The FDA announced it would toughen its approval process for any new radiotherapy medical devices in an effort to reduce patient radiation overdoses. The agency previously allowed a streamlined approval process in which the medical equipment was approved by outside, third party reviewers. That will no longer be allowed and the FDA itself will aggressively review the devices to mitigate overdosing by requiring additional safeguards.
There have been over 1,000 reports of radiation overdose errors in the past 10 years. Most of the reported problems involve computer-controlled machines that generate high-powered beams of radiation to target cancer cells. Problems with the computer software led to most of the errors. Faulty design and use errors have also led to overdosing.
This FDA action comes after a series of New York Times articles which highlighted the crippling effects of radiation overdoses and accusations by some in the medical community that new medical devices were not being aggressively reviewed before being allowed on the market. The articles pointed out the apparent inability of regulators and the medical community to keep pace with the rapid technological advances in the medical device industry.
Reaction to the FDA action was generally favorable although Dr. Howard Amols of Memorial Sloan-Kettering Cancer Center in New York said the FDA did not address the serious, systemic problems of inadequate staffing, personnel competency and hospital quality assurance programs.
Richard J. Arsenault, 2011
