Ask HRC: What is Reported on the Annual MedWatch Summary?

November 23, 2010 | Health System Risk Management


A Healthcare Risk Control (HRC) System member recently asked about the U.S. Food and Drug Administration’s (FDA) requirements for submitting an annual summary of a healthcare facility’s mandatory MedWatch reports. Specifically, the member wanted to know whether reports of blood product deviations—submitted to FDA’s Center for Biologics Evaluation and Research on FDA form 3486—are included in the annual summary of MedWatch reports.

The annual MedWatch summary, also referred to as FDA form 3419, is submitted by healthcare facilities every year by January 1 and identifies all mandatory MedWatch reports sent to FDA during the previous year. A mandatory MedWatch report, also known as a 3500A form, is a notification to FDA of a device-related incident involving a death, serious injury, or serious illness. Healthcare facilities must attach copies of the 3500A forms submitted to FDA during the previous year or provide a description of each event with the annual summary. The annual summary does not require a listing of blood product...

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