Recently in the Journal of the American Medical Association, the FDA renewed its call for the establishment of a national medical device evaluation system in the United States that would draw upon existing clinical data sources, such as electronic health records, insurance claims data, and registries to support the pre- and postmarket evaluation of medical devices.
The proposed National Evaluation System for Health Technology (NEST) would balance a desire to speed up access to new technology and address safety issues throughout the lifetime of the device, writes FDA Commissioner Robert Califf and Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren, in a commentary published July 11.
“Essentially, NEST should be of, by, and for the medical device ecosystem and configured to provide maximal value to stakeholders, including the critical data needed by the FDA to make decisions that currently must be made with less comprehensive information,” the authors wrote.
In the US, adverse events by medical devices are often underreported by clinicians, the authors wrote, while FDA-mandated post-market studies are often incomplete, inadequate, and unenforced. The establishment of an independent coordinating center for NEST that includes representation from patients, the health care and medical device industry, and regulators would use clinical databases and unique device identifiers to determine a mix of pre- and postmarket evaluations needed for a device, depending on its risk–benefit profile.
“Raising premarket standards too high may lead device development and access to other countries with lower barriers and reduce investment in new technology. Conversely, an ineffective postmarket system perpetuates uncertainty about appropriate device use. An ideal approach would match the degree of premarket evaluation with the degree of probable risk and benefit posed by the device, while emphasizing rigorous postmarket evaluation in conjunction with carefully planned premarket clinical studies,” the authors wrote.
One of CDRH’s strategic priorities is to increase to the amount of real-world evidence it uses to support regulatory decision-making by gaining access to 25 million electronic health records with device identification by the end of 2016, and 100 million by the end of 2017.
The approach outlined by Califf and Shuren seeks to nudge medical device testing in the direction of increased postmarket evaluation of medical devices, slightly away from the current system in the United States, which puts high-risk medical devices through rigorous premarket clinical testing, says Joe Lewelling, vice president of emerging technologies and health IT at the Association for the Advancement of Medical Instrumentation (AAMI).
“The creation of an effective national system for healthcare technology evaluation will not only make devices safer, it will allow new, critically needed technologies to get to market faster,” Lewelling says. “In the past, the regulatory emphasis has been on the premarket evaluation side. By providing more extensive clinical data on device safety and efficacy and by helping identify potential problems with devices expeditiously, a robust national evaluation system would allow regulators to speed up the device approval process without compromising patient safety.”
Marilyn Neder Flack, executive director of the AAMI Foundation, says she looks forward to the full implementation of a “comprehensive program” for device evaluation. “Currently, our knowledge about how devices function after they’re on the market can be lacking. It can take years sometimes to figure out if there’s a problem with a device,” she says.