Q&A: Stamp Personal Protective Equipment with ‘Made in America’

November 3, 2020
Frank Diamond

Ashish Diwanji: “The personal protective equipment made and sold in the US has to abide by the standards set up by NIOSH …. The PPE made and sold from China do adhere to the Chinese standards, but their standards are different than ours.”

Infection preventionists and other healthcare professionals still feel the scars of not having enough personal protective equipment (PPE) on hand when coronavirus disease 2019 (COVID-19) first hit back in the beginning of the year. Now, as COVID-19 infection rates spike and healthcare experts worry about possible waves of SARS-CoV-2, concerns over the supply of PPE return. One of the reasons we lacked PPE is because 90% of it is manufactured in China and Chine, the epicenter of the disease, needed all the PPE it could get its hands on. It didn’t want to export it. Domestic PPE production needs to be increased some have argued. Ashish Diwanji, is the president of Lydall Performance Materials, one of the companies that want to manufacture PPE in North America. Diwanji tells Infection Control Today® that one of the best ways to do this is through a public/private partnership. The federal and state governments need to get involved. “The Berry Amendment was an act passed [in 1941] where critical defense related pieces of equipment would have to be sourced from United States manufacturers,” Diwanji tells ICT®. “There are several bipartisan senators and congressmen that we know are working to utilize the Berry Amendment toward having the PPE be considered as part of a critical infrastructure and ammunition for our own defense of the nation.”

Infection Control Today®: How can we ensure that we’re not caught off-guard again in terms of PPE?

Ashish Diwanji: First of all, about the PPE supply, I still think we are in a situation where the domestic demand in North America for PPE, whether it’s masks, gowns, or other critical PPE, is still higher than the domestic production of such critical PPE. That’s point one. I think going back to answer your question as to what we can learn from this is the fact that for years before the pandemic hit in 2019, for years the supply chain for such critical personal protective equipment—whether they’re masks or gowns—the supply chain had moved to China and Egypt. Mostly because of the fact that their costs to manufacture are significantly lower. So, an economic decision was driven for that. For a variety of different reasons. Their labor laws are not as stringent as ours. And their environmental laws are not as stringent as ours for the companies that set up manufacturing in North America. And the third is they do not abide by the quality standards. For example, the personal protective equipment made and sold in the US has to abide by the standards set up by NIOSH [National Institute for Occupational Safety and Health], which is a part of the CDC. The PPE made and sold from China do adhere to the Chinese standards, but their standards are different than ours. So that was the setup, as we entered into the pandemic period back in January and February.

ICT®: A lot of health experts are predicting a second and third wave of COVID-19. So how do we protect ourselves from a PPE shortage again? How do we strengthen the supply line?

Diwanji: I think the way to strengthen the supply line is what our CEO keeps on saying in many of her discussions with the media. Two things. It’s a government/industry partnership in the United States. And the two words I would say are: establish and sustain. I think the first thing we need to do is establish or re-establish or reinvigorate the existing domestic supply chain for PPE, which means not just making the PPE like masks and gowns in the United States, but also ensuring that the supply chain of the materials and the parts that go into making this PPE are secured through domestic sources. The role of establishing and re-establishing that is through the government giving grants or incentives for domestic makers of such PPE and the materials that go into making the PPE to start their supply chains and start the production at a higher level. The second and more difficult pieces you asked in connection with what happens if there is a second or third wave? It is to ensure there is sustainability in the supply chains that are now being established domestically. In order for that sustainability to happen, you need to have two or three. One is a mandate for in-country sourcing of such critical media because I’m not a Doctor [Anthony] Fauci. And I read in several news magazines that perhaps a second wave will come in the next two to three months for just the COVID. And maybe another future virus may come two or three years down the road. I think we have to be able to sustain these manufacturing value chains through things like in-country sourcing, and probably utilization of the Berry Amendment. The Berry Amendment was an act passed [in 1941] where critical defense related pieces of equipment would have to be sourced from United States manufacturers. There are several bipartisan senators and congressmen that we know are working to utilize the Berry Amendment toward having the PPE be considered as part of a critical infrastructure and ammunition for our own defense of the nation. If you think about it in that manner, that’s a great partnership that the government can have to enable the sustainability of this new supply chain that’s being set up.

ICT®: Do you see the government moving toward trying to form this private-public partnership?

Diwanji: I think there’s a third thing that I do see happening, at least [according to] some of the information that I hear in the public media. That the United States government very recently, through what I think is called the Defense Logistics Agency, has just issued a billion dollar contract for PPE medical gowns to several domestic producers. I think the United States government, the federal government, is doing its bit of issuing orders for such PPE. Two, three months ago they issued similar orders for masks, the N95 masks. I think state governments are also doing the same thing. New York State did it. Florida did it. State and federal governments mandate the purchases of such PPE that will help to sustain the infrastructure of work domestic manufacturers are setting up.

ICT®: How long of a timeframe are we looking at here?

Diwanji: I will tell you that in in this case, I am very pleasantly surprised both by the federal and the state and local governments that they have moved fast to release the money for the purchase of such PPE. The challenge remains is given the fact that…. Let’s go back to your very first question: Why was it that for so many years we were sourcing from Asia? The fact that we were sourcing a lot from Asia [was because] the domestic manufacturing of such PPE was at a fledgling low capacity. As the demand surged 10 to 20 times the ability of domestic manufacturers to re-pivot and invest in critical machines, critical talent, that takes time. The federal government and the state governments have released the money. Now what happens is a constriction in the ability of the domestic manufacturers to set up the manufacturing of the PPE. Let’s take N95 masks. To set up the manufacturing of N95 masks takes not just money, but takes machines, people and materials to make these masks. All of that. As the demand goes up 20 to 30 times, it takes time for everyone in the value chain, to ramp up their manufacturing capabilities to be able to supply. So, to answer your question, along with…. The government has done its piece to provide the pool or the demand. Now, we just have patience until the rest of the supply chain is able to fulfill the demand.

ICT®: What do we do in the meantime to ensure the supply remains stable from overseas?

Diwanji: I’ve heard through friends and family members, who are medical professionals, that they’re using their masks or gowns multiple times, which isn’t healthy. An unsustainable situation for everyone involved. In the meanwhile, I think the government is allowing certain importation until we get the supply and demand domestically to meet, to be even. But we need to be very careful of evaluating the quality of this PPE. And very recently, you might have read that the immigration authorities have taken masks several times, and about 65% of those masks failed the critical testing that we need for their performance. That’s the thing what we have to do in the short term is to have lots of testing done of masks or PPE that are being pulled.

ICT®: About a month or two into the pandemic, there was a lot of excitement generated by news that some companies found ways to disinfect N95s for them to be reused safely. Would that be part of a supply chain plan?

Diwanji: I think at this time, every solution should be looked at while we are trying to get the domestic supply equal to the domestic demand. And as much as I am not the person to comment…. An N95, that’s used once, once it goes through it, that’s a technical recycling to clean. Is it going to perform as efficiently as the original mask? If it is, then I would say it’s a good short-term solution. But from what I hear from my technical experts is that the methodology and the science involved in creating the N95 masks to perform when you go through the cleaning, the efficacy of cleanliness decreases. Secondly, as you can imagine, with any filter, whether it’s a filter in our homes or the filter in the operating theaters, right? Those filters work by capturing and trapping the particles. At some point, you have to eliminate and throw away that filter and replace it with a new filter. Because the particles, whether they are airborne or virus or bacteria, are trapped and captured in that filter, and the cleaning mechanisms are not as effective in removing all those particles. They still stick there. At some point, the reuse and reuse of this is not as efficient as a newer piece of filter.

ICT®: Labor costs. You mentioned the reason a lot of this was shipped overseas in the first place was because it was cheaper to produce overseas. You also said that there’s sometimes some quality questions that arise because of that, but it’s going to cost more to make it here, isn’t it?

Diwanji: Well, I think the balance often is the way America generally works. As you know, at the end of the day, it’s a total cost of the product that you buy, right? So, you can have lots of labor do the work on an asset or you can have an asset that is highly productive and be automated to make masks. The new machines that are being installed are highly automated is to make the masks. Total cost to make masks that are as good [as] the ones made in Asia but at a significantly higher quality and meeting all the requirements set by NIOSH. So that’s the way you compete.

ICT®: Is there anything else that you think might be pertinent?

Diwanji: A couple of things. Again, I want to re-emphasize that we look to two things. One is I’m going to reaffirm and sustain, right? This whole partnership between government, the healthcare professionals, the folks who are making the decision to buy in the hospitals and infectious disease experts, we all need to work together to make sure that we’re re-establishing the domestic value chain. That we sustain it domestically. Recognize that it’s not just the United States, but countries in Europe are also following us and establishing a similar model for their in-country sourcing and in-country protection. So that’s it. Be patient and sustain. Good business ethics, government partnership and industry that’s making the PPE; that partnership should continue. The second is, this is just the beginning. PPE is the first barrier and the first protection against official viruses. But remember, most of your folks are also working in hospitals, where there are filters. And the next round is paying attention to the filters. They have air filters, the HAVA filters, the MERV 15, 16 A. The filters used by the folks that put oxygen devices on. The importance of making sure that those filters are also paid attention to. How can we replace them? And how do we ensure that those filters are also sourced domestically? Because that’s going to be the next wave of demanding performance, innovation, and supply chain.

This interview has been edited for clarity and length.