Three prominent health organizations have made 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.
The report, authored by the Medical Device Epidemiological Network Science Infrastructure Center at Weill Cornell, The Pew Charitable Trusts and the Blue Cross Blue Shield Association, examines the role of medical registries in tracking these devices, such as implantable defibrillators, cardiac valves and joint replacements. These future registries would monitor the quality and effectiveness of specific devices as they move from small clinical trials to the marketplace following approval by the U.S. Food and Drug Administration.
|Dr. Art Sedrakyan |
Image credit: Carlos Rene Perez
"We currently have very limited tools and means to understand how most devices perform after they enter the healthcare market," said Dr. Art Sedrakyan, director of the center, associate professor of healthcare policy and research and associate professor of public health in cardiothoracic surgery at Weill Cornell. "We rely on pre-market clinical studies or testing and assume that these devices are good, but past experience proves that's not the case since a number of commonly used devices ultimately fail or do not perform well. Registries will become a critically important cornerstone for surveillance of implantable devices as a result of the FDA's modern vision that is aligned with that of stakeholders."
Unlike countries that have national healthcare systems, the American healthcare industry is fragmented, with clinical data scattered across multiple providers and insurance companies. With no centralized repository of patient data, including the specific device a patient receives and how it performs, physicians have little reliable data to go on when choosing the best and safest products for their patients. Similarly, patients lack the knowledge to ask questions about their healthcare options, Dr. Sedrakyan said.
This gap in post-market information complicates regulators' efforts to identify products that demonstrate a pattern of failure, as was the case with certain cardiac devices and metal-on-metal hips. To close this gap, the FDA two years ago outlined key steps, including the establishment of registries, to create a national system that would quickly identify poorly performing devices. For the time being, these registries would most likely be established and maintained by professional medical societies with the assistance of manufacturers, funding agencies and insurers.
The report's authors met over the course of a year with key experts and officials from societies and organizations to discuss the best ways to achieve the FDA's goal. The result was five recommendations to help guide the FDA: Establishing criteria for determining which device will be included in registries, ensuring registry data is publicly available, making data collection efficient to reduce the burden on those involved, leveraging registry data to advance innovation, and engaging stakeholders.
"Change never comes fast, but we have to create a learning network and align the vision of various stakeholders so that they recognize the potential of registries," Dr. Sedrakyan said. "The value proposition — why registries are needed — hasn't been clearly made in the past. I think we are gradually getting there now."