Editor04.12.10
Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health, sent a letter to medical device manufacturers April 8 stating that the agency is taking action to improve safety of radiation therapy devices.
Analyses of Medical Device Reports (MDRs) by the agency found that device problems seem to be the result of faulty design or use error that could be avoided by adding additional safeguards, according to the letter.
Between Dec. 31, 1999, and Feb. 18, 2010, the FDA received 1,182 MDRs for radiation therapy devices. Of these MDRs, linear accelerators accounted for 74 percent, radiation therapy treatment planning systems (RTP) accounted for 19 percent, and ancillary devices (e.g., radiation therapy simulators) made up 7 percent. The most frequently reported device problems were computer software issues, use of device, and incorrect display, the FDA said.
A separate analysis for software problems identified 362 MDRs. Of these MDRs, linear accelerators accounted for 66 percent, RTP accounted for 29 percent, and ancillary devices accounted for 5 percent.
The FDA plans to hold a public workshop on radiation therapy treatment planning, medical linear accelerators, and ancillary devices. It will be announced in a Federal Register notice.
Topics will include new safeguards and other special controls to improve safety; possible changes in premarket device testing to provide appropriate assurances of safety and effectiveness, particularly for software; and premarket review of all modifications to software, the agency said.
To read the complete letter, click here.
Analyses of Medical Device Reports (MDRs) by the agency found that device problems seem to be the result of faulty design or use error that could be avoided by adding additional safeguards, according to the letter.
Between Dec. 31, 1999, and Feb. 18, 2010, the FDA received 1,182 MDRs for radiation therapy devices. Of these MDRs, linear accelerators accounted for 74 percent, radiation therapy treatment planning systems (RTP) accounted for 19 percent, and ancillary devices (e.g., radiation therapy simulators) made up 7 percent. The most frequently reported device problems were computer software issues, use of device, and incorrect display, the FDA said.
A separate analysis for software problems identified 362 MDRs. Of these MDRs, linear accelerators accounted for 66 percent, RTP accounted for 29 percent, and ancillary devices accounted for 5 percent.
The FDA plans to hold a public workshop on radiation therapy treatment planning, medical linear accelerators, and ancillary devices. It will be announced in a Federal Register notice.
Topics will include new safeguards and other special controls to improve safety; possible changes in premarket device testing to provide appropriate assurances of safety and effectiveness, particularly for software; and premarket review of all modifications to software, the agency said.
To read the complete letter, click here.