SAFETY SURVEILLANCE OF MEDICAL DEVICE-RELATED SURGICAL FIRES Open Access
Joseph, Stephanie (2012)
Abstract
This thesis aimed to identify and analyze surgical fire reports
submitted to FDA's
Manufacturer and User Device Experience (MAUDE) database to support
the Preventing
Surgical Fires (PSF) initiative
(www.fda.gov/preventingsurgicalfires). Surgical fires
occur on or in patients undergoing medical procedures and are
preventable medical
errors. They may occur when an ignition source, oxidizer, and fuel
come together and can
result in serious injury or death. FDA regulates elements of the
fire triangle as either
medical devices or drugs and therefore receives surgical fire
reports submitted to
MAUDE. The internal database was searched over two years
(2008-2009), for keywords
and devices implicated in surgical fires. The records were read
individually to identify
surgical fire reports. The data was analyzed to determine the
number of reports, their
severity, and how many referenced oxygen use, or use of
alcohol-based skin preparation
agents. The total number of surgical fire reports submitted to FDA
in 2008 totaled 65,
and those for 2009 totaled 47 (excluding reports from foreign
sources, these totals are 48
and 39, respectively). Oxygen was involved in 29% of the 2008 total
surgical fire reports
and 30% for 2009. Alcohol-based skin preparation agents were
involved in 4% of the
2008 reports, and 11% of the 2009 reports. Burns were reported in
35% of the 2008
reports and 52% of the 2009 reports. Surgical fires resulting in no
injury were reported in
35% of the 2008 reports, and 38% of the 2009 reports. Outcomes were
unknown in 22%
of the 2008 reports, and 2% of the 2009 reports. One report
involving death was reported
in 2008 and one in 2009. After comparing these results to estimates
in the literature,
surgical fire reports in MAUDE likely underestimate what is
happening on a national
scale (largely due to underreporting). FDA and partners of the PSF
initiative should
develop a case definition for surgical fires so that data can be
better compared. Actions to
stimulate reporting of surgical fires should also be taken.
Publication of these results
may spur clinicians to reassess their risk of experiencing a
surgical fire, and adopt best
practices to mitigate this risk.
Table of Contents
Introduction and Statement of and Context for the Problem
Purpose statement
Introduction and rationale
Problem statement
Theoretical Framework
Research question
Significance statement
Definition of terms
Review of the Literature
Body of ROL
Non-traditional sources:
Summary of Current Problem and Study Relevance
Methodology IntroductionResearch design
InstrumentsPlans for data analysis
Limitations Results IntroductionFindings: 2008 Data Analysis
Other Findings: 2008 Data Analysis
Findings: 2009 Data Analysis
Other Findings: 2009 Data Analysis
Summary of Results
Conclusions, Implications and Recommendations
IntroductionSummary of Study
Conclusions Implications Recommendations ReferencesAppendix A: List of product codes used in search criteria
Appendix B: Detailed Breakdown of Report Counts by Report Source and Event Date
About this Master's Thesis
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