Introduction to Medical Device Problem Reporting for Industry Under the Saudi FDA

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Introduction to Medical Device Problem Reporting
for Industry Under the Saudi FDA
January 2008 Joel J. Nobel, Founder President
Emeritus
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ECRI Institute

• Nonprofit health services research agency
• Collaborating Center, World Health Organization
• Interdisciplinary staff of 300
• Stringent conflict-of-interest regulations
• International scope with consulting, information
  support and technical assistance available
  worldwide
• Offices in Asia-Pacific Region, Europe, Middle
  East (Dubai), and North America

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Mission

• To improve the safety, efficacy, and
  cost-effectiveness of patient care and healthcare
  technology, facilities, and procedures

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Major Programs

• Healthcare technology assessment
• Medical product evaluation, comparison, and
  selection
• Medical device problem reporting accident
  investigation
• Evidence-based Practice Center
• National Clinical Guideline Clearinghouse
• Patient safety
• As designated by the U.S. Government

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Largest information provider and consultant
worldwide for

• Healthcare technologyits assessment,
  planning, selection, procurement, management, and
  risk and quality management

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Integrity

• Neither ECRI nor any of its staff has a
  financial interest in the sale of any medical
  technology. ECRI and its staff accept no
  royalties, gifts, finders fees, or commissions
  from the medical device or pharmaceutical
  industries and are not permitted to own stock in
  or undertake consulting work for such industries.

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Delivery of Knowledge and Judgment

• Publications
• Web-based information databases
• Telephone, letter, fax, and e-mail consultation
• On-site consultation
• Technical assistance
• Training programs
• Symposia

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Healthcare Technology

• Devices, equipment, and related computers and
  software
• Drugs
• Biotechnologies
• Medical and surgical procedures
• Healthcare information systems

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Medical Devices

• Devices, apparatus, or systems employed for
  the prevention, diagnosis, or treatment of
  disease in humansthat do not normally enter
  metabolic pathways.

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The Universe of Medical Devices

• 7,000 Generic Entities
• 1,500 Capital Equipment Products
• 2,000 Surgical Instruments
• 500 Implantable Devices
• More than 2,000,000 Brands, Models, and Sizes
• More than 30,000 Manufacturers

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Nomenclature

• The name of the device category that defines that
  exclusive class of entities to which the device
  under consideration belongs (e.g., single-channel
  electrocardiograph, steam sterilizer).

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Universal Medical Device Nomenclature System
(UMDNS)

• A standard nomenclature developed and maintained
  by ECRI since 1973 to support data
  categorization, storage, retrieval, and exchange.
• Used in more than 70 nations by government,
  hospitals, health systems, and industry for
  medical device planning, procurement, management,
  and regulation.
• Available free to government and nonprofit health
  facilities.

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UMDNS Structure

• Single term for each distinct entity
• Unique code number for each term
• Heavily cross-indexed
• Hierarchical vocabulary
• Widespread use

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UMDNS Code Numbers

• Each unique term has a unique five-digit
  code number. Code numbers do not carry
  information. Older national systems used
  alphabetical or numerical codes to convey
  information such as clinical department or
  medical specialty. This imposes significant
  limitations (e.g., many of the same devices are
  used in different departments or different
  medical specialties).

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Special SFDA Arrangement with ECRI Institute to
Provide Information Database Support to KSA
Hospitals (Demonstration)

• Health Devices Alerts MAUDE
• Medical Device Safety Reports Posters
• Health Device Sourcebase
• Health Device System
• Healthcare Product Comparison System,
• Healthcare Standards
• TARGET

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Industry Access to ECRI Information Services

• Contact ECRI-IMD
• Suite 504
• City Tower 2
• Sheikh Zayed Road
• P.O. Box 71059
• Dubai, UAE
• Telephone [phone]
• E-mail ecri_at_eim.ae

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Visit www.ecri.org
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Thank You