Advances in Biomedicine and Health Science

Risk Management for Medical Devices

CĂLIN CORCIOVĂ, MARIUS TURNEA, RADU CIORAP
Department Biomedical Science
Faculty of Medical Bioengineering, “Grigore T. Popa” University of Medicine and Pharmacy - Iasi
M. Kogalniceanu Street, No 9-13, Iasi
ROMANIA
calin.corciova@bioinginerie.ro, http://www.bioinginerie.ro

Abstract: - Medical devices developed for human application are used for diagnostic or treatment purposes.
They may either be an instrument, an apparatus or a material. Moreover, these devices can be used for daily
patient care as well as for medical scientific purposes. Risk management involves the identification,
understanding, control, and prevention of failures when the medical devices are connected to the patient and
also for the people who use these medical devices. In this paper, we present a multi-criteria decision-making
model to prioritize medical devices according to their criticality. Devices with higher criticality scores can be
assigned a higher priority in a maintenance management program. A computerized medical management
system is described. The results demonstrate that it is a useful tool in tracking device inventory and
maintenance history. Also risk classes have been designed for medical devices based on the time of testing, risk
must be identified in relation to patient and personal staff. The results of this paper take into consideration the
advances in device reliability, reduced preventive maintenance requirements, and internal device surveillance
(self test) along with changes in standards.

Key-Words: - criticality prioritization, medical devices, models, maintenance requirements, risk, software

1. Introduction
The globalization of the medical device market error, should be calculated in both normal and faulty
place, combined with the growth of medical device conditions. If any risk is judged unacceptable, it
usage, has led to a significant increase of the should be reduced to acceptable levels by
complex task of making a medical device safe for appropriate means. An overall risk management
human use activity among device manufacturers. process involves the essential steps in Fig 1 [3]. In
Risk management has become an important order to manage risk, hazards must first be
competitive tool to gain access to foreign markets. identified. By evaluating the potential consequences
As clinicians, patients, regulators, and litigators of hazards and their likelihood, a measure of risk
become more sensitive to safety issues related to can be estimated.
human factors, the importance of appropriate
translation and safety controls will increase [1]. Risk
management is necessary to ensure device usability,
safety, and regulatory compliance. In some cases,
critical human factors and risk management
decisions are made that depend on specific language
in the user interface or labeling. For instance,
hazardous situations can arise based on improper
interpretation of date/time information or units of
measurement displayed.
Risk management involves the identification,
understanding, control, and prevention of failures Fig. 1. Risk Management Flow Chart
that can result in hazards when people use medical
devices. Manufacturers are expected to identify This paper presents a software system,
possible hazards associated with the design in both integrating a number of software packages, serving
normal and faulty conditions. The risks associated specific management processes, each of them able
with the hazards, including those resulting from user to work either as a stand alone application, or

ISBN: 978-1-61804-190-6 51
 Advances in Biomedicine and Health Science
interlinked between each other through properly
designed communication tools and facilities.
2. Problem Formulation
The risk assessment should be done for each new
device type during the incoming inspection when
the device is added to the inventory. The device will
then have a testing frequency assigned. After this is
done, the maintenance history of the device should
be monitored in order to evaluate the effectiveness
of the maintenance program (Fig.2).
Fig. 2 Logical diagram for assessing medical
equipment
The main objective of this software system is to
assist the biomedical engineer or clinical engineer in
performing tasks, concerning the assurance of safety
and efficiency in use of medical equipment.
Requirement analysis resulted in the following
features, which the system should include:
- Management of data for medical devices,
manufactures and suppliers;
- purchasing procedures;
ISBN: 978-1-61804-190-6
- Implementation and management of the quality
and safety protocols and procedures, including the
necessary documentation and data;
- Corrective maintenance activities;
- Scheduling of all the routine procedures, like
acceptance testing, preventive maintenance, quality
and safety inspections;
- Management and monitoring of the training
provided by the manufactures or technical staff
include biomedical engineer or clinical engineer;
- Monitoring of the quality of the overall
performance of the department, using quality and
cost indicators;
- Report generation predefined or customized by
the users.
Medical equipment should be evaluated to
determine how often testing should be performed. If
a device is not tested often enough, it may fail
before the next scheduled maintenance or give
erroneous results. If a device is tested too
frequently, time that could be better spent
maintaining other equipment is wasted. The
biomedical professional’s job is to achieve a balance
between the time and effort needed for periodic
functional testing and the safe use of medical
equipment. In order to maintain an efficient
maintenance program, the frequency of inspection
must be determined [4].
Effort should be spent on equipment where
testing is likely to have an impact on the continued
safe operation of the medical device. The software
has developed to a risk-based system for
determining the maintenance frequency. Intervals
are established for equipment inspection based on
risk, requirements, logistics, and history. Written
criteria are used to identify risks associated with
medical equipment per the maintenance strategy.
The risks include equipment function, physical risks
associated with use, and equipment history as it
relates to patient safety. Life support equipment is
specifically identified and receives the highest
priority for actions.
The risk criterion is divided into four categories:
clinical function, problem avoidance probability,
incident history, and regulatory or manufacturer
requirements. Devices are given a score for each of
these categories. The scores for each category are
added up and a total score is given for each device
type. Maintenance strategies are determined based
on the total score. A combined score of 12 or more
is justification for semiannual testing, a score of 9-
11 is justification for annual testing, and a score of 8
or less is justification for less than annual testing,
either bi-annual or no scheduled testing, depending
on clinical application. The result is a more cost-
52
 Advances in Biomedicine and Health Science

effective test program that will result in improved
patient care through less equipment downtime and
more dollars for direct patient care activities.
3. Problem solution
Understanding what devices are in the facility in
order to provide a quality maintenance program is
critical. Inventory data is used for a variety of
applications including establishing a maintenance
schedule, tracking medical device hazards and
recalls, and deciding when to replace aging
equipment [7].
A computerized medical equipment management
system is an useful tool in keeping track of the
device inventory and maintenance history. Any
medical equipment management software should
track basic device information. At a minimum, the
device type, manufacturer, model, and serial number
should be tracked. This information is essential to
the maintenance program. The clinical use of a
device should be documented. Equipment used for
life support needs to be given a higher priority for
maintenance. Additionally, regulations on life
support devices may be different. Our software
developed in Visual FoxPro respect all these
conditions above.
The equipment location is used to find the
equipment for maintenance. Also, the location is
useful to break up the maintenance schedules by
department (Fig. 3).
The developed program allows user access,
service employees involved, depending on the
characteristics of each job description and duties
(Fig.4).
A record should be kept of all maintenance
performed on equipment, including scheduled
maintenance, repairs, software upgrades, and
incident investigations (Fig.5). Dates of service
should be included in this history.
Fig. 5. Identification data of the medical equipment
The software comprises all the information
stored in predefined catalogs supported by the
system (suppliers, manufactures), as well as data
regarding the types of failures that have occurred, or
can potentially occur to medical equipment.
The Services module, concerns the system
management supporting possibilities. It covers basic
maintenance and management operations. It
includes acquisition, concerning new device
purchase, offer estimation and contract
management, periodic inspections of medical
devices.

Fig.3 Access in to the system

It also contains information about the hospital

itself, its departments, personnel and specialties.
Detailed hospital profile is also available, presenting
an additional general hospital information, including
its identity data, such as address, number of beds,
number of personnel, technical staff.

Fig. 6. Module record of servicing equipment

Clinical function represents how invasive the

equipment is to the patient. At the low end of this
category is a device that does not make patient
Fig. 4. User access in the application contact, for example, an exam light. The high end of

ISBN: 978-1-61804-190-6 53
 Advances in Biomedicine and Health Science
this category is a device used for life support, such
as a ventilator.
Problem avoidance probability is based on
historical data related to medical equipment repair
and maintenance. The low end of this category is
maintenance or inspection having no impact on the
reliability of the device; the high end is common
device failures are predictable and can be avoided
by preventive maintenance. This category also has
an additional level, specific regulatory or
manufacturer’s requirements that dictate preventive
maintenance or testing.
The device incident history is also based on
historic data. This category only has two scores, and
is answered as yes or no. If a device had a history of
being involved in an incident resulting in patient
harm, the device would score high. Otherwise, the
device would score low.
4. Results and discussions
To illustrate risk criteria we discussed the two types
of equipment used extensively in healthcare:
defibrillator and enteral feeding pump.
Defibrillators deliver an electric impulse to the
heart through the chest wall in order to restore a
normal rhythm in patients experiencing ventricular
fibrillation or ventricular tachycardia. The high
electrical energy stops the independent action of the
individual muscle fibers, so that the natural
Table 1 Sample risk assessment for defibrillator
Criteria
Clinical function
No patient contact
Device may make contact with patient non-critical
Device is used for patient diagnosis or direct monitoring
Device is used to deliver direct treatment to the patient
Device is used for a life support
Problem avoidance probability
Maintenance would not impact reliability of the device
Common device failure modes are unpredictable
Common device failure is predictable and can be avoided by preventive maintenance
Specific regulatory requirements dictate preventive maintenance or testing
Incident history
No History
A significant history of incidents exists
Manufacturers/regulatory requirements for specific schedules
No requirements
There are requirements for testing
Times per year tested
ISBN: 978-1-61804-190-6 54
pacemaker of the heart can take over. A set charge is
generated and is delivered through a set of paddles
or disposable defibrillation electrodes through the
chest wall. The defibrillator’s output energy is
typically selectable from 0 J to 360 J. Most
defibrillators also include an electrocardiograph to
monitor the patient’s rhythm. Some defibrillators
include a pacer function. Electrical impulses are
delivered to the heart, causing the heart to contract.
This is used for emergency treatment of asystole,
severe bradycardia, implantable pacemaker failure,
or other conditions requiring emergency cardiac
pacing.
For this equipment verification procedure that
must contain: electrical safety - ground wire
resistance, chassis leakage, and lead leakage - and
performance inspection that include: measure if the
energy output of the defibrillator throughout its
range. At a minimum, measure the output at the
lowest setting, a mid level setting, and the highest
setting. The output should be within 15 % of the set
energy level. At 360 J, the energy output should be
between 306 J and 414 J. Another test is output
energy at maximum setting for 10 charge cycles. On
the tenth shock, the energy output should still be
within 15 % of the setting. Charge time after 10
charge cycles should not exceed 15 s.
Recommended functional test frequency:
semiannual (Table 1).
Risk Score
1
2
3
4
5 5
1
2
3
4 4
1
2 2
1
2 2
TOTAL 13
2
 Advances in Biomedicine and Health Science
Enteral feeding pumps are used in patients
without gastrointestinal complications who are
unable or unwilling to consume adequate nutrients.
Feeding solutions are delivered to the patient
through temporary or surgically implanted feeding
tubes. The pumps accurately control the flow of
liquid feeding solutions that are administered
enterally, through the digestive tract. These pumps
will utilize a pump mechanism such as a rotary
peristaltic pump, linear peristaltic pump, or a
volumetric pump. Most pumps record the dose rate,
dose settings, and infused volume in the memory.
Audible and visual alarms alert the user to flow
changes or malfunctions.
TABLE 2 Sample risk assessment for enteral feeding pump
Criteria
Clinical function
No patient contact
Device may make contact with patient non-critical
Device is used for patient diagnosis or direct monitoring
Device is used to deliver direct treatment to the patient
Device is used for a life support
Problem avoidance probability
Maintenance would not impact reliability of the device
Common device failure modes are unpredictable
Common device failure is predictable and can be avoided by preventive maintenance
Specific regulatory requirements dictate preventive maintenance or testing
Incident history
No History
A significant history of incidents exists
Manufacturers/regulatory requirements for specific schedules
No requirements
There are requirements for testing
Times per year tested
The advantages of this integrated system are
related to flexible management of small databases,
avoiding problems with lost and corrupted records,
higher system reliability, customized search
engines, high record processing speed, system
flexibility and real time data presentation and
analysis. Furthermore, the implementation of a
flexible communication connection between these
specific parts carries out the data transmission to the
central module, producing daily reports for medical
device condition and the necessary maintenance
procedures, needed to be accomplished.
4. Conclusion
Quality health services involve the correct and
efficient resources. A result that can not be
ISBN: 978-1-61804-190-6 55
The delivered volume should be within 10 % of
the set volume. For a set volume of 10 ml, the
measured volume should be within 9 ml and 11 ml.
The measured occlusion pressure should be within 1
psi of the pump’s occlusion pressure. For an
occlusion pressure of 20 psi, the measured pressure
should be between 19 psi and 21 psi. Recommended
functional test frequency: annual (Table 2).
Before returning to use, return any settings that
were adjusted to their original settings. Ensure the
volume of the audible alarms is loud enough to be
heard in normal operating conditions.
Risk Score
1
2
3
4 4
5
1
2 2
3
4
1 1
2
1 1
2
TOTAL 8
1
neglected is balancing investment and equipment
maintenance costs. Organization and proper use
equipment carried by a clear policy, supported by
technical guidance and practical tools to improve the
operation of equipment. Medical will be able to
significantly improve the quality of services
and service efficiency. Such management practices
will contribute to increased efficiency in health
sector will result in improved health outcomes and a
service as durable.
Equipment maintenance analysis to assess the
duration of life can be extended or shortened.
Such equipment maintenance is crucial for life. If
not is met on time and regularly, the device will
deteriorate to the point at which will cost more to fix
than to replace. If we do not interfere at all
 Advances in Biomedicine and Health Science
in the equipment maintenance, it will degrade
irreparably.
The importance of maintenance activities is to
effectively manage the equipment; this task
necessitates complex information about the medical
device. Thus it is necessary to make an archive of
what happened in the past, to tell if the situation
improves and you learn from previous situations.
Finally, record maintenance activities provide the
staff valuable technical information and evidence
that they can use when they need argues need help
or additional resources. Data base system
maintenance helps keep health service records of
repairs and other actions.
References:
[1] T. Cohen, Computerized maintenance
management system: “How to match your
department’s needs with commercially
available products”, Journal of Clinical
Engineering, vol. 20, No. 6, 1995, pp. 457-468.
[2] S. Panousis, P. Malataras, C. Patelodimou, Z.
Kolitsi, N. Pallikarakis, “Development of a new
clinical engineering management tool &
information system (CLEMANTIS)”, Journal
of Clinical Engineering, vol. 22, No. 5, 1997.
pp. 342-349.
ISBN: 978-1-61804-190-6
[3] Risk management guidance, Medical Equipment
Compliance Associates LLC, 2012.
[4] Introduction to medical equipment inventory
management, WHO Medical device technical
series, 2011.
[5] Medical equipment maintenance programme
overview, WHO Medical device technical
series, 2011.
[6] P. L. Jones et all, “Risk management in the
design of medical device software systems”,
Biomedical Instrumentation & Technology,
Jul./Aug., 2002, pp. 237-266.
[7] B. J. Wood, “Software risk management for
medical devices”, Medical Device and
Diagnostic Industry, Jan., 1999, pp 139-156.
[8] Ganeshkumar Palanichamy, Basic principles of
risk management for medical device design,
Wipro Technologies, 2010.
[9] H. Julian, Biocompatibility assessment of
medical devices and materials, John Wiley &
Sons, 1997.
[10] Inspection and preventive maintenance system,
ECRI Institute, 1995.
56