Novel Low Temperature Sterilization Method for Flexible Endoscopes

软性内窥镜低温灭菌新方法

基本信息

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
项目类别：
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

项目摘要

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.

抽象的医疗保健相关感染 (HAI) 是最大的可预防医疗成本就经济和人道主义成本而言。此举的重大意义每年 350 亿美元的医疗保健支出反映了这个问题医学界的相关感染。由于手续较多每年，内窥镜与更多的 HAI 爆发和集群相关任何其他单一医疗设备。大多数与内窥镜相关的医疗保健相关感染都是由于内窥镜故障造成的人员进行复杂而繁琐的后处理消毒程序。遵循适当的消毒程序这一反复出现的问题已经造成需要一种内窥镜灭菌工艺来提高合规性使用快速、廉价的方法对狭窄管腔进行再处理程序医疗设备。最近的研究表明，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。医疗器械中小直径导管的灭菌，例如内窥镜、导管和管材多年来一直困扰着医疗行业。沿着这些思路，近年来，新的微创手术技术呈爆炸式增长多年来使用各种包含长管腔的内窥镜设备使用传统方法很难消毒。这些昂贵的设备通常包含不耐受高压灭菌器或高温的热敏胶水、光学器件或电子器件与医疗环境中的重新灭菌相关。布莱顿开发项目成功实现了第一阶段的所有可行性目标开发了一种创新的内窥镜消毒方法其他窄管腔装置。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感手术器械的快速灭菌，例如昂贵的内窥镜。一期开发的灭菌插入方法简单，安全、经济，并将通过高度无菌改善患者护理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号 10,092,667，该专利涵盖了将用于低温由内而外的核心灭菌剂技术内窥镜的灭菌。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 的要求将这种由内向外的内窥镜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 成功引入该技术所需的步骤使用简单的由内向外灭菌方法的技术进入市场，这在第一阶段被证明是可行的。