The FDA notified healthcare professionals of a Preliminary Health Notification describing deaths and serious complications associated with the use of Negative Pressure Wound Therapy (NPWT) systems.  A Preliminary Public Health Notification is similar to a Public Health Notification. However, it is issued when the information the FDA receives is still evolving, but the FDA decides to contact the health care community to help practitioners make informed clinical decisions.   The FDA has received reports of 6 deaths and 77 injuries associated with NPWT systems in just the last 2 years.

NPWT systems are usually used in the treatment of wounds, burns, ulcers, flaps and grafts.  The healthcare professional applies negative pressure to the wound in an effort to remove fluids, including wound exudates, irrigation fluids and infectious materials. 

Healthcare professionals were advised by the FDA to select patients for NPWT carefully and only after reviewing the most up to date labeling and instructions. Patients should be monitored frequently in the appropriate health care setting and by a trained wound care practitioner.  According to the FDA, healthcare professionals should be vigilant in checking patients for life-threatening complications, including bleeding.

Read the FDA MedWatch safety summary HERE.