A letter from the Food & Drug Administration (FDA) on April 8th, 2010 advised manufacturers of linear accelerators and of radiation therapy treatment planning systems that changes were needed to the device approval process in order to reduce radiation exposure errors.

Errors in radiation exposure during oncology treatments have been widely reported in the media lately, but it’s apparently not new. According to the letter, the FDA has documented over 1000 Medical Device Reports (MDRs) regarding errors in radiation oncology treatments over the past 10 years.

The letter, written by Jeffrey Shuren, M.D., JD. director, Center for Devices and Radiological Health at the FDA, explained that “the analyses of Medical Device Reports (MDRs) revealed device problems that appear to be the result of faulty design or use error that could be mitigated by the incorporation of additional safeguards.”

Over the last 10 years, 74% of the MDR reports were related to linear accelerator equipment and 19% were related to radiation therapy treatment planning systems (RTP); the other 7% of MDRs were related to ancillary equipment.

Shuren said in the letter that computer software issues, use of device, and incorrect display were the most frequently reported problems. The FDA wants manufacturers to find the cause of these errors and implement corrective and preventative actions that may involve technology improvements and/or user error.

As a result, the 510(k) FDA approval process is being reviewed, and the FDA may delay the approval of new radiation therapy treatment related devices. An FDA public workshop will be held about the possible new safeguards and changes to premarket device testing and review process.

Visit the FDA website to read the full Letter to Manufactures. Axis Imaging News will also be following this story in the June print issue. 

 (Source: FDA Letter to Manufacturers)