Medical Device Safety
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• Safety can only be considered in relative terms.
• All devices carry a certain degree of risk and could cause problems in specific
circumstances.
• Many medical device problems cannot be detected until extensive market experience is
gained.
• For example, an implantable device may fail in a manner that was not predictable at the
time of implantation; the failure may reflect conditions unique to certain patients.
• For other devices, component failure can also be unpredictable or random.
• The current approach to device safety is to estimate the potential of a device becoming a
hazard that could result in safety problems and harm.
• This estimate is often referred to as the risk assessment.
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• Hazard is a potential for an adverse event, a source of danger.
• Risk is a measure of the combination of
1) the hazard
2) the likelihood of occurrence of the adverse event
3) the severity or overall impact
• Risk assessment begins with risk analysis to identify all possible hazards, followed
by risk evaluation to estimate the risk of each hazard.
• In general, risk assessment is based on experience, evidence, computation, or even
guesswork.
• Risk assessment is complex, as it can be influenced by personal perception and
other factors such as cultural background, economic conditions, and political
climates.
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• In practice, risk assessment of medical devices is based on the experience of health
care professionals and on safety design engineering.
• In the United States, governmental risk assessment of medical devices is based
mainly on recommendations from members of 16 medical specialty panels, and
devices are categorized into three classes.
• In the European Union and Canada, the classification schemes for medical devices
are predominantly rule based.
• These rules categorize medical devices according to their perceived potential
hazards.
• Canada assigns four classes of devices.
• The European Union assigns three classes with class II being sub-divided into IIa
and IIb (effectively, also four classes).
• The Global Harmonization Task Force (GHTF) is proposing a harmonized scheme
for medical device classification (see [Link] document SG1/N015R18).
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• In classifying devices, potential areas of hazard that warrant consideration include
Degree of invasiveness
Duration of contact
The body system affected
Local versus systemic effects
• An invasive device is usually considered to have higher potential hazard than an equivalent non-
invasive device (e.g. there are invasive and non-invasive blood pressure monitors).
• Similarly, devices that have a long duration of contact, that affect vital organs such the heart or the
great arteries, or that have systemic effects are assigned higher classes of potential hazard or risk.
• The degree of regulation imposed on any device is proportional to its potential hazard.
• This approach is known as risk management.
• It is incumbent on the medical device manufacturer to demonstrate that all possible risks associated
with the device are identified and adequately addressed.
• The role of the regulatory authority is to ensure that the manufacturer has effectively implemented the
risk management process and fulfilled other regulatory requirements.
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• The first requirement of the “Essential principles of safety and performance of medical devices”
recommended by the GHTF (SG1-N020R5) illustrates that:
Medical devices should be designed and manufactured in such a way that, when used under the
conditions and for the purposes intended and, where applicable, by virtue of the technical knowledge,
experience, education or training of intended users, they will not compromise the clinical condition
or the safety of patients, or the safety and health of users or, where applicable, other persons,
provided that any risks which may be associated with their use constitute acceptable risks when
weighed against the benefits to the patient and are compatible with a high level of protection of
health and safety.
• This statement highlights the risk/benefit nature of medical devices.
• The goal, therefore, is to maximize benefit and minimize risk.
• Manufacturers of medical devices also use the risk management approach.
• The International Organization for Standardization (ISO) has produced a document (ISO
14971:2000) providing manufacturers with a framework including risk analysis, risk evaluation
and risk control for risk management in medical device design, development, manufacturing as well
as for monitoring the safety and performance of the device after sale.
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Effectiveness/performance of medical devices
• Every device has a designed purpose. • Clinical effectiveness is a good indicator of
device performance.
• A device is clinically effective when it
produces the effect intended by the • Performance, however, may include
manufacturer relative to the medical technical functions in addition to clinical
condition. effectiveness.
It is easier to measure objectively and quantify performance than clinical effectiveness.
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Phases in the life span of a medical device
• The figure illustrates the major phases in the life span of a medical device from conception
and development to disposal.
• The activity phases are simplified to make it easier to understand the regulatory system.
For example, the development phase includes development planning, design
verification/validation, prototype testing and clinical trials.
• In practice, the phases outlined below may overlap and interact.
• It is important to recognize that any of these phases can affect the safety and performance
of a medical device.
Conception
& Packaging &
Manufacture Advertising Sale Use Disposal
Developmen Labelling
t
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Examples of how each phase can create health hazards are described below:
1 Conception and development
• The scientific principles upon which a device is based are
fundamental to its safety and performance.
2 • For example, a cardiac pacemaker should deliver a minute
electrical impulse of a certain size and shape that simulates the
3 natural functioning of the heart. Significant deviation from this
may compromise safety and performance.
• The more complex the device, the higher the risk of user error.
4 • Soundness of concept and adequacy of design, construction, and
testing (including verification, validation and clinical trials)
5 require the scrutiny of scientific experts to ensure that design
parameters and performance characteristics do not impose
unwarranted risks.
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2 Manufacture
• Good, functional medical devices are produced when the
manufacturing process is adequately managed.
3 • However, poor manufacturing management can produce
inconsistency in the quality of products, such that non-
4 conforming devices can filter through the production line to the
market, even when the original prototype has been well-
designed.
5 • This consideration has led to the development of Good
Manufacturing Practice (GMP) for drugs, biological products
and medical devices.
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Packaging and labelling
2 • Properly packaged medical devices pose little risk to individuals handling them, even if
the medical device is biohazardous.
3 • This highlights the importance of well-designed packaging systems in delivering clean,
sterile and protected medical devices to the point of use.
• Shipping is one of the hazards a medical device and its packaging must survive.
4 • Subtle damage can result during transportation and handling unless the total packaging
system is designed robustly and can withstand various stresses.
5 • Well-sealed packaging is essential for those medical devices that must be maintained
sterile.
6 • Labelling is crucial in identifying the medical device and specifying instructions for its
proper use.
• As for drugs, mislabelling of medical devices can result in serious consequences for the
7 user.
• Hazard warnings or cautions and clear instructions for use are very important. 11
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2 Advertising
• Advertisement has the potential to create expectations and
3 powerfully influence the belief in a medical device’s capabilities.
• It is important, therefore, that medical device marketing and
4 advertising are regulated to prevent misrepresentation of a medical
device and its performance.
• Misleading or fraudulent advertising of medical devices may increase
5 sales.
• However, from the buyer’s perspective, the purchase of an
6 inappropriate medical device is a waste of money that may deprive
the patient of more appropriate treatment and could lead to patient
or user injury.
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2
3
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5 Sale
• The sale of medical devices by the vendor is a critical stage that leads
to the device being put into actual use.
6 • If the vendor is not subject to regulation, then there is higher risk of
exposing the public to low quality or ineffective devices.
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2 Use
• Users of medical devices can have a profound effect on their safety and effective
3 performance.
• Unfamiliarity with a certain technology or operating procedure, and the use of
products for clinical indications outside the scope of those specified in the labelling,
4 can cause device failure even in the absence of any inherent design or
manufacturing defects.
5 • Within the clinical engineering community, it is widely believed that user error
underlies at least half of all medical device-related injuries and deaths.
• The re-use of disposable devices contrary to the manufacturer's instructions, and
6 without proper control or precautions for minimizing associated risks, can be
dangerous.
•
7 The lack of, or inappropriate, calibration and maintenance of medical devices can
seriously jeopardize their safety and performance.
• These issues are often overlooked or underestimated. 14
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2
3
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5 Disposal
• Disposal of certain types of devices should follow specific and stringent
6 safety rules.
• For example, devices that are contaminated after use (e.g. syringes) or
7 devices that contain toxic chemicals, can present hazards to people or
the environment and must be disposed of properly.
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Participants in ensuring the safety of medical devices
Conception & Packaging &
Development Labelling Sale Disposal
Manufacture Advertising Use
MANUFACTURER VENDOR USER
The manufacturer usually The term Vendor includes The User is usually a
manages the first three phases importers, distributors, professional in a health
of the medical device’s life span. retailers and manufacturers care facility, but may also
who sell medical equipment. be the patients
• In addition to these three categories of person who are directly involved with the different phases of medical devices,
the Public/Patient and the Government are also key interested parties.
• The public are the ultimate beneficiary of medical devices, and in the case of over-the-counter (home-use) devices,
they are the user as well.
• The government has the responsibility of overseeing that medical devices sold in the country are safe and effective.
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• Together, the Manufacturer, Vendor,
Manufacturer
User, Public and Government are the
stakeholders.
• All five play critical roles in ensuring
the safety of medical devices.
• The most important factor that
Vendor Government ensures the cooperation of all these
Shared Responsibility stakeholders is an informed and
Communication common understanding of the issues.
Participation • Shared understanding and
Education responsibility are achieved through
Risk/Cost Assessment communication and mutual education,
which can be effectively achieved by
having all stakeholders participate in
establishing the process that ensures
safety and performance of medical
devices.
User Public/Patient
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• The manufacturer, as the creator of the device, must ensure that it is
Manufacturer
manufactured to meet or exceed the required standards of safety and
performance.
• This includes the three phases (design/development/testing,
manufacturing, packaging and labelling) that lead to a product being
Vendor ready for the market.
• The term “user error” is defined as an act that has a different result
than that intended by the manufacturer or expected by the operator.
User • User error may result from a mismatch between variables, for example
the operator, device, task, or environment.
• By incorporating human factor engineering principles in design, and
Public appropriate training for users, the risk of user errors can be
minimized.
Government
The role of each participant/ stakeholder 18
• The vendor provides the interface between the product and the user.
He/she should ensure that the products sold comply with regulatory requirements.
Manufacturer
With increasing public interest in health and a competitive marketplace, vendors should be
careful to avoid making misleading or fraudulent claims about their products or issuing false
compliance certificates.
In addition, used or refurbished devices should be clearly labelled as such.
Vendor
• Participating in post-market surveillance (receiving and reporting customer
complaints/incidents) is critical for ensuring medical device safety and performance.
Vendors should provide after-sale service.
User Medical devices often require specialized training from the manufacturer for proper use and
service; therefore, the vendor should make training a condition to the manufacturer or
importer in accepting to sell the device.
In turn, vendors should take responsibility in supporting or training their customers.
Public
• The vendor must fulfil these obligations specified by the regulatory authority.
For example, the vendor must make arrangements for processing complaint/incident reports
relating to medical device safety and performance.
In the case of home-use medical devices, the vendor should recognize that the device being
Government sold might end up in the hands of a layperson who may need special instructions for the
proper use and maintenance of the device.
In this situation, efforts must be made to provide non-technical instructions and to educate
and help the customer.
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• The user should make sure that he/she has qualifications and training
in the proper use of the device, and is familiar with the indications,
contra-indications and operating procedures recommended by the
Manufacturer
manufacturer.
• It is crucial that experience gained with medical devices be shared with
other users, the vendor and manufacturer to prevent future problems.
Vendor
• This can be done by reporting any incidents to a Coordinating Centre
from which warnings can be issued.
• When using medical devices, users should always bear in mind that the
User
safety and health of the patients are in their hands.
• The user has the responsibility to employ the medical device only for
the intended indications (or to assure that any non-indicated use of
Public the medical device does not compromise the safety of the patient and
other users).
• The user also has the responsibility to ensure proper maintenance of
Government medical devices during active use and safe disposal of obsolete
medical devices.
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Manufacturer
Vendor
• The public are the ultimate beneficiary of medical devices.
• They should be fully aware that all devices carry a certain risk and
User
that they can help to promote safety and performance through self
education and by putting “customer pressure” on manufacturers to
comply with standards.
Public • Medical devices are increasingly available for home use, making the
Public the direct user.
• Purchasers of home-use medical devices should be aware of
Government associated risks and take the responsibility to become educated in the
functions and correct operating procedures for those devices.
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Manufacturer
Vendor
User
• The government has the responsibility to oversee the efforts of
manufacturers and vendors and ensure that medical devices sold or
made available in the country are safe and effective.
Public
• It should provide leadership in creating healthy cooperation among
stakeholders in establishing policies and regulations that are fair and
clear to all.
Government
• Policies and regulations should be reviewed periodically to respond
to changes in technologies by incorporating appropriate amendments.
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Shared responsibility for medical device safety and performance
• In conclusion, the ideal conditions that
will ensure the safety and performance
of medical devices require shared
responsibility by all stakeholders.
• This need for cooperation is illustrated
below.
The circle formed by the stakeholders
illustrates the shared responsibility.
The diamond handshake symbolizes
cooperation and two-way communication
(2-way arrow).
The star highlights how the fundamental
elements for cooperation function best
when all stakeholders communicate with
each other.
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Critical elements for regulatory attention
• Pre-market review contributes to product
control.
• Post-market surveillance ensures that Product Use
medical devices in use continue to be safe and
effective.
• There is an important third element, which is
the representation of the product to the
user.
• This is controlled through labelling (during Representation of
the pre-market stage) and advertising of the Product to User
product.
• Another aspect of product representation,
however, is verbal presentation by the vendor.
• User/public education is key in guarding
against misrepresentation.
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Stages of regulatory control
Conception & Packaging &
Development Labelling Sale Disposal
Manufacture Advertising Use
Pre-Market Placing On-Market Post-Market
Surveillance/Vigilance
Pre-market control is performed Placing-on-market control Post-market surveillance/
on the device to ensure that the ensures establishment vigilance ensures the
product to be placed on market registration, device listing continued safety and
complies with regulatory and after-sale obligations. performance of devices in
requirements. use.
Labelling and advertising control is
maintained for correct product
representation.
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A common framework for medical device regulations
Stage PRE-MARKET PLACING ON-MARKET POST-MARKET
Control/Monitor Product Sale After-sale/Use
Person Manufacturer Vendor Vendor/User
Device attributes Establishment Surveillance/
Safety and registration vigilance
performance -List products -After-sale
available or in use obligations
Manufacturing -Requires vendor to -Monitoring of
Quality systems fulfil after-sale device’s clinical
obligations performance
Items Or Activities Labelling -Problem
Regulated (representation) Advertising identification and
-Accurate description (representation) alerts
of product Prohibits misleading
-Instructions for use or fraudulent
advertisement
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