When the novel coronavirus arrived in the United States this past spring, individuals and non-medical businesses were urged not to buy face masks that qualify as true personal protective equipment (PPE)-N95, KN95, and FFP2 respirators-because there was a critical shortage of qualified respirators, which needed to be reserved for medical personnel. Although the CDC guidance against individuals purchasing PPE has remained the same, the true story is more complicated.

PPE definitions

An N95 respirator meets the National Institute for Occupational Safety and Health (NIOSH) standard of filtering at least 95 percent of airborne particles. KN95 respirators meet a similar standard, but are regulated by China. Level 2 filtering facepieces, or FFP2s, filter at least 94 percent of incoming airborne particles, but are regulated by the European Union (EU); FFP3s filter 99 percent of particles. Surgical masks, by contrast, include a wide array of non-woven material masks designed to protect patients from exhaled bacteria during medical procedures; airborne particle-blocking ranges from 10 to 90 percent, with between 80 and 100 percent of masks failing a “fit test” designed by the Occupational Safety and Health Administration (OSHA). A number of studies cited by the CDC demonstrate no reduction in patient infection when medical personnel wore surgical masks (https://blogs.cdc.gov/niosh-science-blog/2009/10/14/n95/).

CDC guidance

On March 16, the CDC created a page dedicated to N95 respirator use (https://blogs.cdc.gov/niosh-science-blog/2020/03/16/n95-preparedness/), stating, “CDC prioritizes respirator use for healthcare personnel in close contact with (i.e., within 6 feet of) patients with suspected or confirmed coronavirus disease (COVID-19), during aerosol generating procedures, and for infectious diseases when airborne precautions should be followed.” The guidance on this page has not changed in the many months since mid-March.

Family medical practices and local health authorities echoed the CDC guidance, instructing the general public [March 22 communication from Flatiron Family Medical in New York City], “As most have heard there is an extreme shortage of PPE, especially masks. The hospitals state that within a few weeks they will have none at their disposal […] We know that a lot of our patients in their fear have purchased masks (both surgical and N95s). We ask that those of you who have this PPE and are willing to please send it to our office. We will forward to the local hospitals.”

As the weeks of lockdown and increasing regulations on American citizens’ activities stretched on, medical practices and health authorities continued to talk about the critical shortage of PPE, noting that cloth face coverings were inadequate for medical professionals exposed to respiratory viruses. Individuals were instructed that do-it-yourself (DIY) cloth face coverings were OK for their own use to protect others from their own possible germs –but that N95s should be kept for doctors [March 30 communication from Flatiron Family Medical]: “A 2015 study in Vietnam found that hospital health-care workers wearing cloth masks were far more likely to become infected with respiratory and flu-like illnesses than were people wearing disposable surgical masks. Cloth masks stopped just 3 percent of particles, and medical masks stopped 56 percent.”

N95s and KN95s

are available

Businesses and governments stepped up to tackle the shortage of PPE. In Pennsylvania, the Dept. of Community & Economic Development (DCED) created portals for manufacturers of PPE to provide their contact and purchasing information. The DCED used the submitted manufacturer information to create a “PPE and Supplies Business-2-Business Interchange Directory” (https://dced.pa.gov/pa-covid-19-medical-supply-portals/pennsylvania-covid-19-ppe-supplies-business-2-business-b2b-interchange-directory/). On Aug. 10, the Press contacted several N95 distributors in the directory, and found a much more complicated story than the CDC or family practitioners are telling.

Jane Heimbecker of HALO Branded Solutions (https://www.halo.com/) receives PPE orders every week, ranging from 60 to 30,000 pieces, depending on the size of the customer organization. Her company, headquartered in Sterling, Ill., with offices all over the Uunited States, has its own safety department that verifies the FDA approval of N95s and emergency use authorization (EUA) of KN95s and FFPs. Halo has not experienced an inability to fill PPE orders since April, in part because of longstanding partnerships with multiple vendors in China that allow the company to verify the FDA approval or authorization of PPE, as well as “social compliance” with Halo’s own standards for factory worker treatment. The challenges in maintaining its own distribution center stocks of PPE has largely come from delays at Chinese ports, where customs holdups can last weeks. Heimbecker also points out price-gauging by the Chinese government that has created difficulties for Halo’s own pricing. Several weeks ago, China raised the export tax on PPE several times within a single day.

Heimbecker says she has seen shortages recently, but they have been of level 3 and level 4 surgical gowns, not PPE-qualified masks. Citing the use of the same material to fabricate surgical gowns and Clorox wipes, Clorox president Linda Rendle announced in early August that retailers will not be able to restock Clorox wipes until 2021. That’s not a problem for Halo, which has reverse-engineered the formula for the wipes, and is making and selling its own, as well as its own version of CaviCide, a surface disinfectant used in medical practices and nursing homes. “In the last couple of weeks, we were hearing about a shortage of nitrile gloves,” Heimbecker says, but her company has been able to fill all nitrile glove orders placed.

Ihor Terleckyj of Simma International in Berwyn says that his firm primarily supplies private medical practices and nursing homes. During an average week, Simma sells 5,000 to 10,000 KN95s. Terleckyj says that his firm has been able to fill KN95 orders without difficulty since the end of March, but still faces challenges with N95s. “Sometimes we’ll have an order in, for 3M N95s out of China,” he reports, “but all of a sudden, the order will be put on a delay.” He speculates that “customs delays” in China are being used to mask the commandeering of PPE by the Chinese government. “Probably it’s being requisitioned by some national group. That puts us in a bind with our customers.” To mitigate this challenge, Simma has stopped taking orders for any PPE-qualified masks that it doesn’t have in its own physical inventory in the United States. “We stopped doing the pre-order,” Terleckyj explains, “because they just weren’t showing up. We started only selling them when we had them physically delivered and in our inventory.” Like Halo, Simma verifies the FDA compliance of the PPE that it sells. “We’re a very ethical operation, and we make sure that all the analysis sheets come in with them […] We also have a sourcer who works with us in China and does factory inspections.” Terleckyj says that “the biggest lesson the country has learned from COVID is that we have too much reliance for health outside the United States,” and reports that Simma has created a partnership with a distillery in the state of Washington to make hand sanitizer and disinfectant wipes, “so we don’t have reliance outside the United States.”

Tom Gillespie of Signature Emergency Products (SEP) in Boothwyn says that his company has shifted away from PPE-qualified masks lately. In May and June, SEP filled orders totaling up to 500 masks per week, but now sells “just a handful” on a weekly basis. The company supplies dental practices, nursing homes, daycares, and similar facilities with items such as infrared thermometers. It also provides ventilators to individual hospital systems, to state purchasing authorities, and to FEMA.

Gillespie notes that a challenge in procuring KN95s is verifying their effectiveness.“There’s a lot of supply out there; however, it’s a lot of-for lack of a better term-junk […]” Another issue is the terms some manufacturers are requiring. “A lot of them want pre-pay, or have a minimum order quantity of one million.” Gillespie also notes the problems with paid-for products clearing Chinese customs: “I have 1,000 infrared thermometers that have been sitting at customs for a month now, and we just got notification from FedEx that it’s being cleared for shipment.”

Nico Riccione of Apiary Medical Inc. in Breinigsville echoes Gillespie’s concerns about price. He says that his distribution firm has been unable to keep up with demand for N95s since the beginning of the pandemic, but shifted away from KN95s because the prices demanded by manufacturers were too steep.

Next shortage?

Gillespie predicts that the next serious shortage the country will face during the current pandemic is nitrile gloves, because they cannot be cleaned, and cannot be worn for extended periods of time if they tear. SEP uses an ultraviolet disinfection booth for incoming packages to protect its own employees, and Gillespie notes that although UV disinfection can be used on masks, “You can’t do that with nitrile gloves.”