Biomedical Engineering Reference
In-Depth Information
No
Provide warnings
and directions
for use
Is the
product
“duly safe”?
Perform testing
and analyses to
characterize risks
A product
design
Ye s
Implement quality
control measures
Post-market
surveillance
Market
Figure
5.4
Licensing Process of the US Food and Drug Administration.
Adapted from: B. Fishhoff and J.F. Merz, 1994, “The Inconvenient Public: Behavioral Research Approaches to Reducing Product
Liability Risks,” in: National Academy of Engineering.
Product
Liability
and
Innovation:
Managing
Risk
in
an
Uncertain
Environment
, National Academy Press, Washington, DC.
safeguards to prevent future failures. One example of product liability oversight is that of the US Food
and Drug Administration (FDA). Figure 5.4 is a simplified model of FDA's licensing process.
The reasons that products fail are twofold. Either they have flaws or they are misused. Engineers
clearly have an ethical responsibility to prevent the first cause and arguably much of the second cause.
Good engineering practice prevents the first, but what about the second? At what point are engineers to
blame for misuse of their products?
Blame is an interesting ethical and psychological concept. Sometimes, when it is clearly their own
fault, people will willingly accept the blame for not using a device or drug properly. For example, they
may readily see that they ignored a warning label to avoid taking certain drugs while consuming alcohol
or to quit playing contact sports after recurrent concussions. Increasingly more likely, however, they are
looking to blame someone else. This inclination can result both cognitively and motivationally, as noted
by Baruch Fishhoff, a psychologist, and Jon Merz, an engineer:
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Cognitively, injured parties see themselves as having been doing something that seemed sensible at the time,
and not looking for trouble. As a result, any accident comes as a surprise. If it was to be avoided, then
someone else needed to provide the missing expertise and protection. Motivationally, no one wants to feel
responsible for an accident. That just adds insult to injury, as well as forfeiting the chance for emotional and
financial redress.
Of course, the natural targets for such blame are those who created and distributed the product or equipment
involved in an accident. They could have improved the design to prevent accidents. They should have done
more to ensure that the product would not fail in expected use. They could have provided better warnings
and instructions in how to use the product. They could have sacrificed profits or forgone sales, rather than
let users bear (what now seem to have been) unacceptable risks.
Another explanation of misuse may fall under the first definition as a design flaw. It is known as “risk
homeostasis”
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. Basically, users defeat built-in factors of safety by asserting new way to use the products.
If such aggressiveness occurs, it may simply be because consumers want more from their products. Some
