News
Redsense Medical Receives FDA
Clearance for the Redsense safety device for Home/Self Use During Home
Hemodialysis.
May 18, 2010:
The Redsense safety device is now cleared
by FDA for Home/Self use and is consequently available to all patients
with home hemodialysis in the US. Redsense safety device is
designed to detect venous needle dislodgement during hemodialysis and
its use has already improved in-clinic patient safety. Optimizing safety
conditions for home hemodialysis users is a core ambition for Redsense
Medical.
Dialysis equipment today is required to have a system which protects the patient from blood loss due to dislodgement of the venous needle. The commonly accepted solution is to monitor by the venous pressure alarm but a better solution has long been requested. Even with the routine supervision of medical staff still the venous needle can become dislodged: the dialysis machine will then continue to draw blood from the patient’s artery however not returning blood in the loop circuit as the venous needle has become dislodged and the patient’s blood ends up elsewhere. If undetected, this blood loss can have very serious consequences in only a few minutes. Redsense safety device provides a solution to this problem and detects venous needle dislodgement instantaneously; it only takes a few millilitres of blood on the sensor patch to sound the alarm.
It is well known that
home hemodialysis allows for daily treatments, improving quality of
life, morbidity, and life expectancy. Home hemodialysis is also more
cost-effective as it can free hospital beds and reduces the transport
costs related to centralized dialysis care.
Being able to address the
market for home hemodialysis is an important step according to, CEO
Patrik Byhmer:
- This is where
Redsense really can make a difference. It’s very satisfying being able
to increase the level of safety among the users of home hemodialysis.
The product
The
Redsense safety device is the results of close co-operation between
medical staff and engineers. Redsense consists of two parts: a sensor
patch and an alarm unit. An infrared signal is transmitted from the
alarm unit to the sensor patch using fibre optic cable. In the event of
bleeding, inner layers of the patch smear blood over the optical sensor,
which triggers the alarm.
Redsense Medical Receives FDA Approval for Blood Loss Detection Device
SEATTLE, Nov. 1, 2007 (HSMN NewsFeed) -- Redsense Medical's blood loss detection device for monitoring venous needle dislodgement has been granted FDA approval, and is now available for sale in the United States. The Swedish company's patented Redsense blood loss detection system is the world's first such device. Having met Europe's rigorous health & safety standards, the device has already been granted CE approval. With the FDA's approval, Redsense is the first clinically-tested, reliable blood loss monitoring system available in the U.S.About 1.5 million patients worldwide receive over 200 million dialysis treatments every year. The size of the market is forecast to increase due to an aging population and the rise of diseases such as diabetes type II.
Medical professionals have long been aware of the risk of venous needle dislodgement during dialysis treatment. In the U.S. alone, 7 to 10 patients needlessly die each year due to needle dislodgement. It is feared that the true death rate is 3 to 4 times higher than reported. The total number of serious incidents is estimated to be in the thousands.
"Blood loss resulting from disconnection of the venous needle during hemodialysis is a potentially serious event. Redsense has developed an ingenious device to provide prompt warning when this adverse event occurs," said recognized hemodialysis expert Dr. Christopher R. Blagg, Professor Emeritus of Medicine, University of Washington.
Until now, the typical method of needle dislodgement detection for this common form of renal therapy has been venous pressure monitoring, a built-in function of all dialysis machines. However, incidents have been reported whereby significant blood loss occurred before the venous pressure alarm sounded, resulting in serious, even fatal consequences[1].
Developed in response to demands made by dialysis professionals, Redsense will become a vital aid to the dialysis caretaker, increasing patient safety.
"Even with careful monitoring by dialysis professionals, needles do become dislodged, and significant blood loss can occur before dislodgement is detected." Patrik Byhmer, CEO of Redsense Medical, explains. "Other monitoring systems rely on blood pressure or moisture detectors and the reliability of those techniques is uncertain at best. The Redsense blood loss detection device has been clinically tested and is proven to be reliable. Patients can change position or rest without risking an undetected dislodgement. For care providers, this device offers unprecedented peace of mind and the freedom to move freely around the dialysis care unit."
Redsense consists of two parts: a sensor patch and an alarm unit. An infrared signal is transmitted from the alarm unit to the sensor patch using fiber optic cable. In the event of bleeding, inner layers of the patch smear blood over the optical sensor, which triggers the alarm. Redsense does not react to perspiration or water, so moisture alone will not cause an alarm. And because the signal to the sensor is continuous, the alarm reacts instantly to the first milliliter of blood. Nurses and doctors are free to focus on the tangible problems of hemodialysis. And the patient can benefit from the care of professionals who feel in control of their situation.
[1] "Neglected Safety Aspects in Hemodialysis and Their Related Problems," H-D Polaschegg, Hemodialysis Horizons, 2006. "Undetected Venous Line Needle Dislodgment during Hemodialysis," Health Devices Nov 1998;27(11):404-6
Source: Redsense Medical. Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.