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.

Public Health Relevance

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. It is the ultimate goal of this research to develop an inexpensive low temperature sterilization technique for lumen devices that can help reduce the cost to the US health care system from nosocomial infection, save lives, and improve patient care.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43AI122405-01A1
Application #
9139576
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Ernst, Nancy Lewis
Project Start
2016-03-01
Project End
2016-10-25
Budget Start
2016-03-01
Budget End
2016-10-25
Support Year
1
Fiscal Year
2016
Total Cost
Indirect Cost
Name
Brighton Development, LLC
Department
Type
DUNS #
118349872
City
Cary
State
NC
Country
United States
Zip Code
27513