Transparent Test PID for Automated Cleaning Validation

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Solution Overview

Problem

Current surgical instrument holders (PIDs) face challenges in cleaning and disinfection due to complex structures and the inability to be immersed in cleaning solutions, requiring tedious disassembly and lacking means to verify effective cleaning and disinfection without manual disassembly.

Innovation Solution

A method using a transparent test PID coated with protein stains, which reacts with a colorimetric reagent to visualize cleaning and disinfection progress within an automaton, allowing validation of the processing cycle without disassembly, including washing, disinfection, and sterilization verification.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If manual disassembly is performed to verify cleaning and disinfection quality, then verification accuracy is improved, but time consumption and operational complexity increase

Engineering Contradiction:
Improveverification accuracyVSAvoidtime consumption
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent creates a transparent copy or model of the PID instrument holder that replicates the internal structure and soiling conditions. This transparent model allows direct visual verification of cleaning and disinfection quality without manual disassembly of the actual instrument, thus maintaining verification accuracy while eliminating time-consuming disassembly operations.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The transparent PID model serves as an intermediary between the cleaning process and verification. By placing soil indicators on the transparent model and observing them through the transparent walls, the system enables indirect but accurate verification of cleaning effectiveness without direct manual disassembly of the real instrument.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If manual disassembly is performed to verify cleaning quality, then verification reliability is improved, but device complexity and operational difficulty increase

Engineering Contradiction:
Improveverification reliabilityVSAvoidoperational difficulty
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The transparent PID model provides a simplified copy that maintains the essential features needed for verification while eliminating the complexity of disassembly. The model allows reliable verification through direct visual observation of internal surfaces without requiring technical expertise or complex disassembly procedures.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent employs color-changing indicators or contrast agents that change appearance based on cleaning effectiveness. This visual feedback mechanism simplifies the verification process by providing immediate, intuitive indication of cleaning quality through color or transparency changes, eliminating the need for complex operational procedures.

Inventive Principle:
Principle #32Color changes

3Ease of operation

If transparent material is used for PID walls to enable visual verification, then ease of verification is improved, but manufacturing complexity increases

Engineering Contradiction:
Improveease of verificationVSAvoidmanufacturing complexity
Core Design Contradiction:
Ease of operationVSEase of manufacture

Solution Approach 1:

The patent divides the verification function into a separate transparent model rather than requiring the entire PID to be transparent. This segmentation allows the main instrument to remain opaque while creating a simplified transparent replica for verification purposes, reducing manufacturing complexity while maintaining ease of verification.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The transparent model uses modified material properties (transparency) only where needed for verification, while other parameters such as structural integrity and material durability are maintained through appropriate material selection and design adaptations. This selective parameter change balances manufacturing feasibility with verification ease.

Inventive Principle:
Principle #35Parameter changes

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

Enables rapid and efficient validation of cleaning and disinfection processes by visual observation of transparency changes, reducing the need for manual disassembly and saving time in quality control of PIDs.

Implementation Method 1

a reagent visually modifying the transparency properties of said material of said PID test is deposited on the internal and external surfaces

Methodology Applied
Scientific EffectColorimetric reaction: Chemical Bonding

Data Source

PatentEP3569258B1Method for validating the treatment cycle of a dynamic instrument holder
Publication Date: 2023.01.18 SLUPECKI PATRICE

AI summary

A method for validating the treatment cycle, including washing and disinfection operations, of surgical instruments of the type dynamic instrument holder (DIP) within an automated system, characterized in that: a) A reagent visually modifying the transparency properties of said material of said DIP is deposited on the internal and external surfaces of the wall, previously soiled with a test DIP made of transparent material, b) said test DIP is integrated into the automated system, c) The entire treatment cycle is carried out within the automated system, d) At the end of the treatment cycle, the wall of said test DIP is observed, e) The transparency properties of the wall of the test DIP are compared with those before soiling and addition of the reagent, f) The completion of the treatment cycle is validated when the entire wall of said test DIP exhibits material transparency properties identical to those before soiling and addition of the reagent.