Medical Supply Chain Needs More Production in Western Hemisphere, Witnesses Say
Witnesses that represent companies that make masks, gowns and face shields, a group purchasing organization that provides that gear to healthcare organizations, and a hospital chief supply chain officer told the Senate Finance Committee that while moving more production from Asia to the U.S. and close-by countries would help in the next crisis, it's not the solution to the shortages the country has.
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“The fact that so many of our medical supplies are manufactured overseas is not the singular reason for the problems we are facing now. Similarly, onshoring all manufacturing would not solve these problems either,” said Cathy Denning, a senior vice president at Vizient, a group purchasing organization, in her opening statement at the July 30 hearing.
International Safety Equipment Association President Charles Johnson agreed. “Increased support for domestic production can be an answer for future preparedness but not the answer,” he said. He said a surge in demand for masks in past pandemics “led to huge overhangs of inventory,” and the production lines that had been mobilized were then shuttered. “No matter where production is located, It will scale itself to the demand it ordinarily serves,” he said.
Denning said that hospitals are using roughly 10 times their usual amount of personal protective equipment, and in New York and other hot spots, it is up to 15 times their usual N95 purchases.
Companies and the government tried to respond to bad actors selling substandard N95 or KN95 masks, but couldn't stop it all from coming through, witnesses said. Johnson said 3M Company got sales platforms to remove 7,000 fraudulent e-commerce offerings of its product. He said 3M is investing in ways to detect counterfeits, as well.
He said that his trade association's members have offered free testing to buyers who suspect the masks they have bought are substandard. He said in one case, a KN95 mask only had 30% to 45% efficiency in blocking particles, when they are supposed to have 95% efficiency. The goods were marked as FDA-approved.
Denning said in late March, Yale New Haven Health hospitals in Connecticut believed that masks they had been donated that were marked as Dasheng KN95 masks were counterfeit. They were also in the process of buying Dasheng masks, and canceled the orders. “Yale later learned that most of the PPE vendors with whom they had been engaging were not actually dealing directly with factories in China but, rather, third-party distributors or gray market brokers,” she said in her opening statement. Moreover, the sellers sent false test results, and a third-party lab found they were 85% efficient, not 95%.
University of Cincinnati Health Chief Supply Chain Officer Rob Wiehe said his hospitals had avoided such problems, but only through an onerous verification process. “Our standard approach required a potential vendor to submit material specification sheets, FDA Certificates of Approval, Third Party Testing Certification and samples that were reviewed by our infection control team,” he said in his opening statement, according to prepared remarks. “A significant percentage of the information we reviewed did not prove to be authentic. FDA certificates were submitted that did not match what we could find online at the FDA website and Third Party testing certificates were submitted that could not be verified. If a product made it past these initial checkpoints, our team then tested the product to ensure that all materials received matched specification sheets.”
Wiehe said that while they were confident in the quality, the speed of delivery in the first six weeks of the pandemic was a big problem, as China and other countries put export restrictions on the goods, factories were closed during lockdowns, and travel bans affected cargo movement. There was a lack of capacity in air cargo, he said, so, “Suppliers used multiple methods of transport to overcome this constraint including private charters, smaller and more numerous shipments on FedEx or UPS, and ocean freight, which delayed availability by 2-4 weeks.”
Johnson said that protective gear that is not FDA-approved, but is needed at factories or shops to protect workers, has been held up at the U.S. border, even though it was legitimate. He said ISEA was able to help get it cleared, but said, “the fact that it occurred to begin with, we need better communication about the legitimacy of safety products.”