FDA alerts healthcare providers about negative pressure wound therapy
The Food and Drug Administration has issued an alert about deaths and serious complications associated with the use of Negative Pressure Wound Therapy (NPWT).
The FDA said that it has received reports of six deaths and 77 injuries associated with NPWT systems over the past two years. Most of the deaths occurred at home or in a long-term care facility, the FDA said. Bleeding was the most serious complication and was reported in six death and 17 injury reports.
The agency recommends selecting patients for NPWT carefully. Also a trained practitioner should monitor the patient frequently in an appropriate care setting. Healthcare practitioners should be vigilant for potentially life-threatening complications, such as bleeding, and be prepared to take prompt action if they occur. NPWT systems apply negative pressure to wounds to remove fluids.The two biggest players in the NPWT market are Kinetic Concepts Inc. and Smith & Nephew.