Raval Krutik Vipulbhai, Chaudhari Rajeev, Khant Shahil Rameshbhai, Joglekar Omkar, Patel Dipen
Department of Urology, Ruby Hall Clinic, Pune, Maharashtra, India.
Urol Ann. 2017 Apr-Jun;9(2):117-124. doi: 10.4103/UA.UA_167_16.
Healthcare is expensive for a large proportion of the population in spite of high per capita income and good health insurance penetration. In an effort to reduce cost of the procedure, reprocessing of devices was started in the late 1970s. Reprocessing practice includes various measures such as proper cleaning, disinfection, and sterilization procedures. As reprocessing is aimed at reducing cost, there is a potential risk of compromising patient safety due to cross contamination after inadequate sterilization. There is also risk of performance alteration of urological reprocessed devices during sterilization/disinfection processing. Therefore, there is a need for formulating proper guidelines to decide methods of reprocessing for various urological equipment. There is also need to discuss the problematic areas that urologists face and to find their solutions. A PubMed search was made in September 2016, using key words "reprocessing of medical devices," "Single Use Devices," "methods of reprocessing of devices in clinical practice," "use of formalin chamber," "urological disposable sterilization," etc., After excluding duplicates, all English articles were reviewed by title and abstract. Full texts of selected articles were obtained, and these articles were cross-referenced to find any other related articles. All the articles were reviewed. A product can be reused if it can be economically reprocessed with validated protocols with preservation of its function. There is no reason to discard it after one use. This practice is useful for controlling economics of a urological case and to reduce the financial burden. Current Food and Drug Administration guidelines are stringent. The contamination described to test the sterilization process in the suggested guidelines actually does never exist in clinical practice. Therefore, new guidelines considering the clinical practice scenario are desirable.
尽管人均收入较高且医疗保险普及率良好,但医疗保健对于很大一部分人口来说仍然昂贵。为了降低手术成本,20世纪70年代末开始了设备的再处理。再处理实践包括各种措施,如适当的清洁、消毒和灭菌程序。由于再处理旨在降低成本,因此存在因灭菌不充分后交叉污染而危及患者安全的潜在风险。在灭菌/消毒过程中,泌尿外科再处理设备也存在性能改变的风险。因此,需要制定适当的指南来确定各种泌尿外科设备的再处理方法。还需要讨论泌尿外科医生面临的问题领域并找到解决方案。2016年9月进行了PubMed搜索,使用关键词“医疗器械的再处理”、“一次性使用设备”、“临床实践中设备的再处理方法”、“福尔马林腔的使用”、“泌尿外科一次性灭菌”等。排除重复项后,所有英文文章都通过标题和摘要进行了审查。获取了所选文章的全文,并对这些文章进行交叉引用以查找任何其他相关文章。对所有文章进行了审查。如果一种产品可以通过经过验证的方案进行经济地再处理并保持其功能,那么它就可以重复使用。没有理由在使用一次后就丢弃它。这种做法对于控制泌尿外科病例的经济性和减轻经济负担很有用。目前美国食品药品监督管理局的指南很严格。建议指南中描述的用于测试灭菌过程的污染在临床实践中实际上从未存在过。因此,需要考虑临床实践情况的新指南。