Negative Pressure Wound Therapy (NPWT) systems - Preliminary Public Health Notification
MedSun: Newsletter #43, December 2009
FDA MedWatch Safety Alert
FDA notified healthcare professionals of a Preliminary Public Health Notification describing deaths and serious complications associated with the use of Negative Pressure Wound Therapy (NPWT) systems. FDA has received reports of six deaths and 77 injuries associated with NPWT systems over the past two years. NPWT systems are generally indicated for the management of wounds, burns, ulcers, flaps and grafts. 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.
FDA MedWatch Safety Alert. Negative Pressure Wound Therapy (NPWT) systems - Preliminary Public Health Notification. November 16, 2009.