(San Diego, CA) The Research Consortium announced today the availability of a guide to alert consumers to the emergence of substandard and counterfeit reusable face coverings and equip them to identify and avoid them.
Concerned that face coverings vary greatly in their effectiveness at source control and wearer protection, under the oversight of the CDC’s National Institute for Occupational Safety and Health, the ASTM International standards organization created a new international standard for manufacturers and consumers alike.
The new Standard Specification for Barrier Face Coverings (ASTM F3502) establishes baseline design, fit and performance criteria for manufacturers and an easy, uniform method for consumers to evaluate them. Essentially creating the “barrier face covering” product class, it also gave rise to some unintended consequences: substandard and counterfeit face coverings and companies willing to make them. Consumers (individual, government and corporate) need to be aware of, concerned with, and equipped to identify and avoid these products; ergo the guide.
Written by Richard Nicholas, a forty-year veteran of the healthcare industry, and a member of the ASTM committee that developed the standard, it details how consumers can identify substandard and counterfeit products: the distinction being that substandard products simply fail to meet the standard’s requirements, while counterfeits are ones that are falsely claimed to comply with it.
Intended for individuals, employers and professional advisors (e.g., purchasing, HR, workplace safety, loss control, risk management) — as well as medical directors and health system administrators —
How to Avoid Buying Your Family and Employees Counterfeit and Substandard Reusable Face Coverings addresses everything from the standard’s requirements; to interpreting mask classification labels; to consumer warnings about those aspects of face masks that pose potential health, safety and environmental risks (a topic that has not been fully developed in this first version of the standard).
Nicholas surveyed manufacturers, distributors and retailers that falsely represented their face coverings as being “ASTM F3502-compliant” or “certified” and found that noncompliance was both accidental and deliberate. Most were unaware of the standard’s requirements; many mistakenly believed that their “outmoded” past performance tests are sufficient to satisfy the standard; some expressed little concern for putting the public at risk.
Not surprisingly, Nicholas found manufacturers that are knowingly making false claims about their products’ being compliant or “certified” solely to gain market advantage. Some haven’t even gotten their masks fully tested to the standard’s specifications. In part, this is because the laboratories (e.g. Intertek, SGS, Eurofins, ICS, Nelson) have only recently become prepared and accredited to perform ASTM F3502’s unique tests and assessments, and some still remain confused as to its requirements.
According to Nicholas: “Substandard and counterfeit face masks are dangerous because they foster a false sense of security…for wearers and those around them. Consumers must be certain that the products they buy are compliant with the new standard as their well-being, and that of their family and employees, is at stake.”
Among national standards, ours is unique in its use of the rigorous NIOSH-based particle filtration efficiency test which yields much lower results (< 60% vs. > 95%) than the traditional tests familiar to consumers. It requires design, leakage, fit and biocompatibility assessments and retesting after the claimed maximum number of washings to evaluate performance and fit with prolonged use. Manufacturers must evidence meeting ALL the standard’s requirements in a Conformity Assessment Report to be compliant.
ASTM F3502 has been adopted by the FDA. Other agencies (e.g., OSHA) with enforcement capability will soon follow; the FTC, DOJ and some state AGs have already begun counterfeit and fair-trade investigations. A new World Bank sponsored global campaign is underway to raise awareness of community mask standards as well an initiative to establish an online voluntary “registry” for products claiming compliance to evidence such.
Deception isn’t limited to consumers. Yahoo! featured articles having a manufacturer’s claim that its face masks “…got an ASTM certification”. TODAY and NBC News published articles with a false manufacturer claim that its products were among the first to get “certified” and “proven to meet” the new standard. To their credit, upon learning from Nicholas that ASTM doesn’t “certify” face coverings, Yahoo! promptly deleted its articles and NBC News issued this correction: “After consulting lab reports and experts, NBC News confirmed that the masks did not meet a new standard for reusable masks” and removed the product from its best face mask listing.
How to Avoid Buying Your Family and Employees Counterfeit and Substandard Reusable Face Coverings is available here and at www.researchconsortium.org There you will find our other articles and our definitive study: CoVid-19: Its Transmission, and Face Mask Efficacy
The TPA Network Research Consortium is an emerging industry-wide research initiative to help healthplan sponsors evaluate new medical technologies and health innovations…by conducting much-needed payor-focused translational research and facilitating more, smarter and less costly clinical trials.
For full disclosure, the RC developed a patent-pending reusable face covering that is in the prototype stage