Topics: Disposable Face Masks, KN95 Face Masks, Reusable 3-Ply Cloth Mask, Reusable 3-Ply Canvas Masks
Host: Gary Chan
Guests: Misty Mushynsky, Kelly Tran, Melissa Couch
Face Masks 101
Gary: I know that you’ve recently attended an educational webinar and some experience on PPE, perhaps you can tell us a little bit about this and what you learned from it and some specific about masks?
Misty: When I have a client request a quote or information on masks there are a few things I like to note right off the bat;
Firstly, there are hundreds and hundreds of different manufacturers and sources of masks that are newly available to purchase from – and not all are created equal.
At the onset of this pandemic, the FDA (US Food and Drug Administration) and Health Canada issued an Interm Order granting manufacturers an expedited process to produce medical device equipment to aid in preventing the spread of the virus.
Regulatory Requirements Of PPE
This has eased some of the regulatory requirements of PPE, however, in order to legally distribute this product manufacturers must register its establishment and list its devices with the FDA and/or Health Canada.
Manufacturers must also demonstrate that the new device is cleared as “substantially equivalent” to a predicate device in terms of intended use, technological characteristics and performance testing upon request.
It is important that you are ensuring that the manufacturer has been approved by one or both of these organizations, that the manufacturer has completed necessary testing and can provide Safety Datasheets for all of their products.
We have recently learned that the FDA conducted extensive testing on masks from the 80 Chinese factories previously approved by them to produce KN95 masks and of those 80 factories, only 14 are now approved by the FDA due to the failure of most to comply with their standards.
Protecting The PPE Supplies For Our Front-Line Workers
Secondly, equipment specifically manufactured for health care facilities should not be purchased for personal use, it should be left available for our front-line workers. If the manufacturer is a NIOSH (National Institute of Occupations Safety & Health) approved manufacturer – these products should only be going to medical professionals.