Improved communication between customers, the FDA, and AECL could have prevented several of the Therac-25 accidents. All three parties share blame for their actions or inaction regarding these incidents.
The lack of a report to AECL and the FDA following the first incident at the Kennestone Oncology Center demonstrates that the communication system in place failed. Having determined that the machine operated in an unusual manner, the staff at Kennestone should have filed a report with AECL to alert them to the possibility of an equipment malfunction. Blame could be assigned to Tim Still, who contacted AECL about the incident but never explicitly mentioned what had happened or what he suspected. On the other hand, a more aggressive policy of product responsibility at AECL would have led the company to ask Still about the causes for his inquiry. To a cynical observer, it might appear as though both parties were attempting to ignore the incident as much as possible. Whatever their motivations, both parties engaged in vague and incomplete communication.
The difficulty involved in discovering the causes of Therac-25's malfunctions might lead one to ask what action AECL could have taken had they known about the Kennestone incident sooner. They could have warned other customers to be on the lookout for malfunctions, to increase logging and oversight, and to inform AECL if any unusual events occurred. With increased vigilance, the next several incidents would have alerted customers to the possibility of serious product flaws. However, the customers had no reason to suspect the Therac-25's flaws.
The FDA demonstrated the most competent communication policy. Although it could be faulted for an inadequate initial response (by not recognizing the potential seriousness of the incidents when first reported), its later actions forced AECL to provide much greater detail in the corrective action plan than AECL would have otherwise provided.
The lack of accurate and timely information flow brought unnecessary suffering and death to several Therac-25 patients. A more thorough inquiry by AECL customers and more aggressive customer interaction would have exposed the Therac-25 defects in a more timely manner.
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