More than 500,000 medical devices such as life-supporting implantable cardioverter defibrillators (ICDs) are marketed in the United States. The U.S. Food and Drug Administration (FDA) is responsible for market approval and post-approval surveillance (PAS) of medical devices. Two recent studies, which were supported by the Agency for Healthcare Research and Quality (HS10548) through the Centers for Education and Research on Therapeutics (CERTs) program, examined issues involving the safety of cardiovascular medical devices. The studies, which were led by researchers at the Duke University CERT, are described here.
O'Shea, J.C., Kramer, J.M., Califf, R.M., and Peterson, E.D. (2004, June).
"Sharing a commitment to improve cardiovascular devices. Part 1: Identifying holes in the safety net." American Heart Journal 147(6), pp. 977-984.
According to the FDA's Enforcement Report Index, since 1990 there have been more than 130 product recalls affecting more than 900,000 major cardiovascular devices and 16 safety alerts affecting almost 900,000 additional devices. Once a medical device is in the marketplace, its exposure to patients and real-world conditions can uncover new safety concerns that were not fully appreciated during the premarket phase. Premarketing approval is short, so long-term problems with devices, for example, pacemaker batteries that fail without warning, do not surface until after the device is on the market.
Physicians also use devices for indications that were not part of the original approval, a practice known as off-label use, and such use may reveal additional unanticipated safety issues. Design problems, such as a heart valve strut failure, also can surface later, warranting an improved design. Sometimes problems develop in selected patient populations or due to operators who don't have enough training in use of the device.
Thus, post-approval oversight is needed to ensure the continued safety and effectiveness of marketed medical devices. The principal post-approval tools used by the FDA and the industry to achieve these goals are voluntary adverse event/product problem reporting and mandated post-approval studies by the manufacturer (usually targeted to a specific issue, such as long-term performance of a heart valve or pacemaker). However, this feedback loop is currently sporadic and inadequate. For example, despite voluntary and mandatory reporting systems, less than 1 percent of all adverse events related to medical devices are reported to the FDA.
Peterson, E.D., Hirshfeld, J.W., Ferguson, T.B., and others (2004, June). "Sharing a commitment to improve cardiovascular devices, Part II: Sealing holes in the safety net." American Heart Journal 147(6), pp. 985-990.
The authors of this article suggest how existing medical device evaluation and action mechanisms could be improved, based on ideas initially formulated at a 2001 conference, "Sharing a Commitment to Improve Cardiovascular Devices." The authors point out the unique interrelationship and dependency of clinicians, regulators, and industry in the process of ensuring proper use and safety of medical devices for optimal patient care. They call for collaboration and a culture of partnership among all players to promote early identification of device-related adverse events. The authors review four cardiovascular-device-specific areas as a means of identifying challenges to this new collaborative framework: left ventricular assist devices, implantable cardioverter defibrillators, intracoronary brachytherapy, and vascular embolic protection devices.
The authors point out that although industry and regulatory monitoring systems exist, innovative PAS mechanisms may be needed to promote safety and design improvements for certain devices throughout the life cycle. Medical students should be taught early in medical school about these mechanisms and the method of reporting adverse events to the FDA. Once the FDA identifies a potential safety issue with a device, this information should be disseminated promptly and effectively to the clinical community.
The major cardiovascular professional societies should consider more active collaboration with the FDA to disseminate important device safety information. Industry can also improve its communication of device safety data via an E-mail notification system to clinicians. Finally, the authors emphasize the need for high-quality, multicenter device registries as an important strategy for ensuring adequate PAS.
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