[UPDATED 02/24/2011] FDA notified healthcare professionals of an update of activities to date involving NPWT, including a summary of additional adverse event reports received by the FDA since November 2009, as well as new recommendations for health care providers and patients/caregivers, and information about pediatric use. The safety and effectiveness of NPWT systems in newborns, infants and children has not been established at this time and currently, there are no NPWT systems cleared for use in these populations.
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. 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.
[02/24/2011 - Safety Communication - FDA]
[12/10/2009 - Consumer Update - FDA]
[11/16/2009 - Preliminary Public Health Notification - FDA]
[11/16/2009 - Advice for Patients - Negative Pressure Wound Therapy Devices - FDA]