The Food and Drug Administration (FDA) is the U.S. Government agency that oversees most medical products, foods, and cosmetics. FDA regulates medical devices by evaluating and approving/clearing the product to ensure they are safe and effective. PPE, including masks/respirators, medical gloves, and surgical gowns, which is intended for use in preventing or treating disease is considered a medical device and is given a classification. The device/product classification is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. Face masks are considered a Class II (intermediate risk) device.
In 1983, the Centers for Disease Control (CDC) made the first recommendations for the prevention of exposure to blood and body fluids through the use of universal precautions. In December 2003, the CDC published its “Guidelines for Infection Control in Dental Health-Care Settings”. Although CDC has no regulatory authority, its recommendations are considered a standard of care and adopted by most state boards as requirements.
The recommendations state that a surgical mask and eye protection with solid side shields, or a full face shield, be worn to protect mucous membranes of the eyes, nose, and mouth during dental procedures likely to generate splashing or spattering of blood or other body fluids. Due to aerosols, it is not recommended that a face shield be worn alone without a face mask.
The CDC categorizes its recommendation on the basis of existing scientific data, theoretical rationale, and applicability. Categories are based on the system used by CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC). Table 1 shows the categories of recommendations as strong, weak, or unresolved based on evidence.
Table 1. HICPAC categorization scheme for recommendations.
|Category IA||Category IB||Category IC||Category II||Unresolved|
|A strong recommendation supported by high to moderate quality evidence suggesting net clinical benefits or harms.||A strong recommendation supported by low quality evidence suggesting net clinical benefits or harms, or an accepted practice (e.g., aseptic technique) supported by low to very low quality evidence.||A strong recommendation required by state or federal regulation. OSHA mandated and must be followed under penalty of law. Check your state and local laws, some are more strict than OSHA regulations and the most strict must be followed.||A weak recommendation supported by any quality evidence suggesting a trade off between clinical benefits and harms.||An unresolved issue for which there is low to very low quality evidence with uncertain trade offs between benefits and harms.|
Table 2. The CDC 2003 guidelines regarding face masks for the DHCP.
|Wear a surgical mask and eye protection with solid side shields or a face shield to protect mucous membranes of the eyes, nose, and mouth during procedures likely to generate splashing or spattering of blood or other body fluids.||Change masks between patients or during patient treatment if the mask becomes wet.||Clean with soap and water, or if visibly soiled, clean and disinfect reusable facial protective equipment (e.g., clinician and patient protective eyewear or face shields) between patients.|
ASTM International is a globally recognized leader in the development and delivery of international voluntary consensus standards. In April 2011, a new version of the standard specifying performance of face masks was released, ASTM F2100-11. Face mask material performance is based on testing for fluid resistance, bacterial filtration efficiency (BFE), particulate filtration efficiency (PFE), breathability (P-Δ), and flammability. The FDA recognizes ASTM test standards. This standard specifies test results required for labeling mask levels of barrier performance. The ASTM 2100-11 does not evaluate face masks for regulatory approval as respirators, nor address all aspects of face mask design and performance.