Who regulates PPE?

Personal protective equipment (PPE) is a term that refers to any device, garment, or accessory that is worn or used by an individual to protect themselves from hazards that may cause injury, illness, or death. PPE can include helmets, gloves, masks, goggles, respirators, boots, suits, and more, depending on the type and level of risk involved. PPE is essential for workers in various industries and sectors, such as healthcare, construction, mining, manufacturing, agriculture, and emergency services, as well as for the general public in certain situations, such as during a pandemic or a natural disaster.

However, not all PPE is created equal. Different PPE products may have different specifications, standards, quality, performance, and suitability for different purposes and users. Therefore, it is important to have a clear and consistent regulatory framework for PPE that ensures its safety, effectiveness, and availability for those who need it. In this article, we will explore the question of who regulates PPE, and how different regions and organizations have established their own rules and requirements for PPE design, manufacture, testing, certification, distribution, and use.

Who regulates PPE in the United States?

In the United States, the main federal agency that regulates PPE is the Occupational Safety and Health Administration (OSHA), which is part of the Department of Labor. OSHA is responsible for setting and enforcing standards for PPE in the workplace, as well as providing guidance, training, and assistance to employers and workers on how to comply with the regulations. OSHA’s standards for PPE cover general requirements, as well as specific requirements for different types of PPE, such as eye and face protection, head protection, foot protection, electrical protective equipment, hand protection, personal fall protection, and more. OSHA requires that most categories of PPE meet or be equivalent to standards developed by the American National Standards Institute (ANSI), which is a non-governmental organization that coordinates the development of voluntary consensus standards for various products and services in the US.

Another federal agency that regulates PPE in the US is the Food and Drug Administration (FDA), which is part of the Department of Health and Human Services. The FDA is responsible for regulating PPE that is intended for use as a medical device, such as surgical masks, gloves, gowns, and respirators. The FDA reviews and approves PPE products based on their safety and effectiveness for preventing or reducing the risk of disease or injury. The FDA also monitors the quality and performance of PPE products on the market, and takes action against any products that are defective, fraudulent, or misbranded. The FDA also works with other federal agencies, such as the Centers for Disease Control and Prevention (CDC) and the National Institute for Occupational Safety and Health (NIOSH), to provide recommendations and guidance on the appropriate use of PPE for healthcare workers and other groups.

Who regulates PPE in the European Union?

In the European Union, the main legal instrument that regulates PPE is the Regulation (EU) 2016/425, which became applicable on 21 April 2018 and repealed the previous Directive 89/686/EEC. The Regulation is a binding legislative act that applies directly and uniformly to all member states of the EU, and aims to ensure common standards for PPE in terms of health and safety, free movement, and fair competition. The Regulation defines PPE as any device or appliance designed and manufactured to be worn or held by an individual for protection against one or more risks to their health or safety. The Regulation covers all aspects of PPE, such as design, manufacture, testing, certification, labeling, marketing, and use. The Regulation also classifies PPE into three categories of risk: Category I for simple PPE, such as sunglasses and gloves; Category II for intermediate PPE, such as helmets and safety shoes; and Category III for complex PPE, such as respirators and protective clothing against chemicals. Each category of PPE has different conformity assessment procedures and requirements, which involve the participation of notified bodies, which are independent organizations designated by the member states to verify the compliance of PPE products with the Regulation.

The Regulation also refers to harmonized European standards, which are technical specifications developed by European standardization organizations, such as CEN, CENELEC, and ETSI, in cooperation with stakeholders, such as manufacturers, consumers, and regulators. Harmonized standards provide detailed and uniform criteria and methods for testing and certifying PPE products, and confer a presumption of conformity with the essential health and safety requirements of the Regulation. The use of harmonized standards is voluntary, but it facilitates the demonstration of compliance and the free movement of PPE products within the EU. The European Commission publishes the references of the harmonized standards in the Official Journal of the European Union, and maintains a database of the notified bodies and the PPE products they have certified.

Who regulates PPE in other countries?

Besides the US and the EU, many other countries and regions have their own regulatory frameworks for PPE, which may vary in terms of scope, approach, and requirements. Some examples are:

• Canada: The Canadian Centre for Occupational Health and Safety (CCOHS) is a federal agency that provides information and guidance on PPE and other occupational health and safety issues. The CCOHS does not regulate or certify PPE products, but it refers to standards developed by the Canadian Standards Association (CSA) and other organizations, such as ANSI and ASTM. The CSA is a non-profit organization that develops and publishes standards for various products and services, including PPE, and operates a certification program for PPE products that meet its standards. The CSA also accredits testing laboratories and inspection bodies that can verify the compliance of PPE products with the standards. The regulation and enforcement of PPE in the workplace falls under the jurisdiction of the provincial and territorial governments, which may have their own legislation and regulations for PPE.

• China: The State Administration for Market Regulation (SAMR) is the main authority that regulates PPE and other products in China. The SAMR is responsible for setting and enforcing standards, rules, and regulations for PPE, as well as supervising and inspecting the quality and safety of PPE products on the market. The SAMR also oversees the certification and accreditation system for PPE products, which involves the participation of designated certification bodies, testing laboratories, and inspection agencies. The SAMR publishes the list of PPE products that require mandatory certification, as well as the standards and technical specifications that apply to them. The SAMR also works with other ministries and agencies, such as the National Health Commission (NHC) and the Ministry of Industry and Information Technology (MIIT), to provide guidance and support for PPE production, distribution, and use, especially during emergencies, such as the COVID-19 pandemic.

• Australia: The Safe Work Australia (SWA) is a statutory agency that develops and promotes national policies and strategies for PPE and other occupational health and safety matters. The SWA does not regulate or enforce PPE, but it provides information and guidance on PPE and refers to standards developed by Standards Australia and other organizations, such as ISO and IEC. Standards Australia is a non-governmental organization that develops and publishes standards for various products and services, including PPE, and operates a certification program for PPE products that meet its standards. The regulation and enforcement of PPE in the workplace falls under the jurisdiction of the state and territory governments, which may have their own legislation and regulations for PPE.

PPE is a vital component of health and safety in various industries and sectors, as well as for the general public in certain situations. However, PPE needs to be regulated to ensure its quality, performance, and suitability for different purposes and users. Different regions and organizations have established their own regulatory frameworks for PPE, which may have different scope, approach, and requirements. Therefore, it is important for PPE manufacturers, suppliers, and users to be aware of and comply with the relevant rules and standards for PPE in their respective markets and contexts. By doing so, they can ensure the protection of themselves and others from hazards that may cause injury, illness, or death.

Additional PPE facts:

• According to the FDA, all PPE that is intended for use as a medical device must follow the FDA’s regulations and meet specific performance standards for protection. This includes surgical masks, N95 respirators, medical gloves, and gowns. The FDA also regulates the marketing and labeling of PPE, and does not allow any claims of disease prevention or treatment. Source: https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/personal-protective-equipment-infection-control
• According to OSHA, employers are required to provide appropriate PPE for workers who could be exposed to hazards that cause serious workplace injuries and illnesses. These hazards may include chemical, radiological, physical, electrical, mechanical, or biological agents. OSHA also requires employers to train workers on how to use, maintain, and dispose of PPE properly. Source: https://www.osha.gov/personal-protective-equipment
• According to NIOSH, which is part of CDC, respirators are a type of PPE that protect the wearer from inhaling harmful airborne particles, gases, or vapors. NIOSH is responsible for the certification and approval of respirators for occupational use, and has established a rating system based on the level of filtration and resistance. For example, N95 respirators filter out at least 95% of airborne particles, while P100 respirators filter out 99.97% of airborne particles. Source: https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/default.html
• According to the WHO, PPE is one of the key measures to prevent and control the spread of infectious diseases, such as COVID-19. The WHO provides guidance and recommendations on the appropriate type, quality, quantity, and use of PPE for different settings and scenarios, such as health care facilities, community settings, and mass gatherings. The WHO also monitors the global supply and demand of PPE, and supports the procurement and distribution of PPE to countries in need. Source: https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/ppe
• According to a study by the Journal of the American Medical Association (JAMA), the reuse and extended use of PPE, such as masks and gloves, can increase the risk of contamination and infection for health care workers and patients. The study also found that the availability and quality of PPE varied widely across different health care facilities, and that there were gaps in the knowledge and adherence of PPE guidelines among health care workers. Source: https://jamanetwork.com/journals/jama/fullarticle/2767023