McGrath Niamh, Waldron Catherine, Farragher Ailish, Walsh Cathal, Polisena Julie
Evidence Centre, Health Information and Evidence Directorate, Health Research Board, Dublin, Ireland.
Biostatistics Unit, School of Medicine, Trinity College Dublin, Dublin, Ireland.
GMS Hyg Infect Control. 2025 Jun 6;20:Doc25. doi: 10.3205/dgkh000554. eCollection 2025.
To estimate the safety, financial and environmental effects of reprocessing high risk SUMDs.
Systematic review (PROSPERO ID: CRD42022365642) of primary trial and observational studies of human participants receiving reprocessed high risk SUMDs compared with first use of identical SUMDs. Reprocessing was defined as cleaning, disinfection, and sterilisation or related procedures, and function and safety testing. Items were sourced via database, grey literature and supplemental searching of English and German language sources. Included studies were quality appraised and primary outcomes (direct patient safety; indirect financial costs; environmental impacts) GRADE (Grade of Recommendation, Assessment, Development and Evaluation) assessed. Narrative synthesis and where feasible, meta-analysis were undertaken.
Ten studies (N=2,657 participants) examined two implantable (pacemaker, defibrillator) and three catheterisation (electrophysiology polyurethane, ablation and balloon) devices. Safety outcomes were available for both device types and cost outcomes were available for catheterisation devices. Except for one older study, there were no statistically significant differences in the odds of examined safety outcomes between new and once reprocessed SUMDs. Meta-analysis of catheterisation devices resulted in similar results (Infections: OR=0.67, 95% CI: 0.37-1.20, =0.18; Battery depletion: OR=0.2.29, 95% CI: 0.83-6.31, =0.11). One study of balloon catheterisation devices which accounted for indirect costs reported savings of CAN$ 129 per patient. The certainty of evidence, using the GRADE assessment, for each outcome was very low.
We found no evidence of additional adverse safety outcomes for once reprocessed cardiac catheterisation or implantable cardiac SUMDs. However, our confidence that the same findings would be observed in future studies is very low. There was insufficient evidence to establish the cost-effectiveness or environmental impacts of reusing cardiac catheterisation or implantable SUMDs. High-quality randomised controlled trials, analyses of national device reprocessing surveillance systems, cost-effectiveness studies, and life cycle assessments are required in order to facilitate better comparison across devices and reprocessing contexts.
评估对高风险一次性使用医疗器械（SUMDs）进行再处理的安全性、财务和环境影响。
对接受再处理的高风险SUMDs的人类参与者的原始试验和观察性研究进行系统评价（PROSPERO编号：CRD42022365642），并与首次使用相同的SUMDs进行比较。再处理定义为清洁、消毒、灭菌或相关程序，以及功能和安全性测试。通过数据库、灰色文献以及对英语和德语来源的补充搜索获取研究项目。对纳入的研究进行质量评估，并对主要结局（直接患者安全性；间接财务成本；环境影响）进行GRADE（推荐分级、评估、制定和评价）评估。进行叙述性综合分析，并在可行的情况下进行荟萃分析。
十项研究（N = 2657名参与者）考察了两种植入式设备（起搏器、除颤器）和三种导管类设备（电生理聚氨酯导管、消融导管和球囊导管）。两种设备类型均有安全性结局数据，导管类设备有成本结局数据。除一项较早的研究外，新的和经过一次再处理的SUMDs在所考察的安全性结局的几率上没有统计学显著差异。对导管类设备的荟萃分析得出了类似结果（感染：OR = 0.67，95% CI：0.37 - 1.20，P = 0.18；电池耗尽：OR = 0.29，95% CI：0.83 - 6.31，P = 0.11）。一项关于球囊导管类设备的研究考虑了间接成本，报告称每位患者节省了129加元。使用GRADE评估，每个结局的证据确定性都非常低。
我们没有发现证据表明，经过一次再处理的心脏导管类或植入式心脏SUMDs会有额外的不良安全结局。然而，我们对未来研究中会观察到相同结果的信心非常低。没有足够的证据来确定重复使用心脏导管类或植入式SUMDs的成本效益或环境影响。需要高质量的随机对照试验、国家设备再处理监测系统分析、成本效益研究和生命周期评估，以便更好地比较不同设备和再处理情况。
