Complications with Negative Pressure Wound Therapy

FDA is alerting healthcare professionals and patients about deaths and serious complications from Negative Pressure Wound Therapy (NPWT). This therapy promotes wound healing by applying negative pressure to remove fluids and infectious materials from the wound area. NPWT is used in both acute and long-term care facilities and at home. FDA has received reports of six deaths and 77 injuries associated with NPWT systems over the past two years. Although rare, complications can occur wherever these systems are used. Most of the deaths occurred at home or in a long-term care facility. Bleeding was the most serious complication, reported in all of the six deaths and in 17 of the injury reports. Other serious effects included worsening infection of the original open wound, retention of foam dressing pieces, or foam adhering to tissues or becoming imbedded in the wound. FDA has several recommendations to help reduce the risk of serious complications with Negative Pressure Wound Therapy. Here are some o