Badnjevic Almir, Deumic Amar, Trakic Ammar, 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):367-376. doi: 10.3233/THC-229012.
Mechanical ventilators are medical devices used in intensive care units when patients are in need of mechanical aid to facilitate the process of breathing. As the function of breathing is the exchange of gases, the mechanical ventilator takes over that function while the patient is incapable to spontaneous breathing. As these devices are used to maintain the life of patents, their performance must be ensured and there cannot be significant deviations in the volumes and pressure of gases they introduce to the patient. 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 method for conformity assessment testing of mechanical ventilators for post-market surveillance purposes.
The method was developed on the basis of metrology characteristics of mechanical ventilators and evaluation of their vital safety and performance parameters. In addition to the evaluation of essential safety and visual integrity of mechanical ventilators, their performance in terms of volume of oxygen delivered to the patient as well as the flow and pressure of the delivered gas 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 mechanical ventilators as a method used during PMS contributes to significant improvement in devices' accuracy and reliability.
A standardized approach in conformity assessment testing of mechanical ventilators 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.
机械通气机是重症监护病房中使用的医疗设备，用于患者需要机械辅助以促进呼吸过程的情况。由于呼吸功能是气体交换，当患者无法自主呼吸时，机械通气机接管该功能。由于这些设备用于维持患者生命，必须确保其性能，并且它们向患者输送的气体体积和压力不能有显著偏差。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战略性地进行，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。
本文提出一种用于上市后监督目的的机械通气机合格评定测试的新方法。
该方法是在机械通气机的计量特性以及对其关键安全和性能参数进行评估的基础上开发的。除了评估机械通气机的基本安全性和外观完整性外，还评估其向患者输送的氧气量以及输送气体的流量和压力方面的性能。
所开发的方法在2018年至2021年期间在各级医疗机构中得到验证。验证期间获得的结果表明，机械通气机合格评定测试作为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期间对机械通气机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，为使用人工智能开辟了可能性。
