Medical Equipment Module Identification Logic for Device Safety
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Solution Overview
Problem
The use of third-party limited use devices with capital equipment in medical systems poses risks to patient health and increases liability due to inadequate validation and potential contamination, as well as the lack of standard connection systems, which can lock out affordable medical care options.
Innovation Solution
A medical system with an equipment module and a limited use device, featuring a non-proprietary functional interface that uses identification data to modify system operations, ensuring compatibility and safety by enabling or disabling features based on the authenticity of the limited use device, thereby promoting the use of original equipment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If proprietary connection systems are used to prevent third-party device use, then patient safety and reliability are improved, but device compatibility and ease of operation deteriorate
Solution Approach 1:
The connection system is segmented into two independent components: a physical connector that ensures mechanical compatibility and an identification interface that verifies device authenticity. This segmentation allows the system to maintain both compatibility (through the open physical connector) and reliability (through the identification verification layer).
Solution Approach 2:
An identification interface acts as an intermediary between the physical connector and the capital equipment control system. This intermediary verifies the authenticity of the limited use device through identification data exchange, enabling the system to distinguish between authorized and unauthorized devices without preventing physical connection.
2Adaptability or versatility
If standard non-proprietary connectors are used to improve affordability and compatibility, then device compatibility and ease of operation are improved, but patient safety and reliability deteriorate due to third-party device risks
Solution Approach 1:
The connection system is segmented into two independent components: a physical connector that ensures mechanical compatibility and an identification interface that verifies device authenticity. This segmentation allows the system to maintain both compatibility (through the open physical connector) and reliability (through the identification verification layer).
Solution Approach 2:
The identification interface provides feedback to the capital equipment control system regarding the authenticity of the connected limited use device. Based on this feedback, the system automatically modifies its operation to enable or disable specific features, ensuring that safety-critical functions are only activated with authorized devices.
3Reliability
If identification verification is implemented to ensure original device use, then patient safety and reliability are improved, but device complexity increases
Solution Approach 1:
An identification interface acts as an intermediary between the physical connector and the capital equipment control system. This intermediary verifies the authenticity of the limited use device through identification data exchange, enabling the system to distinguish between authorized and unauthorized devices without preventing physical connection.
Solution Approach 2:
The limited use device contains an embedded identification interface that autonomously provides verification information to the capital equipment. This self-service approach eliminates the need for complex external verification systems, as the device itself carries and communicates its authentication data.
4Ease of manufacture
If third-party limited use devices are allowed to reduce costs, then affordability is improved, but patient safety and reliability deteriorate due to inadequate validation
Solution Approach 1:
The identification interface provides feedback to the capital equipment control system regarding the authenticity of the connected limited use device. Based on this feedback, the system automatically modifies its operation to enable or disable specific features, ensuring that safety-critical functions are only activated with authorized devices.
Solution Approach 2:
The system implements partial verification by checking identification data rather than requiring full validation testing for each device. This approach provides sufficient safety assurance for the intended application while maintaining affordability and accessibility.
Data Source
AI summary
Disclosed herein is a medical system including an equipment module, a limited use device, and a functional interface configured to operatively couple the limited use device with the equipment module via a non-proprietary connector. The equipment module includes an identification interface configured to obtain identification data from the limited use device, and the equipment module is configured to modify operation of the system in accordance with a result of obtaining the identification data. A method of operation includes disabling operating features if the brand of the limited use device is different from the brand of the equipment module. Computer logic and a computerized method include detecting coupling of an equipment module to a console and attempting to obtain identification data of the equipment module. As a result, the console enables either a first set or a second set of operations.