By Angie Perry
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17 May, 2020
On May 07, 2020, the U.S. Food and Drug Administration (FDA) along with the Center for Disease Control (CDC) announced the subsequent action taken in its ongoing response effort to the COVID-19 pandemic. The FDA revised EUA guidelines for non-NIOSH-approved respirators factory-made in China. The eligibility criteria was updated by making a few principle changes, including revising one of the criteria requiring an accredited and independent lab test to now mandate that certain respirators previously listed in the whitelist must pass CDC/NIOSH testing. This is described in detail in the EUA. As part of the government’s continuous quality assessment of these respirators, the CDC, working alongside the FDA, conducted additional tests which resulted in findings that some of the respirators authorized under the previous April 3, 2020 EUA were not up to par with performance standards. According to CDC.gov , "NIOSH has been informed that many legitimate manufacturers in China have been counterfeited. In such cases, NIOSH has no way of verifying which products are counterfeit and which are authentic. While the manufacturer listed...is shown as the manufacturer of the product evaluated, NIOSH has been informed that some of these are actually counterfeit products. Some products with legitimate manufacturer names, showing poor filter penetration results (<95%), are counterfeit products. A number of manufacturers have also informed NIOSH that they did not produce the products associated with their name. NIOSH urges purchasers of masks and respirators that may have questions about the authenticity of these products to contact directly the manufacturers and others in the supply chain as needed to verify that they are obtaining legitimate products." As a result, the FDA revised and reissued the EUA to remove all firms that were authorized based on the independent lab test criterion. Additionally, the FDA, in collaboration with CDC NIOSH, is increasing monitoring and sampling of all respirators imported from China – all respirator imports from China that come into the U.S.A. will be subjected to random sampling and testing by CDC NIOSH to determine legitimacy and whether the materials meet acceptable filtration standards. The FDA provided an update on its efforts to combat the disconcerting actions by companies and individuals that are exploiting the widespread fear among consumers during the COVID-19 pandemic. According to the FDA, "In response to scammers on the internet selling unproven medical products, the FDA has taken – and continues to take – a number of steps to find and stop those selling unapproved products that fraudulently claim to mitigate, prevent, treat, diagnose or cure COVID-19. The [Agency] is committed to helping health care providers navigate this dynamic situation, and issued a Letter to Healthcare Providers with considerations for all health care facilities that have respirators in their inventory." The "new list" or "whitelist", formally referred to Appendix A, has been shaved down to a total of fourteen approved manufacturers, whereas previously there was a total of forty-four. What does this mean for PPE distribution in the U.S.A? With the list of approved manufactures of personal protective equipment material cut down by nearly 70 percent, hospitals and government agencies are now even more stretched for supplies than they were before. The shortage of compliant materials from overseas is overwhelming, and new protocols to conserve these materials are being exercised. It is crucial that these groups be supplied with the proper protective materials, therefore this adjustment had to be made. However, it is taking a toll on each party as there is a vast shortage in supply as only fourteen manufacturers are approved to supply the entire U.S.A.'s hospitals and government agencies. With 1.52 million cases of COVID-19 in the U.S., and the death toll climbing closer and closer to 100,000 mark, the shortage in PPE could prove troublesome, until a solution is provided. To view the updated Appendix A whitelist, click here .