The MHRA is the UK executive agency responsible for ensuring the safety and regulatory compliance of medicines and medical devices in the UK market. On March 8, 2022, the MHRA published an updated guidance relating to dialysis care in the United Kingdom, aimed at healthcare professionals and dialysis patients.

The new guidance (https://www.gov.uk/government/publications/dialysis-guidance/dialysis-guidance), which was developed in cooperation with the UK Kidney Patient Safety Committee (KPSC), summarizes the known safety issues with dialysis and other renal therapies and recommends various measures that should be implemented during treatment to minimize or prevent adverse events.

The guidance emphasizes the risk of severe blood loss from VND incidents and states that both staff and patients should be educatedon the possible consequences and implement actions to counter the risk. It goes on to underline that the HD machine itself can not be relied upon to detect VND, and that patients must be individually assessed. High risk patients are recommended to use external alarm devices intended for VND monitoring.

"The MHRA's acknowledgement that venous needle dislodgement is a serious risk that requires specific monitoring is an important step that will protect and benefit the UK dialysis patients,"says Patrik Byhmer, CEO of Redsense Medical AB: "As previously disclosed, the Redsense Alarm, our well-established VND monitoring device, is already registered with the MHRA and will therefore have full access to the UK market even when the country ceases to accept the European CE marking next year."

About venous needle dislodgement (VND) and Redsense

During hemodialysis, vascular access points are opened to the patient's bloodstream to draw and return blood for extracorporeal purification. Sometimes, the venous needle accidentally comes out of the access point - for example if the needle is not secured correctly, or if the bloodline is pulled - which immediately results in blood loss and quickly poses a major risk for the patient. The Redsense Alarm is an established patient safety device that uses fiber-optic technology and light to continuously monitor for blood leakage and alert the nurses' and patient's attention if VND occurs.