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（由适用提供）：就经济和人道主义成本而言，与医疗保健相关的感染（HAI）是最大的可预防医疗费用。该问题的意义反映在医疗界医疗保健相关感染的350亿美元年度支出中。由于每年进行的大量程序，内窥镜与HAI爆发和聚类相比，与任何其他任何医疗设备有关。内窥镜的大多数医疗保健相关感染是由于人员未能补充复杂而乏味的后处理消毒程序而导致的。遵循适当的消毒程序的这种反复出现的问题引起了内窥镜灭菌过程的需求，该过程将通过快速，廉价的方法来提高对医疗设备中立体流明的方法的依从性。最近的研究表明，即使在经过正确的后处理和消毒的内窥镜下，也可能发生患者对患者的HAI传播。多年来，内窥镜，导管和管道等医疗设备（例如内窥镜，导管和油管）的小直径导管的灭菌已经困扰了医疗行业多年。沿着这些线路，近年来，使用各种内窥镜设备爆炸了新的微创手术技术，其中包含长流明的各种内窥镜设备，这些设备包含长时间的长流明，这些灯具极难使用传统方法刻板印象。这些昂贵的设备通常包含热敏感的胶水，光学元件或电子设备，这些胶水不耐受高压灭菌或与重新体现在医疗环境中相关的热量。在第一阶段，布莱顿的开发将探索使用创新的释放插入物来实现热敏感狭窄的狭窄的流明医疗设备（如昂贵的内窥镜）的可行性。消毒插入方法是经济的，简单且安全的，可以改善患者护理，并具有更高的无菌性水平，可验证且容易用于提高合规性。