Pew, BCBSA, and MDEpiNet Address Lack of a Robust System to Assess Medical Device Safety

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Report captures comprehensive recommendations from 30 diverse health care experts

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WASHINGTON—Three organizations today proposed wide-ranging recommendations on the development of registries to address the country’s lack of a robust national system for assessing 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, and the Medical Device Epidemiological Network Science Infrastructure Center at Weill Cornell Medical College.

Medical devices, such as metal hip implants, typically require only a few years of clinical data from a small number of patients in order to be approved by the U.S. Food and Drug Administration (FDA). By collecting data from a larger and more diverse set of patients for a longer period of time, registries could better monitor devices and recognize long-term complications. Data from registries can also help patients and physicians understand the risks and benefits of certain medical devices, which can impact treatment decisions, improve outcomes, and reduce painful and costly surgeries to replace the faulty devices.

"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 diverse group included government officials from 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 strong 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 Blue Cross Blue Shield Association. "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 Science and Infrastructure Center at Weill Cornell Medical College. "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."

The Pew Charitable Trusts is driven by the power of knowledge to solve today’s most challenging problems. Pew applies a rigorous, analytical approach to improve public policy, inform the public, and stimulate civic life. 

The Blue Cross Blue Shield Association is a national federation of 37 independent, community-based, and locally operated Blue Cross and Blue Shield companies that collectively provide healthcare coverage for more than 105 million members—one-in-three Americans.  For more information on the Blue Cross Blue Shield Association and its member companies, please visit bcbs.com. We encourage you to connect with us on , check out our videos on YouTube, follow us on Twitter and check out The BCBS Blog, for up-to-date information about BCBSA.
 
The Medical Device Epidemiological Network Science Infrastructure Center at Weill Cornell Medical College is committed to providing a strong foundation for collection, analysis and dissemination of medical-device data by leveraging resources to facilitate creation of new registries and improve existing ones. MDEpiNet forges stakeholder collaborations and develops data sets and innovative methodological approaches to achieve its mission of improving medical-device safety and effectiveness through the device life cycle.


News Source : Pew, BCBSA, and MDEpiNet Address Lack of a Robust System to Assess Medical Device Safety
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