The U.S. Food and Drug Administration (FDA) is looking to improve the way it works with hospitals to modernize and streamline data collection, specifically safety data, about medical devices.
In a blog post, Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health, wrote that the FDA’s post-market surveillance tools for monitoring medical devices have “inherent limitations.”
“Likely the most well-known of FDA’s post-market surveillance tools is medical device reporting, which FDA requires from certain entities, including device manufacturers and device user facilities, such as hospitals. Federal law requires hospitals and other user facilities to report when they become aware of information reasonably suggesting that a medical device has or may have caused or contributed to a death or serious injury to a patient. They must report these medical device-related deaths to both FDA and the manufacturer, if known; and device-related serious injuries to the manufacturer, or to FDA, if the manufacturer is not known,” Shuren wrote.
However, he noted that such passive surveillance has “important limitations because it relies on people to identify that a harm occurred or a risk is present, recognize that the harm or risk is associated with the use of a particular device, and take the time to report it.”
The FDA plans to work with the hospital community on what role they should play in assuring the safe use of medical devices. “This work will include how they can effectively participate in the National Evaluation System for health Technology (NEST), and whether or not current reporting requirements should remain, be modified, or eliminated in light of more effective modern tools, such as software tools to conduct active surveillance of electronic health information that contains unique device identifiers,” Shuren wrote.
On December 5, FDA will hold a public workshop to solicit input and advice on improving hospital-based surveillance systems and the broader role of using hospitals to evaluate how well devices work in the clinical setting.
“We encourage all hospital stakeholders—from clinicians to IT system managers—to attend and discuss current hospital-based surveillance efforts, the role of hospitals in evidence generation and future opportunities for hospital-based surveillance. We’d also like their input on the incorporation of unique device identifiers (UDIs) into electronic health records to aid in the future development of evidence generation efforts, including the support of better device development, surveillance and health care delivery,” Shuren wrote.
In light of several high-profile device safety issues occurring in hospitals, the FDA, in December 2015, initiated inspections at 17 hospitals. Shuren wrote that from those inspections, the FDA learned three important lessons. “First, some hospitals didn’t submit required reports for deaths or serious injuries related to devices used at their facilities, and in some cases, they did not have adequate procedures in place for reporting device-related death or serious injury events to FDA or to the manufacturers,” he wrote. “Second, hospital staff often were not aware of nor trained to comply with all of FDA’s medical device reporting requirements. Third, we feel certain there is a better way to work with hospitals to get the real-world information we need, and we should work with the hospital community to find that right path, especially in light of developments in the creation and evaluation of electronic health information.”
Shuren also wrote that, in many case, the FDA inspections of these 17 hospitals turned up violations of FDA’s medical device reporting regulation. For some hospitals with significant violations of the regulation, the FDA received a response that the agency determined was not adequate to address those violations, and engaged with those facilities to facilitate an effective path to compliance, according to Shuren.
“Hospitals are our partners in building the infrastructure for NEST. Together we can build a state-of-the-art system that not only quickly identifies life-threatening problems caused by medical devices but also expedites patient access to crucial life-saving devices. Armed with such information, health care providers can help patients make more informed medical decisions that improve their health,” he wrote.
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