DECONTAMINATION
the degree of removal of the individual experimental contaminants. No differences in terms of cleaning performance could be detected between the test detergents.
Cleaning performance evaluation In terms of residual protein, both cleaners showed far lower residual protein than the guideline benchmark of ≤ 80 µg. The cleaning indicator gke-L4 red cleaning indicator was cleaned off more efficiently with tX compared to mC, even though tX was used at a 25% lower dosage than mC. The overall cleaning performance of both products was assessed to be ‘very good’, however it was shown that product tX could be used at a 25% lower concentration without any loss of cleaning performance. This means that thermosept X·tra offers both potential cost and environmental advantages.
Impact on materials
Compared to the test specimens only subjected to cleaning with the two detergents, those which had also undergone steam sterilisation showed demonstrably greater damage. The damaging effects of steam sterilisation after only a few treatment cycles were measurable and clearly visible. All metal test specimens showed clearly visible damage after autoclaving and were particularly sensitive to the treatment step of steam sterilisation. The test specimens only subjected to cleaning with either of the two alkaline detergents showed no visual material changes. Test specimens made of material such as stainless steel, which is used in many medical devices, clearly showed visible material changes after steam sterilisation. At the end of 48 treatment cycles with exclusive cleaning with test detergents, no visible changes were identified, and material abrasion of less than 0.01% was measured. In contrast, all test specimens subject to steam sterilisation showed visual changes in the form of clearly visible discoloration and staining. Looking specifically at the material compatibility results for the anodised aluminium specimens, there were significant differences between the two detergents. The amount of material abrasion from test product tX was significantly less than that from product mC, indicating differing material compatibilities between the detergents.
The study also found that unlike stainless steel, the treatment of anodised aluminium in an autoclave actually strengthens the stability of the aluminium oxide layer and appears to have a positive influence on the durability of the material.
The plastic test specimens were only evaluated in terms of cleaning with the detergents and were not subject to steam sterilisation due to their thermal instability.
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Good compatibility with the products was demonstrated in terms of visual appearance, density measurement and Shore hardness changes. A striking observation was a significant change in the Shore hardness scale amounting to >12% after treatment with product mC, compared to 2% for the product tX.
Study conclusions Testing the detergents under realistic clinical conditions, it was demonstrated that at a 25% lower dosage of test product tX (thermosept X·tra), a comparably good cleaning result was achieved in terms of both protein removal and various other cleaning indicators. The cleaning indicator gke-L4 (red) revealed that tX has an improved cleaning performance compared to mC. Also, product tX demonstrated overall improved material compatibility for various test materials.
The study identified both economic and environmental savings which could potentially be made with at least equal cleaning performance by using thermosept X·tra.3
Conclusion
The chemicals used in WDs are an integral element in the effective instrument reprocessing cycle. Optimum performance of WDs relies on the highest performance of the selected cleaning agent. It is therefore unsurprising that thermosept X·tra is indicated for the safe and effective reprocessing of sensitive, high value instruments including those used during MAS and robotic procedures. Looking to the future, if the number of MAS and robotic procedures is to significantly increase, cost effective reprocessing strategies which do not damage these complex instruments will be needed. Thermosept X·tra is well placed to play a valuable role in these surgical advances. CSJ
About the Author
Dr. Frank Bakker, head of the Application Department, Schülke and Mayr, received his
M.Sc. in Chemical Engineering from the University of Twente, the Netherlands and his Ph.D. in Molecular Biology from the University of Erlangen, Germany. 15 years ago, he started his career in medical device reprocessing and infection prevention as a process engineer for a leading manufacturer of washer disinfectors. In 2010, he moved to manage the Application Department for Schülke and Mayr.
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References 1 Perez R.E and Schwaitzberg S.D, Robotic surgery: finding value in 2019 and beyond, Annals of Laparoscopic and Endoscopic Surgery, Vol. 4, 2019
2 Cole A, O’Neill P, Sampson C, Lorgelly P, Barriers to Uptake of Minimal Access Surgery in the United Kingdom, Office of Health Economics, 2018
3 Professor Widmer, Medical Director and Head of the Hospital Epidemiology department, Mr Schnurbusch, Head of CSSD, University Hospital, Basel, Comparative Study of Mechanised Cleaners in Practical Use at the University Hospital Basel – Background.
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