The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing hemodialysis treatment.
The device includes a blood sensor incorporated into a sensor patch. The sensor monitors potential blood leakage from the venous needle blood access via a light signal and will alarm if blood leakage is detected by the device’s sensor.
All use must be administrated under physician’s prescription, and must be observed by a trained and qualified person considered to be competent in the use of this device by the prescribing physician.
Redsense may be use together with all cleared hemodialysis equipment. Its cleared for sale in the USA by FDA.
The Redsense device is an alarm system for monitoring the venous needle during hemodialysis in clinic or at home. Redsense device is CE marked and quality approved according to European standards.
This document deals with how the risk of venous needle dislodgement is treated under US and European Medical Standards. In both sets of standards, it is acknowledged that venous needle dislodgement can cause potentially lethal situations and that there is currently no optimal system available for detection.
Various organisations and other sources confirm the lack of an optimal alarm, adding proof of incidents where an adequate alarm could have changed the fatal course of events. Redsense is the first clinically tested monitoring system for venous needle dislodgement in hemodialysis.