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About Risk Management For
Medical Devices
ISO 14971 defines risk as the
“combination of the probability of occurrence of harm and the
severity of that harm. Risk management for medical devices is “the
systematic application of management policies, procedures and
practices, to the tasks of analyzing, evaluating, monitoring and
controlling risk.
It’s important to note that severity
is a key component of risk management. Many people erroneously
assume that risk is purely a percentage. If 1 of every 1,000
people dies due to a faulty pacemaker, for example, that’s a more
severe “risk” than having 1 of every 300 who might suffer minor
burns due to poor design of an electrical component of a medical
device.
Risk management consists of two
parts: risk analysis and risk evaluation. This applies to all
phases of the device lifecycle, including planning/product
realization, design and development, purchasing, service and
change control. Types of hazards that need to be evaluated include
energy, biological, environmental, software, user error, labeling,
complexity of use and functional failure hazards. After risk
assessment and evaluation , we must create a plan of attack for
monitoring and controlling those identified risks.
Medical Device risk management is a
not a one-time project. It is an ongoing process of review and
risk assessment throughout the life of the device. Companies that
take the process seriously will reap the rewards of fewer defects,
increased user safety and, in some cases, reduced risk of
litigation. Post-market surveillance and vigilance (alert
watchfulness) are key tools in this process.
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