Kiefner Denise, Benkhai Hicham, Lemanski Sandra, Thanheiser Marc, Kramer Axel
Institute of Hygiene and Environmental Medicine, University Medicine Greifswald, Greifswald, Germany.
Department of Psychology, Chair of Health and Prevention, University of Greifswald, Greifswald Germany.
GMS Hyg Infect Control. 2024 Nov 5;19:Doc56. doi: 10.3205/dgkh000511. eCollection 2024.
This study aims to provide additional support for the equipment needed in hospitals and medical practices for reprocessing transvaginal ultrasound probes (TVUS) through an economic analysis comparing manual and automated reprocessing methods. A questionnaire survey was also conducted in hospitals and medical practices to analyze the current practice of TVUS reprocessing.
The economic analysis compared four manual reprocessing methods using disinfection wipes and one automated device-based disinfection method using hydrogen peroxide vapor. The working times were measured with a stopwatch and complemented by passive working time (disinfection exposure time or machine cycle duration). The personnel costs for the working time were calculated and combined with the calculated acquisition and material costs to determine the total process costs.
The economic analysis revealed that machine disinfection is not only time-saving but also more cost-effective per reprocessing cycle compared to two manual methods using wipes for cleaning and disinfection, where the disinfectant is applied to the wipe before use. However, two methods using ready-to-use (rtu) disinfection wipes from a container were more cost-effective. It is important to note that all wipe disinfection methods would incur additional costs due to the lack of validation. The additional costs for validation could not be calculated due to a lack of experience, making a final cost assessment for wipe disinfection methods currently impossible.Despite extensive efforts to send the survey to hospitals and medical practices through three professional societies and attempts to acquire participants via a publication, only 35 institutions participated. Except for one case, all reprocessed manually. The survey revealed a deficit in knowledge regarding TVUS reprocessing. Manual reprocessing had not been validated despite national legal requirements existing since 2002.
As long as manual reprocessing is not validated in all steps, only machine reprocessing is ethically acceptable for patient safety. Even if manual wipe disinfection is validated, machine reprocessing offers higher patient safety, since deviations from the validated SOP cannot be excluded during manual execution. Machine reprocessing should always be preferred for occupational safety reasons.Since the process costs for methods involving the application of the disinfectant to the wipe before disinfection were higher than for the machine method, the latter is preferred in this comparison. It is not possible to determine whether the overall process is economically superior to machine reprocessing because the cost calculation for rtu disinfection wipes does not include the entire process of reprocessing, including the legally required validation. Due to the better standardization of the machine reprocessing process, along with increased procedural, worker, and patient safety, machine reprocessing should be preferred regardless of process costs, especially if the economic difference is not significant. Additionally, avoiding disposable wipes is beneficial in terms of sustainability.The lack of knowledge regarding national legal requirements and recommendations for TVUS reprocessing is a reason why the principles of reprocessing were not adhered to in several practices. Therefore, it is necessary to convey the basic knowledge of reprocessing during medical studies, followed by further training during specialization. Persons tasked with reprocessing must have the required education or participate in specialized training to demonstrate current knowledge (§ 8 Sect. 7 Medical Device Regulation).
本研究旨在通过对经阴道超声探头(TVUS)手动和自动再处理方法进行经济分析,为医院和医疗诊所再处理TVUS所需设备提供更多支持。还对医院和医疗诊所进行了问卷调查,以分析TVUS再处理的当前做法。
经济分析比较了四种使用消毒湿巾的手动再处理方法和一种使用过氧化氢蒸汽的基于设备的自动消毒方法。用秒表测量工作时间,并辅以被动工作时间(消毒暴露时间或机器周期持续时间)。计算工作时间的人员成本,并与计算出的购置成本和材料成本相结合,以确定总流程成本。
经济分析表明,与两种在使用前将消毒剂应用于湿巾进行清洁和消毒的手动方法相比,机器消毒不仅节省时间,而且每个再处理周期更具成本效益。然而,两种使用从容器中取出的即用型(rtu)消毒湿巾的方法更具成本效益。需要注意的是,由于缺乏验证,所有湿巾消毒方法都会产生额外成本。由于缺乏经验,无法计算验证的额外成本,因此目前无法对湿巾消毒方法进行最终成本评估。尽管通过三个专业协会向医院和医疗诊所广泛发送了调查问卷,并试图通过出版物招募参与者,但只有35个机构参与。除了一个案例外,所有机构都是手动再处理。调查显示在TVUS再处理方面存在知识不足。尽管自2002年以来就有国家法律要求,但手动再处理尚未得到验证。
只要手动再处理的所有步骤未经验证,从患者安全的角度来看,只有机器再处理在伦理上是可接受的。即使手动湿巾消毒得到验证,机器再处理也能提供更高的患者安全性,因为在手动执行过程中无法排除偏离已验证标准操作规程的情况。出于职业安全原因,应始终优先选择机器再处理。由于在消毒前将消毒剂应用于湿巾的方法的流程成本高于机器方法,因此在这种比较中后者更受青睐。由于rtu消毒湿巾的成本计算不包括再处理的整个过程,包括法律要求的验证,因此无法确定整体流程在经济上是否优于机器再处理。由于机器再处理过程的标准化程度更高,同时提高了程序、工作人员和患者的安全性,无论流程成本如何,都应优先选择机器再处理,特别是如果经济差异不显著。此外,从可持续性角度来看,避免使用一次性湿巾是有益的。对TVUS再处理的国家法律要求和建议缺乏了解,是一些诊所未遵守再处理原则的一个原因。因此,有必要在医学学习期间传授再处理的基本知识,随后在专科培训期间进行进一步培训。负责再处理的人员必须接受所需的教育或参加专门培训,以证明其具备当前知识(《医疗器械法规》第8节第7条)。