Suppliers of personal protective equipment have come up with innovative ways to meet the demand, but one expert notes the lack of rigorous research into its efficacy.
A year ago, if you asked anyone outside the healthcare and manufacturing industries what “PPE” was, chances are they wouldn’t have been able to even venture a guess. Now the initialism for “personal protective equipment” has entered the vernacular along with other COVID-19-related terms like “social distancing” and “face mask.”
Common understanding of PPE may have evolved, but the equipment itself —gloves, masks, respirators, gowns — hasn’t changed all that much amid the pandemic. The innovation has occurred mainly in logistics, supply lines and massive increases in production to meet a demand that was beyond imagination not many months ago.
Just trying to keep up
For many manufacturers, keeping up with the demand for PPE has been challenge enough. Tim Post, a spokesperson for 3M, the largest maker of N95 respirator masks, says that at the beginning of this year, most of the orders for the St. Paul, Minnesota, company’s masks came from industrial clients. When the pandemic hit the U.S. in March, the demand from the healthcare sector jumped 20- to 40-fold seemingly overnight. He says that previously, healthcare sector orders for N95s came primarily from hospitals treating patients with highly infectious illnesses such as influenza A and tuberculosis.
To meet that demand, the company dramatically increased production. Post says that globally, 3M has doubled N95 respirator production since January and is on pace to produce 2 billion respirators by the end of the year. In the U.S., 3M was on pace to produce 95 million masks a month by October. That’s triple the production in April, but Post says it still won’t be enough: “The reality is that even with 3M’s accelerated production, combined with capacity from other manufacturers, the demand for N95 and other respirators continues to exceed supply for the entire industry and will for the foreseeable future.”
Charles Johnson, M.A., president of the International Safety Equipment Association, a trade group, says PPE manufacturers are working around the clock to produce the most essential equipment. The pandemic, he says, “has likely forever changed PPE demand within the health and safety landscape.”
All areas of the safety equipment industry, including importers and distributors, have adjusted to meet spiking demand, according to Johnson. Some PPE producers who specialize primarily in sectors such as industrial or construction protection have begun partnering with medical device makers to begin making products for medical settings.
Meanwhile, manufacturers in completely different industries have jumped into the fray. For example, Ford Motor Company shipped out its first powered air-purifying respirators in May, made in partnership with 3M, which provided technical and regulatory know-how. Ford also started making reusable gowns for healthcare workers, sparked by a 500,000-unit order from the state of New Jersey.
Lack of evidence
A few experts say this rush to deploy PPE is happening in the absence of solid evidence about how protective PPE really is. Jos H. Verbeek, M.D., Ph.D., an occupational health physician at the University of Amsterdam, has long advocated for evidence-based improvement of PPE. He has written about the lack of randomized trials to back up the efficacy claims of common PPE items and argues that the industry needs uniform, high standards, which, in his view, are sorely lacking. He told Managed Healthcare Executive® that although the COVID-19 pandemic has centered attention on PPE, that awareness has not translated into systematic improvement: “Everything has been focused on dealing with the crisis, and there hasn’t been any concerted effort in improving the situation: no trials, no comparative studies, no standardized naming.”
In April, Verbeek and colleagues published a Cochrane Library review of PPE studies that also included research into the risk of contamination associated with donning and doffing the equipment. They found that the results of two dozen relevant studies suggested that covering more parts of the body, such as the neck and the head, could improve protection and that modifications like pull tabs to ease removal of the equipment could cut down on inadvertent contamination. In an opinion piece in The BMJ in June, Verbeek said a key takeaway from the review is that there is a frustrating lack of evidence to instruct healthcare workers and manufacturers on which types of PPE work best and how best to handle the equipment in the real world. “All evidence was rated as low to very low quality,” he wrote.
Although much attention has been paid to face coverings and respirators, Verbeek argued that PPE ought to be evaluated holistically because face masks are generally just one of many pieces of equipment used by healthcare workers in high-risk environments. Moreover, he said, the use or misuse of equipment can have a significant impact on effectiveness. Improperly used PPE will not be protective, and Verbeek emphasized the need to address the practical aspects of the gear. “PPE needs to be feasible in healthcare settings because protection depends not only on the technical qualities of the garment but also on the composition of PPE items, interfaces between pieces of PPE, and the ways in which they are put on and taken off,” he wrote.
COVID-19 has pumped billions into the buying and selling of PPE, and, notwithstanding Verbeek’s concerns about the lack of standards, companies leaped at the chance and are out there, selling their PPE ware. For instance, Aegle Gear, which makes scrubs, now sells products treated with Protx2, a proprietary spray created by Intelligent Fabric Technologies (North America) to protect fabric from odor-causing bacteria and fungi. Aegle’s website says the garments have been tested against various pathogens but also carries a disclaimer noting that the Protx2 finish is used “solely to protect the finished product itself,” and the company makes no claims about its health benefits. Intelligent Fabric Technologies says its recently developed follow-on product, Protx2 AV, can effectively protect against SARS-CoV-2, the virus that causes COVID-19.
PPE makers are also busy tweaking products to make them more comfortable. Working with Nissha Medical Technologies, 3M put a hydrophilic film on face shields that wicks away fluid and prevents them from fogging up.
A number of manufacturers, including 3M, are working with the FDA to find and evaluate ways to safely decontaminate and reuse N95 masks. Johnson says developing reusable PPE is now seen as important because it would help alleviate the supply problem.
“Elastomeric respirators (reusable-filter-style respirators) and powered air-purifying respirators provide greater protection and can help to prevent shortages of disposable alternatives,” he says, “so we expect to see them used more often as healthcare facilities continue to battle this and future health emergencies.“
Verbeek acknowledges that new products could improve PPE but says he still sees a problem of science and rigorous evaluation lagging.
The wide array of face coverings designed for source control — protecting people from asymptomatic carriers — is a new product segment, according to Johnson. He says his association and its members are working to establish standards and guidance to ensure that such products are safe and effective. There certainly seems to be a strong appetite for scientific evidence about the effectiveness of face masks: Duke University researchers were in broke-the-internet territory in August when they reported results about how well different face masks hindered exhalation of droplets.
Verbeek concedes that it might be asking too much to conduct rigorous comparative research in the middle of a pandemic, but that doesn’t mean there is no opportunity for progress: “A realistic alternative is to conduct observational studies in which the PPE of healthcare workers is registered prospectively, and the healthcare workers are followed for their risk of infection.”
Jared Kaltwasser is a healthcare reporter based in Iowa.