FDA to impose stricter medical device safety standards

FDA on Thursday released recommendations for improving post-market surveillance of medical devices, the AP/Los Angeles Times reports.

Safety concerns for post-market monitoring of medical devices "grew after last year's slew of high-profile recalls or safety warnings affecting more than 200,000 defibrillators," according to the AP/Times (AP/Los Angeles Times, 11/10). The Heart Rhythm Society also has criticized FDA for not responding adequately to safety concerns and issued a call for action after announcements of the recalls, which involved devices manufactured by Medtronic, St. Jude Medical and Guidant, which has been acquired by Boston Scientific (Bloomberg/Minneapolis Star Tribune, 11/9). FDA earlier this year assembled an in-house task force to investigate the problems. The task force's report cites poor communication, a flawed safety reporting system and inadequate enforcement within the agency. In addition, the task force found that problems with devices are "vastly underreported" and that most data submitted to the agency on devices include "incomplete and unreliable" information. The task force released several recommendations to improve device surveillance that include the following:

• Overhauling FDA's data system, expanding its current reporting system -- called MedSun, which involves a network of 350 hospitals -- and disseminating its findings to more medical professionals outside the network;
• Increasing access to outside databases, such as those maintained by doctor groups and other clinical professional organizations;
• Adopting a "culture of collaboration" between FDA and outside experts on safety issues to improve communication between groups that assess the safety of devices before and after they reach the market (May, Newark Star-Ledger, 11/10);
• Developing a unique tracking number for each medical device to serve as an identifier in the event of post-market concerns about a device;
• Improving the way FDA communicates with the public about recalled medical devices (Snowbeck, St. Paul Pioneer Press, 11/10);
• Integrating the medical device data maintained by the Department of Veteran Affairs, the Department of Defense and CMS; and
• Expanding a pilot programs that collects safety reports from hospitals in real time (AP/Los Angeles Times, 11/10).
  

Comments

"Our goal is to be able to say, 'How can we do a better job synthesizing all of the information that we get?'" Daniel Schultz, director of FDA's Center for Devices and Radiological Health, said, adding, "FDA will have a better system for picking up problems early, being able to analyze them effectively and correctly, and then being able to act on them" (Bloomberg/Minneapolis Star Tribune, 11/9). Stephen Ubl, president of device maker trade group AdvaMed, said that manufacturers do not oppose the recommendations but that a tracking system should be voluntary except when there is a well-documented patient safety issue that could be addressed by a tracking system. Ubl added that any new requirements should be phased in over time (St. Paul Pioneer Press, 11/10). According to the Boston Globe, a new "Democratic-led Congress appears willing to make" changes at FDA. John Manthei, FDA counsel for the Medical Device Manufacturers Association, said, "With congressional oversight, (the FDA is) going to face a much tougher, much tougher environment," adding that Democratic Reps. Henry Waxman (Calif.), John Dingle (Mich.) and Bart Stupak (Mich.) "have made it very clear that FDA is squarely within their crosshairs" (Henderson, Boston Globe, 11/10).

Broadcast Coverage

APM's "Marketplace" on Thursday reported on FDA's plan to improve safety monitoring for medical devices. The segment includes comments from Susan Bartlett Foote, associate professor in the Division of Health Policy and Management at the University of Minnesota; John McCamant, editor of the Medical Technology Stock Letter; and Schultz (Palmer, "Marketplace," APM, 11/9).

A transcript and audio of the segment are available online.