Recent Medical Device Recall Indicates Need for Patient Protections, NEJM Commentary Says

-Kaiser Network

03/06/2008 - The October 2007 recall of the Sprint Fidelis defibrillator lead, manufactured by Medtronic, indicates the need for legislation that would improve information provided to patients and physicians about potential safety concerns in medical devices, according to a commentary published on Thursday in the New England Journal of Medicine, the St. Paul Pioneer Press reports. In the commentary, William Maisel, an expert on medical device safety at Beth Israel Deaconess Medical Center, wrote that the recall marks the latest example of the failure of companies and FDA to provide patients and physicians with adequate information about potential safety concerns in medical devices.

Rob Clark, a Medtronic spokesperson, on Wednesday said that, although the company supports patient protections, the commentary does not include specifics and omits important details about the recall of the Sprint Fidelis defibrillator lead. He said, "The narrative is incomplete and omits facts that are essential to any full accounting or analysis of the events and their ramifications" (Snowbeck, St. Paul Pioneer Press, 3/5).

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