A flood of new masks and hand sanitizers that have been manufactured to meet demand during the COVID-19 pandemic has prompted the Food and Drug Administration (FDA) to offer guidance on faulty and fraudulent versions, and HealthTrust is guiding members to be vigilant.

Karen Wagener, BS, ChE

“With manufacturing being shut down in China for two to three months and a lot of the PPE (personal protective equipment) coming out of China, supplies quickly dried up in other parts of the world,” explains Karen Wagener, BS, ChE, Executive Director, Quality & Regulatory at HealthTrust. “As we were trying to source new supplies, the biggest challenge was verifying these new sources met the appropriate level of protection.”

Carey Watkins, RN, MSN

Carey Watkins, RN, MSN, former Director of Clinical Engagement, Private Label at HealthTrust, says FDA guidance is just one piece of the puzzle. “I feel very confident and relieved to have the FDA’s guidance as a starting point,” she explains. “But with HealthTrust’s recommendations and product review process, I feel we’ve gone several steps further, as well as assisting in the vetting of products for our suppliers to assure that their specifications are acceptable from a regulatory and clinical perspective. Ultimately, this ensures products are safe for our clinicians to use.”

Adapting to a changing landscape

As part of its normal course of business, HealthTrust is well-positioned to vet products that may be added to the contract portfolio. Five Clinical Advisory Boards support strategic sourcing by applying evidence and knowledge to this process, complementing the efforts of the internal Strategic Sourcing team.

HealthTrust’s decisions also typically align with FDA guidance and product approvals. But the pandemic compelled the FDA to accelerate product reviews, and the agency recognized many unproven medical products—some with fraudulent claims—over the last several months. After launching “Operation Quack Hack” in March, the FDA identified more than 700 such products related to COVID-19 by June.

This crackdown was balanced with the FDA’s move to omit certain manufacturer requirements in order to expedite product availability during PPE shortages. For example, the FDA waived the need to file a 510(k) market clearance prior to marketing surgical masks over the summer. However, according to Wagener, the agency later added another pathway to legally market masks and clarified what should be included on labels for fluid barrier protection.

“The landscape for regulatory requirements is still changing in regard to what manufacturers, importers and distributors have to do to legally market and sell hand sanitizers and face masks,” Wagener explains. “While it was necessary for the FDA to do what it did to ensure hospitals didn’t have additional shortages of PPE, it shifted the burden of legitimacy to the purchaser.”

HealthTrust’s team has capably met the challenge both in comprehensively vetting products and communicating with members about what’s safe and unsafe. “Having a team dedicated to reviewing, interpreting and applying the regulations, and vetting products from a clinical perspective, is vital to ensuring only safe and effective products are available to our members,” Wagener says. “I think other organizations might not have fared as well, ending up with more counterfeit or adulterated products.”

Angie Mitchell, RN

Angie Mitchell, RN, former AVP, Clinical Services at HealthTrust, agrees. “Because the measures and structure are in place, we’re able to do a really good job of vetting,” she says. “And it does take a village.”

Going above & beyond

Beyond the critical task of verifying products, quality control efforts from HealthTrust extended to other aspects, such as making sure various mask models fit clinicians. “We also had to make sure that the products the manufacturers were stating their testing belonged to were actually the products they shipped,” Watkins explains. “There was a lot of bait and switch going on.”

HealthTrust member facilities can take some reassurance from these backbone measures, say Wagener and Watkins.

“We’re able to either help prevent a bad product from getting into the hospital or quickly act with a supplier to recall it,” Wagener explains. “We’ve seen enough bad apples and untruthful players that I don’t think we’ll ever go back to the days of solely relying on the FDA. Our efforts will supplement and complement the FDA’s final decisions for vetting these types of devices.”

Watkins urges HealthTrust members to take advantage of both the FDA’s and HealthTrust’s websites to keep abreast of rapidly changing information regarding safe and unsafe PPE products.

For a shareable infographic on hand sanitizer safety, visit education.healthtrustpg.com/clinical-resources/hand-sanitizer-infographic.



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