再加工高风险的一次性医疗器械的安全性,成本和环境影响:系统审查和元分析
Niamh McGrath1, Catherine Waldron1, Ailish Farragher1
1Evidence Centre, Health Information and Evidence Directorate, Health Research Board, Dublin, Ireland.
GMS hygiene and infection control
|July 14, 2025
概括
重制高风险的一次性医疗器械 (SUMD) 显示,对患者的安全风险没有增加. 然而,证据质量非常低,成本效益和环境影响需要进一步研究.
科学领域:
- 医疗器械再加工 医疗器械再加工
- 患者安全 患者安全
- 卫生经济学 卫生经济学
- 环境影响评估环境影响评估
背景情况:
- 一次性医疗器械 (SUMD) 是为一次性使用而设计的,这引发了对浪费和成本的担忧.
- 再加工SUMD涉及清洁,消毒,灭菌和测试,以确保安全性和有效性.
- 评估再加工高风险SUMD的安全性,财务和环境影响对于可持续的医疗保健至关重要.
研究的目的:
- 系统地审查和估计再加工高风险SUMD的安全,财务和环境影响.
- 为了比较重新处理的SUMD与新SUMD的安全性和成本效益.
- 评估SUMD再加工对环境的影响.
主要方法:
- 主要试验和观察性研究的系统审查.
- 包括对人类参与者的研究,使用重新处理的高风险SUMD与新SUMD相比.
- 证据确定性的 GRADE 评估对安全,成本和环境结果的确定性.
主要成果:
- 十项研究 (N=2,657) 检查了可植入和导管装置.
- 除了一项较旧的研究外,在新的和重新处理的SUMD之间没有发现安全结果的统计学上显著差异.
- 一项研究报告说,重新处理的气球导管装置每名患者节省了129加元的成本;所有结果的证据确定性都非常低.
结论:
- 没有证据表明再处理心脏导管或植入式SUMD的不良安全结果增加.
- 对发现的信心非常低,需要进一步进行高质量的研究.
- 关于成本效益和环境影响的证据不足;需要更多的RCT和生命周期评估.
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