DECONTAMINATION
highly alkaline cleaners with limited material compatibility, no additional surfactants and a high level of silicates and phosphates to mildly alkaline cleaners combined with low- foam surfactants and enzymes. It is essential that surfactants used in WDs are very low foaming to ensure compatibility with increasingly sophisticated WDs. Silicates are no longer included in state-of-the-art detergents to inhibit corrosion, because they tend to form unwanted shimmering coatings in various colours on metal surfaces. Instead, alternative corrosion inhibitors are included in the formulation. Similarly, phosphates have been replaced by alternative cleaning intensifiers, which are essential when a detergent has to safely remove organic contamination, such as that found on flexible endoscopes.
Improved product performance, while maintaining material compatibility, are the twin goals of WD detergent product development. The limiting factor in detergent product development is the actual chemical makeup of the detergent. For example, attempts to increase the concentration of the detergent whether in the form of highly concentrated liquids with dosages <0.1% or as concentrated solids have revealed that too high a concentration leads to a deterioration in material compatibility with instruments and some components of the WD. Over concentration can even lead to the deterioration of cleaning results.3
Thermosept X·tra Thermosept X·tra is a high-performance cleaner for the automated reprocessing of medical devices, including the safe and gentle cleaning of commonplace robotic instruments used in minimal invasive surgery. Cleaning efficacy is achieved, by the powerful, synergistic combination
If the volume of MAS and robotic surgery increases, there will be additional pressures on decontaminating highly sensitive and expensive instruments. The complexity of robotic instruments for minimally invasive surgery places high demands on the safe and reliable reprocessing of these instruments.
of enzymes and surfactants. Even at low doses and at low temperatures, the solution removes organic contaminants such as blood, proteins, tissue residues, as well as mucus and fatty impurities. The cleaner is formulated to ensure good material compatibility – even with sensitive materials, such as anodized aluminium and non- ferrous metals.
Hospital based study The cleaning performance and material compatibility of thermosept X·tra was examined in a study conducted in a hospital setting.3
Two alkaline based, silicate-free cleaning agents were tested for a month in the hospital’s CSSD. The two cleaners selected for testing were thermosept X·tra (known in the study as tX) and an alternative, established product – known in the study as mC. Two identical washer-disinfectors (WD) were used, one with product tX and the other with product mC for a one-month period (total of 16 working days). To ensure the validity of the results. The two products were swapped at the half-way stage of the study period.
The same WD programme sequence for automated cleaning was selected on both WDs. The only variance being the
detergent concentration which was adjusted according to the manufacturer’s instructions. A concentration of 0.5% is recommended for product tX while the manufacturer of product mC specified a concentration of 0.7%. To ensure the accuracy of the dosage, it was tested by volume and concentration. The cleaning results were assessed both qualitatively and quantitatively on four separate days and on two treatment cycles of the WD. This meant that a set of eight cleaning test results were available for both products. WD carts were loaded with three test trays equipped with contaminated Crile clamps and cleaning indicators (all in accordance with test guidelines). They were positioned identically for all cleaning runs and this positioning was also documented photographically.
The residual protein content of the Crile clamps used, was determined by an independent company, with the clamps being sent for testing on the respective test day. The cleaning indicators used were assessed on-site applying a double control principle and photographic documentation. To be able to correlate the results of the cleaning test, with the process parameters of concentration, pH, temperature profile and rinsing pressure, these values were determined on all the test days in both WDs. Throughout the study, the influence of the two cleaners on various materials was tested for compatibility. A selection of test materials and instruments were used including stainless steel, aluminium, plastics and metal instruments. It should be noted that this study did not test da Vinci robotic instruments.
The condition of each test specimen was assessed and documented, so that accurate evaluations could be made. All test specimens were subjected to visual assessment before the study began, at the study midpoint and at the end of the study. Materials were evaluated after cleaning with the test detergents and also following steam sterilisation. The plastic test specimens were also evaluated in terms of density changes. At the end of the cleaning cycles, a visual inspection was performed to assess
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WWW.CLINICALSERVICESJOURNAL.COM FEBRUARY 2021
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