FDA Targets 15 Hospitals Over Significant Deviations from Medical Device Reporting Regulation

Regulatory NewsRegulatory News | 24 October 2016 |  By 

The US Food and Drug Administration (FDA) on Monday released a summary of hospital inspection findings, as well as Form 483s for 15 hospitals, detailing failures of the hospitals to report medical device-related adverse events.

Several high-profile hospitals were included in the list, including Los Angeles-based Cedars-Sinai Medical Center and Boston-based Brigham and Women’s Hospital, for their failure to keep written medical device reporting procedures and to report adverse events.

The release of the information comes as the role of hospitals reporting device-related adverse events as part of device surveillance has garnered increased scrutiny in light of several high-profile safety issues.

FDA, in December 2015, initiated inspections at 17 hospitals, chosen because there were reports of events at these facilities related to the spread of uterine cancer from the use of morcellators or the spread of infections associated with contaminated duodenoscopes, Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, wrote in a blog post on Monday. 

Public Workshop

The agency is looking to fill some of those gaps with a public workshop on 5 December as part of efforts to leverage real-world data captured in electronic health information (such as device registries, electronic health records and payer claims forms) to quickly identify poorly performing devices, accurately characterize and disseminate information about real-world device performance and help generate data to support premarket clearance or approval of new devices and new uses of currently marketed devices.

“This workshop is intended to foster a dialogue about the value of, costs of, and challenges with current hospital-based reporting and surveillance, what the role of hospitals should be and reasonably could be in the evolution of device surveillance and in creating more robust surveillance capabilities in the developing national evaluation system, and how that should impact current hospital reporting requirements and future voluntary opportunities to best meet the needs of patients in receiving and hospitals in providing quality care,” FDA says.

Inspection Findings

The findings, from inspections dated December 2015 through April 2016, revealed that 11 hospitals have failed to inform FDA within 10 working days after becoming aware of information that reasonably suggests that a device has or may have caused or contributed to death of a patient at each facility. Facilities that failed to provide this information include:

One of the FDA inspectors also requested device adverse event files from Brigham and Women’s Hospital related to death or serious injury, but the hospital’s director of risk management “stated that the hospital does not maintain files other than what is reported through MedSun. Required information such as records of deliberations and decision making processes used to determine whether a death or serious injury was or was not reportable was not available for inspection.”

Only two of the hospitals inspected by FDA did not receive a Form 483, which can be the precursor to a warning letter: Charlotte-based Carolinas Medical Center and Milwaukee-based Froedtert Hospital.

FDA Summary of Hospital Inspection Information


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