FDA Proposes Stricter AED Oversight
The U.S. Food and Drug Administration (FDA) is looking to toughen rules governing automated external defibrillators (AEDs) after receiving an estimated 45,000 adverse event reports related to the devices over a seven-year period.
The agency has issued a proposed order that, if finalized, would require manufacturers of AEDs, which have been the subject of numerous recalls, to file premarket approval (PMA) applications rather than obtain less-strict 510(k) clearance. Such a requirement would mandate that manufacturers submit clinical data to demonstrate a device’s safety and effectiveness.
AEDs are used to treat patients in cardiac arrest by delivering defibrillation shocks to the heart. Despite the lifesaving potential of these devices, the FDA has received numerous reports of problems responders have encountered while using them, such as the failure or delay to deliver a defibrillation shock; inappropriate cardiac rhythm detection; and inadvertent shocks to rescuers or bystanders.
Many of the problems with AEDs are preventable and correctable and involve the design and manufacture of the devices, as well as inadequate control of components purchased from other suppliers, according to an FDA statement.
If the agency’s proposed rule is implemented, a review of a manufacturer’s quality systems information and an inspection of its facilities would be required. Manufacturers also would have to inform the FDA about any significant manufacturing changes and submit annual reports of the device’s performance.
“Automated external defibrillators save lives,” said William Maisel, MD, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, in a statement. “However, the agency is concerned about the number of recalls and manufacturing problems that have been associated with these devices, and we’re committed to working with manufacturers to address these issues.”
Physio-Control, an AED manufacturer, responded quickly to the FDA’s announcement about the proposed changes. “Physio-Control has the most-robust quality system in the industry and we are extremely confident in our ability to meet these new regulations, if adopted,” according to a statement by Brian Webster, the company’s president and CEO. “The move would level the playing field and require all AED manufacturers, including third-party suppliers, to adhere to the same high quality standards,”
The proposed order was published in the March 25 Federal Register. Interested parties have until June 24 to comment on the proposed order, which is available here.
Posted: March 25, 2013