A board working on a nationwide system to monitor the risks and benefits of medical products on the market outlined some of the projects it hopes to undertake to help boost the safety and effectiveness of devices.
Among the projects being considered by the National Evaluation System for Medical Devices board is quantifying potentially serious but rare adverse events in Class 2 devices. This project would allow experts to link electronic health records and claims data to create a retrospective virtual registry to calculate the rate of these events.
The NESMD board also hopes to enhance existing patient registries to standardize and automate data entry from information collected in EHRs.
In addition, the board wants to promote methods to collect information directly from patients, including safety problems, said Greg Daniel, deputy director of the Duke-Margolis Center for Health Policy at Duke University, during a meeting last week in Baltimore, Md.
The event was jointly sponsored by the FDA and the University of Maryland’s Center of Excellence in Regulatory Science and Innovation, which is funded by the agency to help improve the way drugs and devices are reviewed.
Discussions about the board’s plans come in the wake of a number of medical device-related adverse events, including complaints about metal-on-metal hips and the Essure implantable birth control product. A national system to collect relevant information about medical devices in the postmarket setting would go far toward identifying safety signals earlier and prevent patient harm, CDRH Director Jeffrey Shuren said.
Additional information also would give patients guidance in terms of what devices can help them. Millions of people are living with implanted devices, said Fadia Tohme-Shaya, of the University of Maryland School of Pharmacy; however, a paucity of information as a result of ineffective data generation in clinical trials has discouraged millions of others from obtaining them.
“The lynchpin here is evidence generation,” Shuren emphasized, adding that establishing the NESMD is one of the center’s strategic priorities for 2016 and 2017 (). Shuren provided some color on the “learning medical device ecosystem,” which would replace the passive surveillance system that exists now.
The NESMD would place an emphasis on gathering more data in the postmarket setting through unique device identifiers, EHRs and registries. These data can help devicemakers, which struggle with subject enrollment for postmarket trials, as patients aren’t incentivized to sign up for these studies.
To gain access to evidence, stakeholders have proposed developing a coordinated network to generate usable data.
The network would revolve around a coordinating center, which would serve as a source of safety updates, recall management and effectiveness information, Daniel said.
Shuren said the selection of a coordinating center was pending the outcome of the user fee negotiations. — Elizabeth Hollis