Beware of Offers to Supply N95/KN95 Masks and Other PPE, Test Kits from Non-traditional Suppliers
The COVID-19 pandemic and short supply of N95/KN95 masks, other PPE, and test kits combine to create increased potential for unscrupulous activity and counterfeit products. You and the healthcare providers you serve are urged to exercise extreme caution if offered an opportunity to purchase PPE, test kits and other supplies from non-tradition suppliers or supply chains. We are aware of multiple instances where healthcare providers received offers to supply PPE from non-traditional suppliers, and these offers were questionable due to circumstances such as the manufacturer was not registered with the FDA and/or the product was misrepresented.
The National Personal Protective Technology Laboratory (NPPTL, a division of the CDC) provides information on counterfeit respirators.
Recently the FDA authorized Battelle to employ its Critical Care Decontamination System™ (CCDS). The CCDS can be used to decontaminate N95 masks (healthcare and industrial) that are not cellulose based. There is a CCDS facility in DC, and the decontamination service is being provided to healthcare personnel at no charge. Here is the form to request the Battelle CCDS service. Additional information on this program is provided below under “Additional Resources.”
The FDA Establishment Registration & Device Listing enables you to look up manufacturers who are registered to sell medical devices, including PPE, in the United States. If you search for “ORW” under Product Code, you will be provided with a list of manufacturers that registered with the FDA to sell KN95 in the United States. The presence of a manufacturer on the list is not a guarantee; searching for the manufacturer on the list should be a minimal check performed. The FDA has a toll-free information line open 24 hours a day where you can ask questions about COVID-19 Diagnostic Tests, and COVID-19 device shortages, including all Personal Protective Equipment for masks and respirators: 1-888-INFO-FDA.
The CDC National Personal Protective Technology Laboratory (NPPTL) provides information about N95 masks and alternatives permitted during the pandemic (FDA Emergency Use Authorization (EUA)). The NPPTL page also includes the following statement:
NIOSH has recently received new information from Stakeholders across the United States regarding products from China claiming to meet GB2626 and EN149. Assessment results confirm that some of these products have poor filter efficiency and are of poor quality. NIOSH is working closely with the FDA to align Emergency Use Authorizations to communicate the point of use testing results. [emphasis added]