Data showing the benefit of adding anti-microbial compounds to wound dressings are scant, the FDA said in supporting documents ahead of an advisory panel meeting next year, calling the available research “equivocal and low-quality.”
The FDA’s General & Plastic Surgery Devices Advisory Panel is slated to meet Sept. 20-21 to recommend whether the FDA should reclassify some types of dressings as Class III, which would require pre-market approval based on clinical trials.
“The available evidence does not appear to demonstrate improved clinical outcomes from the use of antimicrobial dressings over non-antimicrobial dressings for the prevention or treatment of local wound infections or to improve wound healing,” the agency said. “Specifically with respect to the prevention of catheter-related bloodstream infections, there may be clinical benefit from the use of antimicrobial dressings.”
Some dressings are likely Class II, subject to the less-stringent 510(k) clearance protocol, the agency said in announcing the panel meeting. Others, especially those with antibiotic compounds, “FDA appreciates the importance of appropriately addressing the risk of antimicrobial resistance (AMR) in light of the increasingly significant national public health concern posed by AMR. FDA is also aware of differences in the claims made for some products even though they may be regulated in the same manner,” according to the federal safety watchdog.
