Biomedical Engineering Reference
In-Depth Information
Another aspect of ALARP that is especially important to device and system designs is that a margin of
safety should be sought. This margin is both protective and reasonable.
20
Reaching ALARP necessitates
qualitative and/or quantitative measures of the amount of risk reduced and costs incurred with the design
decisions:
The ALARP principle is based on the assumption that it is possible to compare marginal improvements in
safety (marginal risk decreases) with the marginal costs of the increases in reliability.
21
One of the challenges in applying a utilitarian model to engineered systems is that financial costs and
benefits are often easier, or at least more straightforward, to calculate than other (i.e., nonmonetizable)
costs and benefits. Another problem is the issue of the costs of not designing a solution to a problem.
For example, as mentioned in Chapters 1 and 5, the current controversies associated with conducting
research at the nanoscale (near the diameter of the hydrogen atom) are sometimes rooted in fears of
the potential Pandora's boxes of unknown technologies. If decisions are only made to avoid these
problems, society exposes itself to opportunity risks. In other words, if we inordinately avoid designs
for fear of potential harm, we may forfeit lifesaving and enriching technologies (e.g., drug delivery
systems that differentiate tumor tissue from healthy tissue based on electromagnetic differences at the
nanoscale).
Engineers must also be aware of vested and hidden interests. An emerging risk management tech-
nique is the so-called outrage management, coined by Peter Sandman, a consultant to businesses and
governmental agencies.
22
The first step of this approach is to present a positive public image, such
as a “romantic hero,” pointing out all the good things the company or agency provides, such as jobs,
modern conveniences, and medical breakthroughs. Although these facts may be accurate, they often
have little to do with the decisions at hand, such as the need for affordable health care. Another way
that public image can be enhanced is to argue that the company is a victim itself, suffering the brunt of
unfair media coverage or targeted by politicians. If these do not work, some companies have confessed
to being “reformed sinners,” who are changing their ways. One of the more interesting strategies put
forth by Sandman is that companies can portray themselves as “caged beasts.” This approach is used to
convince the public that even though in the past they have engaged in unethical and unfair practices,
the industry is so heavily regulated and litigated against that they are no longer able to engage in these
acts. So, the public is encouraged to trust that this new product is different from the ones that came
previously from the company. There is obviously some truth to this tactic, as regulations and court
precedents have curtailed a lot of corporate irresponsibility. But the engineer must be careful to discern
the difference between actual improvement and mere spin tactics to eliminate public outrage. And,
from an ethical perspective, the culture has not necessarily changed, only the extended controls on the
company.
Companies must look at the financial bottom line, but holding paramount the health, safety, and
welfare of the public gives the engineer no room for spin. Indeed, the public often exaggerates risks, and
abating risks that are in fact quite low could mean unnecessarily complicated and costly measures. It
may also mean choosing the less acceptable alternative, i.e., one that in the long run may be more costly
and deleterious to public health. The risk assessment and risk perception processes differ markedly, as
shown in Table 6.2. Engineering design makes use of problem identification, data analysis, and risk
characterization, including cost-benefit ratios. Perception relies on thought processes, including intuition,
personal experiences, and personal preferences. Engineers tend to be more comfortable operating in the
