Novel Low Temperature Sterilization Method for Flexible Endoscopes

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.Narrative The overall national cost of healthcare associated infections (HAI) in the United States is estimated to be between $20 to 45 billion per year. More health care associated infections are attributed to endoscopes than any other single medical device due to the fact that endoscopes and other narrow lumen medical devices are difficult and expensive to sterilize. The current margin of safety associated with reprocessing endoscopes is minimal. In our Phase I feasibility study we successfully developed a simple inside-out method for sterilizing endoscopes by using our novel sterilant polymer technology. It is the ultimate goal of this Phase II research, to generate the required supporting data to commercialize this development for endoscopes by continuing our interaction with the FDA to achieve FDA approval for this development. Upon FDA approval, this inside-out method of sterilization will provide an inexpensive low temperature sterilization technique that can be used safely with plastic endoscopic devices that cannot be currently autoclaved due to melting of the plastic components used to fabricate the endoscope. The novel inside-out sterilization method will, also reduce the cost to the US health care system from nosocomial infection, save lives, and improve patient care.