涉及酒精制剂解决方案的手术火灾,1991-2020年
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
概括
基于酒精的外科皮肤制剂与外科火灾有关. 随着FDA的批准和更新的警告,火灾发生率下降,尽管不适当的准备和氧气接近仍然是风险.
科学领域:
- 医疗器械安全 医疗器械安全
- 手术安全协议 手术安全协议
- 与医疗保健相关的事件
背景情况:
- 1998年以后,基于酒精的皮肤制剂在外科手术中成为标准.
- 有关这些制剂引起的手术火灾存在担忧.
研究的目的:
- 检查与基于酒精的皮肤制剂相关的手术火灾的发生率.
- 了解监管部门的批准和监督对随着时间的推移对火灾趋势的影响.
主要方法:
- 食品和药物管理局 (FDA) 制造商和用户设施设备体验 (MAUDE) 数据库报告的分析,从1991年到2020年.
- 确定造成患者或工作人员伤害的手术火灾,特别是涉及酒精制剂的火灾.
- 检查火灾发生趋势,常见原因和监管变化的影响.
主要成果:
- 报告有674起造成伤害的手术火灾;其中84起涉及酒精制剂.
- 火灾增加了26.4% (1996-2006年),随后火灾减少了9.7% (2007-2020年).
- 不当的准备和接近氧气是主要的火灾原因,头部和部手术的减少.
结论:
- 基于酒精的溶液对外科火灾有很大影响.
- 美国食品和药物管理局批准,警告标签更新 (2006-2012) 和宣传活动可能减少了火灾事件.
- 关于制备技术和氧气使用的持续警对于降低风险至关重要.
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