Related Experiment Video
Updated: Aug 16, 2025
In Vitro Thrombosis Test for Ventricular Assist Devices
Published on: March 21, 2025
A novel method for conformity assessment testing of infusion and perfusion pumps for post-market surveillance
Almir Badnjevic1,2,3,4, Amar Deumic1,2, Merima Smajlhodzic-Deljo1
1Verlab Research Institute for Biomedical Engineering, Medical Devices and Artificial Intelligence, Sarajevo, Bosnia and Herzegovina.
Background:
Introduction of fluids, medicaments and nutrients into the human body during hospitalization is fundamental for treatment and healing of patients. Fluids are introduced by means of infusion pumps while nutrients and medicaments are introduced by perfusion pumps. It is of vital importance for these devices to deliver exact amounts of the aforementioned substances as significant deviations can result in severe patient harm. Therefore it is important to effectively monitor their performance and prevent failures.
Objective:
This paper proposes a novel method for conformity assessment testing of infusion and perfusion pumps for post-market surveillance purposes.
Method:
The method was developed on the basis of metrology characteristics of the devices. In addition to the evaluation of essential safety and visual integrity of infusion and perfusion pumps, their performance in terms of delivered volumes was assessed and monitored.
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 infusion and perfusion pumps as a method used during PMS contributes to significant improvement in devices' accuracy and reliability.
Conclusion:
A standardized approach in conformity assessment testing of infusion and perfusion pumps 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.
