It’s been a year since Covid-19 hit American shores, but frontline workers are still struggling to find adequate shelter. Despite increases in production and drastic measures to expand the range, the lack of personal protective equipment (PPE) has not disappeared. If anything, the situation has become more confusing as the emergency rules remain in place, fakes are on the market and supplies just don’t get where they are needed.
This story will begin at the beginning.
The extraordinary PSA shortages have forced health authorities to make extraordinary decisions: hospitals that need to maintain their limited supplies are reducing the frequency with which supplies are distributed and placing a strong emphasis on who gets the best supplies. OSHA has even published guidelines for dividing workers into risk levels based on patient exposure and the likelihood of encountering Covid-19. Disposable N95 masks have been stretched for days or even weeks, clearing official CDC guidelines for mask reuse. As recently as February, 81% of the nurses surveyed by National Nurses United said they still reuse masks, and the AP reported that “most” hospitals still give one or less masks per employee per day.
A new industry quickly evolved into adapting mask guidelines for repeated use. Peter Tsai, the inventor of the N95 mask, came out of retirement to help the N95DECON project develop methods to disinfect and reuse the masks.
As of April 2020, ECRI data showed that 48% of the hospitals surveyed were already using at least one method to disinfect masks for further use.
Prepare the stage
By the time the pandemic started, the PSA situation in America was already precarious. National inventory had been used up and not replaced during the H1N1 crisis, while American hospitals and other institutions were overly reliant on foreign imports. China, hit by the pandemic months before it spread to the rest of the world, had taken two major measures: seeking help from other countries and curbing its own exports – so few were available for import into America.
American production capacity was too weak to make up for the slack. Manufacturers like Prestige Ameritech, previously burned by unstable demand, simply weren’t prepared for the urgent needs of the pandemic-hit healthcare system.
An industry revival
The desperate need for PPE led to a revival of American manufacturing. Then-President Trump used the World War II-era Defense Manufacturing Act to boost PPE manufacturing, a move the Biden administration will continue. Many US companies in other industries revolved around the manufacture of a wide variety of needed goods, from clothes to hand sanitizers.
Despite the stabilization of production, hospitals are still rationing to ensure an even supply of masks and to keep costs down. Scientists and frontline workers have expressed concern about care and current CDC and hospital guidelines on who needs high-level protective equipment.
To add insult to injury, it must also be questioned whether the PPE available can be trusted.
A flood of forgeries
A rare umbrella EUA has allowed foreign masks of Chinese KN95 to be used here in the US, but that opened the door to counterfeiters and lesser options. ECRI, an organization dedicated to monitoring safety standards in healthcare, found that up to 70% of the KN95 masks tested did not meet the minimum safety standards for use in a healthcare setting. Some imported masks came along with fake National Institute for Safety and Health at Work (NIOSH) approval papers, fake registration numbers, or information copied from other products.
Government agencies are working together to eradicate the counterfeits. Over 11 million have been seized in the past few weeks. Healthcare providers need to consult guides like this one from the FDA to identify legitimate manufacturers, and this one from the CDC tries to filter out the fakes. Despite this, counterfeit shipments are still finding their way into hospitals.
Government action is helping to keep counterfeits out of the hands of workers. However, this can cause problems in other areas.
The great separation
It took some time, but American manufacturers responded to the challenge. Now they have trouble selling them.
Although healthcare workers do not have sufficient PPE and the US strategic inventory has not yet reached the desired level, an export ban has been changed to allow up to 5 million masks to leave the country per month.
Kaiser Health News received a FEMA memo regarding the change, mailed by Joe Biden less than two hours before the inauguration. According to KHN, the memo cites manufacturer Prestige Ameritech’s difficulty in finding buyers for its high-end breathing apparatus and says that lifting that ban will allow American companies to continue their pandemically accelerated pace of production.
Stakeholders like Get Us PPE told KHN that the current CDC guidelines, especially the same pandemic-era emergency guidelines that allow for reuse and elimination of requirements like fit testing, allow hospitals and other employers to use fewer PPE order and restrict who receives protection. High-end breathing apparatus is also not yet recommended outside of the healthcare sector, even for people in high-traffic closed environments such as public transport.
The domestic market is a mess. Smaller clinics and offices don’t know where to get verified PPE, while big stores like Amazon and Facebook keep manufacturers from selling to the public. There is also a cost problem as more expensive American products are reportedly battling the restored flow of cheaper imports.
The safety of our healthcare workers is important and the influx of counterfeit products poses a real risk. With the emergency policies still in place and the changing political field, it is difficult to see exactly where the situation will lead. However, the message from the workers at the front is clear: put more N95 on the faces and do it quickly.
Sean Marsala is a Philadelphia, Pennsylvania-based health journalist. He loves technology, usually reads, surfs the internet, and explores virtual worlds.