1. Team / insight.
Running
the risk
BY LAUR A KAY E
Risk management – two words that make
most people squirm uncontrollably.
Although it is an essential part of
product development - especially in the
medical sector - it is often put off until
documentation is being completed at the
end of a development stage. To do this
is to misunderstand the purpose of risk
management, and is counter-productive.
Risk management is nothing to be scared
of, and can easily be applied throughout
the development process to help create
a better, safer product.
EN ISO 14971:2009 is the standard for
the application of risk management to
medical devices. Officially, it describes
a process for managing risks associated
with medical devices which provides
a means of conforming to Essential
Requirements of the Medical Devices
Directive 93/42/EEC.
Fortunately, it also includes guidance
on how to perform the risk management
and clear, specific definitions of the key
terms, which are subtly but crucially
different from their general meanings.
For example, it is important to note that
the concept of risk has two components:
the probability of occurrence of harm; and
the consequences of that harm, that is,
how severe it might be.
The risk management process is
underpinned by the risk management
plan. Annex F of the ISO standard
has guidance on how to develop a risk
management plan, which should describe
the activities undertaken at each stage of
the device’s lifecycle, the intended use of
the device, and who is responsible for the
risk management activities.
The risk acceptability criteria must be
included, to define which combinations
of probability of harm and severity of
harm are acceptable or unacceptable
(annex D contains guidance on devising
risk acceptability criteria). It’s also worth
considering including the main categories
of harm and their severities; it can take
time to determine the severities of harms
such as under/overdose or a dose to
third party, but these are crucial for the
subsequent estimation of risk.
The next stage, therefore, is to carry out
risk analysis: to systematically identify
and estimate the risks. This can include
techniques such as Preliminary Hazard
Analysis, Failure Mode and Effects
Analysis, Fault Tree Analysis and State
Space Analysis, and it is important to
select methods appropriate to the stage
of the project and the nature of the
product. Annexes C and E of the standard
contain questions and prompts which are
also useful to help to identify risks.
Risk evaluation is the application of the
risk acceptability criteria in order to
determine which risks are unacceptable
and therefore require risk reduction.
The hierarchy of risk control measures
should be applied to reduce risks:
1
Eliminate or reduce risks as
far as possible (inherently safe design
and construction).
2
Where appropriate, take adequate
protection measures, (including alarms
if necessary), in relation to risks that
cannot be eliminated.
3
Inform users of the residual risks
through instructions and warnings.
The risk analysis and evaluation stages
need to be re-visited throughout the
development, to calculate the residual
risk after control and also to determine
whether the control measures themselves
have introduced further risks.

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Risk Management
RISK
SAFETY CRITICAL
MANAGEMENT PLAN
MEDICAL FUNCTIONS
SAFETY CRITICAL
RISK ANALYSIS
MEDICAL FUNCTIONS
}
Risk
Assessment
RISK EVALUATION
SAFETY CRITICAL
RISK CONTROL
MEDICAL FUNCTIONS
Risk
management
is not just ‘some
paperwork
to take care of
before launching
the device’
Residual unacceptable risks are not
necessarily a barrier to marketing the
device. The residual risks need to be
weighed up against the benefits of using
the device, and this risk-benefit analysis
could require the collection of clinical
or other experimental data to provide
evidence of the benefits to the user.
At this stage the risk management
report is produced which reviews the
process so far and summarises status
prior to launch, but risk management
does not stop when the device is
PRODUCTION +
POST-PRODUCTION
RESIDUAL RISK
SAFETY CRITICAL
EVALUATION
MEDICAL FUNCTIONS
+ RISK-BENEFIT ANALYSIS
RISK
MANAGEMENT REPORT
MONITORING
released for production and enters
the market. A process of production
and post-production monitoring must
be employed to ensure that all relevant
information is used to update the risk
analysis. This process can include
customer surveys, servicing records,
complaints, QC reports and any other
sources of data which can be used
to refine the risk analysis estimates
and uncover additional risks which
were not foreseeable during the
development process.
In conclusion, risk management is not
just ‘some paperwork to take care of
before launching the device’; it needs to
be an integral part of the development
process and must continue once
the device is on the market. The risk
management of a medical device can be
long and complicated, but when done
properly it results in a better device –
saving time, money and even lives.
— Laura specialises in engineering
analysis such as math modelling,
tolerance analysis and FEA, and is
an expert in risk management.
laura.kaye@team-consulting.com