Radiation Equipment Faces Tougher FDA Approvals

The U.S. Food and Drug Administration (FDA) has long been criticized for a wide host of issues. Now, following concerns about lax approval standards for <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">radiation equipment, the FDA issued an official letter to makers of linear accelerators, radiation therapy treatment planning systems, and ancillary devices, said DotMed. The letter, which was issued yesterday, said the FDA will be toughening standards for these approvals.

According to the FDA, it is working to improve safety and device safety, said DotMed. In the years from December 31, 1999 and February 18, 2010, the agency received 1,182 medical device reports (MDRs) that were connected with radiation therapy device use, wrote DotMed. Of the nearly 1,200 MDRs, most—74 percent—were linked to linear accelerators; radiation therapy treatment planning systems (RTP) comprised 19 percent and seven percent were linked to so-called ancillary devices, which include radiation therapy simulators reported DotMed.

Most of the reported problems concerned computer software problems, device use, and wrong displays, explained DotMed. In some cases, problems were indicated as being “unknown” because manufacturers could not isolate the issue, according to the FDA letter, which can be accessed at: http://www.fda.gov/Radiation-EmittingProducts/NewsEventsRadiationEmittingProducts/ucm207835.htm

The FDA says that third-party review, which helps speed approval of these devices, “may not be appropriate,” which could lead to an end for this type of approval for these devices, noted DotMed.

“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, quoted DotMed.

The FDA is hosting a public workshop that will focus on radiation therapy treatment planning, medical linear accelerators, and ancillary devices, said DotMed. The workshop will be open to manufacturers and will cover safety issues; pre-market testing and review; and efficacy, with a focus on software efficacy, added DotMed.

The FDA’s track record on radiation device approvals has raised concerns recently. Recently, we reported, as per the the Associated Press (AP), that Dr. Julian Nicholas, a former scientist with the agency said his position was eliminated after he brought up the matter of exposure to radiation from “high-grade medical” scanners. Dr. Nicholas was speaking to a group of imaging specialists when he announced that FDA staffers—and he was among a group of nine—“were pressured to change their scientific opinion,” quoted the AP, by managers in FDA’s medical device division. The group alerted Dr. Jeffrey Shuren last September, said the AP. “Scientific and regulatory review process for medical devices was being distorted by managers who were not following the laws,” Dr. Nicholas said, quoted the AP. It took just one month for Nicholas’ position to be “terminated,” he said, added the AP.

We also wrote that the AP noted last year that scientists under former medical device head, Daniel Schultz, claimed, “they were pressured to approve certain products” against their best judgment.

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