introduction to medical device problem reporting under the saudi fda january 2008 joel j. nobel,...

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Page 1: Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel J. Nobel, Founder & President Emeritus
Page 2: Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel J. Nobel, Founder & President Emeritus

Introduction to Medical Device Problem Reporting Under the Saudi FDA

January 2008Joel J. Nobel, Founder & President Emeritus

Page 3: Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel 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

Page 4: Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel J. Nobel, Founder & President Emeritus

Mission

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

Page 5: Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel J. Nobel, Founder & President Emeritus

Focus

Healthcare technology, its assessment, evaluation, selection, and management

Patient safetyRisk management policies, procedures, and techniquesQuality of care standards and guidelinesHealthcare environmental safety and protection

Page 6: Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel J. Nobel, Founder & President Emeritus

Major Programs

Healthcare technology assessmentMedical product evaluation, comparison, and selectionEvidence-based Practice Center*National Guideline Clearinghouse*Patient safetyMedical device problem reporting & accident investigationCredentialing

Page 7: Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel J. Nobel, Founder & President Emeritus

Largest information provider and consultant worldwide for:

Healthcare technology—its assessment, planning, selection, procurement, management, and risk and quality management

Page 8: Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel J. Nobel, Founder & President Emeritus

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.

Page 9: Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel J. Nobel, Founder & President Emeritus

Delivery of Knowledge and Judgment

PublicationsWeb-based information databasesTelephone, letter, fax, and e-mail consultationOn-site consultationTechnical assistanceTraining programsSymposia

Page 10: Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel J. Nobel, Founder & President Emeritus

Healthcare Technology

Devices, equipment, and related computers and softwareDrugsBiotechnologiesMedical and surgical proceduresHealthcare information systems

Page 11: Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel J. Nobel, Founder & President Emeritus

Medical Devices

Devices, apparatus, or systems employed for the prevention, diagnosis, or treatment of disease in humans—that do not normally enter metabolic pathways.”

Page 12: Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel J. Nobel, Founder & President Emeritus

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

Page 13: Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel J. Nobel, Founder & President Emeritus

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).

Page 14: Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel J. Nobel, Founder & President Emeritus

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.

Page 15: Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel J. Nobel, Founder & President Emeritus

UMDNS Structure

Single term for each distinct entityUnique code number for each termHeavily cross-indexedHierarchical vocabularyWidespread use

Page 16: Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel J. Nobel, Founder & President Emeritus

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).

Page 17: Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel J. Nobel, Founder & President Emeritus

Challenges in Healthcare Technology

Balanced national, regional, and institutional healthcare priority setting and investment

Selection, procurement, and cost control Equipment management and support Clinical level quality control User error and education Patient safety Medical Device Problem Reporting New technologies, such as biotechnologies, genetics, immunochemistry,

molecular biology

Page 18: Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel J. Nobel, Founder & President Emeritus

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

Page 19: Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel J. Nobel, Founder & President Emeritus

Passwords

Passwords will be issued to individual hospitals by SFDAResponses to inquiries and additional training support will be

provided by SFDAPasswords may not be shared with other individuals or

institutions within or outside KSAWe will measure usage of the databases by individual hospitals

and individual passwords

Page 20: Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel J. Nobel, Founder & President Emeritus

Thank You