Negative Pressure Wound Therapy Deaths Continue To Be Reported: FDA

The number of deaths linked to Negative Pressure Wound Therapy systems has continued to mount, even after the FDA issued a warning about potential problems with the devices more than a year ago. 

This week the FDA issued an update on its ongoing investigation into negative pressure wound therapy deaths and injuries.

Negative Pressure Wound Therapy (NPWT) involves the application of negative pressure on a wound and maintaining a vacuum around it. This is done to extract fluids and infectious materials from the wound, and to cause it to dry out, or desiccate. NWPT is most commonly used with burns, flaps, ulcers and grafts, but it is contraindicated for several types of injuries, including wounds where there are exposed nerves, organs and vasculature.

Since the FDA’s first Negative Pressure Wound Therapy warning in November 2009, there have been at least six additional deaths and 97 injuries linked to NPWT use. That brings the total number of incidents to 12 deaths and 174 injury reports since 2007.

Most of the deaths with negative pressure wound therapy have involved severe bleeding. Patients most at risk appear to be those who had blood vessel grafts, wound infections, and those who were receiving medicine for blood clots. There also appears to be a higher risk of bleeding during removal of dressings attached to the tissues, the FDA warns. Most of the deaths also took place in a home, nursing home or other long-term care environment.

The FDA is calling on health care providers to make certain that patients undergoing NPWT are monitored frequently by a trained practitioner. Doctors should be alert for potentially life-threatening complications, including bleeding, and should be prepared to take quick action if those complications arise. They should also be aware of the potential complications that can occur when changing dressings, such as bleeding and infection.

Patients need to be thoroughly trained on the use of such systems and on how to detect signs of complications, particularly if they will be using the system at home, the agency recommends.

The FDA is continuing to review the safety of Negative Pressure Wound Therapy systems and is monitoring for more adverse events. The agency proposed no action, but said that it will make any new information available that might affect the use of such systems.