Three of the medical device industry's most prominent names have joined together to launch a new initiative they say will enhance the methods used to evaluate the safety of medical device products.
The five-year agreement, signed between the US Food and Drug Administration (FDA), Yale University and Medtronic, Inc will "develop a general framework" and "key methodologies, best practices and strategies that are essential to the success of an effective US medical device surveillance registry network," wrote Yale University in a press release.
"We need systems that provide early warning of problems and provide the information to ensure these devices are providing the benefits that we expect," Harlan Krumholz, a professor at Yale, said.
Part of the goal of the registry will be to make sure that medical devices approved or cleared by FDA are safe once used in real-world settings, said Krumholz. FDA has recently been grappling with several medical devices-metal-on-metal hips, vaginal mesh implants and implantable cardioverter defibrillator (ICD) leads, among others-that are alleged or proven to have serious safety issues.
Some of the problems result from either unique features of the medical device approval/clearance pathways or from more basic elements of the clinical trials testing system.
To the former point, some critics point to the 510(k) substantial equivalence pathway, which allows sponsors to clear a product through FDA without conducting clinical testing so long as they can prove their product is "substantially equivalent" to an approved or once-approved predicate device. Devices that have been recalled from the market for safety reasons are not eligible for the process, though devices voluntarily withdrawn for unknown reasons-some are taken off the market before safety issues can be confirmed-are still eligible. The pathway has been behind several failed implantable medical devices, and regulators seem increasingly of the opinion that a surveillance registry may be the best way to keep an eye on the devices.
Other problems with the devices can simply be attributed to a matter of scale and the way in which clinical trials are set up. When required, such as for high-risk devices requiring a premarket approval (PMA) submission, medical devices require fewer patients to show evidence of safety and efficacy than do pharmaceutical products. Further, the products-no different than pharmaceuticals-are tested in highly controlled environments, often by experts in their respective fields and on ideal patients.
In contrast, when these products are brought into wider circulation and used by a wide variety of patients, undiscovered problems can be brought to light.
FDA conceded at various times in 2012 that its medical device postmarketing capacities needed to be improved. "Several high-profile device performance concerns have led some to question whether the Center for Devices and Radiological Health's (CDRH) current postmarket surveillance system is optimally structured to meet the challenges of rapidly evolving medical devices and the changing nature of health care delivery and information technology," FDA wrote in a 30 August 2012 Federal Register posting.
In making that announcement, FDA also proposed a new surveillance system with the capacity to track devices through a unique device identification (UDI) number, the use of medical device registries, modernized adverse event reporting and analysis and new methods of generating and evaluating data.
Regulatory Focus has reached out to Krumholz and Medtronic for more information on the initiative and will post that information as it becomes available.