FDA warns of death, complications from type of wound therapy
Reports of deaths and serious complications in patients who have been treated with Negative Pressure Wound Therapy (NPWT) systems has resulted in a warning to acute and long-term health care facilities staff and consumers by the Food and Drug Administration (FDA).
NPWT is a topical negative pressure, sub-atomospheric pressure dressing or vacuum sealing technique generally indicated for the management of wounds, burns, ulcers, flaps and graphs. NPWT apply negative pressure to the wound in order to remove fluids, including wound exudates, irrigation fluids and infectious materials. The system is thought to benefit wounds healing by removing wound fluid and dessicated tissue, decreasing the level of bacteria in the wound, improving blood flow in the wound and surrounding tissue, promote granulation tissue, and pulling the wound edges together and stimulating cell growth.