FDA warns of death, complications from type of wound therapy
Reports of deaths and serious complications in patients who have been treated with Negative Pressure Wound Therapy (NPWT) systems has resulted in a warning to acute and long-term health care facilities staff and consumers by the Food and Drug Administration (FDA).
NPWT is a topical negative pressure, sub-atomospheric pressure dressing or vacuum sealing technique generally indicated for the management of wounds, burns, ulcers, flaps and graphs. NPWT apply negative pressure to the wound in order to remove fluids, including wound exudates, irrigation fluids and infectious materials. The system is thought to benefit wounds healing by removing wound fluid and dessicated tissue, decreasing the level of bacteria in the wound, improving blood flow in the wound and surrounding tissue, promote granulation tissue, and pulling the wound edges together and stimulating cell growth.
However, the FDA has received reports of six deaths and 77 injuries associated with NPWT systems over the past two years. Bleeding was the most serious complication, occurring in all six deaths and in 17 of the injuries. These complications can occur in hospitals, long-term care facilities, and at home.
Of the 83 reports to the FDA, 27 reports indicated worsening infection from original open infected wounds or from pieces of dressing that remained in the wound, and 32 reports noted injury from foam dressing pieces and foam sticking to tissues or clinging to the wound. Most of these patients required surgery, additional hospitalization, and antibiotics.
The agency is advising health care professionals to select patients for NPWT carefully, after reviewing the most recent device labeling and instructions. Risk factors and characteristics that should be considered before NPWT use include patients at high risk for bleeding and hemorrhage; patients on anticoagulants or platelet aggregation inhibitors; patients with infected blood vessels, infected wounds, exposed organs, or sharp edges in the wound (such as bone fragments); and patients with spinal cord injuries. A full list of risk factors and contraindications can be found on the FDA’s letter to healthcare practitioners.
Patients should be monitored frequently in an appropriate setting by a trained practitioner, and should be vigilant for potentially life-threatening complications, such as bleeding, and be prepared to take prompt action if they occur. Patients who use NPWT at home should receive adequate training from their health care provider on how to use the NPWT device; understand the possible complications that may be associated with using the NPWT device; get NPWT patient instructions their doctor, NPWT distributor, or the manufacturer’s Web site; and talk to their doctors if they do not feel capable of managing the NPWT device at home.
Consumers may report adverse reactions related to negative pressure wound therapy to FDA’s MedWatch Adverse Reporting Program.
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