Pivoting Safely To PPE
…with counterfeits everywhere, how can you confidently source safe products?
5/18/2020 | Jeff Jacobs, The Brand Protector
It seems everybody in the promotional products industry decided to sell personal protection equipment overnight. Most are approaching the opportunity to fill the urgent need with an altruistic heart, but a few opportunists in our industry have offered a toehold to the growing problem of counterfeit products.
I’ve had a couple of conversations this week with distributors hesitantly filling orders for only their best clients, and only on request. They realize there is significant risk to their brand not only from the appearance of taking advantage of high demand, but also from unknowingly selling unsafe product.
At the commencement of “The Mask Rush,” the gold standard was the N95 respirator mask, intended to protect the wearer from incoming airborne particles and from liquids contaminating the face. Highly regulated (CDC, OSHA, and the National Institute for Occupational Safety and Health) and in short supply, priority on these respirator masks was to get them to healthcare providers and first responders. The Food and Drug Administration originally rushed approval to 80 manufacturers in China to make N95-type masks for U.S. healthcare workers on April 3rd. But in an abrupt reversal, the FDA cut that number to just 14 at the beginning of May, saying masks did not meet U.S. standards. According to the Wall Street Journal, tests found 60 percent of 67 different kinds of imported masks allowed in more tiny particles than U.S. standards allow. One Chinese manufacturer’s masks filtered out only 24 to 35 percent of particles, well below the 95 percent threshold that gives the masks their name. The FDA has even issued letters to 14 manufacturers for making “bogus claims” of the capabilities of their masks. It’s easy to see why distributors would be hesitant to navigate the choppy waters of importing these masks, which leads me to an important point: How can you spot a fake, even one made in the U.S.?
According to the National Institute for Occupational Safety and Health here are some signs of a fake N95 respirator mask:
- It features ear loops instead of a headband
- A missing testing and certification approval number on the mask’s exterior face, on the exhalation valve (if one exists), or on the head straps
- No markings on the filtering face piece respirator
- Misspellings, such as the NIOSH acronym
- Decorations of any kind
- Approval for children, since there are no NIOSH-approved respirators for children.
There’s also risk in turning to fabric masks as an option, especially for suppliers not aware of the updated FDA emergency use order (EUO) intended to clarify manufacturing guidelines for fabric masks. The EUO was updated and re-issued to clarify that fabric masks are intended only for “source control.” This means that these style masks provide only a barrier of outbound transmission by covering the mouth and nose during a cough, sneeze, or just while speaking normally. In short, fabric masks are meant to protect others, not the wearer. They’re not meant to give a false sense of security. In fact, the FDA makes it clear these fabric masks are not authorized as personal protective equipment. They are not a substitute for filtering face piece respirators or for surgical face masks. There’s the rub for many distributors. These fabric masks have very specific labeling requirements, they cannot be advertised as PPE, and they have to be traceable for any product failures (like skin reactions from end-users).
Chris Blakeslee, the president of Bella+Canvas, told me there is “an incredible lack of awareness around facemasks” in our industry. Bella+Canvas pivoted early in the mask game, and is now making 100 million masks a week. “In a matter of weeks, our industry has probably become the largest PPE distribution network in the world,” Blakeslee told Promogram. But, he continued, “We’re putting ourselves at risk by being uneducated. We all know how these things go. At some point, someone wearing a face mask is going to get COVID-19, and they’re going to have the perspective that the mask didn’t protect them. If the company who made it didn’t adhere to the guidelines, they’re going to be in trouble.”
Finally, we’ve talked here several times about the promotional products industry being a little slow on the draw when it comes to product safety and sustainable sourcing. No question the trend we’ve seen toward improving that will continue as businesses come back to full throttle, and that’s a good thing. During the time I worked with the Quality Certification Alliance, I had the opportunity to work with several compliance experts from accredited suppliers who both volunteered their time to the non-profit, and also cooperatively shared their companies’ best practices, ultimately helping create the protocols QCA used for accreditation. I had the occasion recently to connect with Larry Whitney, who was president of the Board of Directors during part of my tenure with QCA, and whom I just learned has gone out on his own to form Whitney and Whitney Consulting Group.
Larry spent 15 years with Polyconcept, the last six as director of Global Compliance. Why do I think it’s important to mention this move here and now? One of the key indicators for suppliers truly interested in producing safe and compliant products was the ability to first document the protocols necessary to evaluate products for safety risks, regulatory requirements, and social accountability of supply chains, and then, follow those protocols every day. Larry’s consulting is an extension of what he did at Polyconcept, as well as helping with tariff mitigation and sustainability programs. Should you find yourself looking to jumpstart your current compliance efforts, I’d recommend reaching out to see if Larry might be able to help you. He can be reached at firstname.lastname@example.org.