Two JAMA Studies Question FDA’s Approval Process for Medical Devices

U.S. health regulators aren’t doing enough to ensure the safety and effectiveness of medical devices both before and after they are approved for public sale, according to two new studies published in JAMA Internal Medicine.

One study takes issue with the Food and Drug Administration’s (FDA’s) 510(k) medical device approval process, which allows new devices to forego clinical testing if they are “substantially equivalent” to a device already on the market. Device makers wishing to clear a new device through the 510(k) process, however, are required to present publicly available evidence showing the device’s substantial equivalence to a so-called “predicate device.”

Researchers, including Diana Zuckerman, president of the Center for Health Research in Washington, D.C., looked at 50 devices cleared through this process between 2008 and 2012. They found publicly available data supporting the claim of substantial equivalence for only eight of the 50 devices (16 percent) and 31 of 1,105 of listed predicates (3 percent), according to the study.

“Let the buyer beware before getting an implant in their body, because there may be no evidence the implant is going to benefit them and no study done in case it might harm them,” Zuckerman told Reuters. “Clearly the FDA and companies are failing to provide information to doctors and patients so they can make reasonable judgments to affect their lives.”

In a statement to Reuters Health, the FDA responded that it bases 510(k) approval decisions on far more data than what is publicly available. “This approach has served the American public well by balancing the need for robust evidence to assure safety while expeditiously bringing new technologies to the patients who need them,” according to the statement.

A separate study published in JAMA found fault with the way the FDA monitors high-risk devices not before they’re approved, but after – through what’s known as post-approval studies (PAS).

The FDA may order a PAS of an approved high-risk device, something that it did 223 times for 158 medical devices between January 1, 2005 and December 21, 2011. Just one of the studies prompted action by the FDA other than a change in a device’s label, Ian S. Reynolds and colleagues at the Pew Charitable Trusts found.

The study authors write in their conclusion that, “Post-approval studies have the potential to provide additional information to better understand medical device performance. However, small sample sizes, delays in reaching protocol agreement, and lack of availability of findings may hinder their ability to be clinically useful.”

Commentary accompanying the two articles published by JAMA calls medical device regulation “a work in progress.”

Federal regulators and device manufacturers share responsibility for protecting medical device recipients from preventable harm. Two high-profile cases of the past few years – metal-on-metal hips and surgical mesh – involved devices cleared through the 510(k) approval process and show the widespread harm that can occur from insufficient oversight.

To discuss an injury involving a dangerous medical device with an experienced Seattle personal injury attorney, please contact Morrow Kidman Tinker Macey-Cushman PLLC.