CHICAGO—Veteran’s Affairs will require an alarm that detects venous needle dislodgement in its dialysis centers by Nov. 1, according to a news release from the device’s manufacturer Redsense Medical.
The VA National Center for Patient Safety analyzed 47 bleeding incidents between 2002 and 2010 and found that "Forty of these events were serious bleeding episodes and some of these resulted in fatalities."
As a result of that research, the VA Central Office issued a patient safety alert on July 7 stating that by Nov. 1 all VA dialysis centers will be required to use the Redsense alarm for all patients with needle access undergoing hemodialysis outside of the dialysis clinic area.
Areas considered outside of the dialysis unit include in-hospital wards or ICUs where treatments are done at the bedside, and side rooms or isolation rooms in the hemodialysis unit that do not allow direct line-of-sight visualization of the patient and the dialysis machine during hemodialysis, according to the Redsense news release.
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 via an infrared light and will alarm if needle dislodgement or blood leakage is detected.
Redsense said the alarm could also be used on patients identified by dialysis staff at risk of a venous needle dislodgement. Risk factors include conditions such as confusion, agitation dementia, or uncooperative patients, patients with difficult to secure needles, or other patients with risks which may be of concern to the dialysis team.
"We're very impressed by the thorough way in which Veteran Affairs has investigated the need for improved patient safety in hemodialysis and proud to support the VA's efforts to protect their patients,” Redsense Medical CEO Patrik Byhmer. “Gaining the confidence of the US Veteran's Administration 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."