Novel Low Temperature Sterilization Method for Flexible Endoscopes

摘要 医疗保健相关感染（HAI）是可预防的最大单一医疗成本 在经济和人道主义成本方面。这件事的主要意义 这个问题反映在每年用于医疗保健的350亿美元支出上 医学界的相关感染。由于大量的程序 内窥镜与更多的HAI爆发和集群相关， 任何其他单一医疗器械。 大多数与医疗保健相关的内窥镜感染都是由于 人员遵守复杂和繁琐的再处理消毒 程序.这种反复出现的问题，遵循适当的消毒程序， 需要一种内窥镜消毒方法， 使用快速、廉价的方法对狭窄管腔进行灭菌， 医疗器械最近的研究表明，患者间HAI 即使对内窥镜进行了适当的再处理和消毒，也可能发生传播。 医疗器械（如内窥镜）中小直径导管的灭菌， 导管和管道已经困扰医疗行业多年。沿着这些路线， 近年来，新的微创手术技术迅速发展， 多年来使用各种内窥镜器械，这些器械包含长管腔， 难以使用传统方法消毒。这些昂贵的设备通常包含 不耐受高压灭菌或加热的热敏胶、光学器件或电子器件 与医疗环境中的再灭菌相关。 布莱顿开发公司成功地实现了第一阶段的所有可行性目标， 导致开发了一种用于消毒内窥镜的创新方法， 其他狭窄管腔装置。安全有效的方法使用我们的新型灭菌剂- 释放插入物以实现热敏外科装置的快速消毒 昂贵的内窥镜第一阶段开发的灭菌插入方法简单， 安全，经济，并将改善患者护理，高水平的无菌性， 与繁琐的消毒清洁方法相比， 目前在医院使用。2018年10月，我们获得了美国专利#10，092，667， 涵盖了将用于低温由内而外的核心灭菌剂技术 内窥镜的消毒。在低温条件下，该过程不会 损坏用于制造内窥镜的热敏材料。 在第二阶段，我们将开发所需的备份数据以满足FDA的要求， 将这种用于内窥镜的由内而外的灭菌方法商业化， 以十二指肠镜为模型。具体目标和商业化计划，在此， 详细概述了FDA成功引入该产品所需的步骤， 技术进入市场，使用简单的由内而外的消毒方法， 这在第一阶段被证明是可行的。

ABSTRACT Healthcare-associated infections (HAI) are the single largest preventable medical cost in terms of both economic and humanitarian cost. The major 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 associated 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 medical environment. Brighton Development successfully met all the feasibility goals of Phase I that resulted in the development of an innovative method for sterilizing endoscopes and other narrow lumen devices. The safe efficient method uses our novel sterilant- releasing insert to achieve quick sterilization of heat sensitive surgical devices such as expensive endoscopes. The sterilizing insert method developed in Phase I is simple, safe, and economical and will improve patient care with a high level of sterility that is verifiable and easy-to-use compared to the cumbersome disinfection cleaning methods currently used in hospitals. In October 2018 we received US Patent # 10,092,667, which covers the core sterilant technology that will be used for the low temperature inside-out sterilization of endoscopes. Under the low temperature conditions, this process will not damage the heat-sensitive materials used to fabricate endoscopes. In Phase II, we will develop the required backup data to meet the FDA requirements to commercialize this inside-out sterilization method for endoscopes using the duodenoscope as the model. The Specific Aims and Commercialization Plan, herein, outline in detail the FDA steps required to achieve the successful introduction of this technology into the marketplace using the simple inside-out sterilization method, which was proven feasible in Phase I.