We all know how technology can capture our minds, hearts and souls. As a technology creator there’s the enticement of financial opportunity, but there’s also the sheer excitement of pioneering new capability and invention. Far too often excitement blinds many to the risks new technologies always incur.
Consider the global pandemic. Whether real or fabricated, the ‘emergency’ provided opportunity to launch, on a grand scale, the mRNA and nucleoside technologies that had been on the back burners for years. Yes astronomical profits and yes way cool, but the risks … we are only now beginning to learn.
Rewind 40 years…A history lesson.
Computer technology was expanding and permeating all types of applications to ‘improve’ life. One of those application areas were medical devices. And one of those devices was the Therac-25 , a linear particle accelerator adapted as a radiological tool for treating cancer. Whereas prior models of Therac used electrical circuits or mechanical devices to address safety issues, the Therac 25 used software to manage safety. The designers had faith, without proper due diligence, the software was more reliable than mechanical or electrical systems. A technological illusion. They allowed limited testing and risk analysis based on beliefs of the way software functioned. Nowhere did they include computer failure or user variation in their analysis.
Then came the ‘accidents’ after the product was released. Patients reported being burned. Some feeling a tremendous source of heat. Some screamed under intense pain during treatment with technicians insisting there was nothing wrong with the machine. But in the end the outcomes were horrible – devastating. One women had to have her breast, burned by the radiation surgically removed. Others later died from excessive radiation burns.
It turned out there were ‘bugs’ in the software that were not anticipated in the design stages, and the test protocols were not comprehensive enough to screen for the mode of failure. I encourage the reader to review the full report provided by the link above to appreciate the complexity of the issue. Patients were receiving radiation doses in some cases that were 5 orders of magnitude greater than the set dose.
The Therac-25 incident turned out to be the turning point for regulators regarding software quality in medical devices. The FDA, which also regulates devices calls for special software validation measures, risk analysis and design controls to assure proper safety.
As I recently recalled the Therac-25 incident and pondered on mRNA technology and the hasty release of COVID-19 vaccines, it occurred to me we still haven’t learned our lesson. The COVID-19 vaccine technology in many ways parallels the computer technology that was introduced into the Therac system design. It may very well be history repeating itself. In the present situation it’s the new genetic technology being forced into a vaccine application. But the designers underestimated how truly complex the system is. For the vaccines we may incur many more casualties than what the Therac caused.
For the Therac it took two full years to realize the death and injury that resulted. How long will it take for the vaccines?
Mike Borrello
maborrello
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