Redsense Safety Device Obtains FDA Clearance

FDA has cleared the Redsense safety device for self or home utilization and is available to U.S. patients who perform hemodialysis from home.

The safety device senses the dislodgement of the venous needle at the time of hemodialysis and its deployment has enhanced the safety of in-clinic patients. The main objective of Redsense Medical is to optimize the safety norms for home hemodialysis patients.

Medical staff and engineers together have worked hard to design this innovative device, which has two parts: an alarm unit and a sensor patch. The alarm unit sends an IR signal to the sensor patch through a fibre optic cable. An alarm is triggered in the case of bleeding, as the sensor patch’s inner layers spread the blood on the optical sensor.

The present day’s dialysis equipment needs a mechanism to safeguard the patient from loss of blood owing to the displacement of the venous needle. The generally recognized solution is to check with the help of the venous pressure alarm. However, there was always a need of an improved solution. In spite of the routine monitoring done by the medical staff, there are chances of the needle getting dislodged. But the dialysis machine will still draw blood from the artery but not send it back to the loop as the venous needle is dislodged. If the blood loss is left unnoticed, this can create life-threatening consequences in a short time. The safety device offers an answer to this issue and discovers the dislodgement of venous needle immediately. A small quantitiy of blood on the sensor patch is enough to trigger an alarm.

Home hemodialysis aids better quality of life, timely treatments,and enhances life expectancy and morbidity. In addition, home hemodialysis is cost-efficient as costs related to transportation to the hospital can be saved and allows hospital beds to be reserved for other uses.

Patrik Byhmer, CEO of Redsense Medical, has stated that this is a significant step in home hemodialysis as it improves the user’s safety.