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Medical Device Accident Investigation Seminar

TRAINING SEMINAR ONMEDICAL DEVICE

ACCIDENT INVESTIGATIONfor

Kingdom of Saudi ArabiaSaudi Food & Drug AuthorityRiyadh 11-14 February, 2007

Mark E. BruleyVice President, Accident and Forensic Investigation

ECRI5200 Butler Pike, Plymouth Meeting, PA, 19642 USA

Tel: [your number] E-mail: [your e-mail address]Web Sites: www.ecri.org www.mdsr.ecri.org

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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

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• 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

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ECRI Problem Reporting Network

• Worldwide voluntary reporting since 1971

• Hospitals, Clinicians, Suppliers• Hazard Investigation and resolution • Educates users and manufacturers• Improves products• Decreases risks

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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.

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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

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Aneroid Pressure Gauge Pressure Source

Pressure Transducer

Angioplasty Balloon?

Data Link

The Medical Technology Behind the Accident

Monitors: Alarm Limits, Displays, User Controls, Human Factors

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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