FDA Will Take Steps to Reduce Radiation Errors
Prompted by recent articles concerning radiation errors by the NY Times, the FDA has announced that it will no longer allow new radiation equipment to enter the marketplace through a quick, streamlined process involving third party reviewers. The prior approval process was instituted in the 1990’s to quicken approval time but led to radiation errors and patient suffering.
The FDA found that 74% of the radiation errors involved linear accelerators, computer controlled machines that generate high powered beams of radiation intended to destroy cancer cells. Computer software problems were most frequently cited as the cause of radiation errors.
The more rigorous approval process for new radiotherapy equipment presupposes continuous FDA follow-up and enforcement of the guidelines.
Radiation errors have caused debilitating injuries and even death in some instances.
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