All personal protective equipment (PPE) designed for use as a medical device must adhere to FDA rules and meet particular protection performance standards. Other government entities, such as the ones listed below, provide instructions for the usage of personal protective equipment: The Occupational Safety and Health Administration (OSHA) of the United States Department of Labor ensures that working men and women have safe and healthy working conditions by establishing and enforcing standards and providing training, outreach, education, and assistance. Employers must provide proper PPE for workers who may be exposed to blood or other infectious materials, according to OSHA (such as blood-borne pathogens). OSHA may also compel companies to provide personal protective equipment (PPE) to safeguard employees from other workplace hazards.
29 CFR 1910.1030 Blood borne pathogens: When an employee is exposed at work, the employer must provide necessary personal protective equipment, such as gloves, gowns, lab coats, face shields or masks, and eye protection, as well as mouthpieces, resuscitation bags, pocket masks, or other ventilation devices, at no expense to the employee. Only if blood or other potentially infectious materials cannot pass through or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time the protective equipment will be used will it be considered "appropriate." See Blood-borne pathogens for further details on OSHA's blood-borne pathogen standard.
The National Institute for Occupational Safety and Health (NIOSH), which is part of the Centers for Disease Control and Prevention (CDC), is responsible for the certification and licensing of respiratory protection equipment for use in the workplace. It also covers the standards for quality assurance in the manufacture of respiratory protective equipment. Anyone can make and sell a respiratory protection device, but only those that meet or exceed all of the requirements set forth in the 42 CFR 84 standards are recognized by NIOSH, and only those that have been NIOSH-certified may be sold as an NIOSH-approved respirator.
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