Medical Device Reporting in Ambulatory Care: The 10-Day Reporting Requirement

September 6, 2022 | Ambulatory Care Risk Management


​​​​According to U.S. Food and Drug Administration (FDA) requirements under the Safe Medical Device Act of 1990 (SMDA) and the FDA Modernization Act of 1997 (FDAMA), healthcare facilities must report certain adverse events involving medical devices within 10 work days of "becoming aware" of information that reasonably suggests the device's role in a death or serious injury. FDA defines a work day as a day from Monday through Friday, excluding federal holidays. However, there has been confusion about when the 10-day clock begins to run. Does it run from the time the adverse event occurred? When a physician or nurse became aware of the event? When the risk manager first learned of the event? Or when staff determined that the device contributed to the event?

FDA says that the 10-day clock starts when the facility "becomes aware," meaning "that an employee of the entity required to report has acquired information that reasonably suggests a reportable adverse event has occurred." Device user facilities are considered to have "become aware" when, according to FDA, "medical personnel . . .​ who are employed...

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