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一次性脉冲洗设备的手工件再加工技术的技术特性和生物安全性:一项实验研究
A Pongkunakorn1, M Jutawiriyasakun1
1Department of Orthopaedic Surgery, Lampang Hospital, Lampang, Thailand.
Malaysian orthopaedic journal
|August 12, 2024
概括
在关节和膝关节关节整形手术中重新处理一次性脉冲冲洗设备 (PLD) 是技术上可行的,并且在生物学上是安全的. 这种具有成本效益的策略将PLD成本降低了90%,使其更容易获得.
科学领域:
- 生物医学工程 生物医学工程
- 手术技术 手术技术
- 医疗设备再加工 医疗设备再加工
背景情况:
- 脉冲洗装置 (PLD) 在部和膝关节关节置换术期间对骨表面的清洁至关重要.
- 单次使用的PLD产生大量的医疗废物,并产生高成本,限制了一些患者的可访问性.
- 再加工为医疗器械废物管理提供了可持续和经济的解决方案.
研究的目的:
- 评估重新加工的脉冲冲洗设备 (PLD) 的技术性能.
- 评估再加工的PLDs的生物安全性.
- 为了在不同的电源条件下比较再加工的PLD的性能.
主要方法:
- 测量了新PLD的基线技术性能 (流量,脉冲频率,峰值压力).
- PLDs经历了10次再处理周期,并使用DC15V电池和AC/DC15V3A适配器电源进行了重新测试.
- 亚丁三酸盐 (ATP) 抽样测试和有氧细菌培养评估了生物安全性.
主要成果:
- 与新设备相比,重新处理的PLD与AC/DC15V3A适配器的流速明显更高.
- 用DC15V电池重新处理的PLD的脉冲频率和峰值压力与新设备相比相当.
- 所有生物安全测试 (ATP和细菌培养) 都呈阴性,表明没有污染.
结论:
- 再加工的PLD手工件保持了技术有效性和生物安全性.
- 再加工为一次性设备提供了可行的替代方案,其潜在成本节省率高达90%.
- 再加工的PLDs的临床利用可以提高关节塑性手术的成本效益.
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