Accuracy of Control of Infusion Pumps in the Post-Market: A Practical Approach Based on IEC 60601-2-24:2012
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Keywords
Infusion pump, Accuracy, Post-market, Clinical engineering
Abstract
Background: Infusion pumps are critical medical devices widely used in clinical practice, particularly in intensive care units, where precise delivery of fluids and medications is essential for patient safety. Deviations in flow rate accuracy may lead to underinfusion or overinfusion, potentially compromising therapeutic outcomes. Post-market surveillance of infusion pump performance is therefore a key component of clinical engineering strategies, especially under real-use hospital conditions; Objective: This study aimed to evaluate the post-market flow rate accuracy of volumetric infusion pumps used at the University Hospital of the University of São Paulo (HU-USP), Brazil, in accordance with the requirements of the IEC 60601-2-24:2012 standard; Material and Methods: Three volumetric infusion pumps of the same model, allocated in the Pediatric Intensive Care Unit (PICU), were evaluated. Flow rate accuracy tests were conducted using a measurement system composed of an analytical balance and dedicated software developed for automated data acquisition and processing. The pumps were tested at a low flow rate of 1 mL/hour over 24 hours under ambient pressure conditions, and at a nominal flow rate of 25 mL/hour over 2 hours under three conditions: ambient pressure, overpressure (+100 mmHg), and vacuum (−100 mmHg). The measured flow rates were compared with the accuracy limits specified by the manufacturer; Results: At the flow rate of 1 mL/h, two of the three infusion pumps did not comply with the manufacturer’s specified accuracy limit (±5%), exhibiting underinfusion. At 25 mL/h, all evaluated pumps demonstrated deviations exceeding the expected tolerance, particularly when subjected to pressure variations. In addition, all devices exhibited a consistent delay of approximately 11 minutes in completing the 24-hour infusion period, despite being newly acquired and previously unopened. These findings indicate performance deviations under post-market conditions that may not be identified through routine acceptance testing alone; Conclusion: The results highlight the importance of implementing systematic post-market performance evaluation of infusion pumps as part of clinical engineering management practices. Even newly acquired devices may present deviations that pose potential risks to patient safety, especially in pediatric intensive care environments. The study supports the expansion of this evaluation methodology to the entire infusion pump inventory of the University Hospital, currently comprising 221 devices, and to testing scenarios involving clinically relevant medications and operating conditions. Such an approach contributes to evidence-based decision-making in medical technology management and to the continuous improvement of healthcare quality and safety.
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