Jared Kaltwasser

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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.

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.

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 

® 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 

 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.

Articles

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.

The PPE Scramble

Martin Moll, J.D., advises medical practices of all shapes and sizes in his role as founder and advisor at Breakaway Bookkeeping & Advising. When the topic of price transparency comes up, he immediately points out a fundamental problem.

“If you talk about price transparency, it actually requires transparency,” he said. “And at the end of the day, that’s the hard part for doctors, because they actually don’t know what things cost.”

Typically, doctors don’t calculate the individual costs of services, he said. Instead, they tend to add up their overall expenses and reimbursements and declare it a success if they end up in the black. Price transparency is another item on the miles-long list in healthcare for which the saying is far easier than the doing. Nearly two decades after the introduction of health savings accounts and high-deductible health plans and a full decade after the Patient Protection and Affordable Care Act (ACA), which required hospitals to publish their chargemasters, it’s more idea than actuality.

As an idea, price transparency is easy to grasp because it is so familiar to people living in an economy fueled by consumer spending. For decades, U.S. healthcare has been paid for primarily by third parties, insurers and public payers, and that makes people heedless of cost and not especially interested in shopping for less expensive care. But, the theory goes, if Americans knew the price of healthcare services 

 had to pay a substantial share of the cost, they would be more inclined to shop around, and expensive American healthcare would benefit from a healthy dose of market competition.

But pulling the curtain back on prices isn’t so easy. Despite efforts from presidents on both sides of the political aisle, healthcare prices remain obscure, confusing or both.

In November 2019, President Donald Trump signed an executive order that translated into two new price-transparency rules, one governing hospitals and the other, health plans. Both are scheduled to take effect next year. The hospital rule would require hospitals to make public their rates under negotiated agreements with insurers, as well as how much they are willing to accept in cash payments from patients for particular services. For 300 common “shoppable services,” hospitals would need to make such data available in a consumer-friendly format rather than merely a machine-readable file.

For insurers, the “transparency in coverage” rule would require them to provide cost-sharing information to members, including estimates for covered items and procedures. They would also need to publicly disclose negotiated rates for in-network providers and allowed amounts for out-of-network providers. According to CMS Administrator Seema Verma, the rules would give consumers the information they need to make practical and informed healthcare decisions — and more. “Today’s rules usher in a new era that upends the status quo to empower patients and put them first,” she said in a press release.

But the hospital rule quicky became ensnared in court challenges by the American Hospital Association. In June, a federal district judge ruled in favor of the administration and against the hospital association, referencing the argument that patients who know about prices will put pressure on providers to lower costs. The hospital association said it will appeal the decision. The insurance rule had yet to be finalized as of this summer; once it has been, there is little doubt that it too will face legal challenges.

Katie Keith, J.D., M.P.H., a healthcare consultant who blogs about the ACA for 

, said these rules are deeply unpopular among insurers and hospitals. “I don’t think anyone in the industry wants their prices — their negotiated rates — to be public,” she says. Brian Blase, Ph.D., a former Trump health administration official who was influential in developing price transparency polices, said in a recent 

 blog that hospitals aim to maximize profits and they oppose price transparency because they believe it will reduce those profits.

Other Trump administration attempts at price transparency have also become bogged down. A 2019 executive order that would have required drug companies to disclose the wholesale acquisition costs of drugs in advertisements was blocked after a court ruling that the Department of Health & Human Services did not have the authority to compel such disclosures. In response, the president began calling on Congress for a bipartisan drug price transparency bill. A number of members have been working on such bills, but so far no major proposal has made it to the president’s desk.

Although the administration has moved to trim regulations in a number of different industries, Keith said healthcare is one area in which Trump has pushed to add new consumer-friendly regulations, even when that has meant going to war with industry. “They have really doubled down on interoperability too,” she says. “It’s not quite the same thing as transparency, but it’s kind of that same concept that they want patients to have access to (information).”

Eric Ellsworth, M.S., MBA, director of health data strategy at Consumers’ Checkbook says many of the current forms of healthcare price transparency are not meaningful to consumers. For instance, although some insurance sites give estimates of costs, he says, “you still can’t really take that to the bank. You can’t do anything with that. It’s just sort of an awareness tool.”

In response to the proposed insurance rule, American’s Health Insurance Plans (AHIP), the main trade group for the health insurance industry, submitted a 57-page comment in which they assert that transparency could end up harming consumers. “It will undermine competitive negotiations and push healthcare prices higher — not lower — for patients, consumers and taxpayers,” wrote Matthew Eyles, M.S., AHIP president and CEO. The group argues that if a hospital suddenly found out it was receiving less than a competing hospital for the same procedure, it would demand a higher price. AHIP also criticizes the scope of the transparency, arguing that the rule should focus only on “shoppable” services.

Moll notes that although hospitals are better than smaller medical practices at putting price tags on services, those prices don’t necessarily translate into the cost of the service alone. Hospitals can have drastically different prices on similar services, in part, because they have unreimbursed costs, such as indigent care, that they must account for through billing for reimbursed procedures. The cost of the unit care is almost irrelevant, he says, because hospitals are focused on their overall hospital margin. Moll says there’s currently a gap between reimbursement and value. He described a scenario in which an orthopedic surgeon has significantly lower readmission rates. That surgeon may save the payer money but usually has had little luck convincing insurers to recognize such that with a higher reimbursement rates.

Ellsworth believes the fundamentals of the healthcare marketplace will need to be adjusted before price transparency works the kind of consumer empowerment magic that its proponents envision. He sees the episode-based payment models as a step in the right direction because they give providers an incentive to control costs. Such payment models would also help consumers to see their care for a particular medical problem as a unit, he notes. By choosing between packages of transparently priced treatment options, consumers could make informed decisions about what they are truly want to pay for , says Ellsworth. “People have to get a little more used to defining their own goals,” he says.

Keith says asking consumers to make decisions based on cost effectiveness might be a bridge too far. However, she believes that having price data publicly available could help improve the healthcare system in other ways by, for example, aiding cost-effectiveness research.“I don’t buy that it’s effective at the individual consumer level,” she said. “But for the system, I think it could be really valuable.”

The Trump administration’s attempts at pulling back the curtain have ended up in court.

For Price Transparency, the Outlook is Murky

A new study is lending more credence to the theory that multiple sclerosis (MS) may be linked in some way to stress, although the authors caution that it is exceedingly difficult to tease out whether the link is merely an association or whether stress might play a causal role. 

The latest findings on the MS-stress connection were published in the 

 used data from questionnaires given to 2,930 people with MS and 6,170 controls to see whether any patterns could be found in terms of the occurrence of major life events and the onset of MS. The questionnaires focused on lifestyle environmental factors and, in particular, on 10 specific life events, such as loss of a loved one, unemployment, or the breakup of a marriage or long-term relationship. If a survey respondent said they had experienced one of those events, they were asked to indicate when it happened and how important the event was when it occurred. The investigators only included events in their analysis if the event happened prior to the onset of MS symptoms. Controls were matched to patients with MS based on age, sex, and residential area.

The results showed a statistically significant correlation. Patients who had undergone one of the key life events had an increased risk of MS ranging from 17% to 30%. The authors found the link between stressful life events and MS was higher for women in many cases and that the stressful event typically happened within 5 years prior to the onset of MS symptoms.

Xia Jiang, Ph.D., the corresponding author and colleagues, noted that the subject of MS and a possible link to stress has been studied quite a lot, although many of the studies have been small and had design flaws, which, among other things, have led to selection bias.

Furthermore, the results of the studies have been mixed; for example, the results of two major studies by Danish researchers that were published in 2014 showed that, on the one hand, 

 had a higher risk of MS as adults while on the other, adults who who had gone through a divorce or other stressful events 

A Differing View: The 'Inside-Out' Explanation of How Multiple Sclerosis Occurs

 the topic of stress and MS is controversial partly because inferring causal relationships from the associations shown in observational studies is problematic.

“For example, in retrospective studies, recall bias is a problem,” she said. “MS patients (or anyone who unfortunately gets ill) would be more likely to seek a reason for their disease, so they may recall and report their life events or other relevant events to a greater extent than healthy individuals.”

Prospective studies are also present issues, she said, because the neurological changes in a patient might start years before symptoms of MS are identified, and those changes might lead to negative impacts on the patient’s lifestyle and stress level.

“Stress and MS are both brain-related, [so] it’s difficult to prove causality,” she said. “The two conditions might exacerbate each other, or there might be a reciprocal relationship.”

Indeed, though her study found a notable association between MS and stress, Jiang said it’s far too soon to draw conclusions about the nature of the apparent correlation or what implications such a link might have for patient care.

What they can say, however, is that there seems to be enough evidence to warrant additional study.

A new study finds people who go on to be diagnosed with MS are more likely to have experienced a significant stressful life event, but the author cautions against jumping to cause-and-effect conclusions.

New Study Links Stress and MS, but the Association May Not Be Causal

, M.D., FAAFP, president of the American Academy of Family Physicians, has an apt analogy for the “new normal” of COVID-19: It’s like going from being childless to being a parent.

“There are things that you can’t do anymore,” he says. “You have to make these adjustments in your life to accommodate the absence of things that you would normally do.

If COVID-19 adds a major new level of complication to the daily life of Americans, especially those working in healthcare, the arrival of influenza season could be thought of as the birth of a second complicating factor.

Ever since the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus forced a massive shutdown of the American economy this spring, public health officials have been concerned about what might happen if the new virus were not contained by the time flu season rolled around this fall and winter. Now, with the season just around the corner, everyone from the family practitioner to the CEO of a major health system is preparing to deal with potential outbreaks of the two conditions, both of which can be life threatening.

COVID-19 and flu both come with symptoms such as fever, cough, runny nose and body aches, according to the CDC. Both are highly transmissible, spread mostly by airborne droplets that are exchanged when people are close together and talk, cough or sneeze. The illnesses will resolve in many patients without the need for medical intervention, although a subset of patients with COVID-19 and flu will experience severe symptoms and require hospitalization, and a subset of those will die.

But there are also important differences. Young children are apparently more at risk of suffering from a severe case of flu than they are of COVID-19, although a small number of those with COVID-19 develop multisystem inflammatory syndrome in children. Most people with flu will be contagious for about a day before they start feeling sick and will be contagious for as many as seven days thereafter. With COVID-19, patients can be contagious for multiple days without symptoms, if they show symptoms at all. The CDC says those patients are contagious for at least 10 days after the onset of symptoms. Another difference is that loss of taste and smell has been reported in patients with COVID-19.

Lastly, the FDA has approved multiple vaccines to prevent flu infection and multiple antiviral medications to treat it. Although a dozen or so COVID-19 vaccines are in clinical trials and the world is awaiting the results, so far none of them have been approved.

LeRoy says at the family practice level, screening questions will remain a key starting point in controlling both infections. However, the screening questions don’t always identify patients who could have been exposed to COVID-19, he notes. And the onset of flu season will mean that affirmative responses could have a wider range of causes.

In midsummer, LeRoy started noticing his proportion of telemedicine visits going down, which in turn led to a rise in patients making what he calls “oh, by the way” comments. “(In other words,) …‘Oh, you know, I had a sister or a relative or somebody that tested positive for COVID(-19). Do you think I should get tested?’” he said. “And I’m (thinking), why the heck are you sitting in my exam room?”

Such patients aren’t flaunting protective procedures intentionally, he said, they are simply unaware of the risk they could pose to other patients and to staff.

In an ideal world, patients with flu or COVID-19 should be treated with telemedicine whenever possible. Depending on the level and location of testing available in a particular area, they may simply recover at home and never receive a conclusive diagnosis of either flu or COVID-19. However, LeRoy says one challenge in such cases is making sure patients understand that they must take the utmost precautions, even if they never receive a firm diagnosis.

“I’m finding that I have to be very specific to people about what I mean by ‘quarantine,’” observes LeRoy, “because they (say), ‘Okay, I won’t go to work, but I’m going to go…pick up some groceries.’”

Paul Auwaerter, M.D., MBA, a professor and clinical director at the Division of Infectious Diseases at Johns Hopkins Medicine, said one of the key prevention measures health systems typically take is requiring all staff to get a flu shot, ideally by November. Around the same time, hospitals will start routinely testing patients for the flu. “This is a bit more complicated now because we have COVID-19,” he says. The hope, notes Auwaerter, is that tests for the SARS-CoV-2 virus will be incorporated into some of these molecular respiratory panels. The FDA has granted emergency approval for such an assay, although it is not yet clear when it will be available, nor is it known which types of providers will be first in line to receive the supplies.

Like family practices, hospitals and clinics will need to manage which patients come into the office and which are treated with telemedicine, says Auwaerter. He typically takes a proactive approach with patients who have suspected flu, “in the sense that I would want them to come to the office and see if they’re struggling,” he said.

However, with COVID-19 it could be riskier to invite those patients to the clinic, he said.

A similar problem will be found in the emergency department, because it will be impossible to immediately distinguish between patients with COVID-19 and those with influenza, and a patient with one disease could infect a patient with the other disease. “We know from a number of reports that both viruses can be acquired at once,” Auwaerter remarks.

He said that staff treating patients with flu typically wear standard personal protective equipment (PPE) once patients are admitted to the hospital, but patients with COVID-19 typically require a negative-pressure room to account for the aerosolization of the virus. Johns Hopkins has converted entire floors to treat patients with COVID-19 and suspected COVID-19. Once flu season arrives, however, those floors might be in higher demand. “People with influenza may be cohorted into these floors,” Auwaerter said. “Now, they’re not at any increased risk for getting COVID-19. But these are people (who) we immediately can’t distinguish if they have COVID-19 or not.”

He says hospital leader needs to prepare for the flu season by continuing to do everything they can to secure PPE and think proactively about personnel issues that may arise.

With the risk of additional stress on the healthcare system, both LeRoy and Auwaerter said flu vaccination will be of critical importance. Auwaerter hopes the increased awareness will push flu vaccination rates above the 40% mark seen in the past.

But there is also a chance that COVID-19 social distancing and mask wearing will have a knock-on effect on flu. Instead of a perfect storm, there may be double prevention. Moreover, the lack of international travel may also mean that the flu virus, which tends to swirl around the world, will stay put.

There may also be a bystander effect on the common cold, which tends to be caused by a coronavirus — not SARS-CoV-2, but a coronavirus nonetheless.

“And so, given the fact that influenza A, influenza B, the common cold (rhinovirus), coronavirus-type…common cold viruses, and…SARS-CoV-2 are all spread in similar manners, I suspect that you will see less of the common cold,” LeRoy says, “because not just healthcare workers, but practically everybody is (taking) universal precautions now.”

As a case in point, LeRoy said he gets a summer cold every single summer, even although he is a “fanatic” about washing his hands. “So far, I haven’t gotten a summer cold,” he says. “And it’s probably because other people around me are taking…precautions because of COVID(-19).”

If there’s a silver lining in the pandemic, perhaps these precautions are it, LeRoy says, although he couldn’t help being a bit superstitious. “Now I’ll probably get something just because I’m opening my big mouth about it,” he jokes.

Jared Kaltwasser is a healthcare writer based in Iowa.

But social distancing and face masks may mean less transmission of flu — and fewer colds.

Author | Jared Kaltwasser

Articles

The PPE Scramble

For Price Transparency, the Outlook is Murky

New Study Links Stress and MS, but the Association May Not Be Causal

As COVID-19 Lingers, Flu Could be a Complicating Factor