# Improved cleaning technology for reducing risk of transmitting infection in endoscopy.

> **NIH NIH R44** · ADVANCED BIODEVICES, LLC · 2020 · $993,073

## Abstract

7. Project Summary/Abstract:
Outbreaks of infection caused by contaminated endoscopes are a serious public health problem that has even resulted
in patient deaths. Currently, because of the narrowness of the channels and complexity of the endoscope, there simply
is no reliable way of achieving this. The existing cleaning protocols also are highly dependent on operator technique.
Accordingly, this is an urgent public health problem.
 The work in Phase I has demonstrated that cleaning can be achieved by flowing, through endoscope channels, a
new material based on safe nanofibers in an aqueous composition. The new material forms a highly‐entangled network.
The Phase I study included testing with soils containing live bacteria, and various types of biofilm. This work included
testing many compositions, including variations of both the entangled material and the aqueous composition. The work
included investigating the characteristics and manufacturing processes of this new material, formulating the aqueous
composition, and determining the operating parameters for the cleaning process, including adaptations for different
diameters of channels. Several new methods were developed and used for recovering, sampling, detecting and
quantitating bacteria and organic materials. It has been shown that the flowing composition can effectively scrape and
remove biofilm, even build‐up biofilm, from the walls of the channels of all endoscope‐relevant sizes, even in channels
that are too narrow to brush. It has also been shown that this composition can be fully rinsed from the channels and
that it does not clog the endoscope. The results demonstrated that channels that have been cleaned by the new
technology are essentially indistinguishable from tubing that has never been exposed to bacteria or biofilm. Such
effective cleaning has never before been achieved in endoscope reprocessing.
 Phase II is intended to move this NanoClean technology from these current laboratory results to a point that is
close to commercialization. Phase II will involve developing a robust clinician‐usable system for delivering the cleaning
composition to endoscopes. It will involve scaling up procedures for manufacturing the new nanofiber‐based material
and the overall cleaning composition because it will be necessary to manufacture these in significantly large batch sizes
in a GMP environment. Packaging of the composition for use will also be investigated. Stability and shelf life will be
tested with a target value of one year. Phase II will involve simulated testing in actual endoscopes to compare
NanoClean against current manufacturer‐prescribed cleaning methods for three types of endoscopes (gastroscopes,
colonoscopes and duodenoscopes) from the three major manufacturers (Olympus, Pentax and Fujinon). Phase II will also
include assessing the NanoClean technology with patient‐used endoscopes in an endoscopy facility, and comparing the
NanoClean to manufacturer‐prescribed cleaning methods....

## Key facts

- **NIH application ID:** 9959313
- **Project number:** 5R44AI132040-04
- **Recipient organization:** ADVANCED BIODEVICES, LLC
- **Principal Investigator:** MOHAMED E LABIB
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $993,073
- **Award type:** 5
- **Project period:** 2017-03-02 → 2021-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9959313

## Citation

> US National Institutes of Health, RePORTER application 9959313, Improved cleaning technology for reducing risk of transmitting infection in endoscopy. (5R44AI132040-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9959313. Licensed CC0.

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