Postmarket surveillance for medical devices: America’s new strategy

Journal BMJ
Authors Normand, Sharon-Lise T.; Hatfield, Laura; Drozda, Joseph; Resnic, Fred
Year Published 2012
Link to Publication

Abstract

The FDA’s plan is a big ask but will be well worth the effort

In September 2012, the US Food and Drug Administration (FDA) released its vision for a postmarket surveillance system for medical devices, describing four key strategies to protect public health. But why this initiative now? Firstly, several concerns about the safety of specific devices, such as the Medtronic Fidelis defibrillator lead and the DePuy ASR hip implant, have garnered substantial press coverage. Secondly, the Institute of Medicine recently called for a substantial overhaul of processes for the approval and postmarket safety surveillance of medical devices. Thirdly, the FDA has undertaken several premarket initiatives to improve the efficiency of the regulatory review for innovative devices. With the number and complexity of medical devices growing rapidly, it is timely to complement the new premarket initiatives with a strong postmarket surveillance program.

Regulation of the entry into use of medical devices in the United States was introduced after that for drugs table, and it quickly became apparent that the public health assessment of devices would need to be different from that of drugs. Unlike drugs, medical devices are assembled from many components, may affect patients long after the initial exposure, and have rapid product development cycles, which lead to frequent incremental improvements. Medical devices also pose unique challenges to studying …

Postmarketing Surveillance of Medical Devices – Filling in the Gaps

Journal New England Journal of Medicine
Authors Resnic, Frederic S.; Normand, Sharon-Lise T.
Year Published 2012
Link to Publication

Abstract

Failures of implantable medical devices, although rare, can carry a substantial risk of serious injury. From 2000 through 2011, more than 150 new highrisk medical devices were approved by the Food and Drug Administration (FDA) through the premarket approval (known as PMA) process, and an additional 600 devices were cleared through the less demanding 510(k) process, in four medical specialty areas (cardiovascular care, neurology, obstetrics and gynecology, and orthopedics; see graph). The problem that Hauser describes (pages 873–875) — the erosion of the insulation in St. Jude Medical’s Riata leads for implantable cardioverter–defibrillators — highlights the fact that medical devices are complex assemblies of multiple components, and the failure of any single component can lead to unexpected and serious safety problems. Because it is impossible to design an implantable medical device with zero risk of failure, effective systems for monitoring safety after a device is on the market are essential for protecting the public health. Moreover, since incremental
changes are made in medical devices throughout their life cycles, it is impractical to prospectively study each change comprehensively before marketing. Balancing the need for robust postmarketing safety monitoring with the need to avoid the stifling of innovation is a prime responsibility of the Center for Devices and Radiological Health (CDRH) at the FDA.