by Barbara Kram
, Editor | April 09, 2010
The FDA issued an official letter to manufacturers of linear accelerators, radiation therapy treatment planning systems and ancillary devices on Thursday. The agency indicated it is taking steps to improve the safety and safe use of the devices because of a large number of device problems.
Between December 31, 1999, and February 18, 2010, FDA received 1,182 medical device reports (MDRs) associated with the use of radiation therapy devices. Of these MDRs, linear accelerators accounted for 74%, radiation therapy treatment planning systems (RTP) accounted for 19%, and ancillary devices (e.g., radiation therapy simulators) accounted for 7%. The most frequently reported device problems were computer software issues, use of device, and incorrect display. In some reports, the manufacturer was unable to determine or identify the problem and reported the problem as "unknown," FDA states in the letter.
As a result, FDA said that third party review, an expedited approach to gaining approval to market radiation therapy devices "may not be appropriate," an indication that this previously accepted method of approval will likely end for these technologies.
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"In order to reduce the number of under-doses, over-doses, and misaligned exposures from therapeutic radiation the FDA is taking several steps to improve the safety and safe use of certain radiation therapy devices. 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," the letter states.
FDA will hold a public workshop devoted to radiation therapy treatment planning, medical linear accelerators, and ancillary devices. Manufacturers are invited to attend the workshop to discuss new safeguards and other special controls to improve safety; possible changes in pre-market device testing to provide appropriate assurances of safety and effectiveness, particularly for software; and pre-market review of all modifications to software. Details of the event will be published in the Federal Register.
A series of reports in the New York Times this year documented patient suffering from mistreatment during radiation therapy, drawing attention to the issue of lack of regulatory oversight, lack of machine safeguards, and problems with personnel competence in using the advanced technology.
Read the FDA letter: