Who: Negative Pressure Wound Therapy

What: The Negative Pressure Wound Therapy (NPWT) systems

Why: There have been deaths and serious complications after use of NPWT systems.  So far, 6 deaths and 77 serious injuries have been reported since 2009. 

What Are NPWT systems? NPWT systems are generally indicated for the management of wounds, burns, ulcers, flaps and grafts. They apply negative pressure to the wound in order to remove fluids, including wound exudates, irrigation fluids, and infectious materials. Healthcare professionals were advised to select patients for NPWT carefully, after reviewing the most recent device labeling and instructions. Patients should be monitored frequently in an appropriate care setting by a trained practitioner, and practitioners should be vigilant for potentially life-threatening complications, such as bleeding, and be prepared to take prompt action if they occur