Cost analysis of machine and manual reprocessing of transvaginal ultrasound probes.

Objective: 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. Methods: 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. Results: 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. Conclusion: 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).