FDA Clears First Antiviral Surgical Mask

Tinker Ready

July 05, 2011

July 5, 2011 — The US Food and Drug Administration (FDA) has granted market clearance to the first treated surgical facemask that promises to inactivate virtually all strains of the influenza virus in 5 minutes.

The BioMask has an inner layer treated with copper and zinc ions, which in vitro tests found to be effective against most influenza viruses. The multilayered mask is made by Filligent, a Hong Kong–based company that also makes antimicrobial wipes and shoe inserts.

Traditional surgical masks were designed to maintain sterile care settings and also offer some protection for healthcare workers. The new mask's treated filter is designed to block and inactivate viruses, including newly emerging pathogens such as H1N1 influenza.

The single-use mask enters the market as infection control specialists are debating the efficacy of traditional surgical masks vs N95 respirators, which protect users from aerosol particles. During the initial outbreak of H1N1 influenza in 2009, some health departments recommended N95 respirators, whereas others argued that surgical masks were sufficient.

The manufacturer reports that the FDA granted market clearance under a new medical device classification "OUK" for "anti-microbial/anti-viral surgical facemasks." The classification was created "by the FDA to accommodate Filligent's innovations in infection control and respiratory protection." The mask features plastic coating on the outer layer and a second inner layer treated with metal ions, "which form ionic bonds with negatively-charged side-groups on influenza viruses."

The company notes on its Web site that "Correlation between in-vitro testing results and any clinical event has not been tested," and that no clinical studies have compared the treated masks with untreated facemasks. "[The masks] are intended to be worn by operating room personnel during surgical procedures, to protect both the surgical patient, and the operating room personnel, from the transfer of micro-organisms, body fluids and particulate material."

If the laboratory tests are representative of conditions in a workplace setting, it is likely the mask material will inactivate viruses in a clinical setting, said Lisa Brosseau, ScD, an associate professor at the University of Minnesota School of Public Health in Minneapolis. Dr. Brosseau, who researches industrial hygiene, notes that she has not reviewed the research protocol used to test the masks.

The mask comes with the following notes and warnings:

  • This mask does not eliminate the risk of contracting any disease or infection.

  • Replace if damaged or soiled with blood or other bodily fluids.

  • Do not use if hypersensitive to copper or zinc.

  • Ear adjuster may pose a choking hazard to young children if separated from device. Keep away from young children, discard appropriately.

  • If mask becomes soiled change to a new mask is needed because the antimicrobial agents may not be effective.

  • This mask does not contain natural rubber latex.

  • For use in medical settings only.

  • For adult use only.

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