Page 251 - Safety Risk Management for Medical Devices

230 Safety Risk Management for Medical Devices

33.2 CASSANDRAS
Cassandra was a character in Greek mythology who could foresee future disasters but
was cursed by the gods so that when she would warn people, no one would believe
her. This is a term used to refer to people who warn of future disasters but are not
believed.
Richard Clarke, the former counterterrorism adviser to US presidents Bill
Clinton and George W. Bush, has written a book:“Warnings:Finding Cassandras to
Stop Catastrophes” [36]. In this book, he talks about how Cassandras can/should be
recognized, and how to benefit from their foresight while not being buffeted by too
much fear.
In medical device risk management, we are required to analyze risks from both
known and foreseeable Hazards. Cassandras tend to better see the foreseeable Hazards.
The problem is that if something has never happened before, it may be difficult to
persuade your organization to devote resources to it.
Clarke suggests not to be dismissive. Instead, take a surveillance and hedging strat-
egy. What this means is to spend a small amount of resources and monitor the fore-
seen Hazard. Perhaps do some experimentation, investigate, research, and gather data.
If the data supports the forecast, then devote more resources to mitigate the Hazard.
Otherwise, you may be able to disprove the hypothesis. You don’t have to make a
final decision at once. It can be taken in steps.

33.3 PERSONAL LIABILITY

Hiding safety-related defects or falsifying test results are illegal and carry serious legal
consequences, including personal liability on the part of the perpetrators. For exam-
ple, the Wall Street Journal published a story in Aug 9, 1996 that reported the convic-
tion of three C.R. Bard executives and sentencing them to prison-time for knowingly
conspiring to hide potentially deadly flaws in a catheter model, and selling devices
that had not been approved by the FDA. In another example, The Telegraph published
a story on Dec 10, 2013 about Jean-Claude Mas, the founder of PIP breast implants,
who was sentenced to 4 years in prison for the deliberate use of unapproved silicone
gel in breast implants.
It should be noted that this does not mean that if a medical device causes injury, it
is automatically concluded that people who were involved in the design and produc-
tion of that device are criminally liable. It is understood that even if manufacturers
follow sound practices for risk management, and do all they can to prevent injuries to
people, some injuries are inevitable.