Badnjevic Almir, Deumic Amar, Imamovic Elma, 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):317-325. doi: 10.3233/THC-229007.
Defibrillators are medical devices (MDs) used in the most critical situations, hence their performance must be ensured at all times. This requires defibrillators to be subjected to regular performance assessments after they have been placed on the market. 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 defibrillators.
The proposed method is developed in accordance with the International Organisation of Legal Metrology (OIML) guidelines and is intended to be used for conformity assessment testing of defibrillators for post-market surveillance purposes.
The developed method was validated from 2018 to 2021 in healthcare institutions of all levels. The results obtained during validation suggest that conformity assessment testing of defibrillators as a method used during PMS contributes to significant improvement in devices' accuracy and reliability.
A standardized approach in conformity assessment testing of defibrillators during PMS, besides increasing reliability of the devices, is the first step in the digital transformation of the management of these devices in healthcare institutions opening possibility for use of artificial intelligence.
除颤器是用于最危急情况的医疗设备，因此必须始终确保其性能。这就要求除颤器在上市后要定期进行性能评估。新的《医疗器械法规》（MDR）将医疗器械上市后监督（PMS）定义为由独立的第三方公告机构更具策略性地开展，以期提高设备性能的可追溯性。然而，在标准化合格评定测试方法方面仍存在明显差距。
本文提出一种用于除颤器合格评定测试的基于证据的新方法。
所提出的方法是根据国际法制计量组织（OIML）指南开发的，旨在用于除颤器上市后监督目的的合格评定测试。
所开发的方法在2018年至2021年期间在各级医疗机构中得到验证。验证期间获得的结果表明，除颤器合格评定测试作为PMS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PMS期间对除颤器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，是医疗机构中这些设备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。
