IOM Panel Recommends Changes to FDA Monitoring System for Medical Devices

Main Category: Medical Devices / Diagnostics
Article Date: 20 Jul 2005 - 14:00 PDT

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FDA lacks an effective system for monitoring the safety of medical devices for adults and children alike, according to a report issued on Monday by an... Institute of Medicine panel, the Newark Star-Ledger reports (Cohen, Newark Star-Ledger, 7/19). Rep. Diana DeGette (D-Colo.) requested the report in 2002, as part of an FDA reform bill (Sternberg, USA Today, 7/19). The report was intended to focus on the devices used by children, but panelists identified larger "shortfalls" in FDA's monitoring of devices after approval, the Wall Street Journal reports.

Recommendations
The panel's report recommends that FDA:

• Improve its tracking of studies done by device manufacturers after products are on the market;
  


• Work with the private sector to improve device tracking methods, including the use of digital medical records;
  


• Engage in "less secrecy and more openness in the sharing of information" about benefits and risks of devices (Wilde Mathews, Wall Street Journal, 7/19);
  


• Collaborate with NIH to prioritize research on devices used on children, despite a lack of manufacturers' studies in the field;
  


• Collaborate with parents, patient advocates, health organizations and the medical device industry to increase the reporting of safety concerns (Neergaard, AP/Las Vegas Sun, 7/18); and
  


• Use insurers' electronic claims databases to identify patterns for possible problems (Alonso-Zaldivar, Los Angeles Times, 7/19).
  

In addition, the report recommends that Congress require FDA to create a public database indicating the status and findings of studies and give FDA authority to order more follow-up studies on medical devices (AP/Las Vegas Sun, 7/18). According to the Times, the report also is critical of Congress, indicating that legislators have not provided promised funding increases for expanded device monitoring (Los Angeles Times, 7/19).

Children Should Be 'Special Focus'
George Lister, a pediatrician at the University of Texas Southwestern Medical School and co-author of the report, said that a "special focus needs to be on children." The panel found that doctors frequently "jury-rig" adult devices to fit in children's bodies, sometimes causing unexpected side effects, the AP/Sun reports. The report found that FDA lacks data on how devices affect children's growth and development (AP/Las Vegas Sun, 7/18). The report stated, "FDA could not identify" which post-market study commitments from device manufacturers "involved children, nor say which studies had been initiated or completed or otherwise confirm their progress" (Newark Star-Ledger, 7/19). Mark Bruley, a panel member and medical device investigator for not-for-profit health services research agency ECRI, said, "To make sure that pediatric devices are safe, there are changes that need to be considered across the board for all devices, as an underlying base" (Los Angeles Times, 7/19). In addition, Bruley said a device's functioning can be affected by children's active lifestyle, and also by hormonal changes (AP/Las Vegas Sun, 7/18).

Panel Comments
Hugh Tilson, a professor at the University of North Carolina and head of the panel, said, "The system needs to be public, transparent and understandable" (Wall Street Journal, 7/19). Tilson said FDA has told the panel that the agency is "now taking steps to establish a monitoring system to keep tabs on these post-market studies of medical devices." Tilson added, "Congress needs to ensure that this system becomes a reality and that key information about these studies is made publicly available" (Newark Star-Ledger, 7/19). Bruley said, "Our report is not anything that should inhibit or stifle anyone seeking health care" (Henderson, Boston Globe, 7/19).

Reaction
Susan Gardner, director of the FDA device center's office of surveillance and biometrics, said, "For the most part, they are directions we have either started to go down or would like to go down." Gardner said FDA has implemented an electronic tracking system for post-market studies, and has planned to create guidelines for the device industry on how to execute such studies. Gardner said FDA also is considering the creation of a public Web site that would reveal the status of these studies (Wall Street Journal, 7/19). AdvaMed, a trade group representing medical device makers, declined immediate comment, but the group has told the panel that FDA already has sufficient authority to ensure safety (AP/Las Vegas Sun, 7/18). Senate Finance Committee Chair Chuck Grassley (R-Iowa), who has written legislation to reform FDA's drug safety office, said, "This report exposes a fissure in the FDA's safety mission," adding, "These are the same kinds of problems we see with the ... review of medicines" (Los Angeles Times, 7/19).

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