Surgical Fires Involving Alcohol‐Based Preparation Solution, 1991–2020

Author:

Sunkara Pranit R.1ORCID,Grauer Jordan S.1ORCID,John Jithin2,Jones Edward L.3,Roy Soham4,Cramer John D.1

Affiliation:

1. Department of Otolaryngology – Head and Neck Surgery Wayne State University Detroit Michigan USA

2. Oakland University William Beaumont School of Medicine Rochester Michigan USA

3. Department of GI, Tumor and Endocrine Surgery The University of Colorado School of Medicine Aurora Colorado USA

4. Department of Otolaryngology Childrens Hospital Colorado – University of Colorado School of Medicine Aurora Colorado USA

Abstract

BackgroundAlcohol‐based skin preparations were first approved for surgical use in 1998 and have since become standard in most surgical fields. The purpose of this report is to examine incidence of surgical fires because of alcohol‐based skin preparation and to understand how approval and regulation of alcohol‐based skin preparations impacted trends in fires over time.MethodsWe identified all reported surgical fires resulting in patient or staff harm from 1991 through 2020 reported to the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. We examined incidence of fires because of these preparations, trends after approval and regulation, and common causes.ResultsWe identified 674 reports of surgical fires resulting in harm to patients and surgical personnel, in which 84 involved an alcohol‐based preparation. The time‐adjusted model shows that from 1996 through 2006, there was a 26.4% increase in fires followed by a 9.7% decrease from 2007 to 2020. The decrease in fires was most rapid for head and neck and upper aerodigestive tract surgeries. Qualitative content analysis revealed improper surgical site preparation as well as close proximity of surgical sites to an oxygen source as the most common causes of fires.ConclusionSince FDA approval, alcohol‐based preparation solutions have been associated with a significant percentage of surgical fires. Warning label updates from 2006 to 2012 coupled with increased awareness efforts of associated risks of alcohol‐based surgical solutions likely contributed to the decrease in fires. Improper surgical site preparation technique and close proximity of surgical sites to oxygen continue to be risk factors for fires.Level of Evidence4 Laryngoscope, 134:607–613, 2024

Publisher

Wiley

Subject

Otorhinolaryngology

Reference23 articles.

1. Operating room fires in otolaryngology: risk factors and prevention

2. SchiffenbauerJ.Center for Drug Evaluation and Research: Application Number: 21‐586. Published online 2006.https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021586s000_MedR_P1.pdf.

3. Food and Drug Administration.Drugs@FDA: FDA‐Approved Drugs. Accessed August 22 2022.https://www.accessdata.fda.gov/scripts/cder/daf/.

4. Chlorhexidine–Alcohol versus Povidone–Iodine for Surgical-Site Antisepsis

5. Chlorhexidine Provides Superior Skin Decontamination in Foot and Ankle Surgery

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