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…