FDA gets tougher on radiation equipment in wake of overdoses, software flaws

Following an FDA analysis of more than 1,000 reports of errors involving radiotherapy devices that were filed over the past decade, imaging equipment now will have to go through a more rigorous process to achieve the agency's approval, reports the New York Times.

A more streamlined system was instituted in the 1990s to reduce the FDA's workload and speed approval time. Forty percent of new radiotherapy equipment approved last year had been put through the streamlined process, which sometimes involved the use of third-party reviewers. In an official letter to manufacturers, the Dr. Jeffrey Shuren, director of the agency's Center for Devices and Radiological Health, stated that the expedited process may not be appropriate, and that additional safeguards may "reduce the number of under-doses, over-doses and misaligned exposures from therapeutic radiation."

Most of the problems investigated by the study (74 percent) involved linear accelerators, which deliver concentrated radiation beams directly to tumors, while glitches in computer software were the most frequently reported issue.

In addition to reexamining the process for approving equipment, the FDA will hold a public workshop devoted to radiation therapy treatment planning, medical linear accelerators and ancillary devices.

To learn more:
- here's the New York Times article
- check out this Reuters article
- read this DOTmed News piece