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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：
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.

摘要