Page 23 - Safety Risk Management for Medical Devices

2 Safety Risk Management for Medical Devices

Although the techniques, information, and tips that are offered in this book are
intended for medical technology and devices, other safety-critical fields can also bene-
fit from the knowledge gained herein.
One of the factors that should be kept in mind in the analysis of risks is that the
risk is not a deterministic outcome, but rather a probabilistic phenomenon. The same
therapy from a device could have different consequences for different patients.
Variations in patient physiology and environmental conditions can contribute to vastly
different severities of harm, from patient to patient.
Risk management before a product is launched is about predictive engineering—
to forecast risks, and attempt to reduce and control the risks to acceptable levels. This
is in contrast to postmarket risk management which takes the reactionary approach of
root cause analysis, and Corrective and Preventive Actions after an adverse event has
happened in the field.
Manufacturers are not expected to be error-free, flawless, or perfect. They are
expected to use sound processes and good judgment to reduce the probability of
harm to people.
A sound and properly executed risk management process does not render a risk-
free medical device. It does imply that the best efforts were made to produce a device
that is adequately safe—a device that provides benefits which outweigh its risks.
Human beings are prone to errors and poor judgment. This is called misfeasance in
legal terms. It is different from malfeasance, which is deliberate or deceptive actions
intended to release a device that is not adequately safe.
Safety risk management is applicable to the entire lifecycle of medical devices
including design, production, distribution, installation, use, service, maintenance,
obsolescence, and decommissioning, and even destruction or disposal.
Although Harm is defined as “injury or damage to the health of people, or damage
to property or the environment” [1], in this book, we focus on injury or damage to
the health of people. Damage to property or the environment that has a direct impact
to the health of people is also within the scope of this book.
The words: System, Product, and medical device are used interchangeably in this book
to refer to the target of the risk management process.
Styling—In this book, words that have specific meaning in the world of risk man-
agement are capitalized to distinguish them from the ordinary dictionary meanings.
Examples: Cause, End Effect, and Risk Control.