Groups press FDA to encourage medical-device registries

By Jaimy Lee 

The U.S. healthcare system trails behind other developed countries in tracking the performance of medical devices through registries, but 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 run by Weill Cornell Medical College’s Medical Device Epidemiology Network, issued a set of recommendations Wednesday to improve the role of registries in the U.S.

Device registries gather information about how patients respond after devices are used or implanted. 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. In many cases clinical trials of high-risk devices track a small number of patients for a limited period of time and do not provide long-term data about how the devices perform.

Johnson & Johnson’s high-profile recall in 2010 of metal-on-metal hip implants is often cited as a primary example of the value of registries. Clinicians tracking outcomes of the implants in registries in Australia and the United Kingdom 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.”

Many private organizations have developed their own registries to improve clinical and purchasing decisionmaking. Kaiser Permanente, the Cleveland Clinicand the Veterans Affairs Department are a few examples of health systems that have their own device registries in place. The data in those registries is limited and private to the organizations. The paper argues that registries should be publicly available.

There are other voluntary registries for some medical devices in place. The University of Massachusetts Medical School received federal funding to create a nationwide registry of joint replacements. The American Joint Replacement Registry, which is partially funded by manufacturers and trade groups, is also tracking knee and hip implant surgeries at 357 hospitals in 48 states, according to a registry spokeswoman.

But the organizations acknowledge that not all medical products should require a registry. The paper outlines some areas that must be evaluated, including the cost of establishing and maintaining the registry and the need to publicly share information about their funding, governance and operations.

Medical-device manufacturers have raised some similar reservations. In February, the Advanced Medical Technology Association, a trade group for devicemakers, 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 President and CEO Stephen Ubl said in a statement at the time.

The government is also moving forward with identifying best practices around registry development. The FDA this year formed two groups—the National Medical Device Postmarket Surveillance System Planning Board and a Medical Device Registry Task Force—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 coverage decisions.

As part of the FDA’s ongoing work to improve tracking of technology after it receives marketing approval, the agency issued a 2012 report identifying four ways to strengthen the nation’s post-market surveillance system. One area of focus is the development of registries. Another is the implementation of the unique device identification system, which will require manufacturers to place a unique identification number on most medical devices and their labels. The rollout of the UDI system begins this month when manufacturers will have to begin putting identification data on the labels of high-risk medical devices.

Pew and other groups are lobbying for the Office of the National Coordinator for Health Information Technology to incorporate rules that would require UDI 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

Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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