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Therac-25 Case

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Honesty and Deception

Honesty and Deception issues are central to this case. In several places, AECL representatives made claims of safety for the Therac-25 device that in retrospect seem at least exaggerated.

How did this occur? These claims were made by individuals (salespersons, engineers), on the behalf of an organization (AECL). Individuals making claims like these have some responsibility to check on their accuracy. But salespeople have little expertise to evaluate this information and are thus more dependent on the organization. Engineers, including software engineers, have the capability of evaluating the claims though they may be allowed little time in which to do so. Again, we find a balance between the engineer’s responsibilities to the company (use time efficiently) and to the consumer (evaluate carefully claims made about the product). Because of their special expertise, it is precisely the role of a professional to balance these conflicting responsibilities, and not to neglect responsibility to the consumer.

What organizational responsibilities might there be regarding claims of safety in medical devices? AECL representatives in several instances made claims that no overdoses had occurred with the Therac-25 machine, when there was clear evidence that someone at AECL must have heard of several previous accidents. This suggests that there may have been some internal miscommunication within AECL. Some portions of the organization may have known about the lawsuit regarding radiation harm but not have had the time or seen the need to inform other parts of the organization. For instance, those in the legal division, hearing of the lawsuit, may have assumed that the engineers were aware of the issue and that there was no immediate need to contact them. This sort of miscommunication is a daily matter in organizations, even small one (think of the miscommunication that occurs in your family).

Thus one part of the organization may have been making claims that no accidents similar to the reported ones had occurred based on the information available to them. Still, when the stakes are as high as they were in this case, organizations have a special responsibility to transmit safety critical information as quickly and as accurately as possible. This occurred sometimes within AECL (the FDA was notified quickly of the Hamilton accident) but not all the time.

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