1. The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing 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 Management Part 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. Assess the Risk Step two - Assess the Risk likelihoodhazardConsider the likelihood of the hazard causing an incident during the life of the item. consequencesConsider the consequences of such an incident.  FLINDERS MEDICAL CENTRE

15. Risk Calculator  FLINDERS MEDICAL CENTRE

16. Control the hazard 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