Nocturnal Dialysis – FDA Clears the Redsense Safety Device for 8 Hours

February 18, 2011

HALMSTAD, Sweden and CHICAGO, February 18, 2011 /PRNewswire/ — The
Redsense safety device is the only device cleared by FDA to monitor patients
for potential blood loss from the hemodialysis needle puncture site. With an
8 hour FDA clinical clearance, Redsense is available to help protect patients
undergoing treatment in clinics for longer than 5 hours – such as Nocturnal

(Photo: http://www.newscom.com/cgi-bin/prnh/20110218/437643 )

Dialysis equipment today is required to have a system that protects
patients from blood loss in the event of venous needle dislodgement. The
commonly accepted solution is to monitor by the venous pressure alarm, but a
better solution has long been required. Even with the routine supervision of
medical staff, the venous needle can still become dislodged. When this
happens, the dialysis machine will continue to draw blood from the patient’s
artery, but without returning blood in the loop circuit, meaning the
patient’s blood ends up elsewhere. If undetected, this blood loss can have
serious consequences in only a few minutes. During Nocturnal treatments, the
patient’s attentiveness can alter, which may increase the risk of venous
needle dislodgement as a result. The Redsense safety device provides a
solution to this problem and helps detect venous needle dislodgement
instantaneously; it only takes a few milliliters of blood on the fiber optic
sensor to sound the alarm.

Redsense Medical CEO Patrik Byhmer comments: “This is where Redsense
really can make a difference. It’s very satisfying being able to increase the
level of safety for patients undergoing nocturnal hemodialysis, while
reducing the potential risk exposure to the clinics. This FDA clearance is a
huge step in the right direction for Redsense to become the recognized
standard of care in VND patient safety, in line with existing regulations”.

The product:

The Redsense device is intended to monitor for potential blood loss from
the hemodialysis access site for patients undergoing hemodialysis treatment
at home or in the clinical setting. The device includes a blood sensor
incorporated into an adhesive dressing. The sensor monitors potential blood
leakage from the needle puncture site via an infrared light and will alarm if
needle dislodgement or blood leakage is detected.

The company:

Redsense Medical and the Redsense safety device are the results of close
co-operation between medical staff and engineers. The company has offices in
Sweden and in the U.S.


SOURCE Redsense Medical AB

Source: newswire

comments powered by Disqus