Importance Of Personal Protective Equipments

Importance Of Personal Protective Equipments

The FDA's role in regulating personal protective equipment

 

All personal protective equipment (PPE) that is intended for use as a medical device must follow The 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 the 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 PPEs are reviewed by the 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.

For additional information on the FDA's role in regulating specific PPE, please go to:

Read More at: 

https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/personal-protective-equipment-infection-control