Ambulatory Infusion Pump Remote Software Update
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Solution Overview
Problem
The increasing number of ambulatory medical devices, such as infusion pumps, poses challenges in efficiently and cost-effectively updating their software, as traditional methods like sending devices to servicing facilities or having field service representatives become cumbersome and costly as the number of devices grows.
Innovation Solution
An ambulatory fluid delivery device equipped with a user interface, digital storage, electrical controller, and signal processing component that allows for remote software updates, verification of safe conditions, and automatic installation, using wireless or physical connections to receive and verify updates, ensuring device safety and compatibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional software update methods (sending devices to servicing facilities or having field service representatives visit) are used, then software updates can be performed, but the process becomes cumbersome, time-consuming and costly as the number of ambulatory infusion pumps increases
Solution Approach 1:
The ambulatory infusion pump performs software updates autonomously by receiving update packages wirelessly, verifying their authenticity through cryptographic signatures, and installing them without requiring service provider intervention. The device independently checks safe conditions, validates updates, and manages the installation process, enabling self-service updates that eliminate the need for field service representatives or facility visits.
Solution Approach 2:
A secure communication interface acts as an intermediary between remote servers and the ambulatory infusion pump, enabling wireless transmission of software updates. This intermediary channel allows updates to be delivered remotely through healthcare networks or other communication infrastructure, bridging the gap between centralized update management and distributed device deployment.
2Reliability
If traditional software update methods are used, then software updates can be performed, but administrative burdens increase and operational costs rise with the number of devices
Solution Approach 1:
The pump system autonomously manages the entire software update lifecycle including receiving updates wirelessly, verifying cryptographic signatures, checking safe conditions, and installing updates without human intervention. This self-service capability dramatically reduces administrative burdens and operational costs by eliminating the need for service providers to manually update each device.
Solution Approach 2:
The system implements feedback mechanisms where the pump reports its status, safe condition compliance, and update installation results to remote servers. This feedback loop enables centralized monitoring and management of fleet-wide software updates, allowing administrators to track update progress and verify successful installations across multiple devices efficiently.
3Productivity
If remote software updates are implemented, then update efficiency and cost-effectiveness improve, but device safety and compatibility verification become more complex
Solution Approach 1:
Before installing software updates, the system performs preliminary verification actions including checking cryptographic signatures to ensure authenticity, validating that the update is compatible with the device model, and verifying that safe conditions are met (no patient connection, pump stopped, reservoir empty). These preliminary checks prevent unsafe or incompatible updates from being installed.
Solution Approach 2:
The patent replaces manual verification processes with automated electronic verification mechanisms. Cryptographic signature validation, compatibility checking, and safe condition verification are performed automatically through software and hardware interfaces, substituting complex manual verification procedures with streamlined electronic validation routines.
4Loss of time
If automatic software update installation is enabled, then downtime is reduced, but the risk of installing incompatible or unsafe updates increases
Solution Approach 1:
The system performs all necessary verification actions before automatic installation, including cryptographic signature validation, compatibility verification, and safe condition checking. Only after these preliminary validations succeed does the system proceed with automatic update installation, ensuring that automation does not compromise safety.
Solution Approach 2:
Manual safety verification procedures are replaced with automated electronic validation mechanisms. The system automatically verifies cryptographic signatures, checks device compatibility, and monitors safe conditions throughout the update process, substituting human judgment with reliable automated validation routines that reduce both downtime and safety risks.
Data Source
AI summary
Portable or ambulatory infusion devices and systems capable of remotely updating an ambulatory fluid delivery device include safety protocols that verify the status of the ambulatory fluid delivery device before and after a field update of software. Methods of accomplishing the same field update of software are also described.