several languages including Chinese • 来源于英文原版的多语言翻译， 包括中文版（2009年10月已由中 国计量出版社出版）。
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Medical Equipment Quality Assurance 医疗设备质量保证
• Table of Contents 内容
2
Device is used for patient diagnosis, or direct monitoring
3
Device is used to deliver direct treatment to the patient
4
Device is used for a life support
• IEC 60601-1 & 62353, NFPA 99 and Joint Commission
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Medical Equipment Quality Assurance 医疗设备质量保证
• General procedures 通用流程
– Inventory control 设备总量管理 – Computerized medical equipment management system 自
Required Test Medical Device Test
Equipment
检测医疗设备所需仪器
Electrical Safety Analyzer 电气安全分 析仪 Physiological Simulator 生理模拟器 Defibrillator Analyzer 除颤器分析仪 Pacemaker Analyzer 起搏器分析仪 Electrosurgery Analyzer 电刀分析仪
Common device failure is predictable and can be avoided by 4
preventive maintenance
Specific regulatory or manufacturers requirements dictate preventive 5
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Medical Equipment Quality Assurance 医疗设备质量保证
• Incoming inspections 验收 • Documentation 存档 • Missing equipment 设备缺失 • Safety 安全性
– Electrical, Mechanical, Infection control, and Cleaning equipment 电气、机械、感染控制和清洁
医疗设备质量保证 风险评分系统 – 第一部分
Criteria – choose 1 rating from each category Clinical Function
Weight
No patient contact
1
Device may make contact with patient but function is non-critical
– Definitions 定义 – Risk-Based Assessment Inspection Program 基
于风险的检测计划 – General Procedures 通用流程
• Electrical Safety 电气安全
– Specific Procedures 专用流程 – Appendix – Device Standards 附录 – 标准
Is the powered device used for direct patient treatment or Yes No care? 直接用与病人的治疗或看护的用电设备吗？ Does the powered device provide diagnostic/monitoring Yes No information used in treatment? 用电设备在治疗过程中提供诊断和监护信息吗？
• Pacemakers and ventilators 起搏器和呼吸机
– Therapy 治疗
• Infusion 输液 • Physical therapy 物理疗法
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Medical Equipment Quality Assurance
Form and procedures
Does this powered device come in contact with the patient?Yes No 这个用电设备与病人接触吗？
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Medical Equipment Quality Assurance
Risk Scoring System – Part 1
Ventilator and air flow test system 呼吸机和气流分析仪
• Scoring system determines inspection interval 评分决定
检测间期 – Greater than 13 = 2 x per year 超过13分，一年两次 – Between 9-12 = 1 x per year 在9-12分之间，一年一次 – Less than 9 = 1 x 2 years 低于9分，两年一次
Common device failure modes are unpredictable or not very 2 predictable While common device failure modes are not very predictable, device 3 history indicates that TSP testing frequently detects problems
maintenance or testing
Incident History
No significant History
1
A significant history of incidents exists
2
Manufacturers / Regulatory Requirements For Specific Schedules
• Exception: Certain devices such as life support equipment have more frequent inspections by regulation or manufacturer requirements 例外：某些类似
生命支持设备的仪器按照规定和厂家建议需要更加频繁的检查
动化的设备管理系统 – Device Inclusion: Which devices will be managed 哪些设备
需要管理
• Risk based Assessment 风险评估
– Goals 目标 – Intervals 间期
• Maintenance strategy worksheet 维护策略工作表 – Evaluating program effectiveness 评估计划的有效性
Score
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Medical Equipment Quality Assurance
Risk Scoring System – Part 2
医疗设备质量保证 风险评分系统 – 第二部分
Problem Avoidance Probability Maintenance or inspection would not impact reliability of the device 1
Procedures
医疗设备质量保证手册 检测流程 • Twenty-five (25) Common Devices 25种常规设备 – Patient monitoring 病人监护 – Surgery 外科 – Fetal/neonatal Care 婴儿/新生儿看护 – Life support 生命支持
FBC Products and MD QA 医疗设备质量保证与FBC产品
美国福禄克国际公司 北京办事处 张男
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Medical Equipment Quality Assurance: Inspection Program Development and Procedures 医疗设备质量保证：检查计划和流程开发
No requirements.
1
There are requirements for testing independent of a numerical rating 2
system.
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Medical Equipment Quality Assurance Risk Scoring System 医疗设备质量保证 风险评分系统 – 总结
• Book – 2008; other media • 手册 - 2008 • University of Vermont (USA) • 佛蒙特大学（美国） • Funding from Fluke Biomedical
Corp. (USA) • 美国福禄克国际公司资助 • Translation from English to
医疗设备质量保证 图示和照片
Electrical safety testing to IEC 62353
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Medical Equipment Quality Assurance
Labeling
医疗设备质量控制 标签