CLINICAL ENGINEERING Technology

management
 INTRODUCTION

 Modern health-care institutions are increasingly coming to the

view that technology is an integral part of all Major policy and
program-planning decisions .In many of these hospitals,
technology Management has become the responsibility of the
clinical engineering department.
 the levels of clinical engineering responsibility within the health-
care environment Have evolved to include traditional equipment
maintenance functions such as electrical safety , Equipment
acquisition, repair and maintenance, supervision of service
contracts ,and Computerized equipment control.
 They can provide the hospital administration with information
and guidance regarding the risks ,cost effectiveness, Reliability ,
and maintainability of a wide range of medical devices.
 TECHNOLOGY MANAGEMENT PROGRAM
(TM)
 Major activities:
 # Administrative (policy and financial considerations).
 # Equipment control and maintenance.
 # Technology planning , acquisition and replacement.
 # Establishing equipment maintenance schedules.
 # Supervising repair services As well as service contracts.
 # Training users to properly use medical equipment.
 # Risk management.
 # Quality assurance.
**the primary Goal of any technology management program is to
ensure that the most cost -effective Methods for the safe and
effective operation of medical equipment are utilized { through
the development of institutional policy regarding equipment
acquisition ,use, replacement, and disposition}.
 TM PROGRAM ELEMENTS

 A program to control and monitor equipment performance,

including routine Performance testing, initial inspection,
preventive maintenance, calibration and verification of
performance, repair, and action on device recalls and hazards.
 A program that accurately and consistently computes and
monitors total equipment Maintenance costs, including in-house
costs as well as manufacturer and third-party service contracts.
 Involvement in all aspects of equipment acquisition and
replacement decisions, Development of new services, and
planning of new construction and major renovations.
 Development of training programs for all users of patient care
equipment and for biomedical equipment technicians.
 A quality assurance (QA) program relating to technology use.
 Risk management as it relates to technology.
 EQUIPMENT CONTROL AND
MAINTENANCE
T he follow ing r epr esent t he basic component s of a clinical
equipment pr og r am
 Establishment of a c omplete equipment inv entor y, c ontrol number tagging
system, records , and files c ontaining operating and ser v ic e manuals.
 Initial inspec tion of all dev ic es prior to plac ing them into c linic al use.
 Periodic inspection, calibration and v erific ation testing, and prev entiv e
maintenanc e of all equipment, either by hospital per sonnel or outside
vendor s. Such a program Inc ludes, at a minimum, written inspec tion
proc edures, an inspec tion sc hedule, and a means of doc umenting the
inspection activity.
 Equipment repair, inc luding management and integration of outside ser vic e
ac tiv ities .
 A quality assurance program to deal with hazard and rec all notific ations
and a System to ensure ac tion is taken to c orrec t the problem.
 Detailed strategies for equipment ac quisition and replac ement. This should
inc lude proc edures for c onduc ting pre proc urement sur veys.
 Procedures to dispose of equipment that is no longer needed .
 A method to evaluate the per formanc e and doc umentation of eac h of these
functions .
 TECHNOLOGY PLANNING, ACQUISITION,
AND REPLACEMENT
 Clinical engineers can translate the physical requirements for
the optimal operation of clinical equipment into technical
specifications . They can serve as advisers to hospital
administrators, architects, and engineers to ensure that all
requirements to integrate equipment into the hospital are
met.
 Technological advances and excessive maintenance costs are
the main reasons for equipment replacement. Equipment is
replaced as clinical procedures change and when Maintaining
the device is no longer cost -effective.
 The log of equipment performance, service costs, and
availability of repair parts allows a comprehensive review of a
device's operating performance and thereby helps in making
equipment replacement decisions
 TRAINING IN EQUIPMENT USE

 To reduce user error significantly, clinicians must be trained

in the proper use of the medical equipment Clinical engineers,
however, often conduct The training themselves, especially
when detailed aspects of highly technical equipment use Are
to be discussed.
 Hospitals need to develop a training policy regarding medical
equipment use that should include the following:
 # Assigning responsibility for the training .
 # Monitoring and assessing equipment -related training for its
effectiveness.
 # documenting the training program.
 QUALIT Y ASSURANCE

 Quality assurance is an essential activity in all modern hospitals

 hospitals are required to monitor and document systematically
all Significant aspects of patient-care, analyze the outcome of
procedures , and take corrective action when problems are
identified.
 These new quality assurance requirements provide both a
challenge to and an opportunity for clinical engineering
departments.
 EQUIPMENT-RELATED RISK MANAGEMENT

 Risk management is closely related to both technology management

and quality assurance . Equipment use , abuse , or nonuse are
impor tant factor s in many patient incidents.
 The director of clinical engineering , in Concer t with the risk
manager , should develop a plan for identifying equipment-related
Incidents involving serious injuries or death and should maintain
records of equipment-related Incidents.
 These records can then be used to identify trends with specific types
of equipment, Specific equipment manufacturers , or groups of
equipment user s so appropriate action can be taken.
 The scope of such a plan can var y dramatically based on the skills of
the available clinical engineering per sonnel and the hospital
administrator s .
 Technology management programs must be designed to the needs
of each par ticular facility.
 INITIAL INSPECTION/ACCEPTANCE
TESTING
 When anew medical device is received , an initial
inspection/acceptance test is conducted in order to do the
following:
 @ Verify that all components ,accessories , and options listed on
the purchase request were received.
 @ Verify and record the safety and performance features of the
device prior to its initial use.
 @ Ensuring that the hospital identification tag or unique control
number is affixed to the equipment.
 @ Starting an equipment data file including , a copy of the
purchase order , the initial performance and safety values , and
any warranty data.
 @ Stocking appropriate accessories and user supplies , including
replacement parts.
 @ Setting up training programs for users.
 MAINTENANCE SCHEDULES

 Inspections that are too frequent may degrade device

longevity and may not be cost effective.
 Inspections that are not frequent enough may adversely affect
reliability , accuracy ,and safety.
 A device should be scheduled for periodic maintenance , only
if there is good reason such as :
 * Reducing the risk of injury to patients, staff, or visitors.
 * Minimizing equipment down time.
 * Avoiding excessive repair costs.
 * Correcting minor operational problems.
 * Complying with codes , standards , and regulations or the
strict recommendations of equipment manufacturers .
 SCHEDULED MAINTENANCE SERVICES

 Can be classified into three basic categories:

 # Preventive maintenance : Periodic procedures to minimize
the risk of failure and to ensure continued proper operation.
These include cleaning ,lubricating , adjusting , and replacing
certain parts.
 # Performance testing & calibration : To verify that the
equipment is fully operational and performing within
reasonable, previously specified limits.
 # Safety inspection : Leakage current and ground integrity
should be tested as well as visual inspection for mechanical
safety.
!!! Records of inspections must be kept for accreditation
organizations and also for use in any equipment -related lawsuit.
 SCHEDULED MAINTENANCE SERVICES C O N T IN U E D

 There are five elements to responsive, cost -effective

equipment service :
@ Competent technicians.
@ Repair parts.
@ Service manuals and documentation .
@ Experience with factory back -up.
@ Diagnostic software.
Benefits of scheduled maintenance ser vice program include
increase equipment safety – reduce unscheduled repairs –
prolong the useful Life of a device – reduce costs – improve the
quality of patient care.
 REPAIR SERVICES

 Repair can be defined as troubleshooting to isolate the cause

of device malfunction and then replacement or adjustment of
components or sub systems to restore normal function ,
 Safety , performance , and reliability repair services are
offered by manufacturers , shared -service organizations ,
third-party service organizations, and in -house departments
 With the extent of the repairs varying from circuit board
exchange to component-level repairs .Depending on the
device complexity, component level repairs may be the most
cost-effective and desirable method of repair for a given
device.
 Many companies offer exchange prices on circuit boards,
which significantly reduces the cost of board replacement
 REPAIR SERVICES CONTINUED

Requests for repair services typically come from the equipment

operator in written form
# The request should do the following :
 Identify the device requiring repair ,usually by use of the
hospital identification number or equipment control number .
 Provide as much information as possible regarding the
problem.
 Identify the operator of the device at the time of malfunction .
 Give the time and date of the malfunction .
 Provide the equipment location ,the department , a point of
contact , and a phone number
 T YPES OF MAINTENANCE SERVICES

There are three traditional methods of servicing medical

instrumentation:
1- In-House Equipment Ser vice . The prime advantages of in-house
servicing are immediate availability of service technicians to
troubleshoot and repair equipment , facilitation of other aspects of
equipment operation. Disadvantages focus on the relative costs
associated with operating an in-house Clinical engineering service.
2- Manufacturer Ser vice . Manufacturers usually provide service
through:
(A)a full-service Contract , which generally includes all labor-
related costs , and may include all or certain parts-related costs
(B) a demand service agreement in which the hospital pays on a
time-and-materials basis for each service call, as needed ,and
(C) a combination of the two basic methods. Disadvantages : Cost
maybe greater – Technician experience and qualifications maybe
suspect if subcontractors or dealers are used.
 T YPES OF MAINTENANCE SERVICES C ONTINUED

 3-Third-Party Ser vice .A hospital may elect to obtain service

from an independent, third-party service organization .These
organizations maybe small and specialize in only a few types of
equipment.
 A service organization may have particular difficulty in fulfilling
the hospital's needs for support functions beyond narrowly
defined equipment repair, and it may be at a serious
disadvantage , especially for servicing high -tech equipment , If
the manufacturer Is unwilling to provide needed parts and
diagnostic equipment.
 SERVICE CONTRACTS

 Ful l se r vice includes a specified number of preventive maintenance

(PM) calls at regular inter vals , unlimited repair calls, all par ts except
consumable supplies, all Labor and travel charges, and availability 24
hour s per day ,seven days per week Days per year .
 Li m ited-hour se r vice includes a specified number of PM calls at regular
inter vals, unlimited repair calls , all par ts except consumable supplies ,
and all labor and travel charges during a specified work week
 Li m ited se r vice includes a specified number of PM calls at regular
inter vals , all par ts except consumable supplies, and all labor and
travel up to a maximum number of ser vice calls specified in the
contract.
 D e m and S e r vice includes PM and repair ser vice provided upon request
by the customer and paid on a time -and-materials basis.
 D e pot S e r vice includes all par ts, all labor for repair s and a specified
number of PM inspections at regular Inter vals . All work on defective
equipment must be per formed at the factor y or a regional depot .
 REPAIR PARTS MANAGEMENT

 Repair par ts maintained in the clinical engineering section should

be classified as bench stock . Exceptions are common bulk
hardware items ,such as nuts, bolts, washers , resistors , capacitors
general-purpose semiconductor devices, etc. ., and repair par ts
ordered for immediate use .
 Clinical engineer s should consider the following factor s when
determining what par ts and quantities to place in bench stock :
 @ Critical nature of equipment .
 @ Cost of downtime.
 @ Number of units on hand .
 @ Consumption rate.
 @ Lead time.
 @ Cost of the repair par ts .
 @ Shelf life.
 @ Age of the equipment.
 EQUIPMENT DISPOSITION

 There are several reasons for disposing of old devices:

 # Changes in the standard of care.
 # Safety factors resulting in increased risk.
 # Maintenance problems that cause frequent or expensive
repairs
 # Non availability of repair parts or service.
 # Operational costs.
 # Newly purchased equipment may incorporate a number of
different functions in a single device .
RESOURCES

 Management of Medical Technology -Joseph D. Bronzino

 Clinical Engineering Handbook -Ernesto Iadanza -2020
 The clinical engineering handbook ,joseph dyro2003
 Clinical Engineering: Evolution of a Discipline
Joseph D.Bronzino Trinity College/Biomedical Engineering
Alliance and Consortium (BEACON)

Prepared by : Eng. Mohamed Elghedany