FDA warns of negative pressure devices

WASHINGTON, Dec. 10 (UPI) -- The U.S. Food and Drug Administration has issued a warning about rare, but serious, complications from the use of negative pressure wound therapy devices.

The FDA said the devices help in the healing and closure of wounds by creating negative pressure -- a vacuum -- at well-sealed wound sites to help remove fluids and infectious materials and draw wound edges together.

But in its warning, the federal agency said serious complications, especially bleeding and infection, have been reported in some patients using the devices.

"Over the past two years, FDA has received six death and 77 injury reports associated with (negative pressure wound therapy) devices," the FDA said in a statement. "Most deaths occurred at home or in long-term care facilities. Bleeding was the most serious complication, occurring in all six deaths and in 17 of the injuries."

The federal agency said the reports also included cases of infections from original open infected wounds worsening due to pieces of dressing that remained in the wound, and of injury from foam dressing pieces and foam sticking to tissues or clinging to wounds.

The FDA's warning and its recommendations for patients using negative pressure wound therapy are available at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm193277.htm#FDARecommendations.