3 ms·

This type of equipment has many failsafes and lockouts, but clearly the electronic emergency release and radiation door closing didn't work in this case. The sc

by RK 17y ago

This type of equipment has many failsafes and lockouts, but clearly the electronic emergency release and radiation door closing didn't work in this case. The scandal is that is was a known bug. Obviously this bug only occurred in a specific scenario, because the clinics are required to test the emergency procedures on a regular basis. In this case the US regulatory agency, NRC, initiated an investigation and forced Elekta to fix it. It sounds like they assumed it wasn't critical enough from the initial report that all treatments with this model should stop before the patch was distributed (the incident happened months ago).

bmj 17y ago
As someone who works with software that is audited by the FDA (we build devices to collect data for clinical drug trials), I'm assuming the regulatory agency knew about this issue before the equipment was certified for use. Any bugs that we defer from a product release are documented, and therefore reviewed by anyone that decides to audit the company. We are routinely asked by auditors to explain why certain bugs were deferred prior to release.