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FDA Issues Four Wound Care Precautions

Cheryl Clark, for HealthLeaders Media, January 8, 2010

Hospitals and long-term care facilities should be on the lookout for serious complications and risk of death resulting from use of negative pressure wound therapy (NPWT) systems that can cause fatal bleeding and infections, said the U.S. Food and Drug Administration in a Medwatch Safety Alert issued this week.

"FDA has received reports of six deaths and 77 injuries associated with NPWT systems over the past two years," the FDA said. "Although rare, complications can occur wherever these systems are used... Bleeding was the most serious complication, reported in all of the six deaths and in 17 of the injury reports."

Extensive bleeding occurred in patients with vascular grafts, in sternal and groin wounds, in patients receiving anti-coagulant therapy, and during removal of dressings.

The FDA said 32 reports involved foam dressing retention in the wound, and the majority required surgery to remove the retained pieces.

NPWT systems use a vacuum component that creates a negative pressure within a sealed wound. The system is used for wounds, burns, ulcers, flaps, and grafts. They apply negative pressure in order to remove fluids, including irrigation fluids and infectious material.

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