# Novel Low Temperature Sterilization Method for Flexible Endoscopes

> **NIH NIH R44** · BRIGHTON DEVELOPMENT, LLC · 2021 · $469,708

## Abstract

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.

## Key facts

- **NIH application ID:** 10084252
- **Project number:** 5R44AI122405-03
- **Recipient organization:** BRIGHTON DEVELOPMENT, LLC
- **Principal Investigator:** Joel L Williams
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $469,708
- **Award type:** 5
- **Project period:** 2016-03-01 → 2022-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10084252

## Citation

> US National Institutes of Health, RePORTER application 10084252, Novel Low Temperature Sterilization Method for Flexible Endoscopes (5R44AI122405-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10084252. Licensed CC0.

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