All engineering designs have inherent risks regardless of whether people directly interact with them or not. Risks represent possible negative occurrences that are associated with design operation. When the public’s health and safety is at risk, there often is disagreement over the appropriate approach to risk. The work of engineers in medical device development is designed to affect the health and wellbeing of the public. To ensure the effect on public health is positive, these engineers must approach risk in a way that is neither solely technocratic nor democratic.
Common Medical Device Risks
According to the Center for Devices and Radiological Health (2000), use-related hazards are the most common risk associated with medical devices (CDRH, 2000, p.7). In use-related hazards, it is not primarily the device that fails but the operation of it. Consider the danger of a device that returns reasonable but inaccurate results when used incorrectly. These erroneous results may mask severity and are not aberrant enough to cause doubt. The prevalence and insidiousness of this risk necessitate thorough risk mitigation.
The risk of premature device wear is particularly common in implantable device design. Racine (2013) notes in their journal article covering metal-on-metal total hip replacements that multiple design flaws caused accelerated metal corrosion (Racine, 2013, p. 16). The debris generated caused poorer device performance and damage to surrounding tissue. Reducing this risk is a priority as it results in substantial individual harm and monetary losses for the producer.
Complete device failure is not a common risk among current devices due to improvements in quality and regulation. Strict regulation has not fully ...
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...sk-benefit analysis be used. Engineers in this industry should endeavor to mitigate all risks they feasibly can. Although money may motivate feasibility, a marginal benefit approach should primarily be adopted when the design must be high risk.
The three risks discussed are not paradigmatic examples of risks requiring a completely technocratic or democratic approach. However, they do illustrate some of the organizational impediments to moral responsibility. Use-related risks are a good example of ignorance serving as an impediment to making a more ethical decision. Premature wear risks tend to be an example of a groupthink mindset where everyone agrees that limited data over an insufficient range is satisfactory. Finally, the proposed risk handling procedure endeavors to derail microscopic vision by reducing risk before considering the benefit or even cost.
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