Page 248 - Safety Risk Management for Medical Devices

CHAPTER 32

Axioms

Abstract
Axioms are self-evident truths upon which we build our knowledge and analysis.
Keywords: Axioms; system safety; safety vs. reliability

Ten axioms of medical device risk management that would be useful to keep in mind
are provided below:
1. Safety is not a function, but an attribute
Customers acquire medical devices for clinical benefits, and expect safety
2. Hazardous Situations can arise even when there are no faults, i.e., under
normal operational conditions
3. Safety is an emergent property of the System
Knowledge of safety of System components does not assure safety of the
System
4. A Hazard cannot result in Harm until a sequence of events leads to a
Hazardous Situation
5. Safety and reliability are not the same thing
See Chapter 13, Safety Versus Reliability, for more details
6. Severity is a qualifier for Harm

7. Death is not a Harm
Death is a potential consequence of a Harm

8. Risk Controls are targeted at risk reduction (severity | likelihood)
9. Software is never a Hazard; but can contribute to a Hazard

10. Highly reliable software is not necessarily safe

Safety Risk Management for Medical Devices r 2018 Elsevier Ltd.
DOI: https://doi.org/10.1016/B978-0-12-813098-8.00032-5 All rights reserved. 227