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机器人手术器械再处理的创新(英文版).pdf

上传人: 芦苇 编号:1146403 2026-02-14 17页 2.17MB

1、Innovation in Reprocessing Robotic Surgical InstrumentsName:Nick Dassatti Affiliation:Intuitive1MAT09603 v1 Global 2025 Intuitive Surgical Operations,Inc.All rights reserved.Evolution of Robotic Surgery and ReprocessingManual cleaningAutomated cleaning for robotic instrumentsPre-cleaning devices2MAT

2、09603 v1 Global 2025 Intuitive Surgical Operations,Inc.All rights reserved.Robotic Surgical Innovation Drives Reprocessing InnovationDevelopment of new solutions to improve robotic reprocessing and sterile processing workflows.Automated ultrasonics with flushing and articulation Pre-cleaning pumps D

3、rying cabinets Protection and storage3MAT09603 v1 Global 2025 Intuitive Surgical Operations,Inc.All rights reserved.Reprocessing Innovations and Patient Safety Validation of state-of-the-art reprocessing solutions demonstrates high level of patient safety.10 years of PQ data on robotic instruments r

4、esulted in an average of 34g total protein per device using validated washer-disinfectors.New manual pre-cleaning technologies show improvement of reprocessing workflow with reduced cleaning steps.4MAT09603 v1 Global 2025 Intuitive Surgical Operations,Inc.All rights reserved.Example of PQ testingHis

5、torical Approach to DevelopmentLimitations Requires years of development and validation.Limited by timing of final device design.Dedicated robotic racks and washer-disinfectors.Specialized cleaning cycles.Early design iterationsInstrument manufacturer design freezeReprocessing solutions5MAT09603 v1

6、Global 2025 Intuitive Surgical Operations,Inc.All rights reserved.Development of a New Approach to Automated CleaningKey Questions Can we achieve the high bar set by existing reprocessing solutions?What equipment do global users have?How do we accommodate for the diversity of washer-disinfectors ear

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1. **创新目标**:开发新型机器人手术器械再处理方案,提升患者安全性与工作效率,缩短上市时间。 2. **核心数据**: - 历史PQ数据显示,平均每台器械残留蛋白质34μg(ISO标准)。 - 新方案验证后,蛋白质残留<200μg/器械,血红蛋白<2.2μg/cm²,符合ISO 15883-5:2021。 3. **解决方案**:采用多功能器械托盘,兼容多种清洗消毒设备,减少专用空间,支持常规灭菌循环。 4. **验证结果**:蒸汽灭菌实现6-log杀灭率,生物指示剂无生长;临床PQ测试残留量<100μg。 5. **优势**:快速适配现有流程,减少手动操作,提升兼容性(如瑞士SteriLog案例)。
**创新如何提升安全?** **清洗效率如何优化?** **兼容性如何突破?**
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