Novel Low Temperature Sterilization Method for Flexible Endoscopes

Brighton Development, Llc, Cary NC

Investigators

Abstract

? 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.