FDA Warns of Deaths, Injuries Linked to Negative Pressure Wound Therapy
The Food and Drug Administration is warning today about six deaths and dozens of injuries reported in the last two years among patients who have undergone negative pressure wound therapy (NPWT) for treatment of wounds, burns, and other injuries.
NPWT systems are used to apply negative pressure to wounds and remove fluids and infections. The therapy is commonly part of treatment to manage wounds, burns, ulcers, flaps, and grafts, but fatal complications such as bleeding may occur, the FDA said.
Dozens of NPWT Injuries Reported
In addition to the six reported deaths, the FDA said in the last two years, it has received reports of 77 injuries associated with the use of NPWT systems, officials said. As a result, the FDA has issued a Preliminary Public Health Notification, an early warning issued by the agency at the onset of an investigation into a problem.
The FDA said NPWT patients should be monitored closely in a hospital or other appropriate healthcare setting for development of bleeding and other life-threatening complications.
NPWT involves sealing the wound with gauze or foam filler dressing and using a vacuum source to apply negative pressure to the wound with a tube threaded through the dressing. The vacuum may be applied constantly or only for shorter periods of time, depending on the type of wound being treated and the patient’s condition.
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