Automated Medical Device Sterilization Cycle Selection

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Solution Overview

Problem

Current medical device sterilization systems lack efficient methods for identifying and verifying the compatibility of medical devices with specific sterilization cycles, leading to potential human errors and equipment misidentification, which can result in ineffective sterilization or unnecessary re-sterilization.

Innovation Solution

A sterilization system that includes a sterilizing cabinet with a processor, communication module, and reader for automatic identification of medical devices using image capture, optical analysis, and tracking records, along with a sterility guide database to verify compatibility and select appropriate sterilization cycles based on device-specific requirements.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual identification and verification of medical devices is performed, then flexibility and adaptability are maintained, but human error increases and sterilization reliability decreases

Engineering Contradiction:
Improvesterilization reliabilityVSAvoidsystem complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system enables self-service through automatic device identification using RFID tags and optical scanning, automated compatibility verification against the sterility guide database, and automatic sterilization cycle selection. This eliminates manual identification and verification steps, reducing human error while maintaining reliability without requiring complex manual intervention procedures

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent replaces manual mechanical identification processes with automated electronic identification systems including RFID readers and optical scanning devices. The mechanical verification process is substituted with automated database matching and compatibility checking, significantly reducing human error while improving sterilization reliability

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If automated identification systems are implemented, then human error is reduced and sterilization reliability improves, but device complexity and initial resource requirements increase

Engineering Contradiction:
Improvesterilization reliabilityVSAvoidsystem complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system achieves universality by implementing a multi-functional platform that combines device identification (RFID and optical scanning), database management (sterility guide), compatibility verification, and sterilization cycle selection in a single integrated system. This multi-functionality reduces the need for separate systems and devices, thereby improving reliability without proportionally increasing overall system complexity

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The sterility guide database serves as an intermediary that mediates between device identification and sterilization cycle selection. It stores pre-verified compatibility information and acts as a reference medium, simplifying the decision-making process and reducing system complexity while improving sterilization reliability through automated lookup and verification

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If compatibility verification is performed for each device, then sterilization effectiveness is ensured, but processing time and operational complexity increase

Engineering Contradiction:
Improvesterilization effectivenessVSAvoidprocessing time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The system applies preliminary action by pre-verified compatibility information in the sterility guide database before actual sterilization operations. Device compatibility characteristics and appropriate sterilization cycles are predetermined and stored, allowing rapid automated verification during operation without time-consuming manual assessment, thus ensuring sterilization effectiveness while minimizing processing time

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system uses copying by creating and storing duplicate compatibility verification data in the sterility guide database. Instead of performing complex verification calculations during each sterilization cycle, the system copies pre-verified compatibility information for rapid automated matching, ensuring sterilization effectiveness while significantly reducing processing time

Inventive Principle:
Principle #26Copying

4Productivity

If automated sterilization cycle selection is implemented, then human error is reduced and sterilization effectiveness improves, but system complexity and resource requirements increase

Engineering Contradiction:
Improvesterilization efficiencyVSAvoidsystem complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The system implements self-service by automatically selecting appropriate sterilization cycles based on device identification and compatibility verification results. The processor autonomously queries the sterility guide database, determines compatible cycles, and configures sterilization parameters without human intervention, improving productivity while managing system complexity through automated decision-making algorithms

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system employs feedback mechanisms where the processor continuously monitors device identification results, compatibility verification status, and sterilization cycle execution. This feedback loop allows automatic adjustment and optimization of sterilization parameters, improving productivity and effectiveness while managing system complexity through closed-loop control rather than requiring overly complex open-loop systems

Inventive Principle:
Principle #23Feedback

Data Source

PatentEP3815105B1System and method for automating verification of medical instrument sterilization compatibility and sterilization cycle selection
Publication Date: 2024.10.02 ASP GLOBAL MFG GMBH
  • EP3815105B1 patent drawingFigure 1
  • EP3815105B1 patent drawingFigure 2
  • EP3815105B1 patent drawingFigure 3

AI summary

A sterilization system includes a communication hub that is configured to transfer information between devices of the system such as a sterilizing cabinet, biological indicator analyzer, and a server in order to allow a user to track a medical device throughout a sterilization process. The server may provide data to the sterilizing cabinet during a sterilization process that may be used to verify that the medical device is compatible with the sterilizing cabinet, and to automatically select a compatible sterilization cycle to perform on the medical device. Automatic selection of sterilization cycles and confirmation of compatibility reduces the possibility for user error, which could result in contaminated medical devices being placed back into service. Automatic selection of sterilization cycles also allows users to more efficiently configure and perform sterilization cycles while being confident that the medical device will be sterile upon completion.