©ECRI 2007 1 Medical Device Accident Investigation Seminar TRAINING SEMINAR ON MEDICAL DEVICE ACCIDENT INVESTIGATION for Kingdom of Saudi Arabia Saudi.

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Presentation transcript:

©ECRI Medical Device Accident Investigation Seminar TRAINING SEMINAR ON MEDICAL DEVICE ACCIDENT INVESTIGATION for Kingdom of Saudi Arabia Saudi Food & Drug Authority Riyadh February, 2007 Mark E. Bruley Vice President, Accident and Forensic Investigation ECRI 5200 Butler Pike, Plymouth Meeting, PA, USA Tel: [your number] [your address] Web Sites:

©ECRI

3 I. Introduction ECRI Seminar Materials Review Why Investigate Causes of Accidents/Injuries Mechanisms of Injury Accident Investigation Overview Essential Investigation Elements Information Resources Problem Reporting Programmes Investigation Guidelines/Device Testing

©ECRI Nonprofit health services research agency International scope (Offices: USA, UK, UAE, Malaysia) Collaborating Center, World Health Organization Evidence-based Practice Center, Agency for Health Care Policy and Research National Guideline Clearinghouse Interdisciplinary staff of 250 Stringent conflict-of-interest regulations Largest information provider worldwide for healthcare technology — assessment, planning, selection, procurement, management, and risk and quality assessment Consulting support and technical assistance worldwide

©ECRI ECRI Problem Reporting Network Worldwide voluntary reporting since 1971 Hospitals, Clinicians, Suppliers Hazard Investigation and resolution Educates users and manufacturers Improves products Decreases risks

©ECRI ECRI Problem Reporting Network ECRI Investigates –Analyses Problem –Database Searches –Tests Devices –Contacts Supplier (reviews draft of any reports intended for publication) –Internal and outside review process –Sources remain confidential unless they authorize ECRI to release name.

©ECRI Accident Investigation Undertaken for hospitals, public health agencies, health professionals, insurers worldwide Purpose: determine what happened, why, and design prevention techniques On-site and laboratory investigations Rapid response by interdisciplinary team

©ECRI

9 Aneroid Pressure GaugePressure Source Pressure Transducer Angioplasty Balloon? Data Link The Medical Technology Behind the Accident Monitors: Alarm Limits, Displays, User Controls, Human Factors

©ECRI The Universe of Medical Devices 5,000 generic entities 1,400 capital equipment products 2,000 surgical instruments 450 implantable devices More than 1,000,000 brands, models, and sizes More than 10,000 manufacturers