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Surgical Fires Involving Alcohol-Based Preparation Solution, 1991-2020
Pranit R Sunkara1, Jordan S Grauer1, Jithin John2
1Department of Otolaryngology - Head and Neck Surgery, Wayne State University, Detroit, Michigan, USA.
The Laryngoscope
|June 12, 2023
Summary
Alcohol-based surgical skin preparations are linked to surgical fires. Following FDA approval and updated warnings, fire incidence decreased, though improper preparation and oxygen proximity remain risks.
Area of Science:
- Medical device safety
- Surgical safety protocols
- Healthcare-associated incidents
Background:
- Alcohol-based skin preparations became standard in surgery after 1998.
- Concerns exist regarding surgical fires caused by these preparations.
Purpose of the Study:
- To examine the incidence of surgical fires linked to alcohol-based skin preparations.
- To understand the impact of regulatory approval and oversight on fire trends over time.
Main Methods:
- Analysis of Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database reports from 1991-2020.
- Identification of surgical fires resulting in patient or staff harm, specifically those involving alcohol-based preparations.
- Examination of fire incidence trends, common causes, and impact of regulatory changes.
Main Results:
- 674 surgical fires causing harm were reported; 84 involved alcohol-based preparations.
- A 26.4% increase in fires (1996-2006) was followed by a 9.7% decrease (2007-2020).
- Improper preparation and proximity to oxygen were primary fire causes, with decreases noted in head/neck surgeries.
Conclusions:
- Alcohol-based solutions contribute significantly to surgical fires.
- FDA approval, warning label updates (2006-2012), and awareness campaigns likely reduced fire incidents.
- Continued vigilance regarding preparation techniques and oxygen use is crucial to mitigate risks.
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