Verlab Research Institute for Biomedical Engineering, Medical Devices and Artificial Intelligence, Sarajevo, Bosnia and Herzegovina.
Medical Device Inspection Laboratory, Verlab Ltd., Sarajevo, Bosnia and Herzegovina.
Technol Health Care. 2023;31(1):347-355. doi: 10.3233/THC-229010.
Introduction of fluids, medicaments and nutrients into the human body during hospitalization is fundamental for treatment and healing of patients. Fluids are introduced by means of infusion pumps while nutrients and medicaments are introduced by perfusion pumps. It is of vital importance for these devices to deliver exact amounts of the aforementioned substances as significant deviations can result in severe patient harm. Therefore it is important to effectively monitor their performance and prevent failures.
This paper proposes a novel method for conformity assessment testing of infusion and perfusion pumps for post-market surveillance purposes.
The method was developed on the basis of metrology characteristics of the devices. In addition to the evaluation of essential safety and visual integrity of infusion and perfusion pumps, their performance in terms of delivered volumes was assessed and monitored.
The developed method was validated between 2018 and 2021 in healthcare institutions of all levels. The results obtained during validation suggest that conformity assessment testing of infusion and perfusion pumps as a method used during PMS contributes to significant improvement in devices' accuracy and reliability.
A standardized approach in conformity assessment testing of infusion and perfusion pumps during PMS, besides increasing reliability of the devices, is the first step in digital transformation of management of these devices in healthcare institutions opening possibility for use of artificial intelligence.
在住院期间向人体输入液体、药物和营养物质是治疗和治愈患者的基础。液体是通过输液泵输入的，而营养物质和药物是通过灌注泵输入的。这些设备精确输送上述物质非常重要，因为显著的偏差可能导致严重的患者伤害。因此，有效监测其性能并防止故障至关重要。
本文提出了一种新的用于输液泵和灌注泵上市后监管目的的一致性评估测试方法。
该方法基于设备的计量特性开发。除了评估输液泵和灌注泵的基本安全性和视觉完整性外，还评估和监测其输送体积方面的性能。
该方法于 2018 年至 2021 年在各级医疗机构进行了验证。验证期间获得的结果表明，作为 PMS 期间使用的方法，输液泵和灌注泵的一致性评估测试有助于显著提高设备的准确性和可靠性。
在 PMS 期间对输液泵和灌注泵进行标准化的一致性评估测试，除了提高设备的可靠性外，还是医疗机构对这些设备进行数字化转型的第一步，为人工智能的使用提供了可能性。
