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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：
9139576
负责人：
Joel L Williams
金额：
$ 19.88万
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 2016-10-25
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9139576
关键词：
Accounting Affect Area Biological Caliber Capital Catheters Chemicals Communities Data Development Devices Disease Outbreaks Disinfection Duodenoscopes Economics Electronics Elevator Endoscopes Environment Environmental Monitoring Equipment Ethylene Oxide Evaluation Expenditure Explosion Failure Feasibility Studies Formaldehyde Gases Germicide Glues Goals Hazardous Chemicals Health Care Costs Healthcare Healthcare Systems Heating Hospitals Hour Human Resources Incubators Industry Infection Laparoscopes Liquid substance Marketing Medical Medical Device Methods Nosocomial Infections Operative Surgical Procedures Optics Oxides Partner in relationship Patient Care Patients Performance Phase Plague Polymers Procedures Process Research Residual state Safety Side Sterility Sterilization Surface Surgical Instruments System Techniques Technology Temperature Time United States Validation carbene cold temperature controlled release cost delrin design disease transmission flexibility improved innovation instrument minimally invasive non-compliance novel phase 1 study pressure programs prototype public health relevance retinal rods statistics success transmission process validation studies

项目摘要

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.

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) 是最大的可预防医疗成本。这个问题的严重性体现在医学界每年 350 亿美元用于医疗保健相关感染的支出。由于每年进行大量手术，内窥镜比任何其他单一医疗设备都与更多的 HAI 爆发和集群相关。大多数与内窥镜相关的医疗保健相关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。遵循正确的消毒程序这一反复出现的问题产生了对内窥镜灭菌过程的需求，该过程将通过快速、廉价的方法对医疗器械中的狭窄内腔进行灭菌，从而提高对再处理程序的遵从性。最近的研究表明，即使内窥镜经过适当的再处理和消毒，患者之间的 HAI 传播也可能发生。内窥镜、导管和管材等医疗器械中小直径导管的灭菌多年来一直困扰着医疗行业。沿着这些思路，近年来出现了新的微创手术技术的爆炸式增长，使用各种内窥镜设备，这些设备包含使用传统方法极难消毒的长管腔。这些昂贵的设备通常包含热敏胶水、光学器件或电子器件，无法承受高压灭菌器或医疗环境中与重新灭菌相关的热量。在第一阶段，布莱顿开发公司将探索使用创新的灭菌剂释放插件来实现热敏窄腔医疗器械（例如昂贵的内窥镜）快速灭菌的可行性。灭菌插件方法经济、简单、安全，可通过可验证且易于验证的更高无菌水平来改善患者护理用于提高合规性。