Medical Device Cleaning Composition With EDTA Chelator
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Solution Overview
Problem
Current cleaning and disinfection processes for medical devices, such as endoscopes, are often ineffective due to the presence of organic material, which can harbor microbes and inactivate disinfectants, highlighting the need for a safe, practical, and efficient cleaning composition and method.
Innovation Solution
A cleaning composition comprising ethylenediaminetetraacetic acid (EDTA) as a chelator, a buffer system of potassium phosphate dibasic and sodium hydroxide, diethyl glycol monoethyl ether as a cleaner, propylene glycol as a solubilizer, and water as a diluent, with a pH of at least 9.5, effectively removes foreign matter and prepares medical devices for disinfection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional cleaning compositions are used, then the cleaning process is simple, but the cleaning effectiveness is insufficient due to organic material harboring microbes and inactivating disinfectants
Solution Approach 1:
The cleaning composition performs preliminary action by including EDTA as a chelator that binds to metal ions in organic material, and uses alkaline protease to break down protein-based soils before disinfection. This pre-treatment removes the barrier that would otherwise protect microbes from disinfectants, ensuring subsequent disinfection effectiveness without requiring complex multi-step processes.
Solution Approach 2:
The invention uses a composite cleaning composition that integrates multiple functional components: EDTA (chelator), alkaline protease (enzyme), nonionic surfactant, and buffer system. This composite formulation combines several cleaning mechanisms in one product, achieving reliable disinfection preparation while maintaining ease of use through a single-composition application.
2Reliability
If harsh cleaning agents are used to remove organic material, then cleaning effectiveness improves, but device integrity and safety are compromised
Solution Approach 1:
The cleaning composition uses parameter changes by maintaining a controlled pH range of 9.5-11.9 through a buffer system, which is sufficiently alkaline to break down organic material effectively but controlled enough to prevent damage to medical device materials. The EDTA chelator operates at this moderate alkaline pH to bind metal ions without requiring extreme conditions that would harm device integrity.
Solution Approach 2:
The alkaline protease enzyme in the composition provides accelerated biochemical oxidation of protein-based organic material. This enzymatic action breaks down complex organic soils into smaller, more soluble fragments that can be easily removed, achieving thorough cleaning without the need for harsh chemical oxidants that could damage sensitive medical device components.
3Ease of operation
If simple cleaning compositions are used, then ease of operation is maintained, but cleaning effectiveness is insufficient to prevent microbial survival
Solution Approach 1:
The cleaning composition achieves universality by incorporating multiple functional components that perform different cleaning tasks simultaneously: EDTA chelates metal ions, alkaline protease breaks down proteins, nonionic surfactants emulsify fats and oils, and the buffer system maintains optimal pH. This multi-functional formulation provides comprehensive cleaning effectiveness while maintaining ease of operation through a single-composition application process.
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
The composition efficiently cleans medical devices, ensuring effective disinfection and preventing microbial survival, thereby enhancing the reliability of the disinfection process and maintaining device integrity.
Implementation Method 1
ethylenediaminetetraacetic acid (EDTA) as a chelator
Implementation Method 2
buffer system in the form of potassium phosphate dibasic and sodium hydroxide, present in a total amount of 10 to 20 wt.% of the composition; wherein the composition has a pH of at least 9.5
Data Source
AI summary
Provided herein is a composition that includes: (i) chelator (e.g., ethylenediaminetetraacetic acid (EDTA)), (ii) buffer system (e.g., potassium phosphate dibasic and sodium hydroxide), (iii) cleaner (e.g., diethyl glycol monoethyl ether), (iv) solubilizer (e.g., propylene glycol), and (v) diluent (e.g., water), wherein the composition has a pH of at least about 9.5. Also provided is a method of cleaning a medical device that includes contacting the medical device with the composition described herein, for a period of time effective to clean the medical device. Subsequent to the cleaning, the medical device can optionally be disinfected, dried, and stored.