FDA urged to track safety of medical devices in registries

The U.S. healthcare system trails other developed countries in tracking the performance of medical devices through registries. Now, a group of organizations including the Pew Charitable Trusts and the Blue Cross and Blue Shield Association is urging the Food and Drug Administration to catch up.

The two organizations, along with the Science Infrastructure Center at Weill Cornell Medical College, issued a set of recommendations last week to improve the role of registries. Registry advocates say registries make post-market surveillance of new medical technologies more robust and can help compare older, less-expensive devices to newer more costly products.

They cite Johnson & Johnson's high-profile recall in 2010 of metal-on-metal hip implants as a primary example of the value of registries. Clinicians tracking outcomes of the implants in registries in Australia and the U.K. were the first to identify the higher failure rates of these types of hip implants compared with older implants that had been on the market for years. J&J eventually recalled 93,000 hip implants and the company paid billions of dollars to settle patient lawsuits.

“It's taken us too long to figure out these devices have serious and unexpected safety problems,” said Dr. Josh Rising, Pew's director of medical devices. “There's no reason that we shouldn't be able to identify these problems in the United States.”

Medical-device manufacturers have expressed reservations. In February, the Advanced Medical Technology Association revised its principles for device registries to add questions about appropriate use, the reliability and efficiency of the data-collection methods and the stability of funding. “Registries can be an important tool for gathering useful information about the safety and effectiveness of interventions involving medical devices and diagnostics, but only if they are designed and executed properly,” AdvaMed CEO Stephen Ubl said in a written statement at the time.

The government is moving forward with identifying best practices around registry development. The FDA this year formed two groups to address issues with registry development.

The agency doesn't have the authority to require registry development, but the CMS can require registry data as part of Medicare coverage decisions.

Pew and other groups are lobbying for the Office of the National Coordinator for Health Information Technology to incorporate rules that would require unique device identification information to be captured by electronic health-record systems as part of the next round of meaningful-use requirements.

Follow Jaimy Lee on Twitter: @MHjlee