welcome [mdrao.ca] ben s..pdf · 2018-05-26 · 0 15 30 45 60 75 90 105 120 135 150 165 180 0 15 30...
TRANSCRIPT
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Welcome !Medisafe Research
Validation of the Ultrasonic Process
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Standards
• HTM 2030 - Guidance being used as a standard..
• EN ISO 15883 - Washer-disinfectors
Both call for Validation!
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The link between BSE and vCJD was established in 1996…
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•• Manufacturers ValidationManufacturers Validation
•• Installation & CommissioningInstallation & Commissioning
•• DailyDaily TestsTests
•• Weekly Weekly TestsTests
•• QuarterlyQuarterly Tests and ValidationTests and Validation
•• Annual Annual ValidationValidation
Validation & Routine Testing
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Manufacturers Validation• Manufacturers are obliged to test
machines prior to delivery• Test results are to be available to the
customer
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Installation & Commissioning
• Installation checks and tests to ensure safe and effective operation of the machine
• Ultimate decision to put a machine into operation comes from the hospitals AP
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AP’s
• AP’s (Authorised Person (Sterilisers))• Responsible for overseeing washing,
disinfection & sterilising practices in hospitals
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Soil erosion video
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Soil Residue Testing• Clearly defined Test Load of Instruments
• Tests Correlate to Blood
• Simulates Protein Removal
• Simulates Blood Coagulation
• Quantifiable Test Results
• Convenient and Easy to use
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Soil Residue Testing
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A Regular Laparoscopic instrument
Medisafe`s “See Through”indicator Laparoscopic instrument
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Lumen Test
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Field Distribution in Two Different Ultrasonic Baths
Ultrasonic Cleaner #1 at Z= 65mm
Ultrasonic Cleaner #2 at Z= 65mm
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Hand foil video
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Foil Testing in Action!
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Alternative methods…• Gives Indication of:
• Ultrasonic Cleaning Performance
• Energy Levels Throughout the Tank
• Potential Wash “Overload”
• Required Time for “De-Gas”
• Used for Optimisation - “Fine Tuning”
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More alternatives…..• Measures ultrasonic activity• Quantifies the results• Manual process (i.e. not repeatable)
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Field Distribution in Two Different Ultrasonic Baths
A
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Front
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Position Wire Basket Plate
A 2.10 1.28
B 3.18 1.50
Time Taken for Colour Change – (Mins:sec’s)
Standard SI Digital
Wire Basket:10mm ofofice 1mm wire
Flat Plate: 0.6mm guage stainless steel
Temp:28 Degrees Celcius
Test MethodPereg – Sonoc Check
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What about….???……Ultrasonic Units that Incorporate a
Disinfection Phase???
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A Combination of Tests!
• Classified as a Washer/Disinfector
• Further Design Considerations
• Protein Residue Testing
• Thermometric Testing
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Other considerations…..• Detergents MUST be validated for use
– Re-testing/validation may be required• Records must be kept for 20 years• Records must be kept and maintained
for ALL testing• Any newly designed CSSD must comply
with Building Notes 13
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What are the implications of this testing?
• Supercentres!• 120 being established across the UK• Increase in quality control• Reduction in costs and downtime
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To conclude…..• Emphasis on Validation and Routine
Testing• UK Hospitals are following HTM 2030
NOT ISO 15883• Validation of the Validator!!!
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Thank you !Questions are Welcome…