Article preview from "The Gray Sheet" - April 12, 2010
FDA hopes to reduce dosage errors and misaligned exposures during therapeutic radiation by rethinking pre-market approval strategies for certain radiation therapy devices.
Article preview from "The Gray Sheet" - April 12, 2010
FDA hopes to reduce dosage errors and misaligned exposures during therapeutic radiation by rethinking pre-market approval strategies for certain radiation therapy devices.
CDRH Director Jeffrey Shuren sent a letter April 8 to manufacturers of linear accelerators, radiation therapy treatment planning systems and ancillary devices such as radiation therapy simulators.
Between December 31, 1999, and Feb. 18, 2010, FDA received 1,182 MDRs associated with the use of radiation therapy devices, FDA notes. The problems were the result of faulty design or use errors that "could be mitigated by the incorporation of additional safeguards," the agency said.
The most frequently reported problems were computer software issues, device use problems and incorrect displays.
Next Steps: Public Meeting, Pre-market Changes?
FDA plans to hold a public workshop on these devices to discuss new safeguards and other special controls that could improve radiotherapy device safety, as well as possible changes in pre-market testing to provide "appropriate assurances of safety and effectiveness, particularly for software."
FDA is also considering requiring pre-market review of all modifications to software.
Finally, the agency plans to limit use of some abbreviated 510(k) review processes for these devices. Specifically, "in light of the MDRs concerning these products, and the increasing complexity of these technologies, the submission of a special 510(k) or a third-party review may not be appropriate," the April 8 letter states.
A special 510(k) allows a manufacturer submitting a modification to a cleared product to declare conformance to design controls without providing new data in the submission. Third-party 510(k) reviews are conducted by accredited, non-FDA personnel for a limited subset of lower-risk devices.
Albert Blumberg, M.D., chair of the American College of Radiology's Commission on Radiation Oncology, said the college is "supportive of efforts to make radiation oncology devices as safe as possible."
Given the number of radiation therapy procedures performed over the years, the observed rate of adverse events is relatively low, he noted. But, he said, "We have zero tolerance for any mistake."
"I want to know that when I send my patient back there to be treated, they're being treated correctly," he told "The Gray Sheet."
Articles published in the New York Times in January raised concerns about the effects of radiation overdose and the ability of FDA regulators to keep pace with emerging radiation technologies.
Congress may consider legislation on the matter following a House Energy and Commerce Committee meeting in February (The Gray Sheet' March 8, 2010).
FDA recently launched a separate initiative to address radiation overexposure during medical imaging, including computed tomography scans and fluoroscopy procedures.
- Jessica Bylander
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