How do you validate your instrument manual cleaning procedure?


Ensuring your instruments are clean and free of contaminants before sterilisation is vital to the decontamination cycle.

If an instrument is not clean, it cannot be sterilised. Any debris will prevent steam contacting the surface so even if your steriliser passes the process, the load will not be sterile.

To comply with essential requirements, as per HTM 01-05 you must have a validated method of cleaning your instruments before sterilisation whether you manual clean, use an ultrasonic cleaner or a washer disinfector.

Essential requirements need you to include just one of these methods. However, you must be able to prove that the process is repeatable and validated. Testing this with an ultrasonic cleaner or a washer disinfector is relatively easy as the process is mechanical and there are test products available to check the effectiveness of the cycle and results are documented in a logbook.

Manually cleaning instruments is a much more difficult process to validate however decontamination machines are an expensive investment and one that will be required upon a release date for Best Practice.

If at the moment it is practice policy to manually clean and you do not own an ultrasonic cleaner or washer disinfector, you must be able to prove the validity of your chosen cleaning process.

It should be noted that even if you are using machines to clean, every practice should maintain a manual cleaning process in the event of a breakdown with staff aware of the responsibility of this aspect of the decontamination process.

So how do you create a repeatable and validated manual process?

HTM 01-05 does contain a section regarding manual cleaning on page 63 click here to view >

These instructions are good and will help you create a structured and repeatable process. Any instructions you create should be visible at the point of cleaning. The question then is how to validate the procedure.

When validating the cleaning efficiency of an ultrasonic cleaner or washer disinfector, you should visually inspect a processed load once a day then chemically examine a processed load once a week. The same protocols can be applied to validate your manual cleaning.

As part of your instructions indicate that a daily visual inspection for signs of contaminants should be performed, preferably by a different person from the one who manually cleaned to add further weight to the validation.

Once A Week

Perform a chemical check using a protein detection pen such as Cleantrace to back up the visual inspection, just as you would with a mechanical process.

Make sure that you record the batch number and expiry date of whichever product you use as evidence of the test.

Here at Isopharm we offer a range of Protein residue test pens click here to view available products >

ByRick Craven