Software System for Medical Device Management and Maintenance
C. Luca and R. Ciorap
“Gr.T.Popa” University of Medicine and Pharmacy, Iasi, Romania
Abstract— Concerning the inpatient care the present situa-
tion is characterized by intense charges of medical technology
into the clinical daily routine and an ever stronger integration
of special techniques into the clinical workflow. Medical tech-
nology is by now an integral part of health care according to
consisting general accepted standards. Purchase and operation
thereby represent an important economic position and both
are subject of everyday optimization attempts. For this pur-
pose by now exists a huge number of tools which conduce more
likely to a complexness of the problem by a comprehensive
implementation. In this paper the advantages of maintenance
system architecture on the medical device management are
shown and we are presenting original software that can be
implemented in any hospital without being necessary the exis-
tence of a clinical engineering department.
Keywords— Medical device, maintenance, health technol-
ogy management, maintenance protocols.
I. INTRODUCTION
This article deals with the present situation of service
management as well as facility management of medical
technology and demonstrates a new integrative approach to
optimize the medical device management using a software
system. The concept appeared against the backdrop of fore-
seeable social and technical developments. As a result of
social change acting, hospitals and medical technology
(equipment and services) providers have to rise to new chal-
lenges at the healthcare market. Exemplary to mention are:
- a change in the demographic structure towards an older
society [1],
- a hair-trigger financial situation of hospitals which is de-
termined through a severe regimented service rebate and a
perspicuous slowdown in investment [1],
- high expectations within the society regarding the quality
offer of health care,
- the problem of the acquisition of specialized professionals,
in the regarded case especially in the region of medical
technology services [2]
-the consisting obligations of an incessant quality assurance
and also the documentation of services rendered [1].
In modern and forward thinking Hospitals, it has been real-
ized that prevention is better than cure, and that proactive,
rather than reactive management brings the best results.
S. Vlad and R.V. Ciupa (Eds.): MEDITECH 2011, IFMBE Proceedings 36, pp. 84–89, 2011.
www.springerlink.com
This is true for managing human resources, to change
policies and (just as importantly) for managing the medical
devices that all Hospitals use for diagnostic and clinical care
[2].
II. METHODOLOGY
Many devices require regular and effective maintenance
to operate correctly and meet their design specifications.
The consequences of ineffective maintenance can be huge
in terms of patient care, personnel morale and management
time [2].
Such consequences are often overlooked or miscalculated
because device breakdowns are not just a cause of lost time
but have a direct effect on patient throughput, efficiency and
thus waiting lists. Therefore, the importance of effective
maintenance to reduce the occurrence of such incidents
cannot be overstated [3].
The management of this maintenance for single or few
devices is relatively simple.
However, most Hospitals have thousands of medical de-
vices and to correctly maintain these devices can be difficult
or impossible without a formalized computerized schedul-
ing system (database). Medical Physics departments should
have a structured approach to planned preventive mainte-
nance projects and should implement a computerized sys-
tem, or audit, refine and improve the effectiveness of the
existing implemented system [4].
Maintenance Planning constitutes a sustainable level of
activity (dependent upon adequate resources) commencing
with the development of the maintenance plan, implementa-
tion and performance review [5].
The difference between planning and scheduling needs to
be clear. These are differing areas worthy of differing
measurement and improvement initiatives.
Planning can occur at any stage during the life of a works
order. An electronic indicator in the work-order system
needs to be able to identify the work-order by 'status' i.e.
planned, ad-hoc, remedial, etc.
In this manner work orders requiring parts, procedures,
documents, skills or specialist test equipment can easily be
focused [3].
Software System for Medical Device Management and Maintenance
A work order cannot be considered planned until all of
these have been properly considered and made available.
The analysis of workflows for medical equipment mainte-
nance can be done on the basis of analyzing the actors, the
working steps and the triggering events for maintenance
interventions [4].
First, an actor is the person involved in the maintenance
service. The main kinds of actors are the following:
− Clinical staff, medical qualified personnel (e. g. doctors,
nurses, medical technical assistants, laboratory person-
nel, etc.). They are the users of the equipment.[6]
− In-house (maintenance) technicians in charge of medi-
cal equipment and other employees of in-house mainte-
nance areas (e. g. building services)
− Technicians from external maintenance service provid-
ers (medical technology manufacturer, service provider,
etc.)
Second, a working step is any task required for maintenance
purposes. Some of them can be the following:
− Alarm generation (fault detection), i.e. the action that
fires the maintenance procedure because the occurrence
of a possible misbehavior has been detected.
− Fault diagnosis, i.e. the identification, isolation and
location of the fault and possible causes. All the actors
could be involved in this task.
− Service intervention: this is cut normally into the so-
called first line service which is often ensued by captive
medical technician and if necessary by the following
service of an external service technician (medical tech-
nology manufacturers, other service providers or the
like) [7].
− Documentation: services rendered and expenditures
(time, spare parts, etc.) will be documented in conclu-
sion and future tasks will be specified (e.g. a short-term
inspection of the result of maintenance).
And third, a trigger event is a condition that fires some of
the working steps of the maintenance workflow. The main
triggers are the following:
− scheduled service intervention: via an a priori agreed
appointment (e. g. for a scheduled maintenance, safety-
related inspection or medical engineering inspection),
− spontaneous service intervention: through the occur-
rence of a device error.[7]
The single components (actors, events and working steps)
interact in the course of the service workflow according to
the particular device classes in different manner. Thereby,
different device classes (Magnetic Resonance Imaging
(MRI) vs. syringe pump) make very different demands on a
service management. Several criteria can be used to classify
medical equipment, as for example:
IFMBE Proceedings Vol. 36
85
− Location:
9 stationary medical technology (e.g. MRI)
9 mobile medical technology (e.g. syringe pump)
− Cost:
9 high investment volume (e.g. MRI)
9 low investment volume (e.g. syringe pump)
− Amount:
9 high quantity (e. g. syringe pumps)
9 low quantity (e.g. MRI)
− Diagnosis capabilities:
9 Small: devices without diagnosis capabilities and
non repairable equipment.
9 Medium: devices with the ability for auto diagnosis
9 Large: devices without prerequisites for auto diag-
nosis [3].
As a function of the device class there are different ap-
proaches with regard to the operational costs and the tech-
nologic effort concerning the service management mainte-
nance.
Risk Based Inspection Planning reduces maintenance
costs and improving efficiency.
Fig. 1 Risk Based Inspection Planning
It is becoming ever more important for medical devices
and their component parts to work longer at a minimal in-
crease to costs, improving patient care with higher levels
expected in terms of reliability and quality. Risk-based
inspection (RBI) can provide an auditable response to by
reducing medical device downtime through optimizing
inspection and testing strategies, and carrying out those
inspections where the devices are normally located.
The major benefits this offers the operator are:
9 Reduction in downtime
9 Reduction in the total inspection needed to jus-
tify safe operations
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9 Provision of intelligent 'common sense' inspec-
tion and testing regimes
9 Quantification of real risk.
Too often, the maintenance of equipment and its associated
inspections is regarded by budget holders as an "add-on"
cost. Risk Based Inspections enable budget holders not only
meet their bottom line targets but also their statutory re-
quirements through schemes based on due diligence.[3]
III. RESULTS
Medical devices are complex repairable systems consist-
ing of a large number of interacting components which
perform a system’s required functions. A repairable system,
upon failure, can be restored to satisfactory performance by
any method except replacement of the entire system. Medi-
cal devices usually undergo several types of
tests/inspections during their life cycles as described here:
• Acceptance Test
A series of qualitative and quantitative tasks designed to
verify the safety and performance of newly received equip-
ment, as well as conformity to applicable codes, regulations
and standards.
• Operational Check
Visual and operational check of the equipment’s safety and
functionality typically performed at the beginning of the day
or work period, or just before using equipment on a patient.
• Safety and Performance Inspection (SPI)
A set of qualitative and quantitative tasks designed to verify
the safety and performance of each piece of equipment by
detecting potential and hidden failures and taking appropri-
ate actions.
These tests/inspections are scheduled and it is very impor-
tant that we remember the periodicity of them. This is why
this software system that we developed it is very important
for medical devices proper functioning.
After accomplishing the acceptance test for a newly re-
ceived device, SPIs are scheduled to be performed periodi-
cally. The software system can help the biomedical engineer
to program the safety and performance inspection. If any
problem is found at inspection, corrective actions are taken
to restore the device or its defective parts to an acceptable
level. This operation it is also written in the maintenance
part of the program. By having all the problems that oc-
curred with that medical device a set of failure preventive
actions may be taken to prevent future failures and/or re-
store device function; these include part replacement, cali-
bration, lubrication, etc. to address age or usage related
deterioration.
IFMBE Proceedings Vol. 36
C. Luca and R. Ciorap
When a device fails while it is in use, the problem is re-
ported by the operator, and again appropriate actions (cor-
rective maintenance) are taken. When the repair of a device
is no longer technically feasible or cost effective, replace-
ment becomes the best or the only option. With the help of
this software we can calculate the costs in case of repair,
because he has a data base with the prices of all spare parts
and consumable for each medical device that it is in the
hospital. The user has the possibility to update the prices
every ear, at the signature of a new contract with the service
or supplies company. Figure 2 describes major tests and
actions performed during a device’s life cycle.
Fig. 2 Major tests and actions performed during a device’s life cycle
Currently, most hospitals merely follow manufacturers
recommended intervals for periodic SPI of devices. SPI
intervals differ from 6 to 12 months depending on the de-
vice type and risk level. Class III (high risk) devices such as
defibrillators should be inspected every 6 months, and class
II (medium risk) devices like ECGs should be inspected
annually. However, the optimality and even the necessity of
these recommended intervals are questionable. It is essential
to establish an evidence-based inspection or maintenance
regimen derived from analysis of field data.
Medical Device Management and Maintenance System
Architecture
Currently in Romanian hospitals doesn’t exist a software
tool for medical device management besides accounting
software although the preventive maintenance it is very
important for the medical device proper functioning. This
software:
− will provide a pool of medical devices, all required
information about these devices, and the maintenance
protocols for the devices.
− will also contain complete repair and maintenance his-
tory of a specific device.
− will create optimal maintenance schedule for devices.
− will enable the service technician to carry out and report
maintenance/repair processes .
− thus will prevent/minimize possible future failures.
− will provide an inventory of medical devices, spare
parts and consumables for each device.
The software system that we developed it is original be-
cause we used Visual FoxPro program, not Access or Excel
Software System for Medical Device Management and Maintenance
that are simply inventory programs. With this software the
user can build his own medical device database, spare parts
and consumable database or he can generate the mainte-
nance monthly report. He can also generate a report for
spare part or consumables annual requirements or cost of
individual devices in terms of maintenance.
The application will have a powerful evaluating facility.
Evaluation of the medical devices, the technicians and
the maintenance processes will be made automatically using
scoring databases. These databases will contain grading of
processes/properties which will be added up to make
evaluations. Keeping information of and evaluating the
technical staff is especially important as a significantly large
proportion of total human errors occur during the mainte-
nance phase.
While planning maintenance scheduling, the number and
the availability status of maintenance equipment should be
taken into consideration. Similarly, the number, status, and
expertise of technicians should be an input data. Availabil-
ity of medical device to be maintained and its maintenance
history are also required.
Maintenance frequency is affected by medical device re-
lated factors like:
Fig. 3 Database with medical device
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9 recommendations of the manufacturer and advi-
sory bodies,
9 age of the device,
9 past history of the device,
9 experience and knowledge of the user, and fre-
quency, environment and nature of use.
In case of failure, the action to be taken is to adjust a new
maintenance schedule after approximating repair period;
meanwhile the technician/user will be directed to a repair
request form for the medical device.
These operations will not be done manually; underlying
software will run after each newly entered/updated mainte-
nance document and will make maintenance scheduling.
Qualitative tests mainly consist of visual inspection of
the main parts/components of a device. For a general infu-
sion pump, these include testing its chassis/housing, line
cord, battery/charger, etc. Quantitative tests include measur-
ing parameters of a device to check whether or not the pa-
rameters are in control. Grounding resistance and maximum
leakage currents are among the quantitative tests for a gen-
eral infusion pump.
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A work order presents all PM checks and actions, such as
cleaning, lubricating or replacement of a device or its parts.
A work order is also created for an acceptance test of a
newly received device.
The third process is designing and implementing an opti-
mal maintenance schedule.
Fig. 4 A typical work order
The access is limited with technician’s authorities. The
technician is supplied with the maintenance protocol and the
maintenance history of the device. Besides, he is informed
about the jobs ahead he is responsible for and is alerted for
incomplete jobs.
Operation Modes can be further divided into three.
The first process is forming databases of all devices,
maintenance protocols, technicians, trainings, maintenance
equipment, maintenance calendar, etc. Recording, update
and deletion are main processes in terms of data
management.
Fig. 5 Examples of principal fields in databases
The second process is the display of the database; it in-
cludes construction of many reports.
IFMBE Proceedings Vol. 36
C. Luca and R. Ciorap
9 Preparing proper reports, it will be able to track
the devices in the hospital, the status of devices,
the most problematic devices, the problems ex-
perienced (frequency and reasons either), the
cost of individual devices in terms of mainte-
nance, etc.
9 The reporting process will help the directors in:
• following the medical equipment,
• finding out which devices are most prob-
lematic,
• which are most expensive to maintain,
• finding out the most experienced problems
and the reasons of problems etc.
9 An underlying program will be run in cases of
maintenance entry or update (like case of fail-
ure).
9 A change in technician record or maintenance
accessory record (i.e. ammeter is impaired) will
also cause the program to run.
9 The program will make a new schedule, opti-
mizing many parameters like technician, main-
tenance device, medical device availability, rec-
ommended device maintenance period,
approximate repair duration, historical data
about maintenance activity of the medical de-
vice, etc.
Fig. 6 Example of report designer
9 The beginning to manage this is creating and
maintaining of database files required for
Software System for Medical Device Management and Maintenance
optimization. The rest is to implement a well
built algorithm for optimizing maintenance
schedule.
A new test record / maintenance form will be created for
each maintenance process, which will contain:
9 instructions,
9 a to do list which will be checked out by the
technician as the process goes on,
9 and some information space to be filled by the
technician, like the nature of the problem, the
work carried out, the measurement values, the
results of the work done i.e. succeeded or not,
etc.
These maintenance records will be associated with the de-
vice being processed, and will totally constitute the repair
and maintenance history of the device.
IV. CONCLUSIONS
Hospitals have thousands of medical devices and to cor-
rectly maintain these devices can be difficult or impossible
without a formalized computerized scheduling system (da-
tabase). The maintaining process it is a very important part
for any medical device. If a preventive maintenance it is
correctly done and at time the costs with the medical device
will be cheaper.
This Software System for Medical Device Management
and Maintenance provide a database of medical devices, all
required information about these devices, and the
IFMBE Proceedings Vol. 36
89
maintenance protocols for the devices. With this software the
user can build its own medical device database, spare parts
and consumable database or can generate the maintenance
monthly report. The user can also generate a report for spare
part or consumables annual requirements or cost of individ-
ual devices in terms of maintenance.
Because the application software contain complete repair
and maintenance history of a specific device, will pre-
vent/minimize possible future failures.
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3. Ion R.A. Sonnesmans PJM, Planing maintenance for medical devices,
version B, 2009
4. EN ISO 9001:2000, Quality management systems - Requirements,
Part4.1: General requirements, 17-18.
5. DrägerRemote Service, Dräger Medical AG & Co. KG Lübeck 2007
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Author: Radu Ciorap
Institute: “Gr.T.Popa” University of Medicine and Pharmacy
Street: Kogalniceanu 9-13
City: Iasi
Country: Romania
Email: radu.ciorap@bioinginerie.ro.