FDA: Be Vigilant with Negative Pressure Wound Therapy

The FDA has issued a public health notification about the potential complications, especially bleeding and infection, associated with negative pressure wound therapy. According to the notification, the FDA has received reports of six deaths and 77 injuries associated with NPWT.

Rather than steer healthcare practitioners away from NPWT, however, the FDA is advising that they remain vigilant about following manufacturers' instructions and carefully select the patients who receive treatment. Caregivers should also be prepared to immediately address any complications that might arise from NPWT.

While NPWT is commonly used to manage wounds, burns, ulcers, flaps and grafts, there are a number of situations in which it should not be used. Those include:

• Necrotic tissue with eschar present
• Untreated osteomyelitis
• Non-enteric and unexplored fistulas
• Malignancy in the wound
• Exposed vasculature
• Exposed nerves
• Exposed anastomotic site
• Exposed organs

If you suspect that a reportable adverse event related to an NPWT system has occurred, the FDA urges you to follow the reporting procedure established by your facility.

To view the notification in its entirety, click here.