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SURGICAL INSTRUMENT DECONTAMINATION


Figure 2.


hour timeframe), systems must be in place to keep instruments moist, and, finally, protein-based fully quantifiable process challenge devices should be considered as they come to market.


Efficient prion removal


Prions are easier to remove if they have not dried on the surface of the instrument. To enable efficient prion removal, theatre and SSD staff should ensure that medical devices are transported to the SSD for cleaning and reprocessing as soon as practically possible. For the safety of patients, it is very important that good communications and teamwork feature as part of this process.


All of the recommendations of the revised HTM/WHTM 01/01 guidance [CFPP in England was renamed] have been implemented within the HSDU at UHW Cardiff following the release of the guidance, including: n Installation of an in situ-monitoring protein detection system.


n High-risk sets being collected as soon as possible post-operatively and processed as a priority on arrival in the HSDU.


n Implementation of an automated spray system to keep instruments moist for high-risk, heavily soiled and time- delayed sets.


n Implementation of a trial of the fully quantifiable protein-based PCD.


It was the trial of the protein-based Process Challenge Device (PCD) that instigated the research project which will be explained in this article.


Figure 3.


Implementation of the research programme


I was approached by a company to review the new protein-based PCD following my presenting at the Central Sterilising Club in Cardiff in 2018. The newly developed PCD fully meets the recommendations identified in the updated HTM 01-01, and a trial was agreed to monitor washer-disinfector processes when challenged with a protein-based material. It should be noted that at the time of this initial research, no standard or guidance was available for the manufacture of such PCDs. The PCDs were in development stage; thus the results are for research purposes only. The PCD is a stainless steel token (SAE 316), impregnated with 1000 μg of brain homogenate assay (ovine). The token replicates surgical instruments with residual protein residue present. In addition to the tokens, the system comes with a holder, which takes four tokens, with each position on the holder presenting the washer with different challenges. These are: ‘face up’, ‘face down’, ‘box joint’, and cannulated instruments (Fig. 1).


On arrival of the samples from the company, a testing day was arranged to evaluate the PCDs and washer-disinfector performance, and to review in-situ monitoring effectiveness on measuring the residuals on the processed tokens. A washer-disinfector was selected, and the programmed wash cycle was agreed for use, as this cycle is predominantly used on all of the nine washer-disinfectors at the UHW HSDU. The wash cycle includes:


n A pre-wash for five minutes at below 30˚C.


n A wash for 10 minutes at 60˚C. n A rinse for two minutes at 60˚C. n Disinfection for 2-3 minutes at 90-93˚C. n Drying for 15 minutes.


Alkaline detergent


The chemistry on the washer-disinfector was an alkaline detergent, with a pH of 10 in the wash cycle. As this was a cleaning efficacy test, the cycle was aborted following the rinse in line with the cleaning efficacy test guidance in WHTM 01-01. On completion of the test cycles, the PCDs were removed from the washer- disinfector, and on visual inspection all four tokens had visual protein residues present. The chemistry and wash cycle had no effect on the removal or breakdown of the protein challenge (Fig. 2).


Fully validated washer-disinfector The washer-disinfector was fully validated in line with the recommendations in WHTM 01-01, with weekly, quarterly, and annual test performed with no issues identified. These results were alarming, and highlighted that the washer- disinfector/chemistry can achieve excellent results when faced with soil- based challenges (Test Soil/Soil Based PCDs), but that we are seeing ineffectiveness at removing residual proteins. This initial test instigated the research project, with the Sterile Services manager asking the question: ‘Can we optimise the decontamination process/ chemistry to effectively pass the protein based challenge?’, rather than ‘This PCD


Figure 4. 30 Health Estate Journal July 2020


Figure 5.


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