New MHRA Guidance acknowledges the need to monitor for VND
Redsense Medical announces today that the UK Medicines & Healthcare Products Regulatory Agency (MHRA) has issued a new dialysis guidance, in which venous needle dislodgement (VND) is explicitly acknowledged as an important issue that should be addressed to ensure the safety of patients. Currently, Redsense offers the only standalone blood loss monitor registered with the MHRA for use on the UK market.
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, 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 be updated to comply with the UKCA mark to keep full access to the UK market, before 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.
For more information, please contact:
Patrik Byhmer, CEO Redsense Medical AB (publ)
Phone: +46 35 10 60 30
ABOUT REDSENSE MEDICAL
Redsense Medical is a corporate group with operations mainly in Europe and the United States. The company has developed the Redsense System, an innovation used for monitoring and alarm in the case of blood leakage in connection with a hemodialysis treatment. Redsense Medicalsolves one of the most serious remaining safety problems within hemodialysis – to quickly detect Venous Needle Dislodgement and catheter leakage to minimize blood leakage. The system consists of a patented fiber optic sensor, designed for either venous needle or central venous catheter, which is connected to an alarm unit. From the very start, the development of the company's technology has been based on the demands and safety requirements of healthcare providers in the dialysis sector.