Badnjevic Almir, Deumic Amar, Softic Adna, Pokvic Lejla Gurbeta
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):327-337. doi: 10.3233/THC-229008.
Patient monitors are medical devices used to monitor vital parameters such as heart rate, respiratory rate, blood pressure, blood oxygen saturation, and body temperature during inpatient treatment. As such, patient monitors provide physicians with information necessary to adjust the treatment as well as evaluate the overall status and recovery of the patient. Measurements made by intrinsic sensors of patient monitors must be compliant and provide reliable readings in order to ensure safety and optimal quality of care to the patients.
This paper proposes a novel method for conformity assessment testing of patient monitors in healthcare institutions for post-market surveillance purposes.
The method was developed on the basis of metrology characteristics of sensors used to monitor vital parameters observed by patient monitors and evaluation of their vital safety and performance parameters. In addition to the evaluation of essential safety and visual integrity of patient monitors, their performance in terms of accuracy of the readings is evaluated.
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 patient monitors as a method used during PMS contributes to significant improvement in devices' accuracy and reliability.
A standardized approach in conformity assessment testing of patient monitors 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.
患者监护仪是用于在住院治疗期间监测诸如心率、呼吸频率、血压、血氧饱和度和体温等生命体征参数的医疗设备。因此，患者监护仪为医生提供调整治疗以及评估患者整体状况和恢复情况所需的信息。患者监护仪的内置传感器所进行的测量必须符合要求并提供可靠读数，以确保患者的安全和最佳护理质量。
本文提出一种用于医疗机构中患者监护仪上市后监督的合格评定测试新方法。
该方法是基于用于监测患者监护仪所观察到的生命体征参数的传感器的计量特性以及对其生命安全和性能参数的评估而开发的。除了评估患者监护仪的基本安全性和外观完整性外，还评估其读数准确性方面的性能。
所开发的方法在2018年至2021年期间在各级医疗机构中得到了验证。验证期间获得的结果表明，将患者监护仪的合格评定测试作为上市后监督期间使用的一种方法有助于显著提高设备的准确性和可靠性。
在上市后监督期间对患者监护仪进行合格评定测试的标准化方法，除了提高设备的可靠性外，还是医疗机构中这些设备管理数字化转型的第一步，为使用人工智能开辟了可能性。
