Proceedings of the 20th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Vol.

20, No 6,1998

RISK MANAGEMENT IN MEDICAL EQUIPMENT MANAGEMENT

R.D.Wilkins*,L.K.Holley**

*BiomedicalEngineering Service, Northern Sydney Area Health Service, St Leonards

email: rwilkins@doh.health.nsw.gov.au

**Department of Health Sciences, University of Technology, Sydney, Broadway

email: loraine.holley@uts.edu.au

Biomedical Engineering departments and Clinical

Abstract
The complexity of medical equipment continues to
increase, with a greater possibility that patient care could
be compromised. The ability of the clinical user of
medical equipment to venfy the function of some medical
devices is reducing; in some cases it is non-existent.
In an environment of increasing litigation, the pressure to
“get it right” in the management of medical equipment is
paramount. The financial pressures on health care are
also increasing. The need to minimise medico-legal
proceedings while cutting costs in the management of
medical equipment generate a challenge to balance
conflicting requirements of a Clinical Engineering service.
Risk Management can optimise the balance between
financial pressures, and the desire for safe and functional
medical equipment. This requires professional input from
clinical and engineering professionals to iden* potential
compromises to patient or operator safety, and the
appropriate remedial measures.
While the competing influences of financial efficiency and
clinical safety are relatively well recognised, an additional
moral obligation is less widely recognised. Information
about the management of medical equipment by a health
care establishment should be available to patients. This is
arguably an important part of the patient’s “informed
consent” for a procedure, though not a popular suggestion
with hospital management.
Keywords - Risk Management, Medical Equipment,
patient consent
Historical Background
Much of the management of medical equipment within the
clinical engineering environment originated from the fears
of patient electrocution in electromedical areas in the
1960’s and 1970’s. This resulted in the prediction of what
we now recognise as the “epidemic that never happened”
- extensive medical electrocutions of patients [’I. The
resulting evolution of Medical Electronics departments,
0-7803-5164-9/98/$10.00 0 1998 IEEE 3343
Engineering departments is directly attributable to the fear
of this “epidemic”.
Numerous texts on the management of a medical
equipment inventory were published, all focusing on the
electrical hazards of medical equipment, prescribing that
all equipment should be tested and certified according to
manufacturer’s specifications, supported by extensive
database recording and tracking of medical equipment[31.
Such approaches took no account of differing patterns of
usage, different levels of equipment backup, or operator
skills in the clinical environment. At best, they defined a
conservative average approach to the management of
medical equipment. In an environment of financial
constraints and increased accountability, and changing
public perceptions of health care, this “text book”
approach no longer seems universally appropriate.
Risk Management
The application of Risk Management to many aspects of
modern life involves a new approach to the identification
and management of potential outcomes associated with a
very wide range of activities. While the concept of risk
has long been appreciated in the use and management of
medical equipment, the formalised process of Risk
Management has not yet been extensively applied to the
management of medical equipment.
The renown British physicist Lord Kelvin would
presumably have expected accurate quantification as a
precursor to the activity of Risk Management. He is
quoted as saying that “anything that exists, exists in some
quantity and can therefore be The
implication drawn from the statement is that anything
whch cannot be measured is not a science, and is not well
understood. By this assessment, much of Risk
Management would fail to meet Kelvin’s expectations of a
science. While we can all be impressed as was Lord
Kelvin by numbers, those numbers must ultimately reflect
social values in the priorities they impose on equipment
management processes.
 ~
The Principles of Risk Management are well defined in a
range of text books, and national Standards[’], and are
applicable to the management of medical equipment. The
application of a Risk Management approach enables the
optimisation of the balance between the risks of litigation
and the cost minimisation.
The Risk Management Process
In most texts and references, there are five distinct
components of a Risk Management program:
Establish the context
Identlfy the risks
Analyse and assess the risks
Treat the risks
Monitor and review throughout the process
Perhaps the most important part of the process, and the
most likely to be overlooked is the final monitor and
review. This should be continuous and should feed back
into each of the other processes. Each part of the Risk
Management process is relatively self explanatory,
perhaps with the exception of establishing the context.
It is necessary to establish the organisational context
appropriate to the management of medical equipment - to
understand the organisation and its capabilities, its goals,
objectives and the strategies whch are in place to achieve
them. For example:
Risk management must be implemented in the context
of the wider goals of the organisation.
Failure to reach the objectives of the organisation is
itself one set of risks which should be managed.
Organisational policy helps decide the acceptability of
certain risks.
Social Values and Risk Management
Social values must be considered as a background to Risk
Management procedures. The extent of risk retention
varies according to organisational culture and context.
The European Standard IEC5 13[61,has some important
statements which prevent the endless discussions which
can otherwise focus on “what is safety?”.
“It is impractical to expect absolute safety in the use of
medical ... equipment”.
“The word “safety” generally refers to freedom from
unacceptable risk.
The Standard also quotes another ISO/IEC document:
“..safety is a balance between freedom from risk, and other
demands on a product, process or service, including utility,
suitability and cost”. In any risk assessment process, the
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balance between risk and cost must also take into account
the effect of failure to use the product.
As quoted in Standard IEC513, a medical device which
saves a thousand lives and injures one person may be
preferable to a device which saves a hundred lives and
injures no one. Whether such an ethical position is
universally agreed is unclear.
There are several changes which have increased the
pressure to “get it right” over the last few years:
More equipment exhibits a functional complexity
which requires specialised testing and functional
verification procedures, or test equipment beyond the
expected resources of the clinical user.
Many western societies are progressively becoming
more litigious, with all processes being subjected to
greater scrutiny.
Resources for support of health care equipment
continue to reduce, as the pressure increases to be
leaner and smarter in our operations.
The resource implication is being acknowledged by
Australian Standard AS355 lL7] which no longer specifies
that everythmg possible must be done to support
equipment, but is moving towards the exercise of
professional judgment in the management of equipment.
Thus the management of medical equipment throughout
its clinical life is no longer subject to a prescriptive
approach, but requires the extensive application of
professional judgment.
While manufacturers speclfy the extent and regularity of
functional testing and appropriate their equipment, they
rarely prioritise that testing. They also never acknowledge
that equipment can be subject to very different usage
patterns, and that the importance of the same device
depends on the application. Clearly a device in a day
surgery will be subject to different usage patterns and thus
technical support than that required by the same devices
located in a helicopter-based medical rescue service.
Australian experience indicates that the rescue unit,
subject to extremes of vibration, salt water, sand ingress
and emergency usage, warrants considerably more
extensive and regular functional verification than that
prescribed by manufacturers for what they presumably
anticipate as average conditions of usage.
Clearly some medical equipment has little potential to
compromise patient care, and can justifably be treated just
like the furniture in a health care establishment. However,
some equipment has an enormous potential to compromise
patient care, by virtue of its design and manufacture, its
complexity or obscurity in clinical usage, or perhaps its
demanding requirements for maintenance and functional
verification by the Clinical Engineering sewice.
It is important to recognise that the safe use of medical
equipment should be regarded as the responsibility of the
whole health care establishment, akm to the modern
approach to Occupational Health and Safety issues. The
safe use of medical equipment must include considerations
of user competence which may vary from novice to
experienced, varying technical and clinical knowledge of
users, and the implementation of a continuing education
program for clinical staff.
Considerable information about equipment selection and
support, as well as the local culture concerning medical
equipment management should be available to the
discerning patient in order to support the process of
informed consent.
Current Practice
Few, if any, Clinical Engineering services have the
resources to do everything that they identlfy as being
beneficial in the management of medical equipment. This
dilemma is universal, whether we look at in-house
hospital services, private contractors providing equipment
support services, or equipment manufacturers and their
agents. None are funded to do all that might be expected
when systems are surveyed retrospectively in the light of
threatened litigation.
-
Such a situation is not new practitioners of Clinical
Engineering have always faced this dilemma, and have
addressed it in a variety of ways. Even the Standard
IEC5 13 notes that “Almost any equipment design could be
modified to make it safer...However such improvements
are likely to involve additional costs or a loss of utility.” It
is therefore necessary to decide whether each risk is
acceptable, or whether it should be addressed by remedial
methods. The balance of risk, cost and utility is central to
the design of equipment, and also to the continuing
support of clinical equipment throughout its service life.
The Challenge
The challenge for practitioners of Clinical Engineering is
to implement a process of Risk Management in an
environment of financial constraint, while accommodating
a level of accountability to the patient. This accountability
exists, not only in the event of compromised patient care,
but also to provide appropriately accurate and detailed
3345
information to enable informed patient consent to be
given. The expectation of responsible disclosure of
relevant information is increasing as society moves toward
a less paternal approach to health care, and consumers
take a more active and discerning interest in their own
health and medical care [*I.
The balance between risk and cost is not static - it changes
with time. It is not universal - it dlffers between
establishments. This balance is not readily quantifiable,
though it is supportable by quantified data. It is socially
constrained. The information on which the medical
equipment management decisions are based should be
available as part of the accountability of the health care
establishment.
Our challenge is to manage our operations to optimise the
balance within these constraints.
References
[l] Bruner J.M.R. & Leonard P.F., Electricity, Safety and
the Patient, Chicago, Year Book Medical Publishers, 1989.
[2] Wald A., Book review of Bruner & Leonard in IEEE
Engineering in Medicine and Biology, September 1990,
~~68-9.
[3] Adams J., Risk, London, UCL Press, 1995
[4] Bronzino J.D. (ed) Management of Medical
Technology, Boston, Butterworth-Heinemanq 1992.
[5] Australian Standard AS4360:1995, Risk management.
[6] E C 5 13:1994 Fundamental aspects of safety standards
for medical electrical equipment.
[7] Australian Standard AS355 1-1996, Technical
management programs for medical devices.
[8] Waller L, Patients and their doctors, Issues Paper 4,
Winter, The Australian Institute of Health Law and Ethics,
1997.