The Medical Devices Introductory Course 2020

Terms & Definitions

Harm •Injury or damage to the health of people, or damage to property or the environment

Hazard •Potential source of harm

Hazardous situation • Circumstance in which people, property, or the environment is/are exposed to one or more hazards Severity •Measure of the possible consequences of a hazard

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During transit, sterile barrier fails = non-sterile device

hazard

Probability of hazardous situation occurring P1

Circumstances affecting severity

Sequence of events leading to exposure

Transit damage not noticed = non-sterile device used

Hazardous situation

Probability hazardous situation leads to harm P2

Circumstances affecting severity

probability occurrence P = P1 * P2

= Patient infected ( local ) = Patient infected ( systemic )

harm severity of harm

RISK

The Organisation for Professionals in Regulatory Affairs