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AJN, American Journal of Nursing:
doi: 10.1097/01.NAJ.0000368938.90936.17
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FDA Warning About Negative Pressure Wound Therapy

Wallis, Laura

Section Editor(s): Pfeifer, Gail MA, RN

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E-mail: ajnNews@wolterskluwer.com

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Abstract

Risks of serious bleeding, infection, and even death.

In November 2009, the Food and Drug Administration (FDA) issued a preliminary warning (http://bit.ly/4vF1AZ) to health care professionals and patients regarding reports of rare but serious complications associated with the use of negative pressure wound therapy (NPWT). The warning was issued after reports emerged over the past two years of 77 injuries and six deaths related to the use of NPWT systems. A follow-up guide for patients (http://bit.ly/5vA2To) was issued in December.

Also referred to as vacuum-assisted closure, topical negative pressure, and sealed-surface wound suction, NPWT involves creating a vacuum over the surface of a wound in order to draw out fluids, discourage infection, increase blood flow, and bring wound edges together to speed healing. Since its development in the late 1980s, NPWT has been used for a wide and growing range of acute and chronic wounds, including ulcers, surgical wounds, and burns.

The FDA is urging clinicians and patients to be aware of the risks associated with NPWT and to watch for possibly life-threatening complications, such as bleeding and infection, so that prompt action can be taken. In addition, every provider should fully understand contraindications to the treatment's use (malignancy or exposed vasculature, nerves, or organs in the wound, for example), and carefully consider patient risk factors, such as a high risk of bleeding. Although these complications can occur wherever the treatment is used, most of the reported deaths occurred at long-term health care facilities and at home, and the FDA's guide to consumers stresses the importance of (among other things) patients and caregivers learning how to use the equipment; knowing the signs and symptoms of bleeding, serious infections, and wound deterioration; understanding possible interactions between medications and NPWT; and keeping the manufacturer's instructions handy.

Concerns over practice. Controversy exists over the proper use of NPWT. Continuous, relatively high pressure has been the standard of care for more than two decades, despite a small body of literature (primarily studies in pigs) suggesting that lower levels of intermittent pressure promote faster healing. Continuous, high-level pressure became the standard of care because the earlier equipment lacked sufficient pressure control for intermittent pressure to be practical. Cindy Ahearn, author of a literature review in the June 2009 issue of Ostomy Wound Management, recommends further, better-quality research. "The proliferation of . . . new devices," she wrote, "should inspire productive comparison that will provide information not only on economics of use, but also on what is ultimately best for the patient."

Perhaps more worrisome is that NPWT may not be superior to conventional wound care in the first place. Two 2009 Cochrane reviews call the practice into question. A review by Ubbink and colleagues (http://bit.ly/8gOf2j) concluded that "There is no valid or reliable evidence that topical negative pressure increases chronic wound healing." And a review by Wasiak and Cleland (http://bit.ly/631clS) concluded that there isn't enough valid research "to detect differences, if there are any, between [NPWT] and conventional burn wound therapy dressings.

The FDA also encouraged the reporting of any adverse effects associated with the treatment. For nurses, this is the best way to ensure safer treatments. "Professionals must be much more aggressive in reporting negative outcomes," says Lia van Rijswijk, editor of Ostomy Wound Management and coordinator of AJN's Wound Wise column. She urges nurses to feel confident about using the FDA MedWatch Web site. "There's no need to fear retribution. It's fast and easy, and you don't have to include the prescribing physician." Although a nurse may not want to engage a physician in a debate over use of NPWT, making her or him aware of the FDA alert can be beneficial, and reporting adverse outcomes will lead to more rigorous oversight of the devices. The MedWatch voluntary reporting form can be found at http://bit.ly/bW5WC.

Laura Wallis

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