By: 18 August 2021
Test facility to improve infusion patient safety launched

TÜV SÜD National Engineering Laboratory (NEL) recently launched the UK’s first traceable, dynamic micro-flow measurement test facility for medical infusion devices, as part of a European-wide research programme to improve dosing accuracy.

Due to the widespread use of infusion in hospitals, dosing errors are common, causing morbidity and mortality. NEL’s new Micro-flow Measurement Facility will calibrate and test the performance of medical microfluidic infusion systems to ensure accurate delivery of fluids for a range of products, such as syringe pumps and infusion device analysers.

NEL has developed the facility as part of its research work with MeDD II, the Metrology for Drug Delivery project funded by the European Metrology Research Programme (EMPIR), which aims to develop traceable calibration services for drug delivery systems for flow rates down to 1 µL/min. The Micro-flow Measurement Facility will provide traceable flow rate measurements in the range of 1 µL/min to 10 mL/min, to assess the performance of devices and ensure accurate fluids delivery. The facility is capable of measuring changes in flow rates and hence the performance of drug delivery devices to identify fluctuations or spikes in drug dosing.

Dr Emmelyn Graham, Life Sciences Consultant at NEL, said: “There have been numerous injuries, deaths and adverse health effects associated with the use of infusion pumps. Medical devices are usually calibrated and tested by manufacturers before use, but there is very limited ongoing performance reassessment by end-users. In the UK alone, approximately 80-90% of hospitalised patients receive intravenous therapy. So, it is vital that medication and fluid delivery is accurate and precisely controlled over time, especially for critical drugs at high concentration.

“A well-defined metrological infrastructure is therefore required to prevent incorrect measurements and significantly improve patient safety. This will allow infusion pump manufacturers to include more robust and precise information on the dose delivered to the patient, and drug delivery device end-users to have an enhanced metrological understanding of them. Our new Micro-flow Measurement Facility will play a significant part in achieving this goal, as it can be used by medical equipment manufacturers and end-users to verify performance and provide confidence in medication delivery,” concluded Dr Graham.

NEL’s Micro-flow Measurement Facility will also be used as part of the new EMPIR MFMET research programme to develop globally accepted standards for microfluidic devices used particularly in the health and pharmaceutical industry