The U.S. Food and Drug Administration (FDA) just issued another warning about Negative Pressure Wound Therapy (NPWT) systems. This warning is an update to two earlier device safety notices, said MedPageToday. The FDA is not changing its labeling on these devices at this time.
The agency first announced its concerns about NPWT systems in November 2009 and has, since, received reports of six deaths and 97 injuries “bringing the total to 12 fatalities and 174 injuries since 2007” related to the use of these medical devices, noted MedPageToday.
According to the FDA, medical professionals should know that NPWT systems should not be used with certain types of wounds and that professionals should also look at the many risks associated with the devices before prescribing NPWT system therapy, explained MedPageToday.
The agency explained that NPWTs promote healing in various types of open wounds by removing wound fluids and waste materials (debris) through the creation of a vacuum (negative pressure) at a well-sealed wound site. NPWT may also help with wound healing by drawing wound edges together. NPWT systems consist of a pump that generates a vacuum and creates a negative pressure environment within a sealed wound, dressing materials to pack and seal the wound, tubing for fluid removal, and a container/canister to collect waste materials removed from the wound area by suction.
The treatment, however, can lead to bleeding and infection, according to some of the more common adverse event reports. Bleeding continues to be the cause of the most serious adverse events, and was reported in 12 patients, including three of the additional death reports, the FDA said. Bleeding occurred in patients who had blood vessel grafts, wound infection, those receiving medicine for blood clots, and during removal of dressings attached to the tissues. MedPageToday noted that there exist additional procedures in place in these circumstances. More than half of the additional injuries reported reports occurred either in homes or in long-term care facilities.
Bleeding contributed to shock, low blood pressure, and swelling containing blood (hematoma). Some patients who experienced bleeding required additional surgery, blood transfusions, admission to the emergency room, and hospitalization, the FDA added.
The FDA said that NPWT systems should NEVER be used when any of the following occur or under any of the following circumstances: Necrotic tissue with eschar present, untreated osteomyelitis, non-enteric and unexplored fistulas, malignancy in the wound, exposed vasculature, exposed nerves, exposed anastomotic site, or exposed organs.
The FDA also noted that the following presented increased risks for NPWT use and the system should be very strongly considered in these cases: Patients at high risk for bleeding and hemorrhage; patients on anticoagulants or platelet aggregation inhibitors; patients with friable vessels and infected blood vessels, vascular anastomosis, infected wounds, osteomyelitis, exposed organs, vessels, nerves, tendons, and ligaments, sharp edges in the wound (i.e. bone fragments), spinal cord injury (stimulation of sympathetic nervous system), and/or enteric fistulas; patients requiring MRI, hyperbaric chamber, and/or defibrillation; use near vagus nerve (bradycardia); when circumferential dressing application is needed; in certain modes of therapy, intermittent versus continuous negative pressure; and depending on patient size and weight.
The FDA recommends training for prescribing or performing clinicians who should be providing detailed instructions for patients who will be using these systems in the home.