Video originally created by FDA -- posted by Lawsuit.com on January 19, 2010
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 of them:
• Select patients carefully. This therapy is contraindicated in patients with exposed vasculature, nerves, organs and anastomotic sites, and also for patients with untreated osteomyelitis, non-enteric and unexplored fistulas, malignancy in the wound, and necrotic tissue with eschar present. Also, carefully consider the use of this therapy in patients with certain risk factors, including those with a high risk for bleeding and hemorrhage, and those receiving anticoagulants or platelet aggregation inhibitors.
• Assure that the patient is monitored frequently by a trained practitioner in an appropriate care setting.
• Be vigilant for potentially life-threatening complications, such as bleeding, and be prepared to take prompt action if they occur.
• Finally, if the patient is a candidate for using a Negative Pressure Wound Therapy system at home, instruct the patient and any caregivers about how to use the system and ask them to demonstrate their understanding. Make sure they know the signs and symptoms of potential complications and what to do if they occur.