Badnjevic Almir, Deumic Amar, Ademovic Azra, 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):339-346. doi: 10.3233/THC-229009.
Therapeutic ultrasounds are medical devices used for treatment of conditions such muscle spasms, joint contractures or general muscle pain. Their function relies in the delivery of ultrasonic pulses that generate heat in tissue thus relieving the symptoms of aforementioned conditions. Accuracy of the delivered pulses directly affects the quality and effectiveness of the treatment and has to be ensured throughout the utilization of the therapeutic ultrasound in 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 method for conformity assessment testing of therapeutic ultrasounds for post-market surveillance purposes.
The method was developed based on metrology characteristics of therapeutic ultrasounds and includes visual, electrical safety and performance inspections of therapeutic ultrasounds to ensure that both safety and treatment reliability are achieved.
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 therapeutic ultrasounds as a method used during PMS contributes to significant improvement in devices' accuracy and reliability.
A standardized approach in conformity assessment testing of therapeutic ultrasounds 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.
治疗性超声是用于治疗肌肉痉挛、关节挛缩或一般性肌肉疼痛等病症的医疗设备。其功能依赖于传递超声脉冲，这些脉冲在组织中产生热量，从而缓解上述病症的症状。所传递脉冲的准确性直接影响治疗的质量和效果，在实际使用治疗性超声的过程中必须确保这一点。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。
本文提出一种用于治疗性超声上市后监督合格评定测试的新方法。
该方法基于治疗性超声的计量特性开发，包括对治疗性超声的外观、电气安全和性能检查，以确保实现安全性和治疗可靠性。
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，治疗性超声的合格评定测试作为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期间对治疗性超声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。
