Kendrick DeLaine
Russell Hazelrig
Hunter King
ETM 591
•
History for medical device safety can be
traced back to 2000 B.C.
•
Modern Day Milestones
– 1970:Occupational Safety and Health Administration
(OSHA)
– 1976:Medical Device Amendments
– 1990: Safe Medical Devices Act
•
Western Electric Company: First
Organization to set up an inspection
department. (early 1990’s)
•
Safe medical system: A system that does not cause a
high degree of risk to property, equipment or people.
•
Risk: An undesirable event that can occur and is measured
in terms of probability and severity.
•
Safe/unreliable: Safe but fails frequently
•
Reliable/Unsafe: Device functions normally but
puts people at risk.
•
Three categories of medical device
safety
– Unconditional safety
• Preferred type of device safety
• Elimination of all risks with medical devices
– Conditional Safety
• Used in situations when it is not feasible to have
unconditional safety.
– Descriptive Safety
• Basic transport, replacement, maintenance, mounting
operation, and connection safety.
• Examples: Handle with care, this side up.. etc
•
Three Categories
– Safe design:
• Seven elements.
– Electric shock, radiation, and environmental protection, care for hygienic
factors, heating prevention, mechanical hazard prevention, and material choice
– Safe Function:
• Three elements
– Accuracy of measurement, reliability, and warning for or
prevention of dangerous outputs.
– Sufficient Information:
• Five elements:
– Effective labeling, Instructions for use, production, packaging,
accompanying documentation.
Concept
Definition
Development
Phases of
Device
Cycle
Deployment
Production
 Five
Stages
• Concept- uses preliminary hazard analysis to evaluate safety
problems and its impacts
• Definition- provide verification of initial design and engineering
of device
• Development- directed towards operational use, environmental
impact, producibility, and integrated logistics support
• Production- safety engineering report is made for the device that
identifies hazards with the device
• Deployment – data from any accidents or failures are collected.
The safety analysis is updated and changes to device is reviewed
Technic of
Operations
Review
Human Error
Analysis
Safety
Analysis
Methods
Operating
Hazard Analysis
Preliminary
Hazard
Analysis
 Techniques
and Methods
• Preliminary Hazard Analysis (PHA)
 First analysis preformed
 Identify critical areas, safety design criteria, and
evaluate hazards
• Operating Hazards Analysis (OHA)
 Focuses on hazards from the task by the operating
system as the device is stored, transported, or used.
 Provide a basis for operations safety, warnings, and
emergency procedures.
 Techniques
and Methods
• Technic of Operations Review (TOR)
 A step by step analysis of workplace related
accidents and failures.
• Human Error Analysis (HEA)
 Used to highlight various types of hazards prior to
occurrence.
 Effective Approaches:
 Perform Task
 Observing individual during work periods
 Time
required to obtain results
 Ways and means for getting the
information to subcontractors
 Format and degree of detail of end result
of data
 Type of information needed before
performing the study
 Time frame for the study (review, update,
submission, and completion)
•
FDA and ISO requires Manufacturers to
follow a comprehensive approach to
medical device safety.
– Use a quality assurance manual to satisfy GMP and
ISO 9000 requirements
•
Three Areas
– Area 1: Outline company policy with respect to the
manufacturing of medical devices.
– Area 2: Administration of quality assurance
department and it’s subdivisions.
– Area 3: Outlining quality assurance directives to
implement and monitor device conformance.
Test
Instrumentation
Parts and
Materials QA
Quality
Monitoring
Software
Quality
Assurance
Organization
Reliability
Assessment
Areas of
Quality
Assurance
Programs
Certification
Design
Review
Personnel
Specifications
Labeling
Design
Transfer

Organization – the elements and aspects needed to develop the

Specifications- translating the idea of the device into measureable

Parts and Materials- the parts and materials used in device
program, carry out program requirements, make audit program,
document goals
units; should address reliability, safety, stability, and precision
designs are reliable enough to perform the task needed

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
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Design Transfer- transferring the laboratory design to full scale
production
Reliability Assessment- the basic estimation on the reliability of
the device, for new or modified designs
Design Review- determine and terminate any weaknesses in the
design
Personnel- the people who will review, analyze, and test the
device design

Software- main goal is
software, maintainability,
testability, and correctness

Test Instrumentationcalibrating and maintaining all
pieces of equipment used in
testing the quality of the device

Labeling- display labels,
charts, manuals, panels, test and
calibration procedures; make
sure instructions are easy to
understand for end user
 Quality Monitoring- used to analyze quality problems,
steps to prevent recurring problems identified, and determine
failure patterns
 Certification- technical review that includes adequate
specifications, effectiveness of tests methods, overall quality
assurance plan, and making sure there are no differences between
final end device and approved device specifications
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Reliability Technology, Human Error, and Quality in Health Care
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