FDA Warns of ‘Serious Complications’ from NPWT

SILVER SPRING, Md. — In notifications issued Nov. 13, the
Food and Drug Administration has advised health care professionals
and patients about “rare but serious serious complications —
including deaths — from the use of negative pressure wound
therapy.”

In the notifications, the agency alerted the public and health
professionals that serious complications, especially bleeding and
infection, have been reported in some patients using NPWT devices.
“These complications can occur wherever NPWT is used, including
hospitals, long-term care facilities and at home,” the FDA
said.

NPWT devices can help in the healing and closure of wounds. They
create negative pressure (a vacuum) at well-sealed wound sites that
can help remove fluids and infectious materials and draw wound
edges together.

Over the past two years, the FDA said it has received six death
and 77 injury reports associated with NPWT devices. Most deaths
occurred at home or in long-term care facilities. Bleeding was the
most serious complication, occurring in all six deaths and in 17 of
the injuries.

According to the reports, extensive bleeding has occurred in
patients:

• with blood vessel grafts in the leg;
• with breastbone or groin wounds;
• receiving medication for blood clots; or
• during removal of dressings attached to the tissues.

The reports also included cases of infections from original open
infected wounds worsening due to pieces of dressing that remained
in the wound, and of injury from foam dressing pieces and foam
sticking to tissues or clinging to wounds. Most of these patients
required surgery, additional hospitalization and antibiotics,
according to the notice.

FDA said it is addressing these problems and will continue
monitoring adverse events associated with NPWT devices. In the
meantime, the reports of the adverse events led FDA to issue
recommendations for patients using NPWT at home:

• Receive adequate training from a health professional (for
  example, your doctor, a nurse, or a home health care provider) so
  that you understand how to use your NPWT device. Demonstrate to
  your trainer that you know how to use the device properly.
• Find out how long you should expect to use the device.
• Understand the possible complications that may be associated
  with using the device. Know the warning signs so you can recognize
  complications early. Watch especially for bleeding, which can be
  life-threatening. If you see signs of bleeding, seek medical
  assistance immediately.
• Before using NPWT at home, ask your health professional what to
  do if complications do occur. Find out who to contact, how to
  recognize bleeding and serious infection and how to recognize if
  your wound condition is worsening.
• Get NPWT patient instructions (labeling) from your doctor, home
  health care provider, NPWT distributor or the manufacturer’s Web
  site. Keep these instructions where you can easily find them.
• Let your health professional know if you do not feel capable of
  managing the NPWT device at home. He or she might recommend that
  you be assisted by an appropriate caregiver.
• Ask your health professional whether you need to stop taking
  aspirin or any other medications that affect bleeding or blood
  clotting, and what the associated risk is of stopping or avoiding
  such medicines.

To read the full FDA article, which includes instructions for
reporting adverse reactions related to NPWT, see “Negative
Pressure Wound Devices Draw FDA Notice, Advice“.