Make Sure Your PPE Matches the Hazard
Recently released U.S. Food and Drug Administration guidance regarding gowns is a good reminder to periodically evaluate personal protective equipment (PPE) used in the laboratory. The Occupational Health and Safety Act requires employers protect workers from hazards in the workplace. PPE such as a gown is one measure for protecting health care workers from exposure to hazards such as infected blood and other specimens. While the FDA indicated it doesn’t intend to address exposure to specific diseases or pathogens, such as Ebola, its guidance concerning gowns used in health care settings calls attention to the inconsistent terminology regarding gowns that can create confusion. Acknowledging that terminology for gowns “has evolved,” the FDA noted that gowns are described using many different terms, including surgical gowns, cover gowns, comfort gowns, and isolation gowns. So it issued guidance to describe its “premarket regulatory requirements and the performance testing needed to support liquid barrier claims for gowns intended for use in health care settings.” The guidance emphasizes that not only labeling or terminology used to describe the gown but claims about liquid barrier protection determine whether a gown requires FDA approval as a Class II medical device. It says that gowns claimed to provide […]
Recently released U.S. Food and Drug Administration guidance regarding gowns is a good reminder to periodically evaluate personal protective equipment (PPE) used in the laboratory. The Occupational Health and Safety Act requires employers protect workers from hazards in the workplace. PPE such as a gown is one measure for protecting health care workers from exposure to hazards such as infected blood and other specimens. While the FDA indicated it doesn’t intend to address exposure to specific diseases or pathogens, such as Ebola, its guidance concerning gowns used in health care settings calls attention to the inconsistent terminology regarding gowns that can create confusion.
Acknowledging that terminology for gowns “has evolved,” the FDA noted that gowns are described using many different terms, including surgical gowns, cover gowns, comfort gowns, and isolation gowns. So it issued guidance to describe its “premarket regulatory requirements and the performance testing needed to support liquid barrier claims for gowns intended for use in health care settings.” The guidance emphasizes that not only labeling or terminology used to describe the gown but claims about liquid barrier protection determine whether a gown requires FDA approval as a Class II medical device. It says that gowns claimed to provide moderate or high level barrier protection (e.g. ANSI/AAMI Level 3 or 4 barrier protection claims) will require premarket notification and a 510k filing.
That guidance and the clarity it seeks to bring, raises a good point about PPE. Periodically reevaluate the hazards in your laboratory and the PPE your staff are using. Is it appropriate for the current hazard? Does it meet current standards for that type of PPE? The FDA’s announcement of its guidance notes that it’s important “for both industry and gown users to have a clear and consistent understanding of the terms used to describe the protective ability of gowns.” Make sure your personnel understand the protective qualities of PPE used in your lab and that it fits with the hazards your lab staff face.
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