Redsense blood loss detection device gains EU approval
13 March 2007
Redsense Medical’s device for blood loss detection during
haemodialysis has been approved for sale in Europe and granted the CE mark.
The device comprises two parts: a sensor patch and a base unit. Connected to
the base unit by a small wire. The sensor patch employs fibre optic
technology to continuously monitor the venous needle access point. If the
needle dislodges and bleeding begins, an alarm is raised by the base unit
worn on the patient’s arm.
The blood loss detection device has proved to
be highly effective and user friendly, with no more than an on/off switch.
Dialysis equipment must provide a system to protect the patient from blood
loss due to dislodgement of the venous needle.
Considerable, or even fatal, blood loss can occur when the venous needle
becomes dislodged. Although it is currently permissible that
this requirement can be met by venous pressure monitoring, a better solution
has long been requested by the medical staff.
After a number of incidents in a Swedish dialysis clinic, cooperation
between the clinic's technicians and a company specialising in medical
technology led to the creation of Redsense Medical in 2006. The
company has offices in Sweden and in the Seattle, USA.
Redsense Medical anticipates approval for the device from the US FDA during
spring/summer 2007 and also to start production in this period.