Novel Low Temperature Sterilization Method for Flexible Endoscopes

软性内窥镜低温灭菌新方法

• 批准号: 9907419
• 负责人: Joel L Williams
• 金额: $ 52.19万
• 依托单位: BRIGHTON DEVELOPMENT, LLC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-03-01 至 2021-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9907419
• 关键词: Achievement; Affect; Area; Biological; Caliber; Catheters; Communities; Consumption; Data; Development; Devices; Disease Outbreaks; Disinfection; Documentation; Duodenoscopes; Economics; Electronics; Elevator; Endoscopes; Environment; Equipment; Expenditure; Explosion; Failure; Feasibility Studies; Formaldehyde; Gases; Germicide; Glues; Goals; Hazardous Chemicals; Health Care Costs; Healthcare Systems; Hospitals; Hour; Human Resources; Incubators; Industry; Laparoscopes; Legal patent; Liquid substance; Medical; Medical Care Costs; Medical Device; Methods; Modeling; Nosocomial Infections; Operative Surgical Procedures; Optics; Oxides; Partner in relationship; Patient Care; Patients; Performance; Phase; Polymers; Procedures; Process; Product Approvals; Research; Rod; Safety; Side; Sterility; Sterilization; Surface; Surgical Instruments; System; Techniques; Technology; Temperature; Time; United States; United States National Institutes of Health; Validation; Work; carbene; cold temperature; commercialization; controlled release; cost; delrin; design; disease transmission; flexibility; healthcare-associated infections; improved; innovation; instrument; meetings; melting; minimally invasive; non-compliance; novel; phase 1 study; procedure safety; programs; statistics; success; transmission process; validation studies

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.

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。这一点的重大意义 这个问题反映在每年350亿美元的医疗支出上 医学界的相关感染。由于程序繁多， 每年进行的内窥镜检查与更多的HAI暴发和聚集性有关 任何其他单一的医疗器械。 大多数医疗保健相关的内窥镜感染都是由失败引起的 人员遵守复杂繁琐的后处理消毒 程序。遵循适当的消毒程序的这个反复出现的问题已经造成 需要一种内窥镜灭菌过程，以提高对 用一种快速、廉价的方法对狭窄的管腔进行再处理 医疗器械。最近的研究证明，患者之间的HAI 即使使用经过适当再处理和消毒的内窥镜，也可能发生传播。 内窥镜等医疗设备中小直径导管的灭菌， 导管和管子多年来一直困扰着医疗行业。沿着这些思路， 近年来，出现了许多新的微创外科技术。 多年来使用各种内窥镜设备，这些设备包含的长腔非常 用传统方法难以灭菌。这些昂贵的设备通常包含 不耐高压灭菌或加热的热敏胶、光学器件或电子产品 与医疗环境中的再消毒有关。 Bright ton Development成功地实现了第一阶段的所有可行性目标 导致了一种创新的内窥镜消毒方法的开发， 其他狭窄管腔装置。安全有效的方法使用我们的新型消毒剂- 释放插入物以实现热敏外科设备的快速灭菌，例如 昂贵的内窥镜。在阶段I中开发的灭菌插入方法很简单， 安全、经济，并将改善患者护理，实现高水平的无菌 与繁琐的消毒清洁方法相比，可验证且易于使用 目前在医院使用。2018年10月，我们获得了美国专利#10092667，其中 涵盖将用于由内而外低温的核心灭菌技术 内窥镜的消毒。在低温条件下，这一过程不会 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 将这种内窥镜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FDA为实现成功引入这一目标所需的步骤 技术进入市场，使用简单的内向外灭菌法， 这在第一阶段被证明是可行的。