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 of 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...
Welcome !Medisafe Research
Validation of the Ultrasonic Process
Standards
• HTM 2030 - Guidance being used as a standard..
• EN ISO 15883 - Washer-disinfectors
Both call for Validation!
The link between BSE and vCJD was established in 1996…
•• Manufacturers ValidationManufacturers Validation
•• Installation & CommissioningInstallation & Commissioning
•• DailyDaily TestsTests
•• Weekly Weekly TestsTests
•• QuarterlyQuarterly Tests and ValidationTests and Validation
•• Annual Annual ValidationValidation
Validation & Routine Testing
Manufacturers Validation• Manufacturers are obliged to test
machines prior to delivery• Test results are to be available to the
customer
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
AP’s
• AP’s (Authorised Person (Sterilisers))• Responsible for overseeing washing,
disinfection & sterilising practices in hospitals
Soil erosion video
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
Soil Residue Testing
A Regular Laparoscopic instrument
Medisafe`s “See Through”indicator Laparoscopic instrument
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
Hand foil video
Foil Testing in Action!
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”
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
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Front
Front
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
What about….???……Ultrasonic Units that Incorporate a
Disinfection Phase???
A Combination of Tests!
• Classified as a Washer/Disinfector
• Further Design Considerations
• Protein Residue Testing
• Thermometric Testing
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
What are the implications of this testing?
• Supercentres!• 120 being established across the UK• Increase in quality control• Reduction in costs and downtime
To conclude…..• Emphasis on Validation and Routine
Testing• UK Hospitals are following HTM 2030
NOT ISO 15883• Validation of the Validator!!!
Thank you !Questions are Welcome…