Several new studies published Sept. 29 in JAMA: Internal Medicine, have brought significant questions to light regarding the U.S. Food and Drug Administration’s (FDA) regulation and safety approval process of medical implantable devices.

First among these studies is the newly published research of Diana Zuckerman, PhD, National Center for Health Research, Washington, DC, and her colleagues, who have found that information is typically lacking on most implanted medical devices cleared by the FDA, despite a legal obligation that requires companies to submit scientific evidence about the devices’ substantial equivalence to other devices already on the market. Each year the FDA clears about 400 implanted medical devices that are considered moderate- to high-risk without clinical testing. The FDA must provide scientific evidence that a new device is “substantially equivalent” to devices already on the market. Examining the evidence companies submitted about their devices and whether it was publicly available by using FDA databases, Zuckerman and her team identified the first two implanted medical devices approved in each of five categories for each year from 2008 through 2012. Their results showed that scientific data to support a claim of substantial equivalence were publicly available for eight out of 50 (16 percent) newly cleared implants and 31 (3 percent) of 1,105 devices already on the market. “For implants cleared between 2008 and 2012, however, we repeatedly found that scientific evidence of the substantial equivalence, safety or effectiveness of medical devices was not publicly available in accordance with the legal requirements,” writes Zuckerman. “To protect the public health and allow for independent judgment of the quality of the scientific evidence that supports the marketing of medical devices, the FDA should enforce the law.”

In a separate study, Ian Reynolds, MPH, Pew Charitable Trusts, Washington, DC, and his co-authors conducted an investigation to assess the safety and efficacy of devices after they had been approved by the FDA. While the FDA does conduct its own post-approval studies (PASs), including 223 studies of 158 medical devices between Jan. 1, 2005 and Dec. 31, 2011, Reynolds and his colleagues found that small sample sizes, delays in reaching protocol agreement, and a lack of availability of findings may hinder their ability to be clinically useful. They found that while it is unclear whether the PAS program achieves its aims, improved completion and accessibility of the studies could provide vital answers in regards to the safety and effectiveness of medical devices.

In a related commentary, Elisabeth Dietrich, MPH, University California, San Francisco, and Joshua M. Sharfstein, MD, Maryland Department of Health and Mental Hygiene, Baltimore, write “The mission of the FDA is to protect the public health by providing reasonable assurance that marketed medical devices are safe and effective and to promote the public health by streamlining regulatory processes and eliminating unnecessary barriers to medical device innovation. At times, the agency has rightfully been criticized for pursuing one goal at the expense of the other. In recent years, the FDA’s Center for Devices and Radiological Health has been actively undertaking reforms to advance both goals simultaneously and to improve the scientific rigor of its operations. It is important to recognize and support this progress, even as the FDA’s performance continues to be monitored through research and oversight.”

Meanwhile, as Josh Rising, MD, MPH, Pew Charitable Trusts, Washington, DC, and his co-author Ben Moscowvitch, MA, Pew Charitable Trusts, Washington, DC, point out in their own essay, the FDA’s Sentinel Initiative is a national electronic system for using health insurance claims data to monitor the postmark safety of prescription drugs, while the Vaccine Safety Datalink – a collaborative project between the Centers for Disease Control and Prevention and a number of health care organizations – integrates multiple electronic data sources to evaluate the safety of vaccines. They note that as of now, no similar programs exist for the post-market surveillance of medical devices. With features that would make it possible to search device identifiers by version or model, linking to a patient’s electronic health records, insurance claims, and medical device registries, as well as a publicly searchable database, they add that such a system would greatly improve the way the FDA assesses the performance of medical devices.

Keywords: Prostheses and Implants, Electronic Health Records, Registries, Vaccines, Public Health, Safety, United States Food and Drug Administration, Marketing

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