Safety recommendation
HSIB recommends that the Medicines and Healthcare products Regulatory Agency [Head of Metabolic Disorders and Renal Systems] communicates to all relevant stakeholders and acts on the available evidence concerning the management of the risks associated with arterial transducer line sets.
Response:
We consider that the safety issues arising following use of open arterial transducer line sets are closely associated with environmental factors and that these systems are safe when used as intended.
However, given the human factors when these devices are in use, there is some evidence that closed loop systems used in continuous blood pressure monitoring reduces the risk of contamination where a glucose containing flush fluid was erroneously used (British Journal of Anaesthesia 104 (4): 446–51 (2010)). In 2014, we issued an article in our monthly bulletin Drug Safety Update on this topic.
We plan to update this information following the publication of the HSIB report to raise awareness of this safety issue (ACTION). We will contact manufacturers of arterial line systems mostly used in the UK to raise this safety concern (ACTION) and ask how they consider to best mitigate this risk. To support this action, we will seek experience from international regulators relating to blood sample contamination associated with open arterial line systems to further understand the magnitude of this safety concern (ACTION). We will furthermore discuss the issue with NHS supply (ACTION) to understand their scope in changing supply of devices to aid patient safety.
Response received on 7 November 2022.