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

Abstract

Dialysis machines are used regularly in healthcare practice. They are classified as a type of medical device with moderate and high risk therefore significant requirements are placed on their safety and performance every time they are used on patients. 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 dialysis machines for post-market surveillance purposes. 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 Dialysis machines with respect to their metrological characteristics during PMS. 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 dialysis machines as a method used during PMS contributes to significant improvement in devices' accuracy and reliability. A standardized approach in conformity assessment testing of dialysis 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.