Groups Press FDA to Make Better Use of Device Registries

Three organizations have proposed wide-ranging recommendations on the development of registries to address America’s lack of a national system to assess the safety and effectiveness of medical devices.

Registries, which contain information on patients treated with specific medical devices, could fill this gap by tracking the performance of the devices over time and quickly identifying those that fail, according to a new report released by The Pew Charitable Trusts, the Blue Cross Blue Shield Association (BCBSA), and the Medical Device Epidemiological Network (MDEpiNet) Science Infrastructure Center at Weill Cornell Medical College in New York, N.Y.

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.

“Our ability to assess medical devices once they enter the market is weak, as recent failures of metal-on-metal hips and implantable cardiac defibrillators have demonstrated,” said Josh Rising, director of the medical device initiative at Pew. “Registries can be a powerful tool for health care professionals, patients, and manufacturers who need reliable information on device performance.”

The report is based on a series of meetings in which more than 30 health care experts discussed major objectives for optimizing the use of registries. The group included government officials from the FDA and the Centers for Medicare & Medicaid Services, as well as representatives ranging from device manufacturers to patient advocates. The findings are intended to inform the implementation of recommendations from a 2012 FDA report, “Strengthening Our National System for Medical Device Postmarket Surveillance,” which laid out a strategy for building a national system to assess the long-term effectiveness of medical devices.

The new, co-authored report outlines five objectives that would allow medical device registries to better contribute to the national surveillance system, including:

• Establishing criteria for determining whether a device registry is the appropriate tool for post-market surveillance.
• Ensuring that registry findings—as well as information about a registry’s governance and financing—are publicly available to help patients, doctors, payers and manufacturers make informed decisions.
• Implementing efficiencies to help streamline registry data collection and reduce the time and cost of reporting.
• Leveraging registries to accelerate medical device innovation and help fulfill related regulatory responsibilities.
• Resolving varying legal interpretations of provisions governing quality improvement activities and research as they apply to registries.  

“Registries have the potential to dramatically improve our understanding of how medical devices perform in the real world when used by patients and medical professionals outside of a tightly controlled environment,” said Naomi Aronson, Ph.D., executive director of clinical evaluation and policy for BCBSA. “We encourage the health care community to put these recommendations into practice.”  

In developing the recommendations, the report’s authors looked to established device registries around the world that have made significant gains with regard to patient safety and improved outcomes. For example: 

• In 2007, the Australian Orthopaedic Association’s National Joint Replacement Registry reported that a particular metal-on-metal hip implant had twice the failure rate of conventional implants. Australia stopped using this specific hip replacement system in December 2009 because the registry identified problems with the device; the United States continued using the device until subsequent data led to its worldwide recall in August 2010. 
• The Kaiser Permanente Total Joint Replacement Registry is used to improve the quality of care and also achieves cost savings. For example, in 2007, two knee replacement systems were identified as having high failure rates. The next year, decreased use of these implants avoided an estimated 16 surgeries to replace the faulty implants. 

“The successes of established registries in the United States and abroad demonstrate that registries can become a central part of an effective post-market surveillance system for medical devices,” said Art Sedrakyan, M.D., Ph.D., director of the MDEpiNet. “U.S. registries can also improve their processes and work together to develop a learning network. Implementation of our recommendations can help physicians, patients, manufacturers, and the FDA get the needed data on medical devices and build a higher-quality health care system.”

Many private organizations have developed their own registries to improve clinical and purchasing decisionmaking. Kaiser Permanente, the Cleveland Clinic and 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. Last winter, 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.