FDA Issues Health Notice on NPWT Complications

It’s business as usual for makers of negative pressure wound therapy (NPWT) systems — despite a recent FDA public health notice about deaths and injuries related to the devices. The notice details reports of six deaths and 77 injuries associated with NPWT systems over the past two years. Kinetic Concepts, the largest manufacturer of NPWT systems, said it will continue education initiatives on the appropriate use of the product, but it is not planning any other action related to NPWT.
Devices & Diagnostics Letter