PPB August 2020

Currently, the Occupational Safety and Health Administration (OSHA), an agency within the Department of Labor, oversees these requirements. OSHA publishes guidelines for conducting a hazard assessment of the workplace, determining appropriate PPE and providing training on correct usage. Specific requirements for PPE are published in 29 CFR 1910. OSHA relies on standards established by the American National Standards Institute (ANSI) to define compliance requirements for many categories of PPE, including respirators and masks used in a workplace setting. For certain masks and respirators, the Respiratory Protection Standard (29 CFR 1910.134), which is a standard that was enacted in 1988, regulates these types of PPE. Assigned Protection Factors (APF)—the workplace level of respiratory protection a device is expected to provide—were subsequently enacted in 2006. Following the Ebola crisis in 2015, ANSI Z88, which is the standard for respirators, was updated to reflect the needs of health-care workers. ANSI Z88 established the best practice minimum filtration as that provided by N95 respirator approved by the National Institute of Occupational Safety and Health (NIOSH). Government-published guidelines for masks and mask usage in health-care settings are found in the Hospital Respiratory Protection Program Toolkit (2015) issued jointly by the Department of Labor, OSHA, the Department for Health and Human Services, the Centers for Disease Control (CDC) and National Institute of Occupational Safety and Health (NIOSH). Access the publication at www.osha.gov/Publications/ OSHA3767.pdf. With the continuing health emergency, the United States has experienced a shortage of critical PPE. Through the issuance of Emergency Use Authorization (EUA) declarations, current Good Manufacturing Practices (GMP) requirements are suspended until the end of the current health-care crisis, or until otherwise communicated by the FDA. For more detail, read the National Law Review article at www.natlawreview. com/article/fda-issues- emergency-authorized-use- manufacturers-face-masks. This suspension includes the quality system requirements under 21 CFR Part 820 regarding design, manufacture, packaging, labeling, storage and distribution. Manufacturers are still required to ensure compliance with all manufacturing, product and marketing requirements, despite the procedures for submissions to the FDA being suspended at this time. Notably, NIOSH standards and requirements continue to be enforced. Guidance from the FDA has continued to evolve related to face masks and respirators. Which Mask Is Right For Your Customer? Ensuring the safety of any product for its intended use starts with understanding who the ultimate customer is and how the product is likely to be used. The nature of the current crisis is that it is health-related and affecting society broadly. Normally, when considering which PPE to use, risk is limited to a workplace and perhaps a set of operations. Health-care providers require PPE, enabling them to more safely perform their job responsibilities, particularly in an infectious environment. Essential workers are also recommended to use PPE in their work. Due to the contagious nature of COVID-19, even people practicing social distancing are recommended to use PPE or other face coverings to limit the potential spread of the virus. The NIOSH Hospital Respiratory Protection Program Toolkit provides these key definitions for face coverings intended to protect against the spreading of viruses: Respirator: A device worn over the nose and mouth to protect the wearer from hazardous materials in the breathing zone. Respirators must be certified by NIOSH for the purpose for which they are used. Surgical respirator: A filtering facepiece respirator with fluid- resistant face mask material on the outside to protect the wearer from splashes. Also known as a surgical N95 respirator, it meets a filtration efficiency level defined in 42 CFR 84.181. N95 respirator: A general-use term for a half mask air-purifying respirator with NIOSH-approved N95 particulate filters or filter material that meets the filtration efficiency level defined in 42 CFR 84.181. N95 filter: A type of NIOSH- approved filter or filter material, Essential workers are also recommended to use PPE in their work. Due to the contagious nature of COVID-19, evenpeople practicing social distancing are recommended to use PPEor other face coverings to limit the potential spread of the virus. | AUGUST 2020 | 77 THINK