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Die Leistungsfähigkeit der Aufbereitungseinheit für Medizinprodukte (AEMP) ist essenziell für die Gesundheitsversorgung. Herausforderungen wie Fachkräftemangel und zunehmend komplexere Medizinprodukte machen kontinuierliche Prozessverbesserungen in der AEMP erforderlich. Ein datenbasierter Vergleich zwischen AEMPs kann Schwachstellen aufdecken, durch Handlungsempfehlungen Zeit und Kosten bei der Prozessverbesserung sparen und somit die Patientenversorgung verbessern. Der Lehrstuhl für Medizintechnik der RWTH Aachen entwickelt mit der DGSV e.V. eine AEMP-Benchmark zur Erfassung und Analyse von AEMP-Prozessen in Deutschland. Aufbauend auf in Vorarbeiten erhobenen Anforderungen und potenziellen Vergleichsgrößen wurde 2023 mittels einer Online-Umfrage eine Pilot-Datenerhebung für das Benchmarking durchgeführt. Die 48 erhobenen Datensätze von unterschiedlichen AEMP wurden zunächst bereinigt. Die Vergleichsgrößen wurden in Schlüssel-Leistungsindikatoren (engl.: Key Performance Indicators, KPI) und Leistungsbestimmende Faktoren (engl.: Performance Shaping Factors, PSF) unterteilt. Anschließend wurde eine statistische Analyse des Einflusses der PSFs auf die KPIs mit einem Signifikanzniveau von 0,05 durchgeführt. Die KPIs zeigten eine weite Streuung bei Qualität und Sicherheit. Für die Qualität waren das Sterilisator-Nutzvolumen und die gemeinsame Auswertung von Reklamationen mit den Kunden besonders starke Einflüsse. Für die Sicherheit der Beschäftigten waren vorhandene Einarbeitungskonzepte und häufige externe Fortbildungen besonders positive Einflüsse. Weitere signifikante Faktoren wurden identifiziert und in den praktischen Kontext eingeordnet. Insgesamt wurde damit das Ziel des Benchmarkings erreicht, Unterschiede in der Leistungsfähigkeit aufzudecken und PSF mit einem besonders starken Einfluss zu identifizieren. Eine Weiterführung des Benchmarkings erscheint sinnvoll, da zeitliche Veränderungen sichtbar gemacht werden können und durch eine größere Datenbasis eine Verbesserung der statistischen Auswertung und die Identifikation weiterer signifikanter PSF möglich ist. [ABSTRACT FROM AUTHOR]

When developing devices and processes, viable spores and biological indicators can be used to detect the presence of the sterilising agent. In particular, a change in the D values can provide important information. But indicators, which can only be evaluated in a laboratory after 7 days’ incubation, are not recommended for routine operations in the healthcare setting. Chemical indicators are useful for distinguishing between sterilized and unsterilized items of packaging. They are needed for the Bowie & Dick test but are not suitable for demonstrating proof of sterilization. [ABSTRACT FROM AUTHOR]

Background: Wiping is an effective and established method for decontaminating surfaces, it involves applying liquid while simultaneously removing soils. Chlorine dioxide is a high-level disinfectant that can be applied to surfaces, including those of medical devices, with the aid of mechanical action or wiping. The European Standard (EN) 16615 evaluates the microbiocidal efficacy of a chemical disinfectant when it is applied with mechanical action, i.e., when applied by wiping. It has been suggested that manual methods employing human intervention can lead to variations in a validated process. One such assumption is that variable wiping force that exists between users may influence the effectiveness of the process. Method: The average wiping force of individuals with varying physical characteristics was investigated. A bespoke testing apparatus was employed in a series of EN 16615 four-field tests, with the aim to investigate if variable wiping force between individuals impacts the microbiocidal efficacy of a chlorine dioxide-based wipe disinfectant if tested as applied as in practice. Results: Individuals applied variable forces when wiping. Physical attributes such as hand dominance and body build were shown to influence the force applied. The average wiping force calculated from this pool of participants was found to be lower than the stated range given by the EN 16615. The pre-impregnated chlorine dioxide-based wipe achieved biocidal efficacy in the series of EN 16615 tests. No trend relating to the efficacy of the product and the different forces applied could be drawn. Conclusion: The data demonstrates that individuals apply different forces to a surface when wiping. However, the variability expressed when wiping has no impact on the microbiocidal efficacy of a manually applied chlorine dioxide-based disinfectant. [ABSTRACT FROM AUTHOR]

A validated manual cleaning process is a prerequisite for effective manual chemical disinfection. Following their use, semi-critical ultrasound probes (transducers) have high loads of transmission gel contamination. Objective proof of adequate gel removal during cleaning can be provided following sample collection in a foil tube by eluting with defined volumes of ultrapure water and total organic carbon (TOC) analysis. This can also be done using a correlated ready-to-use test kit and photometric quantitative detection of carbomers. The cleaning optimization achieved with these methods, comprising the steps of wet wiping twice, swabbing the grooves with cotton tips and cleaning through elution in the foil tube, always yielded residual gel amounts of < 500 µg carbon. Based on the around 260 cm² surface area coated with gel, this was well below the warning threshold specified in DIN EN ISO 15883-5 (2020) of ≥ 6 µg carbon/ cm². Accordingly, this manual cleaning method produces a valid result in only one to two minutes, thus paving the way for effective disinfection. [ABSTRACT FROM AUTHOR]

The novel emergence of variant Creutzfeldt-Jakob disease (vCJD) in the United Kingdom in 1995/96 as a result of the transmission of bovine spongiform encephalopathy (BSE) agents from cattle to humans triggered a previously unprecedented crisis in Europe at the interface of animal health and human public health. This prompted Germany to reconsider, among other things, the practice of reprocessing medical devices with regard to the unconventional BSE/ vCJD pathogens, so-called prions (from “proteinaceous infectious particles”). In 2002, a vCJD task force set up with this objective presented recommendations for minimizing/reducing the risk of vCJD transmission through surgical instruments and other medical devices. According to these recommendations, routine reprocessing should combine at least two procedures that are also (at least partially) suitable for decontamination/inactivation of these pathogens if there is no identifiable risk of contamination with prions. In practice, this includes in particular careful cleaning (decontamination), preferably with alkaline detergents, and subsequent sterilization with moist heat (“steam sterilization”) at 134°C with a holding time of 5 minutes. The validation of the processes is of great importance. From today’s point of view, the central recommendations of the vCJD Task Force for medical device reprocessing have proven to be sustainable with good practicability. The effectiveness of the recommended measures against prions has been confirmed on a broad basis in numerous studies. In line with the paradigmatically high demands that prions place on hygiene in the reprocessing of medical devices, this effectiveness in practice extends simultaneously to conventional pathogens such as bacteria, viruses or fungi. In perspective, this also applies at least in part to potential new challenges, such as those that have been discussed for some time with regard to self-replicating protein particles of Alzheimer’s or Parkinson’s disease and other protein aggregation diseases. [ABSTRACT FROM AUTHOR]

Background: Experts in Steam Sterilization recognize the importance of configuring the vacuum system to control wet loads, but the impact has not been quantitatively demonstrated. This pilot study aims to analyse the impact of different vacuum configurations on the final volume of condensate in steam sterilized loads. Methods: Several vacuum configurations have been tested: number of vacuum pulses in the conditioning phase, vacuum depth in the conditioning phase, time delay when reaching the vacuum set in the conditioning phase, vacuum speed in the conditioning phase, and vacuum depth in the drying phase. Results: The findings showed a strong relationship with condensate formation, confirmed by Pearson Correlation Coefficients: number of pulses (-0.962), vacuum depth (0.89), time delay when reaching the vacuum set in the conditioning phase (-0.949), vacuum speed (0.969) and vacuum depth in the drying phase (0.989). The best-case scenario was characterized by 4 vacuum pulses, 50mbar vacuum depth in conditioning, 180 seconds of vacuum delay before steam injection, 283seconds (3mbar/sec) vacuum speed and 50mbar of vacuum depth in drying; resulting in an average volume of 8.7mL. All the vacuum measurements are absolute terms (0mbar means the theoretical complete absence of air). Conclusion: The configuration of the vacuum system can potentially impact the control of wet loads. [ABSTRACT FROM AUTHOR]

BICARMed® is a pre-treatment method using a pressurized sodium bicarbonate jet. We evaluate here the benefit of BICARMed® to facilitate and improve the quality of the final cleaning and compare it to the pre-treatment by immersion. After use in the operating room, the instruments are randomly divided into 2 arms. Arm A: pre-treatment with detergent-disinfectant (n=539 instruments); Arm B: pre-treatment with BICARMed® (n=555 instruments). At the end of the pre-treatment, the instruments were cleaned in a washer-disinfector (WD) and the residual contamination after cleaning was visually assessed and evaluated by a semi-quantitative colorimetric method. The percentage of soiled instruments after cleaning in the WD was on average higher in arm A (44.7%; n=241) than in arm B (19.8%; n=110) (p-value < 0.001). Contaminated areas and color intensity were also higher in arm A. The effectiveness of the bicarbonate pre-treatment improves the quality of the final cleaning. [ABSTRACT FROM AUTHOR]

The EN ISO 15883-4:2018 standard version [1] features, in addition to a description of the scope of type testing of washer-disinfectors for reprocessing thermolabile endoscopes (EWDs), the important new normative Annex H “Establishing endoscope type test groups”, which specifies how the test endoscopes to be used for type testing are to be selected. While in the previous version of this standard from 2009 [2] endoscopes had also to be used for the individual tests described, no information was given on what basis these endoscopes were to be selected. The newly published Annex H attempts to close that gap in that it describes a systematic selection procedure based on various design characteristics of the endoscopes to be declared compatible. To achieve uniform interpretation and implementation of the revised provisions of EN ISO 15883-4:2018 [1], the Type Testing EWDs working group was set up, comprising employees of manufacturing companies of EWDs, flexible endoscopes and process chemicals. The findings of the working group are being published in three parts. This second part now focuses, in particular, on Annex H by interpreting, and using examples to explain, the selection criteria used therin. A flow chart describes in detail all the steps needed for this selection procedure and gives tips on which individual endoscope design characteristics are to be used and how these can be set in relation to each other. In addition to drawing up a new list of representative test endoscopes, the publication also explains how further endoscopes from a new or already considered manufacturer are to be added to a machine that has already undergone type testing. This evaluation requires comprehensive information, which the manufacturers of the flexible endoscopes must make available to the EWD manufacturers. Therefore, this selection calls for close cooperation between the parties involved. [ABSTRACT FROM AUTHOR]

Copyright of Serbian Dental Journal / Stomatološki Glasnik Srbije is the property of National Library of Serbia and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The performance of a Central Sterile Supply Department (CSSD) is crucial for patient care. However, there is currently no standardized, data-based way to compare the performance assessment and evaluation of CSSDs. Best practices as well as any deficiencies and any needs for novel solutions could be identified by comparing performance indicators and their determining factors. A proven method for comparing processes is benchmarking. In preparation for the development of a CSSD benchmark, the question is what requirements for a CSSD benchmark can be derived based on the literature on existing benchmarks. Thirty-six journals and six databases were searched for publications on the creation of benchmarks, as well as existing benchmarks for CSSDs, hospitals or manufacturing processes. The 375 matches found were filtered by evaluating abstracts, with the remaining 71 publications examined and categorized by content. The literature review documented numerous requirements in the categories of organization, field of participants, data and criteria for comparison. The derivation of action plans was identified as a critical step. The list of requirements thus obtained allows users to evaluate CSSD benchmarks but can also be used as a basis for developing one. Building on this work, the next steps will be to compile a glossary with uniform definitions of terms, to develop tools for the implementation of CSSD benchmarks and to develop practical units of reference as an alternative to the established “sterilization unit” (StU) to capture the complexity and effort of processing per tray. [ABSTRACT FROM AUTHOR]

Single-use N95 respirators (N95) have been an invaluable component of personal protective equipment (PPE) for healthcare workers (HCW) against SARS-CoV-2. There was an urgent need to take and adapt conservation strategies to extend the useful life of N95 during worldwide shortages. This publication demonstrates the success of a mixed protocol under crisis capacity such as the COVID-19 pandemic, based on scientific evidence and standardized, validated and controlled, to certify safety and effectiveness of the N95 without adding risks to HCW. [ABSTRACT FROM AUTHOR]

Durch exakte Dokumentation des Arbeitsablaufes, beginnend mit der Nutzung eines Instrumentes bis schlussendlich der Reinigung, Verpackung, Sterilisation und Lagerung, sowie der entstehenden Kosten hinsichtlich der vorzuhaltenden Geräte, des Personals, Verbrauch von Strom, Wasser und von Verbrauchsmaterialien, können die Kosten für 1 STE im ambulanten OP-Zentrum des Projektgebers berechnet werden. Aus diesen Daten lässt sich dann analog ein excelbasiertes Berechnungstool entwickeln, in dem die analysierten Kostenarten systematisch aufgeschlüsselt, verteilt und auf einen Nenner gebracht werden. Durch Division mit den produzierten Sterilguteinheiten kann dann ein Preis für die Kosten kalkuliert werden. [ABSTRACT FROM AUTHOR]