Safety flaws from faulty metal-on-metal hips and defibrillator leads have been a pock mark on the medical device industry. Those issues and others stemmed in part from the fact that they occurred over a long period of time, while premarket data collection is understandably limited to a few years. To improve postmarket monitoring, three prominent stakeholders released a report today on the optimal use of medical device data registries to enable postmarket surveillance.
"Registries can be a powerful tool for healthcare professionals, patients, and manufacturers who need reliable information on device performance," said Josh Rising, director of the medical device initiative at The Pew Charitable Trusts, in a statement.
The recommendations from Pew, insurance group Blue Cross Blue Shield Association and Weill Cornell Medical College focus on appropriate use, efficiency and minimizing conflict:
- Establishing criteria for determining whether a device registry is the appropriate tool for postmarket 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 can be powerful tools, the report says. It points to the Australian Orthopaedic Association's National Joint Replacement Registry, whose data led the country to stop using some metal-on-metal hips in December 2009; the U.S. discontinued use of the device in August 2010.
"The successes of established registries in the United States and abroad demonstrate that registries can become a central part of an effective postmarket surveillance system for medical devices," said Dr. Art Sedrakyan of Weill Cornell Medical College in a statement. "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 healthcare system."
Medical device registries are a concern of medical device company leaders as well. During an address to Congress, Mike Mussallem, the CEO of Edwards Lifesciences ($EW), said that "many physicians have told us that it takes longer to fill out the TVT (Transcatheter Valve Therapy) Registry form than it does to perform the procedure."
In an interview with FierceMedicalDevices, Rising concurred that the length and time is an issue, but said the problem can be addressed by integrating data from existing electronic sources as much as possible. "It won't always be possible and there may be times when you need unique fields from industry, but it's really important to minimize the burden on hospitals," he said.
And industry can benefit from the data collection as well. In spite of his concerns, Mussallem also told Congress how Edwards benefited from the TVT registry; the information helped to expand the indications for use of the Sapien artificial heart valve, making it available to a wider audience.
- read the release
- get the report