New Radiation-Emitting Medical Device Transparency Site Launched by FDA
The FDA has launched a new web site aimed at making the processes and decision-making rationales for the development of regulations concerning radiation-emitting medical devices more transparent.
The Center for Devices and Radiological Health (CDRH) Transparency web site is part of a continuing initiative by the agency to increase transparency and public accessibility, but it also comes at a time when the health risks of radiological procedures are under the microscope due to concerns over cancer and over-exposure to radiation.
CT scan procedures across the country are under close scrutiny by the FDA after the discovery that a number of patients have suffered radiation overexposure from CT Scans performed incorrectly. The FDA is currently reviewing CT scan procedures nationwide, and released interim guidance for health care professionals and radiologists in December. The guidance advised them to review procedures and CT scan settings, and to be thorough in checking the amount of dosage prescribed for each CT scan patient.
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The recent FDA investigation was sparked by the discovery of CT scan radiation over-exposure problems that may have affected more than 200 patients at Cedars-Sinai Medical Center in Los Angeles last year. Since then, the FDA has uncovered at least 50 more radiation CT errors.
The new web site will give the public access to premarket submissions for new or improved radiation-emitting medical devices, postmarket performance and safety documents, FDA compliance and enforcement actions, science and research program data, performance metrics and educational resources. In addition, the site will allow visitors to perform a Total Product Life Cycle search, which will pull premarket and postmarket data on a particular medical device from multiple sources and compile them into a single “snapshot.”
CDRH Director Jeffrey Shuren, M.D. said that the web site will give the public a window into the FDA’s regulation of radiation-emitting medical devices. “It provides a closer and clearer look at what we do and why we do it,” Shuren said.
The new site follows an initiative announced earlier this year by the National Institute of Health (NIH), which plans to track radiation exposure in patients’ medical records. Their record-keeping will also not focus on radiation errors, but instead will watch the accumulation of radiation exposure from a variety of treatments.
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