Infusion Pump Wireless Control with Smartphone Safety Validation
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Solution Overview
Problem
The use of consumer electronic devices like smartphones for programming medical devices such as infusion pumps poses safety and reliability concerns due to their vastly different safety and reliability profiles.
Innovation Solution
A safety processor acts as an intermediary between the smartphone and the medical device to review transmissions, ensuring compatibility and adherence to acceptable parameters before delivering commands to the medical device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If consumer electronic devices like smartphones are used to program medical devices such as infusion pumps, then ease of operation and accessibility are improved, but safety and reliability deteriorate due to vastly different safety profiles between consumer and medical devices
Solution Approach 1:
A safety processor is introduced as an intermediary device between the smartphone and the infusion pump. The safety processor receives commands from the smartphone, validates them against pre-established safety criteria (such as checking if bolus amounts are within safe ranges), and only forwards validated commands to the infusion pump. This mediator architecture allows the system to maintain ease of operation while enforcing medical-grade safety standards.
2Reliability
If a safety processor is introduced as an intermediary between smartphone and medical device, then safety and reliability are improved, but device complexity increases
Solution Approach 1:
The system is segmented into three distinct functional modules: the smartphone application layer for user interaction, the safety processor layer for validation and mediation, and the infusion pump layer for execution. This segmentation allows each component to be optimized independently - the safety processor can be a simple validation device without the complexity of full medical device functionality, while the infusion pump maintains its core functions without needing to directly interface with consumer electronics.
3Object-affected harmful factors
If the safety processor validates smartphone compatibility and command parameters, then harmful factors are reduced, but loss of time occurs during validation processes
Solution Approach 1:
The safety processor performs preliminary validation of smartphone compatibility and command parameters before commands are executed. Compatibility checks are performed in advance, and command validation (such as checking bolus amounts against safe ranges) occurs immediately upon receipt but before forwarding to the infusion pump. This preliminary action prevents unsafe operations while minimizing user-perceived delay.
Data Source
AI summary
A system and method provide for enhanced reliability and safety of programming and/or operating a medical device, such as an infusion pump, with a remote control device, such as a mobile phone (e.g., a smartphone). A processor can determine whether the smartphone is compatible with the medical device by checking the type and version of the smartphone as well as the versions of the operating software and/or firmware resident on the phone.