1. Kendrick DeLaine Russell Hazelrig Hunter King ETM 591

2. 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 1990s)

3. 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.

4. 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

5. 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.

6. Phases of Device Cycle Concept Definition Production Development Deployment

7. 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

8. Safety Analysis Methods Technic of Operations Review Operating Hazard Analysis Preliminary Hazard Analysis Human Error Analysis

9. 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.

10. 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

11. 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)

12. 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 its subdivisions. – Area 3: Outlining quality assurance directives to implement and monitor device conformance.

13. Areas of Quality Assurance Programs Test Instrumentation Reliability Assessment Organization Parts and Materials QA Quality Monitoring Software Quality Assurance LabelingSpecifications Design Transfer Personnel Design Review Certification

14. 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

15. 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

16. 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

17. 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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