FDA Responds To Radiation Overdoses With Stricter Regulation

by Tamar Zaidenweber

I recently posted a blog entry about the dangers of newer radiation therapy machines and the fatal mistakes that have been made by their operators.

Today, the New York Times published an article entitled “F.D.A. Toughens Approach to Radiation Equipment” by Walt Bogdanich, which states that “The Food and Drug Administration said Thursday that it was taking steps to reduce overdoses, underdoses and other errors in radiation therapy by strengthening the agency’s approval process for new radiotherapy equipment.”

Rather than currently allowing a third-party approve the machines, which was a policy implemented in the 1990s to streamline the approval process, the F.D.A. will require the products undergo the normal approval process to ensure their safety.

It is unclear from the article if the F.D.A. will go back and review previously approved medical devices, or if this policy will only apply to machines without current market approval.

Additionally, while the F.D.A. has announced that it plans to hold a public workshop on linear accelerators, radiation treatment planning and ancillary devices, some are concerned that may not be sufficient.

The article quotes Dr. Howard I. Amols, chief of clinical physics at Memorial Sloan-Kettering Cancer Center in New York, who was concerned that the F.D.A.’s decision did not address some of the serious concerns associated with linear accelerator accidents; including staffing shortages, personnel competency and hospital quality assurance programs.

While no policy decision will ever placate everyone, I applaud the F.D.A.’s efforts to monitor and more closely regulate the introduction of such dangerous machines to market.


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