The FDA states that Personal protective equipment (PPE) refers to protective clothing, helmets, gloves, face shields, goggles, facemasks and/or respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness.
“PPE is commonly used in health care settings such as hospitals, doctor’s offices and clinical labs. When used properly, PPE acts as a barrier between infectious materials such as viral and bacterial contaminants and your skin, mouth, nose or eyes (mucous membranes). The barrier has the potential to block transmission of contaminants from blood, body fluids or respiratory secretions,” according to the FDA. “PPE may also protect patients who are at high risk for contracting infections through a surgical procedure or who have a medical condition, such as, an immunodeficiency, from being exposed to substances or potentially infectious material brought in by visitors and health care workers. When used properly and with other infection control practices such as hand-washing, using alcohol-based hand sanitizers, and covering coughs and sneezes, it minimizes the spread of infection from one person to another. Effective use of PPE includes properly removing and disposing of contaminated PPE to prevent exposing both the wearer and other people to infection.”
All personal protective equipment that is intended for use as a medical device must follow FDA’s regulations and should meet applicable voluntary consensus standards for protection. This includes surgical masks, N95 respirators, medical gloves and gowns. The consensus standards and FDA’s 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.
Some PPE are reviewed by FDA before they can be legally sold in the United States. In this review, known as Premarket Notification or 510(k) clearance, the manufacturers have to show they meet specific criteria for performance, labeling and intended use to demonstrate substantial equivalence. One way substantial equivalence may be demonstrated, in part, is by conforming to consensus standards for barrier performance and resistance to tears and snags. Voluntary consensus standards may also be used to demonstrate sterility (when applicable), biocompatibility, fluid resistance and flammability. Manufacturers must validate the methods used to test conformance to standards and support each product with appropriate performance test data.
The health care segment of the global PPE market is expected to see rapid growth in the coming years, according to a MarketWatch new release.
The PPE market is expected to grow from $38.52 billion in 2015 to $62.86 billion by 2022, according to the news release.
“Health care segment is expected to witness maximum growth on account of rapidly launching new and advanced products,” according to the release.
