Articles on Law, Science, and Engineering

CLASSIFYING MEDICAL DEVICES[index]

Some medical devices, such as a tongue depressor, have a low indeterminacy index and a low dangerousness index. Others, such as a pulse oximeter, have low indeterminacy but high dangerousness. Medical devices such as anesthesia machines combine high indeterminacy and high dangerousness, creating a high legal risk when in the hands of an incompetent user. Thus, logically, anesthesia machines resemble airplanes, not lawnmowers. Because they combine high indeterminacy and high dangerousness indices, they cannot be rendered safe for incompetent users.

However, licensing authorities have not adopted this logic for anesthesia machine users. The result has been the decimation of the anesthesia machine industry in the United States. Since competence is not required of anesthesia machine users, the courts have adopted a lawnmower standard rather than an airplane standard. From an engineering perspective, requiring complex devices to be idiot proof is absurd. Legally, however, it is a reasonable response to the real world operating environment for medical devices.

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