Kendrick DeLaine Russell Hazelrig Hunter King ETM 591.

Kendrick DeLaineRussell 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.

Phases of Device Cycle

Concept Definition

Production

Development

Deployment

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

Safety Analysis Methods

Technic of Operations

Review

Operating Hazard Analysis

Preliminary Hazard Analysis

Human Error 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.

Areas of Quality

Assurance Programs

Test Instrumentatio

n

Reliability Assessment

Organization

Parts and Materials QA

Quality Monitoring

Software Quality

AssuranceLabeling

Specifications

Design Transfer

Personnel

Design Review

Certification

Organization – the elements and aspects needed to develop the program, carry out program requirements, make audit program, document goals

Specifications- translating the idea of the device into measureable units; should address reliability, safety, stability, and precision

Parts and Materials- the parts and materials used in device designs are reliable enough to perform the task needed

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 Instrumentation- calibrating 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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