Enhancing the safety of ambulatory infusion pumps
We brought our extensive embedded and FDA device development experience to the table as we improved the safety of our client’s ambulatory infusion pump.
We designed a new, easier to use set of pump configuration parameters. Our work helped users in hospitals reduce clinical errors and improve patient outcomes.
What We Did
A global pharmaceutical and medical device client wanted to improve the safety of their ambulatory infusion pump by implementing new key features. These features would allow hospitals to set limits for pump dosing and reduce entry errors by clinicians.
We worked directly with medical practice SMEs to design the safety features to work within the existing product workflow. We designed a new set of pump configuration parameters. We also created a way to configure the pump from a PC application and transfer those parameters via a serial connection. We authored all of the technical documentation and records used for the 510(k) FDA submission.
- Defined and implemented data transfer protocols so that hospital therapy programming safety limits could be set on a PC and transferred to a pump
- Re-designed pump programming screens and workflow used by clinicians to restrict dose and delivery rates thereby reducing drug delivery errors
Hospitals now have significantly more control over how these pumps are used and the drug delivery programming parameters. With these new capabilities, the number of clinical errors are significantly reduced, creating a huge impact on patient safety and treatment outcomes.
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