FDA Examining Role Of Hospitals In Medical Device Surveillance
On October 25, 2016, FDA announced an upcoming public workshop entitled, "The Role of Hospitals in Modernizing Evidence Generation for Device Evaluation: Harnessing the Digital Revolution for Surveillance." FDA's notice of this workshop is published in the Federal Register here.
The workshop, to be held on December 5, 2016, will remind hospitals of their reporting obligations under current FDA regulations and explore potential opportunities for changing those requirements to enhance national device surveillance in the future. In light of recent hospital-based disease outbreaks associated with the use of contaminated medical devices, as well as multiple initiatives by FDA to create a more comprehensive national device surveillance program, FDA is soliciting feedback from hospital stakeholders and others on a broad range of questions covering current requirements and future opportunities to improve postmarket device surveillance.
This Alert summarizes the key aspects of FDA's announcement and the significance for regulated stakeholders.
Hospital Reporting of Adverse Events
A primary objective of the public workshop is to educate hospitals and other user facilities about the current FDA reporting obligations applicable to user facilities of medical devices. Under FDA regulations, "device user facilities," including most hospitals, ambulatory surgical facilities, nursing homes, outpatient diagnostic facilities, and outpatient treatment facilities, are required to submit medical device reports (MDRs) to FDA or the device manufacturer upon becoming aware of certain reportable events.1 Specifically, device user facilities are required to report to FDA and the manufacturer (if known) within 10 work days of becoming aware of a device-related death, or to the manufacturer (if known) or FDA (if the manufacturer is unknown) within 10 work days of becoming aware of a device-related serious injury.2 A user facility also must submit an annual report to FDA if it submitted any individual MDRs during the applicable reporting period.3
In addition to reporting adverse events, hospitals and other user facilities are required to develop, maintain, and implement written MDR procedures that ensure: (i) timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements; (ii) a standardized review process or procedure for determining when an event meets the criteria for reporting; and (iii) timely transmission of...
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