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Patient Controlled Analgesia Infusion Pump

Challenge

A global pharmaceutical and infusion pump company needed to reduce use errors of an existing patient controlled analgesia infusion pump (a class II medical device). Hospitals needed a way to impose drug-specific dosing controls without having to configure at each pump. Our client was also looking to expand the reach of their product to other countries.

Solution

An effective solution required adding wireless connectivity to the pump in order to communicate with a single, hospital-wide, medication management system. Pump programming workflows were re-designed to support dosing control limits received from the backend system. These limits alert the clinician to potential programming errors as well as limiting how much medication can be delivered. Wireless connectivity also allowed many other product improvements such as communication of real-time pump status information, automatic transfer of pump operation logs, remote pump configuration/setup, and field upgradability. Working closely with our client, SEP led activities to:

  • Develop firmware to manage communication with centralized system through on-board custom network interfacing hardware
  • Define and implement application level communication protocols utilizing XML-based messages
  • Collaborate with client’s medical and marketing personnel to design and implement new pump capabilities, taking into consideration human factors issues
  • Development of a bootloader for field upgradeability
  • Add support for automatic programming of therapy settings
  • Manage safety risks by contributing to hazard analysis and fault tree analysis
  • Created all software design and verification documentation used in the 510(k) submission to the FDA
  • Localize the product for the French-Canadian market and update the UI of the product to ensure easy addition of new languages in the future

Result

This product resulted in a major advance in infusion pump design reducing dosing errors caused by nurse programming mistakes. There is no doubt that the new safety features of this product have helped avoid over-medication and saved patient lives. Our work allowed for international expansion of our client’s life saving product.

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