Page 40 - Safety Risk Management for Medical Devices

Understanding Risk 19

Michael Lewis says in the Undoing Project [13] “What people call risk aversion is
tantamount to a fee that people pay, willingly, to avoid regret a regret premium.”
Let’s say you are at a horse race, and you have $5 to bet. They give you 10 to 1 odds
on a horse. That is, there is a chance that in a short amount of time you can get
1000% return on your money. Or, you can lose your $5. Avoiding taking this risk
means you are willing to pay a $50 premium not to feel the regret of losing $5, if your
horse didn’t win. How this plays out in medical devices is that people are willing to
forego a high chance of benefit from a device, to avoid a low chance of receiving
health damage from the device. This calculus changes if a person is desperate. For
example, terminal patients are willing to accept higher risk devices for a lower benefit.

4.5 RISK COMPUTATION

Clause 4.4 of ISO 14971 [3,7] requires that the manufacturers estimate the risks
associated with each Hazardous Situation. The Standard [3,7] offers a figure in its
annex E, which is replicated in Fig. 4.1. The interpretation of this figure is that after
a Hazard has manifested, through the progression of a sequence of events, a
Hazardous Situation is realized, where people, property, or the environment are
exposed to the Hazard(s). The probability of occurrence of the Hazardous Situation
is called P 1 . Given the Hazardous Situation, there is a probability that the subject

Figure 4.1 ISO 14971 Figure E.1.