The Food and Drug Administration (FDA) has issued safety information regarding Negative Pressure Wound Therapy (NPWT) systems. Healthcare professionals have been notified by the US authority regarding deaths and serious complications associated with the use of these systems.
The FDA has received reports of six deaths and 77 injuries associated with NPWT systems over the past two years.
NPWT systems are generally indicated 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.
Healthcare professionals are advised to select patients for NPWT carefully, after reviewing the most recent device labelling and instructions.
Patients should be monitored frequently in an appropriate care setting by a trained practitioner, and practitioners should be vigilant for potentially life-threatening complications, such as bleeding, and be prepared to take prompt action if they occur.
For further information visit the FDA website.
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