医疗器械不良事件调查和管理培训课程（香港）

依桐听雨

医疗事故时有发生，当贵公司产品或医疗机构发生了事故或严重不良事件，你想了解它是如何发生的，它的根本原因是什么，事件是否必须报告，以及如何防止再发生。对各种类型的事故，调查工作对于恢复运营、最大限度减少部门间的冲突、维护员工信心起着至关重要的作用。

本课程针对医疗器械事故、危害和问题，重点讲解了适用的调查技术、问题报告、管理和信息资源，探讨对减少危害和潜在责任的风险管理策略，并进行案例讲解。

本课程系香港生产力促进局（HKPC）特邀美国紧急医疗研究机构（ECRI）专家赴港，特别为医疗器械企业或医疗机构开设，旨在帮助各单位更有效的开展事故或不良事件的调查及相关工作。

讲师介绍：Scott R. Lucas博士
项目经理，ECRI（Emergency Care Research Institute, 紧急医疗研究机构）
Dr. Lucas’ accident investigation experience and education is diverse in both biomedical engineering and injury biomechanics. He has been a key investigator in dozens of healthcare related accident investigation cases at ECRI Institute. In a previous position he managed more than 100 injury biomechanics investigations cases at an international consulting firm.  He conducts adverse event investigations for hospitals as they relate to medical technologies, policies, procedures, and protocols. Investigated technologies have ranged from cardiac rhythm management devices and cardiopulmonary bypass machines to surgical equipment such as staplers and drills. An experienced lecturer, Dr. Lucas’ presentations have been included in the accident investigation courses presented at ECRI Institute’s.
Dr. Lucas earned a Bachelor of Science degree in mechanical engineering from the Virginia Polytechnic Insti-tute and State University, a Master of Science degree in biomedical engineering and a Doctor of Philosophy degree in mechanical and aerospace engineering from the University of Virginia. He is licensed as a Profession-al Engineer in the states of Virginia and Pennsylvania.

培训地点：香港生产力促进局，九龙塘达之路78号生产力大楼四楼
                    The Terrace, 4/F, Hong Kong Productivity Council, 78 Tat Chee Avenue, Kowloon, Hong Kong

培训时间：2013年3月26日～28日，每天上午9:00～下午5:00

培训语言：英文

课程大纲：
        Ø      Why Medical Device Accidents Happen
        Ø      Accident Investigation Overview
        Ø      Information Resources for Accident Investigation
        Ø      Device Inspection and Testing
        Ø      Human Factors Considerations in  Accident Investigation
        Ø      Interviewing Techniques
        Ø      Investigation Reports
        Ø      Concluding the Investigation Process
        Ø      Medical Device Problem Reporting Programmes
        Ø      Technology Management and Preventive Measures
        Ø      Vendor Investigations of Medical Device Accidents
        Ø      Medical Device Safety & Handling Near Misses
        Ø      Monitoring Technologies
        Ø      Gas Embolism Accidents
        Ø      Medical Device Fires
        Ø      Skin "Burns" from Medical Devices
        Ø      Focus on Drug Delivery Pumps
        Ø      Focus on Electrosurgical Units (Surgical Diathermy)
        Ø      Surgical Instrument Breakage
        Ø      Focus on Defibrillators
        Ø      Focus on Respiratory Care & Anesthesia Equipment
        Ø      Focus on Warming Devices
        Ø      Focus on Radiographic/Imaging Equipment
        Ø      Simulated investigations using actual medical devices involved in accidents or reported problems

报名与咨询：请联系香港生产力促进局
Mr Bryan SO, Senior Consultant, Automation Service Division (Tel: +852 2788 5548; Email: bryanso@hkpc.org)
Ms Carol LIU, Cadet Engineer, Automation Service Division (Tel: +852 2788 5550; Email: carolliu@hkpc.org)

报名方式：见附件第3页报名表Flyer-Adverse Event Investigation(HKPC)

培训费用：每人14000港币或1800美金，深圳市医疗器械行业协会会员可享有部分优惠，具体请与HKPC联系确定。

fengsy

{:6_225:}{:6_219:}学习也要付出，顶。