The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical Centre
The Electrical Testing of Laparoscopic Instruments WORKSHOP Testing of Medical Devices Mr John Robson Director, Biomedical Engineering Flinders Medical.
Jan 03, 2016
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The Electrical Testing of Laparoscopic Instruments
WORKSHOP
Testing of Medical DevicesMr John Robson
Director, Biomedical Engineering
Flinders Medical Centre
“reasonably practicable”
Occupational Health, Safety and Welfare Act 1986
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
• 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 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
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Forms of Hazards
• Physical Hazards
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Forms of Hazards
• Chemical Hazards
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Forms of Hazards (cont’)• Radiation Hazards
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Forms of Hazards (cont’)
• Biological Hazards
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Forms of Hazards (cont’)
• Ergonomic Hazards
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Forms of Hazards (cont’)• Psychological Hazards
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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.
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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
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Step three - Control the hazardControl the hazard
• Apply the following hierarchy
– EliminationElimination
– SubstitutionSubstitution
– Engineering ControlsEngineering Controls
– Administrative ControlsAdministrative Controls
– Personal protective equipmentPersonal protective equipment
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Documentation
“If it counts, count it”
Albert Einstein
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