The Food & Drug Administration is warning about serious complications that could arise from the use of negative-pressure wound therapy and working to develop regulatory science with Georgetown University.
The FDA has received notice that six people have died and 97 have been injured since the watchdog agency issued a public health notice on NWPT after reports of deaths and injuries in Nov. 2009. The FDA has received reports of 12 deaths and 174 injuries altogether since 2007, according to a press release.
NWPT devices use a vacuum pump to create negative pressure around a wound site to remove fluids and infectious debris. Wound infection occurred in about half of the reported cases, with bleeding as the most serious complication, according to the FDA alert.
Most of the deaths and injuries occurred at patients’ homes or in long-term care facilities, but the FDA stressed that complications can occur wherever NPWT systems are used.
The agency advised healthcare providers to select patients for NWPT carefully and made recommendations about what kind of wounds the treatment should not be used for, including those with exposed nerves, blood vessels or organs.
Manufacturers of NWPT devices include Smith & Nephew (NYSE:SNN) and Kinetic Concepts Inc. (NYSE:KCI). In its 2010 annual report, San Antonio, Texas-based KCI said NPWT products generated about $1.25 billion in worldwide sales during each of the past two years — or more than 60 percent of its overall business.
The FDA is moving on another front: Regulatory science. The agency announced plans for a partnership with Georgetown University Medical Center to "stimulate innovation in regulatory science, ethics, education, and training."
The partnership includes joint research, co-mentorship of doctoral and post-doctoral students and scientific staff exchanges.
"Georgetown University Medical Center’s partnership with the FDA is backed by an outstanding cadre of scientists who all share a common goal of improving the lives of people around the world through robust research and its application," GUMC School of Medicine executive dean Dr. Howard Federoff said in prepared remarks.