Reprocessing Validation using in-house equipment of the client

Why:

The case study aims to address how to design an automatic cleaning and disinfection process validation considering that washer disinfectors to be used were installed in the client facilities, not in close proximity to the testing facilities.

For Whom:

The case study is designed for the medical device manufacturer seeking to prove the automatic and cleaning validation process of their surgical instruments, using the washer disinfectors they own in their facilities.

How:

Three major analytes were to be determined during the validation: protein residues, Total Organic Carbon (TOC) residues and bacteria remaining after disinfection process.
Prior to performing the cleaning and disinfection procedure within the client’s facilities, the extraction method was set and validated for protein residue, TOC and bacterial count in Eurofins’ laboratory with testing units were provided by the client.
Once the methods were established, testing units of the instruments as well as controls were soiled in Eurofins’ laboratory and transported by an analyst to the client’s facilities to undertake the cleaning and disinfection procedure. Sufficient units were prepared to be able to enumerate residual proteins, residual TOC and surviving microorganisms on the test units.
The process was performed in triplicate in three different washer disinfectors.
Once all the processes were finalised, test units and controls were returned to Eurofins’s laboratory for extraction and subsequent analysis.

Outcomes:

The results were satisfactory, showing that the instruments of the manufacturer were satisfactorily clean and disinfected, using their designed programs in their facilities. This allowed the manufacturer to offer the service of cleaning and disinfection to the hospital that they provide the instruments to. Furthermore, reproducibility and robustness of the method could be proven by the use of three different washer disinfectors.