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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

The Electrical Testing of Laparoscopic InstrumentsWORKSHOPTesting of Medical Devices

Mr John Robson

Director, Biomedical Engineering

Flinders Medical Centre

reasonably practicable

“reasonably practicable”

Occupational Health, Safety and Welfare Act 1986

slide3
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

relevant references
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
five step procedure
Five Step Procedure

1. Identify hazards

2. Assess the risk

3. Plan control measures

4. Implement Plan

5. Review and Monitor

 FLINDERS MEDICAL CENTRE

forms of hazards
Forms of Hazards
  • Physical Hazards

 FLINDERS MEDICAL CENTRE

forms of hazards7
Forms of Hazards
  • Chemical Hazards

 FLINDERS MEDICAL CENTRE

forms of hazards cont
Forms of Hazards (cont’)
  • Radiation Hazards

 FLINDERS MEDICAL CENTRE

forms of hazards cont9
Forms of Hazards (cont’)
  • Biological Hazards

 FLINDERS MEDICAL CENTRE

forms of hazards cont10
Forms of Hazards (cont’)
  • Ergonomic Hazards

 FLINDERS MEDICAL CENTRE

forms of hazards cont11
Forms of Hazards (cont’)
  • Psychological Hazards

 FLINDERS MEDICAL CENTRE

step two assess the risk
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

risk calculator
Risk Calculator

 FLINDERS MEDICAL CENTRE

step three control the hazard
Step three - Control the hazard
  • Apply the following hierarchy
    • Elimination
    • Substitution
    • Engineering Controls
    • Administrative Controls
    • Personal protective equipment

 FLINDERS MEDICAL CENTRE

documentation
Documentation

“If it counts, count it”

Albert Einstein