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):357-365. doi: 10.3233/THC-229011.
Dialysis machines are used regularly in healthcare practice. They are classified as a type of medical device with moderate and high risk therefore significant requirements are placed on their safety and performance every time they are used on patients. The new Medical Device Regulation (MDR) defines medical device post-market surveillance (PMS) as performed by independent, third-party, notified bodies more strategically in hope to improve traceability of device performance. However, there is still an apparent gap in terms of standardised conformity assessment testing methods.
This paper proposes a novel evidence-based method for conformity assessment testing of dialysis machines for post-market surveillance purposes.
The novel method is developed according to the International Organisation of Legal Metrology (OIML) guidelines and is to be used for the purpose of conformity assessment testing of Dialysis machines with respect to their metrological characteristics during PMS.
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 dialysis machines as a method used during PMS contributes to significant improvement in devices' accuracy and reliability.
A standardized approach in conformity assessment testing of dialysis machines 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.
透析机在医疗实践中经常使用。它们被归类为中等和高风险的医疗器械，因此每次在患者身上使用时，都对其安全性和性能有很高的要求。新的《医疗器械法规》（MDR）将医疗器械上市后监管（PMS）定义为由独立的、第三方的、已通知的机构更具战略性地进行，以提高设备性能的可追溯性。然而，在标准化一致性评估测试方法方面仍然存在明显差距。
本文提出了一种用于透析机上市后监管目的的基于证据的新型一致性评估测试方法。
该新方法是根据国际法制计量组织（OIML）指南制定的，用于在 PMS 期间对透析机的计量特性进行一致性评估测试。
该方法于 2018 年至 2021 年在各级医疗机构进行了验证。验证过程中获得的结果表明，作为 PMS 期间使用的方法，对透析机进行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 期间对透析机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管理的第一步，为人工智能在这些设备中的使用开辟了可能性。
