FDA to launch ‘active’ monitory system to improve medical device safety

A congressional watchdog agency has reported that the FDA is launching a surveillance system to actively look for safety problems with medical devices - 12 years after it was mandated to do so.

The new system aims to detect potential safety issues nearly in real time by monitoring data like electronic health records and billing claims. That data is sometimes called real-world evidence (RWE).

Until now, the FDA has relied largely on spotty reports from manufacturers, hospitals, nursing homes and patients, which has resulted in underreporting and delays in identifying harmful products.

Often, physicians and patients aren't warned in time. Surgical mesh, CPAP machines, and metal joint implants are just a few of the problematic devices that have been highlighted in news reports about their widespread harms.

Yet some experts are skeptical that the advent of active monitoring will do much to improve medical device safety. Journalists should continue to be watchdogs for medical device safety. Here are some factors.

Active surveillance will have a slow start.

In a report issued in July, the U.S. General Accounting Office said the FDA plans to begin actively monitoring two types of devices for safety issues this year: the duodenoscope, a lighted tube used for viewing the small intestine; and robotically assisted surgical devices used in gallbladder removal. The GAO said the FDA plans to expand to 18 or more devices by 2028.

That's a tiny fraction of the more than 6,000 types of medical devices that the FDA regulates. Madris Kinard, MBA, chief executive officer of Device Events, a software service for tracking medical device adverse events, noted in an email that the FDA is "far behind" in implementing what the agency has heralded as a "collaborative national evaluation system for health technology."

Tracking RWE for two products by the end of this year "doesn't begin to scratch the surface" of objectives established by the National Evaluation System for health Technology, an organization that has been working with the FDA to establish the active surveillance system, she added.

Key narrative details could be missed.

The new system uses resources that could be directed to enforce requirements that hospitals and device makers promptly submit reports to the FDA's MAUDE database, Kinard said.

"MAUDE is more proactive than is understood because often a malfunction appears that, if it were to happen again, could cause serious injury or death," she said, adding that MAUDE "also contains a narrative that is publicly available and provides context for the event," which active surveillance may not provide.

Implementation challenges remain.

According to the GAO report, the FDA has encountered "key challenges" of inadequate funding and limited use of unique device identifiers in electronic health records and billing claims, impeding the identification of patients who have a particular device. The GAO outlined steps that the FDA is taking to address those challenges.

Diana Zuckerman, Ph.D., president of the National Center for Health Research, a public health watchdog group, said in an interview that Congress and the FDA could do more to resolve those issues. For example, she said, the FDA could require a percentage of device makers' user fees to support safety monitoring despite industry objections.

More surveillance doesn't address lax standards for new devices.

Surveillance does not address a basic issue: few, if any medical devices enter the marketplace with rigorous testing to show that they are safe or effective.

That's in part because the FDA "clears" most devices via the Premarket Notification pathway known as 510(k), which requires manufacturers only to show that a device is "substantially equivalent" to another product that is already on the market. The FDA often defines that broadly to include substantial differences in materials, shape, size or mechanism of action.

In 2016, Congress reduced standards of evidence for device approval via the 21st Century Cures Act. Zuckerman said she expects some lawmakers to push for legislation that will further lower the bar this fall. For journalists, she said, "This would be the time to bring some attention to what Congress is doing and what they've done in the past."

What questions should journalists be asking?

Investigative journalist Jeanne Lenzer, who wrote the book, "The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It," said via email that journalists should ask questions about the new active surveillance system.

Lenzer offered the following:

• The FDA has partnered with 18 hospitals and a pharmacy chain to share data for postmarket surveillance. What proportion of all hospitals and pharmacies does this represent, and might there be problems identifying safety risks due to inadequate numbers of patients?
• How will reporting be complicated by the fact that patients frequently change providers and insurers or fail to seek care if they become uninsured?
• Will this new system help patients who have been implanted with devices that do not have a unique identifier?
• Why, after more than two decades of recognizing the problem, isn't there a plan to have mandatory tracking of unique device identifiers for all higher and high-risk devices?
• Does Congress need to grant the FDA the power to require manufacturers to maintain mandatory registries for all higher-risk devices and more funding to carry out postmarket surveillance?

Other resources

• IMPLANT FILES - The International Consortium of Investigative Journalists' project found more than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices reported to the FDA over a 10-year period.
• "He Regulated Medical Devices. His Wife Represented Their Makers." - a New York Times story about the conflicts of interest of Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.
• International Medical Devices Database - This resource includes a glossary of terms that are commonly used in recalls and safety alerts.
• 80,000 Deaths. 2 Million Injuries. It's Time for a Reckoning on Medical Devices - a New York Times opinion piece.