Transcript No Slide Title

Medical Device Universe and Nomenclature
Saudi Food & Drug Authority
November 2005
Joel J. Nobel, M.D.
Founder and President Emeritus, ECRI
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Discussion Outline
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ECRI Background
Universe of Medical Devices
Characteristics of Device Problems
The Challenge of Problem Reporting
Nomenclature
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ECRI Attributes
• Nonprofit health services research agency
• Collaborating Center, World Health
Organization
• Interdisciplinary staff of 250
• Stringent conflict-of-interest regulations
• International scope with consulting support
information and technical assistance available
worldwide
• Offices in Asia-Pacific Region, Europe, Middle
East, 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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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
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Major Programs
• Healthcare technology assessment
• Medical product evaluation, comparison,
and selection
• Evidence-based Practice Center*
• National Clinical Guideline
Clearinghouse*
• Patient safety
• Medication error prevention
*as designated by U.S. government
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Largest information provider
and consultant worldwide for:
Healthcare technology—its 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, 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.
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ECRI Medical Device Reporting
System
• In operation for 34 years
• Preceded all other systems
• Based on reports from 3,000 member
hospitals worldwide
• Linked to technical investigation capability,
feedback to manufacturers & dissemination
of information to the health community
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ECRI Medical Device Reporting
System
• User education and feedback to reporters
• Close cooperation with medical device
regulatory agencies such as U.S. FDA &
European organizations
• Worldwide adverse effects investigation
• Undertakes more on-site investigation of
injuries and deaths than does FDA
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The Universe of Medical Devices
and Healthcare Technology
in Perspective
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Perspective
When we focus on a very specific tree, such
as medical devices, we tend to to lose sight
of the forest. Let us first gain a broad
perspective of where devices fit in the grand
scheme of things so we can apportion our
efforts appropriately to achieve the greatest
good
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Healthcare Objectives
• Prevent significant disease
• Diminish pain and disability
• Postpone death—when it is
meaningful to do so
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Disease
Low investment in:
• Medical care
• Preventive medicine
• Sanitation
• Housing
• Education
Low capital
accumulation
Low income
Low human
energy
Low efficiency
Low
productivity
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Fundamental Challengers to
Healthcare Technology
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Malnutrition
Regulating fertility
Environmental factors
Education
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National Healthcare
Determinants and Healthcare
Technology
National Characteristics
• Social Structure
• Political System
• Conflicts
• Values
• Law
• Custom
• Religious Beliefs
• Educational
attainment
• Wealth
National
Priorities
National
Budget
Disease Prevalence and
Conditions,
Epidemiological Data
National Health Budget
Healthcare Priorities and Resources
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Healthcare Priorities and
Resources
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Leadership
Management systems
Personnel
Rules and regulations
Standards of care
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Education and training
Facilities
Research
Communications
Healthcare technology
(Drugs, Devices & Procedures)
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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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Technology Diffusion
The degree to which a specific
technology is adopted and comes into
broad use.
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Life-Cycles of Healthcare Technologies
Source: Banta HD, Behny CJ, Willems JS. Toward rational technology
in medicine. New York: Springer Publishing Company; 1981.
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Medical Devices
Devices, apparatus, or systems
employed for the prevention,
diagnosis, or treatment of disease in
humans—that do not normally enter
metabolic pathways
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Hybrid Devices
Despite this classical definition there are, for
purposes of regulatory classification,
anomalies and hybrids such as drug eluting
stents. Technology convergence will lead to
more hybrid “devices.” Where does a invitro grown tissue matrix fit?
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The Universe of Medical
Devices
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7,000 Generic Entities
1,600 Capital Equipment Products
2,000 Surgical Instruments
700 Implantable Devices
More than 2,000,000 Brands, Models, and
Sizes
• More than 35,000 Manufacturers
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Changing Nature of Medical
Devices
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Medical Devices, until the 1960’s were a three
element system of device, user and patient. Since
then many have evolved into a five element
system
Device
Computer
Software
User
Patient
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Five Element Medical Devices
Embedded or connected microprocessors
and computers and their associated software
have often increased diagnostic and
therapeutic capabilities, speed and
sometimes safety, but at the cost of
complexity and new risks on occasion as
well. Adverse effects are sometimes caused
by multiple elements and factors
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Device Use Environments
• Hospital
• Outpatient clinic
• Freestanding specialty center (e.g., dialysis,
surgery)
• Hospice
• Home
• Ambulance and EMS
• Field hospital (military or disaster teams)
• Industrial dispensary
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Device Users
• Healthcare personnel (physicians, nurses,
aides, technicians, technologists, EM staff,
corpsmen)
• Lay personnel (patients, their family
members, companions, and others)
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User Error versus Use Error
The traditional term of “user error,” which
had the advantage of clarity, is being
replaced by the politically correct term “use
error,” which muddies the notion of
individual responsibility. Most device
related patient injuries and deaths are
caused by user error.
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Device Users
• The majority of medical device users are
not physicians
• The more specialized the user & limited
their range of tasks e.g. a radiology or
laboratory technician, the fewer errors they
tend to make, assuming reasonable training
• The more general the user, the more errors
tend to occur
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Factors Impacting Medical Device
Adverse Effects (1)
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Core device concepts
Design
Human factors and ergonomics
Software
Manufacturing quality
Clinical trial validity
Regulatory concepts and actual practices
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Factors Impacting Medical
Device Adverse Effects (2)
• Institutional healthcare priority setting and
investment
• Selection, procurement, and cost control
• Equipment management and support
• Clinical level quality control
• Training & education
• Risk management program
• Internal incident reporting program
• Information culture
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Concepts and Definitions
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Acceptance Test
A detailed procedure to verify the
safety and performance of a device
prior to its use, either after initial
receipt (i.e., incoming or
commissioning inspection) or
following major repairs,
modifications, or overhaul.
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Calibration
Determination of a device’s
accuracy, using test equipment of
verified and appropriate accuracy,
and adjustment of that device to
meet recommended accuracy
requirements.
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Ease of Use
Ease of use is determined by
equipment human factors design,
the user-friendliness of software,
and the availability and clarity of
instructional materials and training
programs.
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Effectiveness
A technology’s ability to fulfill its
intended clinical purpose under
actual, real-world conditions.
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Efficacy
The ability of a diagnostic or
therapeutic modality to fulfill its
intended clinical purpose under
ideal conditions.
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Inspection
Checks the physical integrity and
function of a device and ensures
that it meets appropriate safety and
performance requirements of the
manufacturer and biomedical
engineering service.
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Medical Device Nomenclature
The name of the device category that
defines that exclusive class of entities
to which the device under
consideration belongs (e.g., singlechannel electrocardiograph, steam
sterilizer).
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Modification
Replacement, remounting,
adjustment, or addition of
components or subsystems to a
device to improve safety, reliability,
or performance, as recommended by
the manufacturer or other recognized
source.
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Overhaul
Replacement of worn parts, upgrading
or modification, calibration, or
refinishing according to or in
conformance with manufacturers’
recommendations.
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Performance
The ability of equipment to fulfill
its intended purpose and its
conformity with its technical
specifications.
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Preventive Maintenance
Periodic procedures to minimize
the risk of failure and to ensure
continued proper operation.
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Reliability
A measure of consistent
performance and safety without
failure.
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Repair
Troubleshooting to isolate the cause
of device malfunction, followed by
replacement or adjustment of
components or subsystems to
restore normal function, safety,
performance, and reliability.
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Safety
Safety is a systems concept, rather
than simply a product attribute.
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Technology Management
A disciplined group of interrelated processes
that supports the safe and cost-effective clinical
application of technology, ensures its readiness
and reliability, protects economic investment in
technology through appropriate service and
maintenance, and ensures that clinical personnel
use equipment safely, effectively, and with
appropriate selectivity.
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Universal Medical Device
Nomenclature System™
(UMDNS™)
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Medical Device Term
The name of the device category that
defines that exclusive class of entities
to which the device under
consideration belongs (e.g., singlechannel 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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Universal Medical Device
Nomenclature System (UMDNS)
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Single term for each distinct entity
Unique code number for each term
Heavily cross-indexed
Hierarchical vocabulary
Widespread use
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Universal Medical Device
Nomenclature System (UMDNS)
(contd.)
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Translated into various languages
Frequently updated
Fully supported
The key to all major information systems
and databases on medical devices
• Promulgated by ECRI and WHO
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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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Information Principle (1)
The more general a term, the easier it is to file data
and the harder it is to find (e.g., you could file
everything in the world under “miscellaneous,” but
you couldn’t find anything quickly). If you used
several general categories (e.g., animal, vegetable,
mineral, synthetic), medical device data would fall
in three of the four files and would be difficult to file
and still difficult to find.
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Information Principle (2)
The more specific a term, the more time-consuming
it is to file the information initially, but the easier
and faster it is to find. Since information is labeled
or filed once and retrieved frequently, it is more
cost-effective to expend the energy up front than
later.
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Information Principle (3)
Hierarchical terms work best for paper-based filing
systems and also facilitate computer databases.
Hierarchical terms begin with the most general and
proceed to increasingly specific descriptors, for
example:
• Rifle, caliber .30, gas operated, M-1
• Electrocardiograph, multichannel, interpretive
• Densitometer, bone, isotope, dual-photon
absorptiometry
• Defibrillator, external, automated
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UMDNS Translations
English-language base system translated into:
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French
German
Polish
Russian
Spanish
Turkish
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Thank you
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