Negative Pressure Wound Devices Draw FDA Notice, Advice

December 10, 2009

The Food and Drug Administration (FDA) has notified health professionals, and advised patients, about rare but serious complications -- including deaths -- from the use of negative pressure wound therapy (NPWT).

Negative pressure wound therapy devices can help in the healing and closure of wounds. They create negative pressure (a vacuum) at well-sealed wound sites that can help remove fluids and infectious materials and draws wound edges together.

In a notification to health professionals and advice for patients issued on Nov. 13, 2009, FDA alerted that serious complications, especially bleeding and infection, have been reported in some patients using NPWT devices. To read the full FDA Consumer Update article, see Negative Pressure Wound Devices Draw FDA Notice, Advice, at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm193277.htm.