手术器械的生命周期:全球,环境和监管方面的考虑
Eric R Wahlstedt1, John C Wahlstedt2, Jenna S Rosenberg3
1University of Kentucky College of Medicine, Lexington, Kentucky, USA.
World journal of surgery
|March 26, 2024
概括
医院不断升级手术设备和用品,造成全球差距. 解决监管和废物管理方面的挑战对于低收入和中等收入国家 (LMICs) 的可持续外科生长至关重要.
科学领域:
- 全球健康 全球健康
- 手术技术 手术技术
- 医疗保健管理的管理
背景情况:
- 快速的技术进步导致富裕医院的手术设备和用品经常升级.
- 这导致使用过,过期或剩余的医疗产品的持续营业额.
- 低收入和中等收入国家 (LMICs) 可持续外科生长的机遇和挑战来自于这些生命周期.
研究的目的:
- 审查与外科设备和供应生命周期有关的问题.
- 讨论对LMICs可持续外科生长的影响.
- 确定设备监管,维护和废物管理中的关键挑战.
主要方法:
- 关于手术器械和供应生命周期的文献评论.
- 对LMICs监管环境的分析.
- 检查设备配送,维护和废物管理方面的挑战.
主要成果:
- 在LMICs中存在显著的监管差异和不一致的执法,阻碍了协调.
- 医疗器械分类和命名的异质性使监管和分销复杂化.
- 由于资源有限,挑战包括监管合规,维护和废物管理.
结论:
- 在获得高质量的外科设备和用品方面,全球仍然存在重大差异.
- 制造和处置法规的协调是至关重要的.
- 需要改善利益相关者沟通才能找到有效的解决方案.
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