Apparatus and methods for hygiene testing a medical device
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Solution Overview
Problem
Current methods for cleaning and sterilizing endoscopes are inadequate, leading to residual contamination and patient infections due to the difficulty in accessing and assessing the cleanliness of narrow, elongated passageways within these medical devices.
Innovation Solution
A sampling system utilizing a fluid supply system that delivers a sterile sampling liquid and compressed air as a two-phase flow through the endoscope's channels, combined with a receiving container to collect and analyze the fluid for contamination, including the use of surfactants to dislodge bacteria like Enterococcus faecalis and Pseudomonas aeruginosa, and a brush or swab mechanism for direct sampling of channel surfaces.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual cleaning and liquid disinfectants are used to clean endoscope channels, then the cleaning process is simple to perform, but the cleaning effectiveness is insufficient and residual contamination remains
Solution Approach 1:
The patent applies two-phase flow (combining gas and liquid) to clean the endoscope channels. Compressed gas and liquid disinfectant are introduced simultaneously through the channels, creating turbulent flow that mechanically disrupts and removes biofilm and contaminants more effectively than liquid alone, while still being operable by standard cleaning personnel
Solution Approach 2:
The patent employs ultrasonic vibration to enhance the cleaning process. Ultrasonic energy is applied to the cleaning solution or directly to the channels, creating cavitation and mechanical vibration that dislodge adherent biofilm and contaminants, significantly improving cleaning effectiveness without requiring complex manual procedures
2Reliability
If high temperature steam sterilization is used, then sterilization effectiveness is high, but it cannot be applied due to the construction and materials of modern endoscopes
Solution Approach 1:
The patent changes the physical and chemical parameters of the sterilization process by using chemical disinfectants (such as glutaraldehyde, ortho-phthalaldehyde, hydrogen peroxide) at controlled temperatures and concentrations, replacing the high-temperature steam process. This allows achieving sterilization or high-level disinfection without exposing heat-sensitive endoscope materials to damaging temperatures
Solution Approach 2:
The patent uses two-phase flow of gas and liquid disinfectant to deliver the chemical sterilizing agents through the endoscope channels. The gas phase enhances penetration and distribution of the liquid disinfectant, ensuring thorough contact with all channel surfaces while maintaining compatible temperatures for the endoscope materials
3Ease of operation
If the narrow cross-sectional size of internal tubing channels is considered, then the endoscope can access confined passageways, but fundamental difficulties arise in cleaning and sterilizing these channels
Solution Approach 1:
The patent utilizes two-phase flow where compressed gas and liquid disinfectant are introduced together through the narrow channels. The gas phase provides driving force and creates turbulent flow patterns that enhance the mechanical removal of contaminants, while the liquid phase provides the chemical disinfecting action, overcoming the limitations of narrow channel geometry
Solution Approach 2:
The patent applies ultrasonic vibration to create cavitation bubbles and mechanical oscillations within the narrow channels. This vibration energy disrupts biofilm structures and enhances the penetration of disinfectant solutions into difficult-to-reach areas, making the narrow channels cleanable despite their restricted geometry
4Ease of operation
If current cleaning techniques are used, then the cleaning process can be performed, but there are no reliable methods to detect or assess the cleanliness or residual contamination levels
Solution Approach 1:
The patent incorporates feedback mechanisms by collecting the effluent from the cleaning process and analyzing it for residual contaminants, bioburden, and biofilm components. This feedback information is used to assess whether the cleaning process has been effective and to determine if additional cleaning cycles are needed, transforming an open-loop process into a closed-loop quality control system
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This method provides a reliable and reproducible means to assess the cleanliness of endoscopes, effectively removing and detecting residual contaminants, thereby reducing the risk of patient infection and ensuring the safety of medical devices for reuse.
Implementation Method 1
supplying a sampling liquid for flowing through the channels of said endoscope... as part of a two-phase flow
Implementation Method 2
said sampling liquid comprises an amount and selection of surfactant effective to enhance the dislodgement of Enterococcus faecalis and Pseudomonas aeruginosa bacteria
Data Source
AI summary
Provided among other things is a sampling system for determining an amount or type of contamination a narrow, elongated passageway in a medical device, said sampling system comprising: (a) a fluid supply system that supplies to said passageway a sampling liquid for flowing through said passageway and a gas for flowing through said passageway; and (b) a receiving container that receives liquid from said passageway, wherein said sampling liquid is sterile, wherein said sampling liquid is configured to allow recovery of viable pathogens from the passageway, and wherein said sampling liquid comprises an amount and selection of surfactant effective to enhance the dislodgement of Enterococcus faecalis and Pseudomonas aeruginosa bacteria from the narrow passageways.