19 Jul 2016
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.
Source: 24x7
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