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In 1996, I was working for IBM. I had just started working in the emerging field of web application development, and I worked with a man named Phillip. I really enjoyed working with Phillip, even though we did not see eye-to-eye on many things. Nonetheless, we had long in-depth conversations about everything under the sun.

One day, Phillip told me a story about a major software problem he'd been involved with. It had to do with medical accelerators that are used in radiation therapy. As Phillip told the story, people had died as a result of a malfunction that the machine developers could not reproduce. He told me that people had been sent to observe the operator of the machine and one factor that stood out was that the operator typed very, very fast. Turns out, this was a key contributor to the malfunction; the software failed (reproducibly) in such circumstances, and patients were exposed to lethal amounts of radiation.

This story came back to my mind because [livejournal.com profile] james_nicoll posted a link to an investigation of this incident. After reading the report, a few things stand out to me:

  1. There are six incidents in total. The second incident took place in Canada -- the other five in the US.
  2. The report's description of the first and third incidents indicate that they were not properly investigated, even though the first incident involved a lawsuit. The report states:
    • "There was no admission that the injury [in the first case] was caused by the Therac-25 until long after the occurrence, despite claims by the patient that she had been injured during treatment, the obvious and severe radiation burns the patient suffered, and the suspicions of the radiation physicist involved"; and
    • "As with the [first] overdose, machine malfunction in this [third] accident in Yakima, Washington, was not acknowledged until after later accidents were understood."
  3. In both the first and third incidents, the machines remained in service.
  4. The fourth and fifth incidents happened at the same hospital in Texas. The machine was in service for three weeks between these two incidents, although it was out of service for one day for testing. This part is creepy:
    • "The operator was isolated from the patient, since the machine apparatus was inside a shielded room of its own. The only way the operator could be alerted to patient difficulty was through audio and video monitors. On this day, the video display was unplugged and the audio monitor was broken."
  5. Even though the manufacturer was aware of the first and second incidents, a representative told the Texas hospital that the machine could not cause an overdose of radiation.
  6. The Canadian incident lead to the following:
    • The machine was taken out of service when the patient returned to the hospital and complained of burning three days after the incident
    • The Canadian Radiation Protection Bureau got involved (and the US FDA was notified), and a report was written requiring the machine manufacturers to install additional safety devices (these changes hadn't yet been made when the fourth and fifth incidents took place)
    • An independent consultant was hired to investigate the incident and write a report which insisted on other changes (which the manufacturer did not do)
    • A "voluntary recall" was issued by the manufacturer
    • The report doubts that these investigators correctly identified the cause of the problem: however, the process (I believe) was the correct process and recommended some of the same corrective actions
  7. Although each incident lead to extreme (and often fatal) overexposure to radiation, there were at least two different situations that caused the overexposure.
  8. The report states, "Once the FDA got involved in the Therac-25, their response was impressive, especially considering how little experience they had with similar problems in computerized medical devices". However, two incidents went by without any reporting to the FDA.

Recently, on my journal, someone remarked that "health care is a business transaction between an individual and his physician. Government has no business interfering." And while I'm sorry to seem like I'm singling that person out, I want to be clear that I think that that is a complete and utter crock of shit.

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BC Holmes

February 2025

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