![]() ![]() The National Institute for Occupational Safety and Health (NIOSH) regulates the testing and certification of respiratory protection equipment. The Centers for Disease Control and Prevention (CDC) publishes guidelines on the use of surgical masks in health care settings. 6, 7, 8 The FDA requires no minimum level of filter performance. 3 Two types of filter efficiency tests are recommended: (1) particulate filtration efficiency (PFE) using a nonneutralized aerosol of 0.1-μm latex spheres at a challenge velocity between 0.5 and 25 cm/s (approximately 8 to 380 L/min for a 9-cm radius mask) 4, 5 and (2) bacterial filtration efficiency (BFE) using a nonneutralized 3 ± 0.3-μm Staphylococcus aureus aerosol and a flow rate of 28.3 L/min. FDA recommends that manufacturers demonstrate surgical mask performance in 4 areas: fluid resistance, filter efficiency, differential pressure, and flammability. The Food and Drug Administration (FDA) oversees the sale and marketing of medical devices, including surgical masks, which may be known as procedure masks, dental masks, and laser masks as well as masks used in surgery settings. There is ongoing debate, however, about the use of surgical masks as respiratory protection devices. In some health care settings, applications have evolved from prevention of patient wound infection to prevention of employee exposures. 1, 2 Today, surgical masks vary widely in style and intended application and can be found in a broad range of hospital and health care settings. Surgical masks have been in widespread use since the early 1900s to help prevent infection of surgical wounds from staff-generated nasal and oral bacteria. ![]()
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