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FDA Turns Adverse-Event Reporting Scrutiny On Hospitals

 
• By David Filmore

The US agency detailed potential adverse-event reporting violations at 15 hospitals in FDA-483 forms that were posted online by FDA to highlight the need to shift to an active, electronic based device surveillance system.

Recent high-profile device safety alerts prompted the US FDA to take the unusual step of inspecting hospital facilities for their compliance with adverse-event reporting regulations. The audits, which took place from December 2015 through April of this year, resulted in FDA-483 forms detailing potential violations at 15 of the 17 hospitals the agency inspected, the agency disclosed Oct. 24.

The findings highlight continued challenges in collecting meaningful safety data using the passive US Medical Device Reporting (MDR) system, FDA...

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