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Introduction to Medical Device Problem Reporting for Industry Under the Saudi FDA
January 2008Joel J. Nobel, Founder & President Emeritus
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
Mission
To improve the safety, efficacy, and cost-effectiveness of patient care and healthcare technology, facilities, and procedures
Major Programs
Healthcare technology assessmentMedical product evaluation, comparison, and selectionMedical device problem reporting & accident investigationEvidence-based Practice Center*National Clinical Guideline Clearinghouse*Patient safety
* As designated by the U.S. Government
Largest information provider and consultant worldwide for:
Healthcare technology—its assessment, planning, selection, procurement, management, and risk and quality management
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, finder’s 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.
Delivery of Knowledge and Judgment
PublicationsWeb-based information databasesTelephone, letter, fax, and e-mail consultationOn-site consultationTechnical assistanceTraining programsSymposia
Healthcare Technology
Devices, equipment, and related computers and softwareDrugsBiotechnologiesMedical and surgical proceduresHealthcare information systems
Medical Devices
Devices, apparatus, or systems employed for the prevention, diagnosis, or treatment of disease in humans—that do not normally enter metabolic pathways.”
The Universe of Medical Devices
7,000 Generic Entities1,500 Capital Equipment Products2,000 Surgical Instruments500 Implantable DevicesMore than 2,000,000 Brands, Models, and SizesMore than 30,000 Manufacturers
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).
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.
UMDNS Structure
Single term for each distinct entityUnique code number for each termHeavily cross-indexedHierarchical vocabularyWidespread use
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).
Special SFDA Arrangement with ECRI Institute to Provide Information & Database Support to KSA
Hospitals (Demonstration)Health Devices Alerts & MAUDEMedical Device Safety Reports & PostersHealth Device SourcebaseHealth Device SystemHealthcare Product Comparison System,Healthcare StandardsTARGET
Industry Access to ECRI Information Services
Contact ECRI-IMD Suite 504 City Tower 2 Sheikh Zayed Road P.O. Box 71059 Dubai, UAE Telephone: +971 (4) 3322682
E-mail [email protected]
Visit www.ecri.org
Thank You
