FDA Issues Four Wound Care Precautions

In its warning, the FDA issued four precautions for providers:

1. Select patients carefully because the NPWT system is contraindicated in patients with necrotic tissue with eschar, untreated osteomyelitis, non-enteric and unexplored fistulas, malignancy in the wound, exposed vasculature and nerves, exposed anastomotic site or exposed organs. Carefully consider the use of this treatment in patients with high-risk of bleeding and hemorrhage, and those receiving anticoagulants or platelet aggregation inhibitors.


2. Assure the patient is monitored frequently by a trained practitioner in an appropriate care setting.


3. Be vigilant for potentially life-threatening complications, such as bleeding.


4. If the patient is a candidate for the use of the NPWT system at home, instruct caregivers to demonstrate their understanding of the signs and symptoms of complications.