Did you know that a world-wide PPE database with detailed certification history verified by a third party and fraud alert does not exist? Until now. We just created it.
Carfax is a USA company that provides you with a detailed history of an automobile. Carfax will let you know if a car has been involved in an accident, recalled by the manufacturer, or tampered with illegally. While getting this level of detail with your PPE is difficult with the current state of defragmented credentialing (or the lack of a worldwide blockchain solution), I believe that we can still provide basic approval, authorization, certification, testing, or counterfeit alert by different governments or safety organizations. Hence we scoured the world wide web for data about your PPE. Here is where we got our data.
To address the current COVID-19 public health emergency, the FDA issued an expedited authorization of medical products. Since the early FDA authorization fiasco in April 2020, the FDA has since amended their PPE to include only vetted and certified PPE. We believe that this list is an excellent starting source for quality PPE. We recommend that health care providers only purchase PPE that is on this FDA EUA list.
Canada has also created a list of authorized medical devices for uses related to COVID-19. PPE on this database has been vetted by the Canadian government.
The Centers for Disease Control and Prevention provides a list of FDA cleared N95 that has both NIOSH approval and FDA clearance.
The Centers for Disease Control and Prevention provides a list of N95 that has approval by the National Institute for Occupational Safety and Health. These do not have the FDA clearance but have been cleared for healthcare use under the FDA EUA.
The Centers for Disease Control and Prevention has tested non-NIOSH approved respirators (typically KN95s) via The National Personal Protective Technology Laboratory (NPPTL). This list does not reveal if the respirator tested was either the original or counterfeit. Most of these respirators were submitted by hospitals or government agencies for testing.
FDA was criticized for giving EUA authorization to companies and respirators that were incompletely vetted by the FDA. They removed many companies from the list several times. Removal does not necessarily mean that the respirator was bad, but that FDA did not perform the particulate filtration efficiency assessed by NIOSH using a modified version of NIOSH’s Standard Test Procedure.
This is the Canadian recall notice for respirators that failed the 95% filtration efficiency testing.
CDC has compiled a list of counterfeit respirators that are falsely marketed and sold as NIOSH approved respirators. Unfortunately, this is not a comprehensive list.
European Union does not provide a quality list of CE or authorized list of PPE due to its fragmented structure. However, they do offer an alert registry of PPE that are potentially ineffective or counterfeit.