Schaal Tom, Schmelz Ulrich, Pitten Frank-Albert, Tischendorf Tim
Faculty of Health and Healthcare Sciences, University of Applied Sciences Zwickau, Zwickau, Germany.
University of Fulda, Fulda, Germany.
Sci Rep. 2025 Jun 2;15(1):19311. doi: 10.1038/s41598-025-03364-2.
Cold atmospheric plasma-aerosol (CAP-A) offers a promising alternative to conventional sterilisation and disinfection methods, which are often unsuitable for thermolabile medical devices due to high temperatures, toxic chemicals or radiation. CAP-A efficiently inactivates microorganisms and viruses without compromising the material integrity. Given the ongoing risk of infection associated with ultrasound probes and other delicate diagnostic instruments, this study investigates whether an indirect CAP-A method can meet all requirements for effective and safe disinfection of thermolabile medical devices. The disinfection of thermolabile medical devices was carried out in a container saturated with indirect CAP-A. A transvaginal ultrasound probe was used as a reference product. The study involved six test organisms, with five measurements taken at six different measurement points. The study showed that Enterococcus hirae (mean logarithmic reduction factor (LRF) > 6.23), Staphylococcus aureus (mean LRF > 6.51), and Enterococcus faecium (mean LRF > 6.16) demonstrated a germ reduction of > 99.9999%. For Pseudomonas aeruginosa (mean LRF > 5.40) and Escherichia coli (mean LRF > 5.29), a germ reduction of > 99.999% was achieved, and for Candida albicans (mean LRF > 4.95) and Clostridioides difficile (mean LRF > 4.62), a germ reduction of > 99.99% was demonstrated. The log reduction demonstrates a complete inactivation of the six tested microorganisms. The initially defined requirements for an effective disinfection process for thermolabile medical devices were met in the CAP-A method. Regarding highly tenacious microorganisms, such as Clostridioides difficile, the method of CAP-A proved effective, superior to alcohol-based methods, and with no resistance development observed. Its efficacy is otherwise only known in corrosive chemicals, such as hydrogen peroxide, chlorine, and chlorine dioxide. However, these chemicals have corrosive-oxidative effects on the surfaces to be disinfected and are critical in terms of market launch and hazardous material classification. Therefore, the method of CAP-A, provides an effective, material-friendly alternative.
冷大气等离子体气溶胶（CAP-A）为传统的灭菌和消毒方法提供了一种有前景的替代方案，传统方法由于高温、有毒化学物质或辐射，往往不适用于热敏性医疗设备。CAP-A能有效灭活微生物和病毒，同时不损害材料完整性。鉴于超声探头和其他精密诊断仪器存在持续的感染风险，本研究调查了间接CAP-A方法是否能满足热敏性医疗设备有效且安全消毒的所有要求。热敏性医疗设备的消毒在充满间接CAP-A的容器中进行。使用经阴道超声探头作为参考产品。该研究涉及六种测试微生物，在六个不同测量点进行了五次测量。研究表明，平肠球菌（平均对数减少因子（LRF）> 6.23）、金黄色葡萄球菌（平均LRF > 6.51）和粪肠球菌（平均LRF > 6.16）的杀菌率> 99.9999%。对于铜绿假单胞菌（平均LRF > 5.40）和大肠杆菌（平均LRF > 5.29），杀菌率> 99.999%，对于白色念珠菌（平均LRF > 4.95）和艰难梭菌（平均LRF > 4.62），杀菌率> 99.99%。对数减少表明六种测试微生物完全失活。CAP-A方法满足了最初为热敏性医疗设备有效消毒过程定义的要求。对于高度顽强的微生物，如艰难梭菌，CAP-A方法被证明是有效的，优于基于酒精的方法，且未观察到耐药性产生。其有效性仅在腐蚀性化学物质中已知，如过氧化氢、氯和二氧化氯。然而，这些化学物质对要消毒的表面有腐蚀氧化作用，在市场推出和危险物质分类方面至关重要。因此，CAP-A方法提供了一种有效、对材料友好的替代方案。
