Transcript Slide 1
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
Mission
To improve the safety, efficacy, and cost-effectiveness of
patient care and healthcare technology, facilities, and
procedures
Focus
Healthcare technology, its assessment, evaluation,
selection, and management
Patient safety
Risk management policies, procedures, and techniques
Quality of care standards and guidelines
Healthcare environmental safety and protection
Major Programs
Healthcare technology assessment
Medical product evaluation, comparison, and selection
Evidence-based Practice Center*
National Guideline Clearinghouse*
Patient safety
Medical device problem reporting & accident investigation
Credentialing
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
Publications
Web-based information databases
Telephone, letter, fax, and e-mail consultation
On-site consultation
Technical assistance
Training programs
Symposia
Healthcare Technology
Devices, equipment, and related computers and software
Drugs
Biotechnologies
Medical and surgical procedures
Healthcare 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 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
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 entity
Unique code number for each term
Heavily cross-indexed
Hierarchical vocabulary
Widespread 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).
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
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
Passwords
Passwords will be issued to individual hospitals by SFDA
Responses to inquiries and additional training support will be
provided by SFDA
Passwords may not be shared with other individuals or
institutions within or outside KSA
We will measure usage of the databases by individual hospitals
and individual passwords
Thank You