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Determining Who Should Use a Medical Device

The courts have not established criteria for classifying machines as to the necessary competence of the user. The critical parameters for such a classification may be grouped under the heading of indeterminacy. If indeterminacy is measured from 0 to 1, a completely understood machine with a limited number of fixed behaviors would have an indeterminacy index approaching 0. A machine with an unlimited repertoire of behaviors would have an indeterminacy index of 1. The more indeterminate a machine, the more the designer must rely on the user to control the behavior of the machine. A lawnmower has a low indeterminacy because it has a limited purpose and well-defined operational modes. Conversely, personal computers and airplanes are highly indeterminate.

The indeterminacy index must be coupled with a dangerousness index to predict legal liability properly. An unprogrammed personal computer is highly indeterminate, but its potential for injuring people is limited. An airplane is also indeterminate, but it has great potential for causing injury. Using the 0 to 1 scale for dangerousness, a computer might be 0.05 and an airplane 0.9. The legal risk associated with the use of a machine by an incompetent user will be a function of the indeterminacy and the dangerousness of the machine. Applying this analysis to a lawnmower, one finds that although a lawnmower is dangerous, it is dangerous in a limited number of manageable ways. Through proper engineering, a lawnmower can be made relatively safe for an inexperienced user. An airplane, however, combines both high indeterminacy and high dangerousness and cannot be made safe for an inexperienced user.

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. Anesthesia machines combine high indeterminacy and high dangerousness, creating a high legal risk when in the hands of an unsophisticated user. Legally, anesthesia machines should be treated like airplanes, not lawnmowers. Because they combine high indeterminacy and high dangerousness indexes, they cannot be rendered safe for incompetent users.

Unlike the Federal Aviation Authority, boards of medical examiners do not require physicians or other persons to be trained and certified to operate medical devices. Since there is no legal requirement of proved competence for anesthesia machine users, the courts have adopted a lawnmower standard rather than an airplane standard to judge the design of anesthesia machines. From an engineering perspective, requiring complex devices to be error proof is absurd. Legally, however, it is a reasonable response to the real-world operating environment for medical devices.


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