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The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices

The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices. Mr John Robson Director, Biomedical Engineering Flinders Medical Centre. “reasonably practicable”. Occupational Health, Safety and Welfare Act 1986. Risk.

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The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices

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  1. The Electrical Testing of Laparoscopic InstrumentsWORKSHOPTesting of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical Centre

  2. “reasonably practicable” Occupational Health, Safety and Welfare Act 1986

  3. Risk “the chance of something happening that will have an impact upon objectives. It is measured in terms of consequences and likelihood.” AS/NZS 4360: 1999

  4. Relevant References • AS/NZS 3551 : 1996 • Technical management programs for medical devices • ANSI/AAMI EQ56 : 1999 • Recommended practice for a medical equipment management program • AS/NZS 4360 : 1999 • Risk Management • ISO 14971 - 1 (soon to be released as AS/NZS) • Medical devices - Risk ManagementPart 1: Application of risk analysis

  5. Five Step Procedure 1. Identify hazards 2. Assess the risk 3. Plan control measures 4. Implement Plan 5. Review and Monitor  FLINDERS MEDICAL CENTRE

  6. Forms of Hazards • Physical Hazards  FLINDERS MEDICAL CENTRE

  7. Forms of Hazards • Chemical Hazards  FLINDERS MEDICAL CENTRE

  8. Forms of Hazards (cont’) • Radiation Hazards  FLINDERS MEDICAL CENTRE

  9. Forms of Hazards (cont’) • Biological Hazards  FLINDERS MEDICAL CENTRE

  10. Forms of Hazards (cont’) • Ergonomic Hazards  FLINDERS MEDICAL CENTRE

  11. Forms of Hazards (cont’) • Psychological Hazards  FLINDERS MEDICAL CENTRE

  12. Step two - Assess the Risk • Consider the likelihood of the hazard causing an incident during the life of the item. • Consider the consequences of such an incident.  FLINDERS MEDICAL CENTRE

  13.  FLINDERS MEDICAL CENTRE

  14.  FLINDERS MEDICAL CENTRE

  15. Risk Calculator  FLINDERS MEDICAL CENTRE

  16. Step three - Control the hazard • Apply the following hierarchy • Elimination • Substitution • Engineering Controls • Administrative Controls • Personal protective equipment  FLINDERS MEDICAL CENTRE

  17. Documentation “If it counts, count it” Albert Einstein

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