SAFETY SURVEILLANCE OF MEDICAL DEVICE-RELATED SURGICAL FIRES 公开

Joseph, Stephanie (2012)

Permanent URL: https://etd.library.emory.edu/concern/etds/2z10wr02p?locale=zh
Published

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 Introduction

Research design

Instruments

Plans for data analysis

Limitations Results Introduction

Findings: 2008 Data Analysis

Other Findings: 2008 Data Analysis

Findings: 2009 Data Analysis

Other Findings: 2009 Data Analysis

Summary of Results

Conclusions, Implications and Recommendations

Introduction

Summary of Study

Conclusions Implications Recommendations References

Appendix 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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