology or a related field is required. Maintaining a high level of productivity. 7. visitors and patients. Experience: No experience required above minimum education. screening and referring calls as appropriate and providing information to staff. 12. 9. 8. These activities include: 1.

Education: Two-year degree or equivalent training in electronics. Being able to effectively work with clinicians to troubleshoot clinical problems with medical equipment.2 Biomedical equipment technician – mid-level Job description: Performs tasks involving the installation and maintenance of therapeutic. mentoring and guidance for entry level technicians. performing any necessary communication and follow-up with owner department. Being able to prioritize work and initiate new work and tasks. Working independently in both routine and complex tasks. Participation in incident investigations as requested and provides follow-up to management. 6. diagnostic and monitoring medical equipment. maintenance. 5. Coordination of initial inspection and installation of new equipment as requested. Providing training. Assisting with pre-purchase evaluations of equipment as required. Coordination and management of projects from start to completion. 2.SAMPLE Appendix G. 3. and repair of a diverse range of clinical equipment including life support equipment. mechanical or electromechanical repair or equivalent. Being able to solve technology problems for the clinicians. These activities include: 1. 80 Medical equipment maintenance programme overview . 4. 7. biomedical equipment technology or a related field is required. Experience: At least three years experience as a biomedical equipment technician or a minimum of five years experience in electronic. Participation in committees as requested. preferably in a healthcare setting. 8. Performance of both routine and complex tasks associated with the installation.

2. biomedical equipment technology or a related field is required. mentoring and guidance to entry-level and mid-level technicians. Leadership and prioritization of work in the absence of the manager. Routinely coordinating and managing projects. These activities include: 1. complex and specialized tasks associated with the installation.3 SAMPLE Biomedical equipment technician – senior-level Job description: Performs tasks involving the installation and maintenance of therapeutic. Assisting in developing technical specifications for equipment purchases. Education: Two-year degree or equivalent training in electronics. WHO Medical device technical series 81 . Experience: Requires a minimum of four years experience as a biomedical equipment technician. diagnostic and monitoring medical equipment. Conducting training sessions for department staff covering safe operation and maintenance of equipment for entry-level and mid-level technicians. 5. maintenance and repair of a wide range of clinical equipment including life support equipment. 3. Training. Being able to consistently perform a wide variety of routine. performing any necessary communication and follow-up with the department.Appendix G. 6. 4.

5.SAMPLE Appendix G. Ensuring that applicable accreditation standards are met. Evaluation and assistance in acquiring new technology for patient care. 7. 17. Ensuring the timely completion and documentation of all maintenance activities. 9. 82 Medical equipment maintenance programme overview . Maintaining the stock of repair parts to ensure appropriate maintenance of equipment.4 Clinical engineering supervisor/manager Job description: Responsible for directing and managing clinical engineering activities directly related to safe and effective medical equipment. 12. Evaluation of possible service contracts and outside vendor relationships. maintenance and repair of the medical equipment. 8. 10. Assisting and overseeing writing specifications for new equipment. Maintaining familiarity with regulatory codes and standards. Education: Requires a two-year degree in clinical/biomedical engineering or equivalent. Collaboration with clinical staff to provide the highest level of patient safety. Managing other projects as assigned. 3. 14. 6. Representing clinical engineering at meetings as assigned. 4. Acquisition. These activities include: 1. Ensuring departmental policies and procedures are followed. 16. 13. Assistance in the management of the computerized maintenance management system. Ensuring timely completion of preventive maintenance. Managing department productivity and performance improvement initiatives. Coordination of preventive maintenance and repairs by outside service personnel. 15. 11. 2. Experience: Work requires minimum of three years of clinical/biomedical technology experience including management and leadership experience. Instructing hospital personnel on safe and proper operation and maintenance of medical equipment. A four-year degree in clinical/biomedical engineering is preferred.

3 Planning a maintenance programme within a regional health system H.1 Planning a maintenance programme at a district hospital H.4 Managing a maintenance programme within a regional health system WHO Medical device technical series 83 .Appendix H Examples of actions performed when developing maintenance programmes at the facility level H.2 Managing a maintenance programme at a district hospital H.

• Identify budget sources. Appendix H. manager • Develop the budget for operating the programme. Clinical engineering department • Identify managerial capabilities within the hospital for manager/administrator management of the programme. Clinical engineering department • Develop the budget for implementing the programme. Administrator Human resources • Plan additional training for technicians. • Plan for basic computer resources.1 Planning a maintenance programme at a district hospital Critical factor Action Responsible party Inventory • Create an inventory of all medical equipment in the hospital Clinical engineering department using a computer spreadsheet or simple CMMS software. 84 Medical equipment maintenance programme overview . • Develop links to external resources. Physical resources • Plan for build-out of space and acquisition of tools and Architect equipment. Methodology • Identify current resources Clinical engineering department • Define maintenance methodologies: manager – Simple maintenance tasks – hospital staff – critical equipment of greater complexity – service contracts Financial resources • Plan for service contracts.

manager • Compare costs to budget. • Monitor services provided under service contracts.Appendix H. • Document work on work order forms and. Clinical engineering department manager/technician Performance • Monitor performance measures. review variances. identify Clinical engineering department improvement opportunities for improvement. Operational • Develop procedures and schedules for inspection and Clinical engineering department management preventive maintenance. manager WHO Medical device technical series 85 . plan for future budgets. • Work closely with clinicians. manager • Develop policies for prioritizing corrective maintenance activities. Financial • Monitor costs associated with service contracts and with Clinical engineering department management work carried out by the technician. in Technician the CMMS software.2 Managing a maintenance programme at a district hospital Management Action Responsible party component Personnel • Assign scheduled and unscheduled work to the repair Clinical engineering department management person. Clinical engineering department monitoring manager Performance • Compare performance to objectives annually. if available. manager • Monitor hours worked by the technician and timely completion of scheduled and unscheduled work assignments.

Administrator Human resources • Identify current human resources (one engineer and a few Clinical engineering department technicians with varying skills). • Develop budget for operating the programme. manager • Plan additional general and specialised training for Clinical engineering department technicians.3 Planning a maintenance programme within a regional health system Critical factor Action Responsible person Inventory • Create inventory of all medical equipment in the system using Clinical engineering department full-featured CMMS software. with “first look” by hospital staff Financial resources • Identify financial resources (moderate). tools. manager/administrator • Plan management training for the engineer. Appendix H. Methodology • Define maintenance methodologies: Clinical engineering department – simple and moderate maintenance tasks – hospital staff manager – critical equipment of greater complexity – service contracts. 86 Medical equipment maintenance programme overview . Administrator • Plan for transportation among hospitals and clinics. manager • Develop budget for implementing the programme. Physical resources • Identify physical resources (some space. Administrator/transport services officer • Plan for service request dispatching and clerical support. • Plan for basic computer resources. Clinical engineering department manager • Plan for build-out of space and acquisition of tools and Architect equipment. • Develop links to external resources. • Identify budget sources. Clinical engineering department • Plan for service contracts. and equipment).

manager • Monitor hours worked by the technical staff and timely completion of scheduled and unscheduled work assignments. • Implement performance improvement initiatives and monitor for success.’ Performance • Prepare written report comparing performance Clinical engineering department improvement to objectives and identifying opportunities for manager improvement. review variances. • Technical personnel document work on work order forms Technician and in the CMMS software.4 Managing a maintenance programme within a regional health system Management Action Responsible person component Personnel • CMMS assigns scheduled and unscheduled work using Clinical engineering department management defined protocols. • Participate in medical equipment planning. Financial • Monitor costs associated with service contracts and with Clinical engineering department management work carried out by technical staff. • Work closely with clinicians and conduct customer Clinical engineering department satisfaction surveys. incident investigation and committee activities. manager/technician Performance • Monitor performance measures plus additional measures Clinical engineering department monitoring supported by the CMMS.Appendix H. manager • Compare costs to budget. manager • Develop policies for prioritizing corrective maintenance activities. • Monitor services provided under service contracts. and implementation of ‘best practices. performance benchmarking. WHO Medical device technical series 87 . Operational • Develop procedures and schedules for inspection and Clinical engineering department management preventive maintenance. manager • Manage compliance with applicable standards. plan for future budgets.

int http://www.int/medical_devices/en/ . ISBN 978 92 4 150153 8 Department of Essential Health Technologies World Health Organization 20 Avenue Appia CH-1211 Geneva 27 Switzerland Tel: +41 22 791 21 11 E-mail: medicaldevices@who.who.