Device makers every year submit more than 1 million reports of adverse events, of which about 5 percent involve serious injuries or deaths. Now the U.S. Food and Drug Administration has released an in-depth report on the future of adverse event tracking for medical devices, potentially setting the stage for creation of an ambitious nationwide system of post-market device monitoring.
A panel with representatives from two dozen agencies, organizations and large device makers such as Medtronic Inc., Aetna Inc. and the American Medical Association, prepared the report that was commissioned by FDA.
In a blog post, FDA described that the report “provides a pathway to realizing a national system that harnesses novel data sources, modern analytical techniques and the participation of all stakeholders to optimize patient care.”
The report identified implementing the FDA’s nascent system of so-called unique device identifiers, phased in between now and 2020; ensuring that different types of electronic health records can communicate and devising a system that doesn’t create red tape for providers; and finding adequate funding as challenges, adding that the proposed system will be extensive and expensive – needing at least $200 million in startup cash.
The report suggested that the system should be structured as a public-private partnership with a governing board appointed through a transparent process. The surveillance system should begin with a two-year stage of pilot projects and then enter a five-year phase of implementation, the authors recommended.
“Any effort to create a stand-alone, isolated system will significantly increase the work required to develop data and conduct analyses on surveillance, lowering the value of the system and threatening its viability,” the report said.
Recent harm and litigation involving defective surgical mesh, metal-on-metal hip implants and other products has “raised questions about FDA’s ability to monitor and act on potentially important safety concerns,” according to the report, and the proposed modernized system would have far-reaching benefits for patient safety and device maker liability.
Improved tracking could also help providers make smarter choices about which devices to use and could assist health insurers in developing better coverage policies, the report said. It may even result in relaxed approval standards at the FDA, since unexpected problems would be more quickly spotted. “This shift does not mean FDA accepts less evidence of safety and effectiveness, but [it] is an acknowledgement that post-market data better reflects the real world,” the authors wrote.
FDA plans to accept public comments on this report and a separate task force report will be released later this year to further inform its efforts before moving forward.