The FDA received reports of six deaths and 77 injuries from NPWT systems in the past two years, most of which occurred at home or at long-term care facilities.
NPWT systems are generally used for the management of wounds, burns, ulcers, flaps and grafts. They apply negative pressure to the wound in order to remove fluids, including wound exudates, irrigation fluids and infectious materials. NPWT systems consist of the following components: an apparatus that generates vacuum and is capable of creating a negative pressure environment within a sealed wound; dressing materials used to pack the wound and seal it; a conduit for fluid removal from the wound bed; and a container/canister to collect waste materials that are removed from the wound bed via suction.
The FDA recommends that healthcare providers select patients for NPWT carefully and consider wound type and patient risk factors before prescribing the use of NPWT.
Read the FDA’s alert on negative pressure wound systems.
