DEVICE SAFETY: Negative pressure wound therapy: Use with care
Nasrin Mirsaidi MSN, RN, CNOR

September 2010 
Volume 40  Number 9
Pages 64 - 66
  PDF Version Available!

NEGATIVE PRESSURE wound therapy (NPWT) is used to treat acute and chronic wounds. A vacuum source creates continuous or intermittent negative pressure inside the wound to remove fluid, exudates, and infectious materials to prepare the wound for healing and closure.1 NPWT systems consist of a vacuum pump, drainage tubing, a foam or gauze wound dressing, and an adhesive film dressing that covers and seals the wound.Since 1997, when the first device indicated for NPWT was cleared by the FDA for marketing in the United States, the system has evolved considerably. New device and dressing features have been added that make the system safer, more efficient, and more user-friendly in care settings other than hospitals, such as in long-term-care facilities, rehab centers, and even patients' homes.Although many patients have benefited from NPWT, adverse events—including deaths and serious injuries—have been reported to the FDA. The following is a case example:An older adult underwent bilateral femoral endarterectomy for severe peripheral arterial disease. About 1 week after the procedure, the patient required surgery for wound exploration and evacuation of blood clots and then was diagnosed with an infection of the right groin incision. An NPWT system was applied to the wound and the patient was discharged home on antibiotic and anticoagulation therapy.Ten days later, the patient experienced a massive hemorrhage from the right groin wound. When paramedics arrived at the home, they provided basic life and advanced cardiovascular life support. After transport to the ED, the patient was pronounced dead. The cause of death was exsanguination.The most serious adverse events associated with NPWT, blood loss and infection, can be prevented if healthcare professionals pay close attention to: * device labeling, including warnings, instructions for use, indications, and contraindications * criteria for patient selection, wound type, and appropriate care setting based on each

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