The ability to deliver fluids at automated intervals is one of the major advantages of infusion pumps. The increasing demand for safety-driven, patient-focused and clinician-friendly infusion pumps is beneficial for healthcare providers by giving an edge to manufacturers using automation to make high-quality pumps. However, the infusion pump market recently has been troubled by security concerns and product recalls.

FDA recently recalled Baxter’s Infusion Pump, both SIGMA Spectrum Infusion Pumps with Master Drug Library, and Spectrum IQ Infusion Systems with Dose IQ Safety Software. Baxter has received more than 130 reported complaints and 3 serious injuries leading to a class Ⅰ recall notice by the FDA. The false alarm occurrence is problematic for clinicians as it delays a patient’s treatment. Also, unnecessary alarm-induced stoppages are contributing to clinician fatigue as quoted by the FDA.

Since the pandemic (2020) Becton Dickinson’s (BD) Alaris infusion pumps have been the subject of more than half a dozen Class I hardware and software recalls. Smiths Medical also warned of Infusion pump manufacturing issues causing false alarms or under delivery/not delivery of fluids at all.

Automation in the healthcare industry led to the creation of a smarter infusion pump, which is now a potential cause of issues in these pumps. Manufacturers have issued letters to both consumers and healthcare providers guiding them to follow the operator’s manual for smoother execution.


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