DECONTAMINATION
value, which can be added to the previous value. An absorption curve can be produced, which shows the kinetics of discolouration as the gradual loss of colour of the aluminum plates over time. The evaluation was performed every 30 minutes. The same test conditions as in part A were used regarding Concentration and Temperature. The plates were additionally evaluated with a compatibility rating system where “0“ (zero) means no impact at all and “5” means high surface changing impact (corresponding to a high alkaline detergent under the same conditions).
Acceptance criteria
This study is mainly a comparative study. However, no visual changes of the material after the complete duration of testing (96h contact time, for comparison: with a cleaning time of 10min, 96 h would be reached after 570 reprocessing cycles) was documented as “PASS”.
Results
Immersion test with visual inspection All materials except aluminum (silver and blue) did not show any visual changes after the complete duration of the test (96 hours) and are therefore all considered a “PASS”. The various concentrations / exposure times did not have any impact on the results. The temperature was monitored in the water bath. Considering that there were no alterations in temperature, the curve is not shown.
Aluminum showed an impact which differed depending on the different test conditions. The results for blue and silver aluminium; both showed the same effect. As expected, the concentration of the detergent plays a big role in the effect on aluminium. In figure 2, it is shown that 0.2 % concentration has a lower effect than 0.5 %. This is applicable for both detergents (Belimed Protect Mild Alkaline Enzyme Cleaner and Detergent A). The Belimed Mild Alkaline Enzyme Cleaner showed to be less aggressive than Detergent A, when using 0.5% of detergent. Signs of colour loss occurred after a longer period when compared to Detergent A.
Discolouration kinetics test with blue anodised aluminium
Graph 1 shows the results for the tests with blue aluminium in 0.5% solution at 60˚C. Neutral pH (pH7) is recognised as having little impact on material compatibility,
therefore. A Neutral Enzyme Cleaner was included in the test as a reference / control. The curve clearly shows that a neutral detergent has the least impact, followed by Belimed Protect Mild Alkaline Enzyme Cleaner. Detergent A has the highest degree of colour loss. It is important to note that the test bodies were submerged in the cleaning solution and that no mechanical force was applied during this test.
Conclusion
The results of this study prove the assumption that a Neutral (Enzyme) Cleaner has less damaging effect on instrument materials compared with a Mild Alkaline Enzymatic Cleaner.
It also showed, that not all Mild Alkaline Enzymatic Cleaners have the same detrimental effects on materials. In this test we could see that Belimed’s Mild Alkaline Enzyme Cleaner is significantly less aggressive to the tested Aesculap materials, when compared to detergent. We can therefore deduce that this Cleaner also has a superior compatibility of materials in comparison. Moreover, for all materials except aluminium, there are no visual changes after the complete test period of 96 hours.
The duration of the test (96h contact time) represents a cleaning time of approximately 10 mins and approximately 570 reprocessing cycles for a single instrument. When we take this number for sterilisation containers made from anodised aluminium, this offers positive results for material compatibility with no colour loss effect (or aesthetic variance). In terms of compatibility with anodised aluminium, Detergent A produced visible colour change significantly faster under otherwise identical conditions, which indicates that Belimed Protect Mild Alkaline Enzyme Cleaner is measurably less aggressive than the tested Detergent A. Since the Neutral Enzyme Cleaner proved to be the least aggressive option in terms of material compatibility the general recommendation is to use this solution for reprocessing of sterilisation containers made from aluminium. In summary, our findings strengthen the statement that choice of cleaning detergent is important for CSSD, and one should choose wisely, taking into consideration all possible variables. Here at Belimed we combine our core competence in automated reprocessing, with powerful cleaning and disinfecting solutions to achieve optimal cleaning
In summary, our findings strengthen the statement that choice of cleaning detergent is important for CSSD, and one should choose wisely, taking into consideration all possible variables.
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results and the highest level of material compatibility, for medical device longevity. We can confirm, that a neutral enzymatic cleaner is gentler to instrument materials – especially to sensitive materials such as anodised aluminium, for example. Further, by testing two different mild alkaline cleaners we were able to demonstrate further variances in material compatibility with the results obtained from coloured aluminium. By measuring the amount of colour extracted at a range of temperatures with different concentrations of each cleaner, we were able to visually compare and describe the contrast between two cleaners of the same category. It is important to follow the manufacturer’s recommendations for reprocessing of medical devices according to EN ISO 17664. Test results demonstrated that Belimed
Protect mild alkaline cleaner can fulfil both needs: optimal cleaning efficacy, while also being gentle to materials, therefore rendering excellent material compatibility with a broad range of materials from Aesculap Surgical. CSJ
About the author
Christian Garbin spent his early years in the chemical – pharmaceutical industry, being involved in product development and production process optimisation. Later, he dived into laboratory medicine, specifically the technical aspects of metabolic diseases. With this experience gained in the hospital and pharmaceutical industry, Christian decided to build upon his business acumen by taking a commercially driven role and immersing himself in the diverse world of medical adhesives, while completing further studies in Business Administration. Christian is now the Technical Market Manager for Belimed’s Consumable range of infection prevention products and brings together a unique blend of technical knowledge and commercial understanding to expertly support Belimed’s customers to achieve the best clinical outcome. Christian is based in Belimed’s Zug Headquarters, where he can be found optimising the cleaning process of Belimed reprocessing equipment in combination with the NEW Belimed Protect range of cleaning and disinfecting chemistries
NOVEMBER 2019
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