The U.S. Senate Finance Committee met for a second time in three days to address the supply of personal protective equipment (PPE) for the COVID-19 pandemic. While a witness said the Defense Production Act (DPA) is no panacea for production, one message emerging from the hearing is that producers need to hear from end users about demand just as much as users need to know about available inventories.

The July 28 hearing featured some partisan political fireworks, as did the July 30 event. However, the U.S. government officials who testified at the earlier hearing emphasized the need of bringing the manufacture of PPE back to the Western Hemisphere – if not to the U.S.

“It’s a fact that the federal government’s approach to emergency preparedness has always been fraught with challenges,” Finance Committee Chairman Chuck Grassley (R-Iowa) stated at the opening of the July 30 hearing. Grassley went on to note that this statement applies to multiple presidential administrations, regardless of party affiliation.

For his part, Sen. Pat Roberts (R-Kan.) noted that President George W. Bush had asked Congress for $8 billion to start working on a pandemic supply chain program. “Unfortunately, Congress did not respond to his request,” he lamented. Roberts also said that the U.S. Strategic National Stockpile (SNS) was not intended to address all needs across the nation.

Meanwhile, Sen. Ron Wyden (D-Ore.) said he agreed that counterfeit PPE is a problem. But he blasted “the Trump administration’s casual disinterest” in ensuring adequate supplies of PPE as a root cause of the pandemic.

Support for Alexander legislation

Charles Johnson, president of the International Safety Equipment Association, of Arlington, Va., said his association supports the legislation drafted by Sen. Lamar Alexander (R-Tenn.) for pandemic preparedness. He said that given existing PPE production capacity, no amount of planning would have sufficed to address the current crisis.

The Federal Emergency Management Agency must have the authority to gather data from state and local governments regarding local PPE inventories, Johnson said, and he requested that manufacturers of gloves and garments be added to the list of industries that will be insulated from product liability litigation during the course of the public health emergency.

While more than one witness made the case that suppliers and manufacturers need a sense of the local, state and national demand for PPE, Johnson said that without such data, manufacturers and distributors “are flying blind.”

Too much inventory will kill businesses

Johnson also said that a more robust manufacturing base might ensure that a 90-day inventory in the SNS would suffice. However, he explained that the federal government needs a planning process that anticipates demand “on a much more granular level.” A greater volume of production would help in times of crisis, but more taxpayer support for domestic product “is an answer, but not the answer” to preparedness.

“I would once again highlight that a systemic approach” is needed to ensure that companies remain viable between pandemics, Johnson said. However, policymakers must ensure that a massive overhang of inventory does not accumulate because such a development “is a perfect way to put that capacity out of business.”

Rob Wiehe, senior vice president for supply chain and logistics at UC Health in Cincinnati, said his institution has faced shortages of PPE in recent months because supplies were diverted to so-called hot spots. He advocated in favor of a distribution strategy that addresses both national and state-level demand, adding that he has seen prices for PPE that were 10 times the rates charged prior to the pandemic. Still, availability must supersede any concerns over pricing, he added.

Wiehe said transparency of both existing inventory and production capacity is essential in a crisis, but noted that the Centers for Medicare & Medicaid Services could mandate that hospitals retain a certain volume of inventory on hand. This kind of requirement would not necessarily be onerous, but Wiehe said clinics may have ordered more than needed in the past few months to ensure sufficient inventories, a move he blamed on lack of data regarding inventories at distribution points.

DPA ‘can’t make production appear out of thin air’

More than one committee member made the case that legitimate imports of PPE have been held up by federal agencies concerned about counterfeit and subpar products. While several committee members argued that the DPA should be invoked, Johnson was cautious. “[T]he DPA is not magic; it cannot stretch back into the past and make production lines appear,” he emphasized. “[W]e want to stress that [the DPA] can’t make production appear out of thin air.”

For his part, Ernest Grant, president of the American Nurses Association (ANA), said the association’s members previously had reported in surveys that their employers were mandating re-use of single-use PPE. Preliminary data from a more recent survey of ANA members “shows that nothing has changed,” he said. PPE inventories are still short, and some purchases are of poor quality. At the same time, some items are labeled one-size/fits-all, even though these items don’t fit at all, thus exposing the health care professional to an elevated risk of infection.

Grant said some face shields are unusually prone to fogging, resulting in some incidents, although he offered no specifics. The PPE crisis is multifactorial, but “more must be done by both the state and federal governments” to provide transparency of inventory, as well as equitable access for smaller hospitals and hospital chains, which may find themselves in bidding wars against their larger brethren.

Grant said masks can irritate the skin when worn over long periods of time, something manufacturers might want to address in terms of future design and materials.

Wiehe said UC is on allocation for testing supplies, which makes it difficult to anticipate the volume of testing the clinic’s labs can handle. The lab at UC is adequately staffed for the installed equipment base, but the normal turnaround times for molecular testing are lengthened by the highly variable demand for tests. “That lack of coordination from end to end contributes to the frustration you’re hearing” about testing, he said.

The availability of swabs, many of which had been imported from Europe prior to the pandemic, was a sticking point at UC as well. Wiehe noted that some 3D-printed swabs have not performed as well as advertised; therefore, the UC labs have not used those items. “We are on allocation from pretty much everybody” upstream in the supply chain, he said.