Sunday, September 30, 2012

Addressing Adverse Events Reporting

The FDA’s Center for Devices and Radiological Health (CDRH) just published the report “Strengthening Our National System for Medical Device Postmarket Surveillance” that addresses the need for a Unique Device Identification (UDI) system to report adverse events. Developing the UDI system would help the FDA, the healthcare community, and industry to more accurately report and analyze device-related adverse events.

The Report mentions four specific actions:

  • Establish the UDI system and promote its incorporation into electronic health information
  • Promote the development of national and international registries for selected products
  • Develop and use new methods for evidence generation, synthesis, and appraisal
  • Modernize adverse event reporting and analyses
Right now, FDA reports that there are serious problems in reporting adverse events involving medical devices. Today, information on adverse events is contained in the Manufacturer and User Facility Device Experience (MAUDE) database which contains voluntary reports received since 1993.

However, after many years use, the number of adverse event records contained in MAUDE is now exceeding its design capacity plus there are limitations in using spontaneous reporting systems. Therefore, modernizing adverse event reporting is a key requirement to developing a comprehensive medical device postmarket surveillance system and requires the use of the UDI system.

The “Adverse Spontaneous Triggered Events Reporting (ASTER) study has demonstrated that facilitated, “triggered reporting” increases the number of adverse events reported by clinicians. CDRH is piloting ASTER-D to help hospital EHRs and Incident Reporting Systems detect and automatically report devices associated with adverse events to the FDA.

FDA is presently working on a new system called the “FDA Adverse Event Reporting System” (FAERS) that will have expanded capacity and modern analytic capability for identifying and extracting relevant information in automated fashion and in more versatile reporting formats.

FDA is also addressing mobile applications for adverse event reporting. CDRH has partnered with Boston Children’s Hospital to develop and implement a mobile app to use to securely report medical device adverse events. Work is currently underway to refine the app so that CDRH can receive reports via FDA’s electronic submission gateway.

Go to for more information.