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):377-387. doi: 10.3233/THC-229013.
Anaesthesia machines, as moderate to high-risk medical devices intended for use on patients during surgical procedures must be safe and reliable with traceable performance every time they are used in healthcare practice. 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 anaesthesia 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 anaesthesia machines with respect to their technical and 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 anaesthesia machines as a method used during PMS contributes to significant improvement in devices' accuracy and reliability.
A standardized approach in conformity assessment testing of anaesthesia 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.
麻醉机作为中等至高风险的医疗器械，在手术过程中用于患者，必须每次在医疗实践中使用时都是安全可靠且性能可追溯的。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，希望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的差距。
本文提出了一种用于麻醉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。
根据国际法制计量组织（OIML）的指南制定了新方法，旨在用于 PMS 期间对麻醉机的技术和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。验证期间获得的结果表明，作为 PMS 期间使用的方法，对麻醉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 期间对麻醉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，还是这些设备在医疗机构管理数字化转型的第一步，为人工智能的使用开辟了可能性。
