FDA’s Role in Protecting Patients from Unsafe Medical Devices

We thank Ian Reynolds, Kirsten Paulson and Josh Rising, MD from the Medical Device Initiative, Pew Health Group, Pew Charitable Trusts for this contribution.

*********************

From artificial hips and coronary stents to insulin pumps and imaging equipment, medical devices play a vital role in human health. Yet while these products can significantly improve quality of life and patient outcomes, devices must also be closely studied and monitored to ensure their long-term safety. It’s up to the U.S. Food and Drug Administration to make sure that this happens.

For women, these issues are particularly important in light of recent problems with surgical mesh and metal-on-metal hip implants.

Within the past few years, the FDA has received many reports of complications related to the use of surgical mesh in women to repair weakened or damaged muscles and ligaments that keep pelvic organs, such as the bladder, in place. These complications included infection, pain, urinary problems, and recurrence of the original problem. In January 2012, the FDA responded by ordering 33 manufacturers to conduct post-market safety studies of their products. Although these studies will not produce results immediately, they will eventually generate data that will allow FDA, patients and clinicians to better understand safety risks with these devices.

After receiving more than 17,000 reports of adverse events associated with metal-on-metal hip implants, the FDA last month convened an advisory committee hearing to examine the safety of these products. A recurring theme was the higher risk these devices pose for women, echoing a 2011 report from the National Joint Registry for England and Wales that “revision rates”— the frequency with which these devices needed to be surgically removed and replaced—were “significantly higher for women.” In May 2011, the FDA ordered more than 100 safety studies of the implants, yet, according to an analysis that Pew co-authored in the New England Journal of Medicine, the agency and device makers have yet to agree on how to design more than three quarters of the studies. It’s unclear if any of the studies have even begun.

In addition to ordering additional studies when problems arise, such as with surgical mesh and metal-on-metal hips, it is important that FDA also have systems in place to detect when problems might be occurring. Fortunately, the FDA Safety and Innovation Act, signed into law July 9th, takes significant steps to better monitor medical devices already on the market. These provisions move FDA away from an outdated system of passive monitoring—through submission of adverse event reports by manufacturers and medical facilities—to an active surveillance system.

The law calls for the FDA to incorporate medical devices into its Sentinel Initiative, a national system used to track drug safety by proactively monitoring data from electronic health records, insurance claims and other sources. It also calls for timely implementation of the Unique Device Identifier (UDI), an important patient safety advancement that will require devices to carry more detailed identifying information akin to a bar code that will allow the FDA and manufacturers to more precisely track the use of medical devices and any problems that might be occurring.

With these enhancements, the FDA will have the ability to obtain rapid responses to safety questions about thousands of medical devices used every day across the country. It also gained clearer authority to order safety studies such as the ones the agency required for surgical mesh and metal-on-metal hips. But the FDA can only protect patients if it quickly implements the UDI and Sentinel for medical devices, and exercises its authority to require manufacturers to conduct additional studies when needed. For the sake of thousands of women suffering from complications associated with surgical mesh, metal-on-metal hip implants, and other devices, these patient safety efforts must be prioritized.