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 Testing Washer Disinfectors for Instruments 
The use of a Washer Disinfector that complies with HTM2030 has many advantages:
  • Operator safety
  • Consistent cleaning effect
  • Higher temperature wash stage
  • Consistent detergent dilution
  • Cycle include initial wash stage to aid the wash process
  • Predetermined rinse stage to remove detergent
  • Use of low pH detergent
  • Cycle will include hpt water disinfection
  • Cycle will include a drying stage
  • Staff time is not used washing instruments
  • Instruments are dry at the end of the cycle
  • Testable both for cleaning effect and disinfection
To obtain reliable effective results w/d machines require regular maintenance and testing. The routine testing of w/d machines for instruments can be divided into time periods: Daily, weekly, quarterly and annual tests.

Table showing required tests and frequency

Test

Daily      

Weekly    

Quarterly

Yearly   

Automatic Control Test

Y

Y

Y

Y

Safety Checks

Y

Y

Y

Y

Water Hardness  

Y

Y

Y

Water Conductivity  

Y

Y

Y

Cleaning Efficacy  

Y

Y

Y

Verification of Calibration  

 

Y

Y

Thermometric Test    

Y

Y

Water Chemical Purity      

Y

Drainage      

Y

Door & Door Interlock      

Y

Water Vapour Discharge      

Y

Aerosol Discharge      

Y

Chemical Additive Dosing      

Y

Load Dryness      

Y

Automatic Control Test

This is an observational test that aims to ensure that the machine is operating its cycle within the required specification by visually monitoring the machine's own instruments. It is reliable to use the machine's own instruments as these are checked quarterly during the 'Verification of Calibration of Machine Instruments' test. A stopwatch is required so that each stage of the cycle can be timed, and all data should be recorded within the machine's own logbook.

The principle behind the Automatic Control Test is to create a continuous performance record that is unique to the machine. This ensures that any deviation from normal performance can be identified.

If the machine has a printer installed, the Daily Automatic Control Test may be replaced by attaching a printout to the machine's logbook, however this is at the discretion of your Authorizing Engineer.

A successful Automatic Control Test for an Ultrasonic Cleaner should comprise of:

  • The cycle time and temperature remains consistant with results of previous tests
  • The machine should display 'Complete Cycle' message
  • There is no observed deviation from normal performance
  • Machine logbook is updated

Safety Checks

Safety checks ensure Operator Safety and correct cycle function and usually consist of:

  • Safety valve operation
  • Door pressure interlock
  • Door cycle start interlock
  • Door in-cycle interlock
  • Condition of door seal
  • Cleaning of filters and strainers
  • Check of spray arms for free movement (If relevant)
  • Check of spray nozzles for blockage (If relevant)

Not all checks are required daily, however it is at the discretion of your Authorizing Engineer as to the regularity of the tasks listed.

Water Hardness

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Water Conductivity

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Cleaning Efficacy

Cleaning Efficacy tests are done to prove that the machine is reducing the amount of contamination on an instrument to an acceptable level during the cycle. Due to the extent of contamination that occurs both naturally and during use it is impossible to test for every possibility. Protein is a component of the majority of contaminations so it is this that most test methods focus on.

The most common test is the Ninhydrin method where a processed object is swabbed, ninhydrin solution is applied to the swab, then incubated. If any protein has been picked up by the swab, the Ninhydrin will cause a colour reaction indicating possible contamination.

The Ninhydrin method can be used to test an actual surgical instrument that has been contaminated through theatre use, or a surgical instrument or Surrogate Device coated in Test Soil.

A Surrogate Device is used to mimic the characteristics of a surgical instrument. Due to the value of some surgical instruments, a Surrogate Device provides an economic alternative that still provides an acceptable process challenge.

Test Soil is used to mimic contaminants that would be found on an instrument prior to processing. Test Soil is available in a variety of forms and it is down to your Authorizing Engineer to dictate the preferred type.

When testing using the Ninhydrin method a successful test should comprise of:

  • Take three sterile swabs.
  • One swab should be contaminated with protein, treated with ninhydrin and incubated. This will tell you what to look for in a 'fail' result ie: protein is present.
  • One swab should be treated with sterile water, ninhydrin and incubated. This will tell you what to look for in a 'pass' result ie: protien is not present.
  • One swab should be treated with sterile water, swabbed against a processed instrument or surrogate device, and incubated. This should then be compaired with the 'fail' and 'pass' results to determin the outcome of the test. If there is purple discolouration on the swab it is an indication that protein is present.
  • Machine logbook should be updated.

Verification of Calibration of Machine Instruments

This test checks the machine instruments indicated values against the measured values of a recorder/data logger. At a mid point in the process cycle, visually check what the machine instruments state and compare against the measured values.

Thermometric Test

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Generic Instrument Washer/Disinfector Cycle 

Water Chemical Purity

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Water Test Recommended Level for Final Rinse
Appearance: Clear, bright & colourless
pH: 5.5 to 8.0
Conductivity: Below 30 uS.cm-1
Total Dissolved Solids: Below 4 mg/100ml
Hardness: Below 50 mg/l CaCO3
Chloride: Below 10 mg/l
Heavy Metals: Below 10 mg/l
Iron: Below 2 mg/l
Phosphate: Below 0.2 mg/l
Silicate: Below 0.2 mg/l
Bacterial Endotoxins: Below 0.25 EU/ml
Total Viable Count: Less than 1 cfu/100ml
Environmental Mycobacteria: No recovery

Drainage

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Door & Door Interlock

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Water Vapour Discharge

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Aerosol Discharge

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Chemical Additive Dosing

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Load Dryness

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Eschmann Spare Parts 
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Isopharm Sentry Limited | The Validation Centre | Thornbury Hill Lane | Near Firbeck | Rotherham | S81 8JW | United Kingdom
Tel +44 (0) 1709 811460 | Fax +44 (0) 01709 811461 (Sales)
| Fax +44 (0) 01709 811462 (Accounts)

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