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The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical Centre

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Page 1: The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical

The Electrical Testing of Laparoscopic Instruments

WORKSHOP

Testing of Medical DevicesMr John Robson

Director, Biomedical Engineering

Flinders Medical Centre

Page 2: The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical

“reasonably practicable”

Occupational Health, Safety and Welfare Act 1986

Page 3: The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical

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

Page 4: The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical

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

Page 5: The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical

Five Step ProcedureFive Step Procedure

1.1. Identify hazardsIdentify hazards

2.2. Assess the riskAssess the risk

3.3. Plan control measuresPlan control measures

4.4. Implement PlanImplement Plan

5.5. Review and MonitorReview and Monitor

FLINDERS MEDICAL CENTRE

Page 6: The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical

Forms of Hazards

• Physical Hazards

FLINDERS MEDICAL CENTRE

Page 7: The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical

Forms of Hazards

• Chemical Hazards

FLINDERS MEDICAL CENTRE

Page 8: The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical

Forms of Hazards (cont’)• Radiation Hazards

FLINDERS MEDICAL CENTRE

Page 9: The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical

Forms of Hazards (cont’)

• Biological Hazards

FLINDERS MEDICAL CENTRE

Page 10: The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical

Forms of Hazards (cont’)

• Ergonomic Hazards

FLINDERS MEDICAL CENTRE

Page 11: The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical

Forms of Hazards (cont’)• Psychological Hazards

FLINDERS MEDICAL CENTRE

Page 12: The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical

Step two - Assess the RiskAssess the Risk

• Consider the likelihoodlikelihood of the hazardhazard causing an incident during the life of the item.

• Consider the consequencesconsequences of such an incident.

FLINDERS MEDICAL CENTRE

Page 13: The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical

FLINDERS MEDICAL CENTRE

Page 14: The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical

FLINDERS MEDICAL CENTRE

Page 15: The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical

Risk CalculatorRisk Calculator1000

EXTREME RISK

(guideline exposure rates) (guideline cost impacts) 900

100% ALMOST 800

CERTAIN VERY HIGH

700 RISK

VERY RARE NUMEROUS CATASTROPHE

82% QUITE (once per year or less) FATALITES ($50 million) 600

POSSIBLE RARE HIGH RISK(a few per year) MULTIPLE DISASTER 500

INFREQUENT FATALITIES ($5 million)

65% UNUSUAL (once per month) 400

BUT POSSIBLE OCCASIONAL SINGLE VERY SERIOUS SUBSTANTIAL(once per week) FATALITY ($500,000) 300 RISK

FREQUENT

40% REMOTELY (daily occurrence) SERIOUS SERIOUS 200

POSSIBLE CONTINUOUS INJURY ($50,000) MODERATE(several daily occurrences or more) 175 RISK

CASUALTY IMPORTANT

24% CONCEIVABLE TREATMENT ($5,000) 125

BUT VERY

UNLIKELY FIRST AID NOTICEABLE 100

TREATMENT ($500)

0% PRACTICALLY 75

IMPOSSIBLE

50 RISK PERHAPS

ACCEPTABLE

25

0

CONSEQUENCES

TIE LINE RISK SCORE

POSSIBLEEXPOSUREPROBABILITY

FLINDERS MEDICAL CENTRE

Page 16: The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical

Step three - Control the hazardControl the hazard

• Apply the following hierarchy

– EliminationElimination

– SubstitutionSubstitution

– Engineering ControlsEngineering Controls

– Administrative ControlsAdministrative Controls

– Personal protective equipmentPersonal protective equipment

FLINDERS MEDICAL CENTRE

Page 17: The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical

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Albert Einstein


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