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

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. OBJECTIVE This paper proposes a novel evidence-based method for conformity assessment testing of anaesthesia machines for post-market surveillance purposes. METHOD 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. RESULTS 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. CONCLUSION 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.