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US Food and Drug Administration: adverse event reporting

¹US Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD, USA.

CRNA : the Clinical Forum for Nurse Anesthetists

|December 29, 1998

Summary

Anesthesia device adverse events from 1996-1998 show cardiovascular and surgical devices were most reported. Deaths were linked to cardiovascular, hospital, and gastrointestinal devices, with ventilator alarm failures being common.

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Area of Science:

Medical device safety
Anesthesiology
Healthcare technology assessment

Background:

Adverse event reporting is crucial for monitoring medical device safety.
Understanding trends in anesthesia device-related incidents informs regulatory and clinical practices.

Purpose of the Study:

To analyze adverse event reports for anesthesia devices submitted to the US Food and Drug Administration (FDA) between 1996 and 1998.
Identify frequently reported device types and causes of death associated with anesthesia devices.

Main Methods:

Retrospective review of FDA adverse event reports.
Data extraction and categorization of device types and reported failures.
Analysis of incident reports focusing on anesthesia-related devices.

Main Results:

Cardiovascular, general surgical, and plastic surgical devices were most frequently reported.
Deaths were most commonly associated with cardiovascular, general hospital, and gastrointestinal devices.
Ventilator failures were frequently linked to audio or visual alarm system malfunctions.

Conclusions:

Anesthesia device safety requires ongoing vigilance, particularly for cardiovascular and surgical equipment.
Addressing alarm system failures in ventilators is critical for patient safety.
Regulatory bodies and manufacturers must prioritize identified high-risk device categories and failure modes.

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