Negative Pressure May Have Unnoticed Complications
By Robert Finn
Elsevier Global Medical News
The Food and Drug Administration has warned health care providers and patients to be vigilant for potentially life-threatening complications with the use of negative-pressure wound-therapy devices.
The agency issued the official notification late last year after receiving reports of 6 deaths and 77 injuries associated with the devices.
"Most of the deaths reported to [the] FDA occurred at home or in a long-term care facility," the notice stated.
Bleeding was the most serious complication and was involved in all of the deaths and 17 of the injuries, according to the FDA, but infection played a role in 27 reports. The infections arose from the original open wound or dressing pieces retained in the wound. Overall, 32 of the injuries involved retention of foam dressing pieces. Most of those patients required surgical procedures, wound debridement, and treatment of wound dehiscence as well as additional hospitalization and antibiotic therapy.
The FDA's notification included a list of wound types and conditions for which negative-pressure wound therapy (NPWT) is contraindicated. The agency also provided a list of risk factors that health care providers should consider before using NPWT (see boxes below).
"In the appropriate wounds and in the appropriate areas," NPWT is still useful, said Dr. Paul Y. Takahashi in an interview. But I think we have to be pretty cautious." Dr. Takahashi of the Mayo Clinic, Rochester, Minn., is a certified medical director and an expert in wound care.
"It's still an FDA-approved device," he said. "It still can help, particularly with preventing amputations. It can help in some situations in which a flap or a skin graft is not appropriate. And it certainly can still be beneficial for wounds that are not healing. But I think you really have to be well trained in using the negative pressure device, and when you remove it ... make sure it's well observed, make sure things are healing in nicely and that you're not having excess bleeding."
One issue is that complications can go unnoticed in NPWT-treated wounds, Dr. Takahashi said. Unlike standard wound dressings, which are changed at least daily, NPWT dressings may not be changed for 3 or 4 days, masking any problems.
Staff and patients should be alert for certain problem signs, Dr. Takahashi said. The edges of the wound should maintain a nice pink color. It's time to become concerned when the edges start turning red or the area becomes painful. Other concerning symptoms include fevers, chills, and changes in blood pressure.
The full text of the FDA's notification. The agency also prepared a patient handout, available.