A novel method for conformity assessment testing of anaesthesia machines for post-market surveillance purposes.

Journal: Technology and health care : official journal of the European Society for Engineering and Medicine
PMID: 36530110

Abstract

BACKGROUND: 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.

Authors

  • Almir Badnjević
    Faculty of Pharmacy, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.
  • Amar Deumic
    Verlab Research Institute for Biomedical Engineering, Medical Devices and Artificial Intelligence, Sarajevo, Bosnia and Herzegovina.
  • Zijad Dzemic
    Institute of Metrology of Bosnia and Herzegovina, Sarajevo, Bosnia and Herzegovina.
  • Lejla Gurbeta Pokvić
    University of Donja Gorica, Podgorica, Montenegro.

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