Page 250 - Safety Risk Management for Medical Devices

CHAPTER 33

Special Topics

Abstract
In this chapter some special topics are covered that are not per se, part of the risk management
process, but are of interest to practitioners of medical risk management.
Keywords: Personal liability; combination medical devices; complacency; Cassandras

In this chapter some special topics are covered that are not per se, part of the risk
management process, but are of interest to practitioners of medical risk management.

33.1 THE CONUNDRUM

Human psychology tends to become myopic and lose sight of potential dangers, if
there are no perceptible signs of danger. This is why most governments tend to react
to disasters at a much higher cost, than prevent disasters at a lower cost.
Likewise, when risk management predicts high risk of an adverse event, if there
have not been any reported occurrences of the adverse event, people tend to think “it
hasn’t happened before, therefore likely it will not happen in the future.” This kind of
thinking diminishes the level of attention that high-risk events deserve.
Successful risk management results in nothing bad happening. This may lead to a
lack of appreciation by the outsiders, including management. A sense of complacency
could set in, and attention and investment in risk management can diminish.
Sometimes even political motivations and aspiration can get involved. Careers tend
to get advanced when a person steps up in a crisis and saves the day. It is thought that
Winston Churchill said: “Never waste a good crisis.” Heeding warning of risk man-
agement to avert an unprecedented crisis could appear as wasting money and resources
on something that has not happened before. And if nothing happens, the precaution-
ary actions don’t receive credit. On the other hand, ignoring the warnings of risk
management and taking a chance could result in the crisis, which could create the
opportunity for a “hero” to step up and fight the fires. It doesn’t matter whether the
hero succeeds or not. Heroism will be rewarded.

Safety Risk Management for Medical Devices r 2018 Elsevier Ltd.
DOI: https://doi.org/10.1016/B978-0-12-813098-8.00033-7 All rights reserved. 229