Medical device regulations and patient safety in developing countries

Medical Device Regulations and Patient Safety
in Developing Countries

Michael Cheng

International Development Worker, Canada, cheng12@sympatico.ca

Keywords: medical device regulations, patient safety,
acquire it and subsequently, the users have the
medical device user responsibilities, medical device
responsibility to ensure its safe use with a patient [2].
education, healthcare facility responsibilities


2. Three Essential Steps
Abstract


The three essential steps to ensure patient safety in
Globally harmonized safety and performance criteria
using medical devices are discussed below.
for medical device regulations enunciated by the

Global Harmonization Task Force ensure product
2.1 Step 1 - General product safety.
safety and instructions for use. However, ultimately

patient safety requires users to take up their A country (economy) should establish regulations to
responsibilities. Three essential steps to ensure
ensure that medical devices available on its market are
patient safety in using medical devices are discussed
generally safe. The assessment of the general safety
herein. These three steps can be incorporated into a
aspects of a medical device in compliance with the
graphic three-stage life-span policy framework to
GHTF criteria [6] required a high level of expertise;
promote safe and optimal use of medical devices;
however, there are ways to reduce this regulatory
such a simple framework can facilitate education and
burden [10]: i) take advantage of the resources and
communication on medical devices among all work done by the Founding Members of the GHTF,
stakeholders. The term “user” in this paper means all
or by other countries/economies with a well
those who use medical devices directly or indirectly
established medical device regulatory system, by
including government, healthcare facilities, individual
accepting their Domestic Market Authorization for a
professionals or lay persons.
particular device. This way, a regulatory authority

can ensure that its own citizens are protected to the

same degree as the citizens of the recognized
1. Introduction
country/economy; ii) for local manufacturers, or a

device that does not yet have any market
The intrinsic safety of medical devices cannot be
authorization, a regulatory authority can engage an
guaranteed. The globally harmonized safety and
international Conformity Assessment Body (CAB) [5]
performance criteria [6] for medical device to assess a medical device’s compliance with a
regulations enunciated by the Global Harmonization
specified medical device regulation.
Task Force (www.GHTF.org) are endorsed by the

five founding members (Australia, Canada, European
2.2 Step 2 - Product safety in local context
Union, Japan the United States) who produce the
Traditionally, the majority of medical devices are
majority of global medical devices. The GHTF
designed for use in industrialized countries; and local
scheme is increasingly used by countries/economies
environmental conditions and human factors in
around the world and is based on risk management
developing countries will have an impact on the safety
principles to ensure that the manufacturer meets the
of such devices. Therefore, before adopting a medical
regulatory requirements in designing, producing, device, user assessment of the appropriateness of the
packaging and labeling the product [10]. Labeling
device, given local environmental conditions
includes a description of the device, the intended use
(climatic, organizational, infrastructural etc) and
and instructions for use.
human factors, is an essential step.

Safety assessments of medical device in compliance
Medical devices are designed to operate safely within
with the GHTF criteria can be regarded as a general
defined temperature and humidity ranges. In
product safety assessment that leads to a market
developing countries, many healthcare facilities are
authorization issued by a country’s (or economy’s)
without environmental control and are subject to
regulatory authority (first step). Two additional steps
extreme temperature and humidity variations that can
are essential to ensure ultimate patient safety: it is
cause malfunctioning and jeopardize safety.

the users’ responsibilities to make sure that, from the
Electrical power voltage stability (supply level
large authorized medical device market, they select
variation) and continuity (power outage), as well as
the device appropriate to their human factors and
the quality of community water supply (purity,
environmental conditions before making a decision to
hardness) can all affect device safety. For example,
the findings from a mission to an island state [13]

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revealed that illness symptoms of patients under
and establish in-house training programs to ensure
dialysis treatment were caused by impurities of the
continuing safe use.
community water supply. The frequent break-down
Many medical devices require proper maintenance
of a computer-controlled sterilizer was due to the
(including repair and calibration) to preserve their
hardness of the community water supply that quality state of safety. To solely rely on the vendor to
produced sediments blocking water flow required to
provide such services is not practical: apart from
operate the sterilizer. Although a sterilizer is not used
great costs, such services often are not readily
directly on a patient, the malfunctioning of a central
available geographically in most developing countries
sterilizer impacts patient safety of the entire resulting in weeks or months of down-time waiting
healthcare facility.
for services. For example [13], an island state had
The keynote address of the GHTF 2006 conference
five hospitals that relied mostly on external expertise
[1] asserted that “human factors in medical sent bi-annually from Australia to maintain its
technology are key to patient safety”, and pointed out
medical devices. Simple devices such as
the five dimensions that influence human factors were
laryngoscopes and operating room suction pumps
physical, psychological, organizational, policy and
were left non-functional until the next bi-annual
political. In the United States, an FDA guidance
repair. This situation had serious patient safety
document on human factors [7] states that “a device
implications in terms of diagnoses and treatment. If a
that is easy for one person to use safely and
suction pump stops functioning during a surgical
effectively might present problems for another person.
procedure and there is no immediate repair or
Similarly, a device that is easy for a certain group of
replacement, patient safety is jeopardized.
users to use safely and effectively could be difficult
The importance of maintaining simple but essential
for another group”. Clearly such situations will apply
medical devices is often overlooked. It was
even more so if users in different countries with
demonstrated [13] that 90% of the medical devices in
diverse psychological, organizational, healthcare the five hospitals waiting for external maintenance
priorities, resource and political background are
expertise could actually be repaired by a local
considered. Medical devices that are difficult to use
technician with basic training. It is important that
carry high risks of use errors that compromise patient
healthcare facilities in developing countries establish
safety.
in-house or shared regional medical device
Developing countries need to assess the multi-
maintenance services [4] to keep essential devices in
dimensions of human factors, environmental good working order and arrange with vendors for
conditions in their local context before deciding to
training to do at least frontline maintenance on
adopt a medical technology with associated devices.
complex devices, leaving only specialty services to
the vendor or company contracts. Device down-time

can be fatal to patient safety. The problems of
2.3 Step 3 - User training and device maintenance
medical device maintenance in developing countries
seem to be ever present as reported in a recent WHO
Unlike a pharmaceutical where active ingredients
meeting [12]. Effective medical device maintenance
deliver their intended effect, a medical device is a tool
programs can be greatly enhanced by Good
dependent on user skills to effect patient outcome. A
Management Practices where user training and device
“perfectly” safe device, if used incorrectly, will harm
maintenance are strengthened with other essential
the patient.
management elements [3, 8, 11}
Vendors of medical devices normally will provide

user training upon delivery of the device, but this is
3. Simple Framework for Education and
often not sufficient because familiarity or skills in
Communication
using the device take time to develop and refresher

training courses are often necessary. A practical
Education and communication is key to patient safety.
solution is for healthcare facilities to establish on-
Various groups of professionals in industrialized
going in-house training programs for medical device
societies and international agencies are eager to help
users. Such programs are particularly important when
developing countries in safe and optimal utilization of
healthcare professionals in developing countries are
medical devices. However, the vast amount of current
changed frequently. For example, during a mission to
literature and guidelines on medical devices activities,
an island state [13], a fibreoptic gastrointestinal scope
written in different contexts by different groups
was reported to have caused an injury to a patient. No
employing diverse terminologies, has made it difficult
defect was found in the device but it was revealed that
for anyone to navigate and digest the information.
the surgeon who originally bought the gastrointestinal
Simple and easy-to-use guidelines are needed.
scope and had had training on its use had left, and the

replacement surgeon had no training before using
It appears useful to find a simple framework to relate
gastrointestinal scope. Health facilities must mandate
the vast medical device literature to all stakeholders to
user training before anyone can use a medical device
inform and cooperate with each other. A graphic
overarching policy framework (Figure 1) has been

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developed and used in a World Bank Brief [9] to

convey medical device issues to the World Bank Task
4. Conclusion
Managers and their client country counterparts such

as Ministers of Health. The framework provides a
1) Medical device regulations govern product safety
big-picture view of three key activities of stakeholders
while patient safety relies on users taking up their
over the life span of a medical device. It consists of
responsibilities to assess a device appropriate to their
three stages reflecting the consumer market: 1) market
local context and subsequently to ensure its safe use.
product regulation for general safety and
performance; 2) user assessment according to needs;
2) Education and communication is key to patient
and 3) user utilization and disposal.
safety. The simple policy framework (Figure 1)

provides a big-picture view to promote safe as well as

optimal utilization of medical devices. Developing
See Figure 1 on last page
countries should take advantage of richer countries’

work done on stage 1 and stage 2 in the framework,

but it is important to carefully analyze and interpret
This simple framework can be easily understood by
the results in their local contexts. Ideally, they will
all stakeholders including the public and used as a
place an emphasis on stage 3 and allocate adequate
basic reference. Any medical device literature or
resources for healthcare facilities to establish Good
detailed activities can be linked back to this Management Practices for medical devices because
framework for their ultimate impact on the three key
only they can help themselves to this operation stage.
functions. For example, the three essential steps

described in Section 2 can be incorporated as
Future work
components into the corresponding three stages of

framework in Figure 1. In stage 2, focused
1) The three-stage policy framework in Figure 1 is an
assessment, in addition to product safety in local
early attempt to find a simple tool to facilitate
context, can also include formal Health Technology
education and communication on medical device
Assessment (HTA) for various desirable cost and
matters among the stakeholders with widely different
benefits considerations. Here again as in step 1,
backgrounds. Readers are encouraged to further
developing countries can take advantage of work done
explore the usefulness of this framework, to improve
by industrialized countries (www.HTAi.org and its
on it or to create a better tool. The writer
links) but it is important to analyze and interpret the
(cheng12@sympatico.ca) would be grateful to learn
results in local context. In stage 3, user training and
about the results of their effort
device maintenance are two of the essential elements

of Good Management Practices [3, 8, 11].
2) Along with the goal to develop simple guidelines

that are easy to use in developing countries, a
As another example, this graphic framework can help
challenge for the clinical engineering communities
reader to better understand the important World
and international development agencies is to identify
Health Assembly Resolution WHA60.29 [14] on
what are the essential elements for managing medical
medical devices. The five recommendations to
devices that constitute Good Management Practices.
Member States in that Resolution are complex.
A nine-element scheme has been proposed [3] as a
Readers can see that the key messages from the
starter. Further collaborative development from
Resolution relate well to the policy framework in
international clinical engineering communities is
Figure 1. The use of the framework helps to organize
necessary to arrive at a harmonized guidance on this
key messages of WHA60.29 in a logical sequence for
subject.
action.

References



1. J. B. Cooper. “Medical Technology: Patient
4. M. Cheng. “Priority in maintenance
Safety is Paramount. Keynote Address,
essential medical equipment”, World Health
GHTF 2006 Conference
Forum, vol.15, pp196-199, 1994
2. M. Cheng, B. Fahlgren. “A Stakeholders
5. European Commission: “New Approach
Responsibilities Framework for Medical
Notified and Designated Organisations”
Devices”. Joint Word Bank-World Health
http://ec.europa.eu/enterprise/newapproach/n
Organization Poster Presentation, GHTF
ando
Conference 2006, Lübeck, Germany, 2006
6. Global Harmonization Task Force.
3. M. Cheng, J. Dyro, “Good management
“Essential Principles of Safety &
practice for medical equipment”, Clinical
Performance of Medical Devices” Guidance
Engineering Handbook. Burlington, MA:
document SG1-N41R9:2005.
Elsevier Academic Press. ISBN:
http://www.ghtf.org/documents/sg1/sg1n41r
012226570X, 2004
92005.pdf

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References (cont.)

7. USFDA. “Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk
Management”, 2000
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094460.htm
8. World Bank. “Proceedings: International Forum for Promoting Safe and Affordable Medical
Technology in Developing Countries”. Washington DC: 2003
9. World Bank. “An Overview of Medical Device Policy and Regulation.” Washington DC, 2007
http://siteresources.worldbank.org/HEALTHNUTRITIONANDPOPULATION/Resources/281627-
1109774792596/HNPBrief8.pdf
10. World Health Organization. Medical Device Regulations: Global Overview and Guiding Principles,
ISBN 92 4 1546182, 2003. http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf
11. World Health Organization. Chapter 2 “Medical Equipment Management in District Health Facilities:
Guidelines for Development and Operations” Western Pacific Regional Office, Manila, Philippines, ISBN 92-
9061-121-9, 1998
12. World Health Organization. “Report of the 2nd Meeting of the WHO Technical Advisory Group on
Health Technology”, Rio de Janeiro, Brazil, 08-09, November 2009
13. World Health Organization. “Biomedical equipment and maintenance”. Mission Report
MR/1999/0446: Western Pacific Regional Office, 1999
14. World Health Organization. The World Health Assembly Resolution WHA60.29, 2007
http://www.who.int/medical_devices/resolution_wha60_29-en1.pdf









1. Device Market Regulation
2. Adoption / Selection
3. Utilization / Disposal



General assessment with

Safe, effective use and
globally harmonized criteria
Focussed Assessment according
performance surveillance

local needs and context




Good Manufacturing Practices
Good Management Practices


Figure 1: graphic life-span policy framework to promote safe and optimal use of medical devices

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