Novel Low Temperature Sterilization Method for Flexible Endoscopes

 描述(由申请人提供)：就经济和人道主义成本而言，医疗保健相关感染(HAI)是最大的可预防的医疗成本。这个问题的重要性反映在医学界每年用于医疗保健相关感染的350亿美元支出中。由于每年进行的手术数量很多，内窥镜比任何其他单一的医疗设备都与更多的HAI爆发和聚集性有关。大多数医疗保健相关的内窥镜感染是由于工作人员未能遵守复杂而繁琐的后处理消毒程序造成的。遵循适当的消毒程序的这种反复出现的问题产生了对内窥镜灭菌过程的需求，该内窥镜灭菌过程将利用快速、廉价的方法来灭菌医疗器械中的窄腔，从而改善对后处理过程的遵从性。最近的研究证明，即使使用适当的再处理和消毒的内窥镜，也可能发生人与人之间的甲型HAI传播。内窥镜、导管和管子等医疗器械中小直径导管的灭菌问题多年来一直困扰着医疗行业。沿着这些思路，近年来出现了大量新的微创手术技术，使用各种内窥镜设备，这些设备包含用传统方法极难消毒的长腔。这些昂贵的设备通常包含热敏胶、光学器件或电子设备，它们不能耐受高压灭菌或与Medica环境中的重新灭菌相关的热量。在第一阶段，Bright ton Development将探索使用创新的灭菌剂释放插件来实现对昂贵的内窥镜等热敏性窄腔医疗设备的快速灭菌的可行性。消毒插入方法是经济、简单和安全的，并将以可验证和容易的更高水平的无菌来改善患者的护理 使用以提高合规性。

 DESCRIPTION (provided by applicant): Healthcare-associated infections (HAI) are the single largest preventable medical cost in terms of both economic and humanitarian cost. The significance of this problem is reflected in the $35-billion annual expenditure made for healthcare associated infections in the medical community. Due to the large number of procedures done each year, endoscopes are associates with more HAI outbreaks and clusters than any other single medical device. The majority of healthcare associated infections from endoscopes result from the failure of personnel to comply with complicated and tedious reprocessing disinfection procedures. This recurring problem to follow proper disinfection procedures has created a need for an endoscope sterilization process that will improve compliance with reprocessing procedures with a fast, inexpensive method to sterilize narrow lumens in medical devices. Recent studies have documented that patient-to-patient HAI transmission could occur even with properly reprocessed and disinfected endoscopes. Sterilization of small diameter conduits in medical devices such as endoscopes, catheters, and tubing has plagued the medical industry for years. Along these lines, there has been an explosion of new minimally invasive surgical techniques in recent years using various endoscopic devices that contain long lumens that are extremely difficult to sterilize using traditional methods. These expensive devices often contain heat sensitive glues, optics, or electronics that will not tolerate autoclave or heat associated with re-sterilization in the medica environment. In Phase I Brighton Development will explore the feasibility of using an innovative sterilant-releasing insert to achieve the rapid sterilization of heat sensitive narrow lumen medica devices such as expensive endoscopes. The sterilizing insert method is economical, simple, and safe and will improve patient care with a higher level of sterility that is verifiable and easy to- use for improved compliance.