FDA looks to modernize hospital medical device safety reporting

The Food and Drug Administration wants to improve the way the regulatory agency works with hospitals to collect data regarding medical devices and adverse events.

According to Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, the FDA has several tools for monitoring medical devices after they are on the market—called postmarket surveillance—but they have inherent limitations.

“The most well-known of FDA’s postmarket surveillance tools is medical device reporting, which FDA requires from certain entities, including device manufacturers and device user facilities, such as hospitals,” Shuren writes in an October 24 blog.

However, he notes that some hospitals have not submitted “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.”


Shuren contends that more modern, efficient software tools able to conduct active surveillance of electronic health information containing unique device identifiers could help solve the limitations of current postmarket surveillance.

Hospitals, which Shuren calls the “nation’s hubs for real-time healthcare data,” are “uniquely positioned to help identify new safety problems with devices as well as changes in the frequency of already known safety problems because they use these technologies in the real-world setting of clinical practice.”

An October 25 notice published in the Federal Register claims that an FDA-proposed National Evaluation System for health Technology (NEST) would leverage real-world data “captured in electronic health information (such as device registries, electronic health records, and payer claims forms)” incorporating “unique device identifiers to quickly identify poorly performing devices, accurately characterize and disseminate information about real-world device performance, including the clinical benefits and risks of marketed devices, and efficiently generate data to support premarket clearance or approval of new devices and new uses of currently marketed devices.”

Also See: EHR, claims data critical to success of FDA’s National Device Evaluation System

Toward that end, the FDA on December 5 will conduct an all-day workshop in Rockville, Md.—entitled The Role of Hospitals in Modernizing Evidence Generation for Device Evaluation: Harnessing the Digital Revolution for Surveillance—to solicit input from hospitals and other healthcare providers on how to improve its data collection about adverse events related to medical devices.

“Recently, the role of hospital reporting of device-related adverse events in device surveillance and, more generally, device evaluation, has garnered increased scrutiny,” states the FDA announcement. “This public workshop will further explore the critical role of hospitals in the evolution of device surveillance and in creating more robust surveillance capabilities.”

Jay Bhatt, senior vice president and chief medical officer for the American Hospital Association, says that hospitals across the country are working hard to prevent medical errors, improve health outcomes, and provide the best care possible to patients and their families.

At the same time, Bhatt acknowledges that while “hospitals have an array of reporting requirements that they are following when a safety event occurs,” there is a need to modernize medical device safety reporting.

“We know the road to quality improvement includes simple, safe, standardized processes,” according to Bhatt. “The FDA recognizes that today’s system is not working as intended for patients. America’s hospitals and others, including lawmakers on Capitol Hill, agree there should be a better way. We will continue to work with the agency to improve the reporting process so that problems can be quickly addressed and information shared with device makers, FDA, clinicians and patients and their families to improve safety.”

Online registration to attend the FDA’s December 5 workshop can be accessed here and must be completed by November 28. The meeting will also be webcast live.

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