The regulation of personal protective equipment

What PPE means 

Personal protective equipment, better known as PPE, refers to protective clothing including helmets, gloves, face shields, goggles, masks, and/or respirators or other equipment designed to protect the user from injury, the spread of infections or disease.

Some of the PPE main characteristics:

  • PPE is widely used in healthcare settings such as hospitals, physician offices, and clinical laboratories. Its use has become more common in recent months due to its high demand from the Covid-19 pandemic.
  • When appropriately used, PPE acts as a barrier between infectious substances, such as viral and bacterial contaminants, and the skin, mouth, nose, or eyes (mucous membranes). 
  • Materials used to make PPE have the potential to block the transmission of contaminants from blood, body fluids, or respiratory secretions. 
  • PPE can also protect patients at high risk of infection from a surgical procedure or who have a medical condition, such as an immune deficiency, from exposure to potentially infectious substances or material brought in by visitors and healthcare workers. 
  • When used correctly and with other infection control practices, such as handwashing, alcohol-based hand sanitizers, and covering coughs and sneezes, the spread of infection from one person to another is minimized. 
  • Effective use of PPE includes the proper disposal and removal of contaminated PPE to prevent both the user and others from getting infected.

When an outbreak of infection affects a large population in the United States, the Centers for Disease Control and Prevention (CDC) is responsible for making specific recommendations for infection control measures in different circumstances and settings. 

CDC has provided the following recommendations:

  •  All personal protective equipment (PPE) intended for use as a medical device should follow FDA guidelines and should comply with applicable voluntary consensus standards of protection. 
  • This includes surgical masks, N95 respirators, medical gloves, and gowns. The consensus standards and FDA requirements vary depending on the specific type of PPE. 
  • When these standards and regulations are followed, they provide reasonable assurance that the device is safe and effective.
  • The FDA reviews some PPE before it can be legally sold in the United States. 
  • In this review, known as premarket notification or 510(k) clearance, manufacturers have to demonstrate that they meet specific performance, labeling, and intended use criteria to show substantial equivalence. 
  • One way to demonstrate substantial equivalence is, in part, to meet agreed-upon standards for barrier performance and resistance to tearing and snagging. 
  • Voluntary consensus standards can also be used to prove sterility (where applicable), biocompatibility, fluid resistance, and flammability. 
  • Manufacturers should validate the methods used to prove compliance with the standards and support each product with appropriate performance test data.

We are working hard to create a safe environment for everyone.

As different governments strengthen their masking ordinances, at We Shield, we work hard to create a safe and clean environment for our frontline workers and individuals at most risk of contracting COVID-19. We are sourcing and distributing top quality personal protective equipment and safety supplies at the best pricing on the market.