由 John W. Mitchell
, Senior Correspondent | April 11, 2016
An ongoing effort to create a centralized-medical device evaluation body to ensure effectiveness has reorganized at the Duke-Robert J. Margolis, M.D. Center for Policy.
Known as the National Medical Device Evaluation System (NMDES), the planning board leading the effort will develop resources to improve medical devices.
“Our Center and the Planning Board understand the critical need to develop, in a cost-effective way, more comprehensive evidence on the safety, effectiveness, and high-value uses of medical devices,” Dr. Gregory Daniel, Ph.D., MPH, Deputy Director at Duke told HCB News. “This is the best opportunity to do that.”
Daniel said that the NMDED Planning Board is designed as a multi-stakeholder group with representation from patients, clinicians, researchers, health systems, health plans, device manufacturers, health IT experts, and government agencies.
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Evidence of this need, said Daniel, can be seen in the January report released by Senator Patty Murray (WA) titled “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Devices Safety Fails Patients”. The report examined the recent spate of patient infections and death linked with ongoing problems with improperly sterilized endoscopy scopes
In the report, Murray called for medical device oversight monitoring similar to the surveillance of drug safety under the FDA’s Sentinel Surveillance reporting program launched in 2008.
“There is currently no efficient and cost effective way to develop actionable evidence of the safety and effectiveness of medical devices, particularly in the post-market,” said Daniel. “The lack of unique device identifiers, high cost of manual data entry, and difficulty in enrolling the patient in post-market studies are all obstacles in this process.”
He added this mean that patients and the clinicians that care for them often do not have the information they need to make informed decisions.
The next step is to establish, with both public and private funding, a governing structure to uphold the system principles as laid out in 2015 report recommendations by the Brookings Center for Health Policy, a precursor group to the NMDES. This, said Daniel, would be followed by demonstration projects to gather evidenced-based data and the benefits of better coordination in the development of medical devices. He added that this information would also help reduce the cost and time-to-market for new, innovative devices
“Setting up a coordinating center to activate and build a virtual network of device data and evidence development activities can truly help better learn from real patient experiences with devices, in much more cost-effective and timely ways that are not possible today,” said Daniel.