Fears of an avian influenza or Severe Acute Respiratory Syndrome (SARS)-like pandemic in the United States may have subsided somewhat in the years since H5N1 first ravaged parts of Asia, but concerns linger about our nation’s supply of face masks should a pandemic erupt. Pandemic planning is an imperfect science because it is difficult to impossible to know when and where the outbreak will occur, as well as the duration and severity of the event. Also, it is challenging to predict which influenza strains will be implicated in a pandemic outbreak, with annual influenza strains often evading public health experts’ forecasts and scientists’ formulations for the current season’s flu vaccines.

According to the Pandemic Influenza Plan of the Department of Health and Human Services (DHHS), the U.S. must have a national stockpile of 40 million doses (two doses per person) of vaccine against influenza virus subtypes considered to pose a substantial pandemic risk (currently avian H5N1). Additionally, the plan calls for domestic influenza vaccine manufacturing capacity to produce sufficient pandemic vaccine for the U.S. population within six months of the onset of an influenza pandemic. The plan also calls for the availability of at least 81 million treatment courses of approved antiviral drugs, enough for treatment of approximately one-quarter of the U.S. population, and 6 million additional treatment courses in reserve for domestic containment. The plan alludes briefly to the necessity of maintaining equipment and supplies in the Strategic National Stockpile (SNS) and state stockpiles sufficient to enhance medical surge capacity.1

Influenza vaccines and antiviral drugs are normally the first defense against the flu, but availability and immediacy could be problematic during a pandemic. A pandemic may be particularly devastating because human populations will have little, if any, baseline immunity to an entirely new, mutated viral strain. What is critical to remember is that during a pandemic, the primary prevention strategies of vaccines and antiviral prophylaxes are likely to be either unavailable or initially limited in quantity and availability, so reliance upon secondary prevention strategies, including the use of face masks and respiratory etiquette, may be more of a last resort. In the absence of primary prevention, measures to prevent or slow transmission of the virus in both the healthcare and community sectors must be used. Such measures include isolating patients, limiting contacts with infected persons, and otherwise minimizing the likelihood of exposure to the virus, as well as frequent handwashing and requiring infected individuals to be quarantined or equipped with medical masks that might limit respiratory transmission of the virus.2

A report from the Institute of Medicine noted, “In the event of pandemic influenza, supplies of effective vaccines and antiviral medications are likely to be inadequate to treat a very large number of affected individuals. Therefore, non-pharmacological interventions will be important, including the use of respiratory protection through respirators or medical masks or both. WHO recommends non-pharmacological interventions that focus on delaying the spread of infection and reducing the impact of the disease. WHO’s recommendations include permitted, but not required, routine mask use by the general public.”2

Masks will be needed to limit or prevent human-to-human transmission of influenza among healthcare providers and members of the general public. And that’s where it becomes dicey. In the past decade, most U.S. face mask sellers have moved their manufacturing operations overseas. A handful of U.S.-based manufacturers remain, and they cannot produce enough masks to protect Americans during an impending pandemic.

The DHHS recognizes that an inadequate stockpile of face masks and other items of personal protective equipment (PPE) could pose a national security threat. How bad could it get? No one really knows, as the utilization of healthcare during a pandemic is mostly suppositions on paper currently. The DHHS pandemic flu plan attempts to characterize the damage, noting, “Pandemic planning is based on the following assumptions about pandemic disease: susceptibility to the pandemic influenza subtype will be universal; the clinical disease attack rate will be 30 percent in the overall population; illness rates will be highest among school-aged children (about 40 percent) and decline with age; among working adults, an average of 20 percent will become ill during a community outbreak; of those who become ill with influenza, 50 percent will seek outpatient medical care. The number of hospitalizations and deaths will depend on the virulence of the pandemic virus. Estimates differ about 10-fold between more and less severe scenarios.”1

Chettle3 paints a picture for us: “In a severe pandemic, millions of desperately ill people needing hospitalization will quickly overwhelm the healthcare system to the point of collapse. There will be an immediate shortage of hospital beds; critical supplies (surgical gloves, masks, gowns, IV bags, and antibiotics); and trained staff to care for patients. For example, in the U.S., there are about 965,300 staffed hospital beds — not nearly enough. During the peak week of a pandemic, the following numbers of staffed beds and ventilators would be needed in the U.S. for influenza patients alone: 191 percent of current non-ICU beds, 461 percent of ICU beds, 198 percent of all available ventilators. Projections of hospitalizations are only estimates. However, the gap between our current resources and our needs is staggering. These numbers assume that 25 percent to 30 percent of the U.S. population will fall sick and that illnesses will be spaced over eight weeks. It is expected that even in the peak weeks of a pandemic, no more than 10 percent of a community’s population will be ill at any one time.”

Chettle3 adds, “For the healthcare providers who do care for patients with pandemic influenza, the risk of infection is likely to be significantly increased by a lack of PPE. Supply chain problems are expected to develop once a pandemic begins, and most hospitals, with their ‘just-in-time’ delivery of supplies, have not stockpiled PPE. Without N95 masks, goggles, and gloves, will HCWs put themselves at risk taking care of infectious patients?”

The move of face mask manufacturing overseas has weakened the nation’s domestic pipeline and opened the U.S. to unnecessary risk, says Mike Bowen, executive vice president of Prestige Ameritech, a Texas-based company with a history. In 1997, a leading face mask manufacturer, Tecnol Medical Products, Inc. was acquired by Kimberly-Clark Health Care; at the time of the merger, Tecnol had an 87 percent market share, according to Bowen. Prestige Ameritech was started in 2004 by former Tecnol executive Dan Reese; two years later, Reese was joined by Bowen, also from Tecnol. Bowen and Reese realized that when the major mask makers took their manufacturing overseas, the remaining domestic producers of face masks would be sorely pressed to meet the need during a pandemic or bioterrorism event.

Bowen reports that in the last year, Prestige Ameritech has gained 5 percent in market share due to private-label arrangements with bigger mask manufacturers that import most of their masks from China, Thailand and Mexico. According to Bowen, about 90 percent of U.S. masks are foreign made. Taking part in the exodus overseas since the late 1990s were many of the largest glove manufacturers, including Kimberly-Clark Health Care, 3M, Medline, Precept, Cardinal Healthcare, and Molnycke, who manufacture mainly in Mexico, China, and Thailand. Companies that still manufacture all or most of their masks in the U.S. are Prestige Ameritech, Alpha Protec, Crosstex and Gerson.

In late 2007, U.S. mask manufacturers met with representatives from the DHHS to discuss the pandemic readiness problem. Bowen says at that time meeting participants were given a copy of a DHHS presentation outlining these shared readiness concerns, something Bowen adds that Prestige Ameritech has been voicing for several years. Bowen says DHHS told him a directive from the Department of Homeland Security prompted the agency to address gaps in the country’s pandemic plan, including the fact that country’s few remaining face mask companies supply just 10 percent of the mask supply. “DHHS has no money allocated to fix the problem,” Bowen says. “So far, DHHS has conducted facility tours and submitted questionnaires to mask sellers, but as yet, they do not appear to have a plan.”

Bowen believes moving manufacturing operations overseas severely hampers the ability to provide the basics of barrier protection in a pandemic. “When DHHS came to visit Prestige Ameritech last November, they echoed what we’ve been saying for nearly three years: ‘In the event of a pandemic, foreign suppliers will divert mask supplies to their own people (under orders from their respective governments), leaving America to fend for itself.’” Bowen adds, “In the event of a pandemic, mask-producing countries will divert mask supplies to their own people, removing up to 90 percent of America’s ongoing supply. Prestige Ameritech and the few remaining American mask producers could not make up the difference. Hospitals would be out of masks in days or weeks at the most. When the masks run out, there would be no protection for America’s HCWs. If, however, America’s healthcare facilities began buying American masks, the mask makers would return to the U.S. and we would, soon, have the necessary infrastructure with which to build stockpiles to protect America during a pandemic."

In today’s global economy, the healthcare industry is more vulnerable than ever before. Gihring4 cautions that many of the raw materials used in medical supplies and pharmaceuticals come from foreign suppliers and if global supply chains are damaged, U.S. supplies are threatened. A survey conducted by Novation and the University HealthSystem Consortium (UHC) that asked materials managers to determine the status of their pandemic disaster preparations revealed that many hospitals would run out of supplies in less than a week during a pandemic. More than half of the materials managers surveyed (68 percent) reported that their facilities developed comprehensive pandemic-specific disaster plans. Seventy-nine percent said they could continue operations without external resources for less than one week, while 54 percent said operations could continue for one to three days. The majority of managers (93 percent) surveyed have made arrangements with product suppliers to receive critical items. More than half of the survey participants have arranged for products to be delivered automatically if a pandemic event occurs. More than half also claim they can manage critical business functions offsite and can support existing business functions with limited staffing through cross-training. More than half of survey participants (60 percent) keep their pandemic supplies separate from standard inventory and almost one-third (31 percent) of the participants have preprinted disaster preparedness order forms.

Healthcare has embraced the “just-in-time” (JIT) concept of supply (maintaining minimal inventories and delivering products only when needed) procurement, an idea that works under normal utilization scenarios, but may crumble under the weight of a pandemic. Not because of what the healthcare institution is doing, but because of factors out of the hospital’s control, such as reduced manpower and transportation challenges within medical-supply delivery channels. JIT purchasing is at odds with the very idea of pandemic planning and stockpiling, which is a “just-in-case” approach. Detractors of JIT point to the 2003 SARS outbreak during which healthcare professionals in Toronto reported a shortage of N95 respirators because much of the supply was diverted to Asia, which suffered the greatest number of illnesses and deaths. Healthcare providers hoarded and rationed these respirators, or made do with face masks with lesser protective properties.

Masks aren’t the only PPE item subject to potential scarcity. In early July, Hong Ray Enterprises, one of the largest manufacturers of vinyl gloves and a major manufacturer of nitrile gloves, announced that it would be unable to fulfill some of its contracts because of a number of factors, including China’s restrictions on industry in order to help reduce air pollution levels in time for the 2008 Summer Olympics held in Beijing in August. The restrictions were in effect until mid-September, in time for the Paralympics to wrap up.

Hong Ray Enterprises notified Medline Industries, Inc. and other U.S. customers that they are facing “force majeure conditions” and that they will be unable to meet their normal agreements to customers; Hong Ray is Medline’s largest exam glove supplier. “This disruption to supply will have a cost impact on the entire industry,” said Tripp Amdur, president of Medline’s glove division, in a press release issued July 3. “We are moving quickly to secure adequate supply for our customers through alternative factories, at ultimately a much higher cost. It is crucial that we act fast for exam gloves, however, because it’s a high-demand item that can spike in times of crisis situations such as SARS and the pandemic flu.”

In its letter to its U.S. customers, Hong Ray Enterprises cited a number of events and government actions that have led to its inability to fulfill its contracts, including a fire at a major raw material manufacturer, dramatic changes in government policy impacting labor, taxes and credit and pollution-control measures associated with the Beijing Olympics. According to Amdur, Hong Ray’s situation is by no means unique: “All of our suppliers are facing enormous and unexpected obstacles in fulfilling their contract obligations. While Hong Ray is the first factory to formally declare ‘force majeure,’ other factories, including those that manufacture latex gloves, face similar circumstances. In Malaysia, for example, the government recently declared a change in pricing for natural gas, almost tripling the price overnight.”

In mid-August, Kimberly-Clark Health Care also issued a press release addressing Hong Ray’s production shortfalls, shipping delays and price increases. “With the market changing over the past several months, we ramped up our production of Sterling Nitrile Exam Gloves in October 2007 as one of many safeguards to ensure we could supply a superior alternative to vinyl and latex gloves should predictions of production shortfalls hold true,” said John Dodd, vice president of global healthcare product supply. “We will continue to invest in our nitrile glove processes to make certain that we can support our customers in what has become a very volatile global market.” Kimberly-Clark Health Care reaffirmed that its current supply of nitrile gloves are stocked and available, as they are manufactured at two Kimberly-Clark-owned facilities in Thailand and are not subject to the shortages or quality concerns of the heavily outsourced vinyl glove market.

While a “perfect storm” of market conditions and labor costs had a hand in the manufacturing migration overseas, Bowen points to the chokehold group purchasing organizations (GPOs) have on companies’ access to the marketplace. “Selling individual products to individual hospitals became impossible over a decade ago,” Bowen says. “In order to gain price-sensitive GPO contracts, America’s medical companies utilize cheap offshore labor. The GPO focus on price tends to turn products into commodities and give foreign suppliers the advantage.”

Bowen adds, “The head of infection control at a leading GPO thinks that America has a ‘glut’ of face masks and respirators. Today, price is the most important consideration in face masks. As long as this is true, America won’t be ready for a pandemic.” Bowen adds, “Public and governmental pressure will increase to the point that the GPOs will voluntarily institute ‘buy American’ policies for pandemic medical countermeasures in order to be good corporate citizens.”

A sense of apathy about a potential pandemic has settled in five years after SARS and two years after the initial avian influenza scare. Bowen says the lack of pandemic preparedness is a critical concern, but “more importantly, the federal government is saying it.” Bowen adds, “The DHHS recently wrote, ‘Annual production of surgical masks to the U.S. market is about 3.8 billion masks; 90 percent comes from overseas (Asia).’ Additionally, they said: ‘Industrial surge capacity of respiratory protection devices will not be able to meet need and supplies will be short during a pandemic.’ They went on to say that America needs 5.3 billion respirators and 26.9 billion surgical masks in stockpiles and that we only have 0.2 percent of that number in stockpiles today.”

In the DHHS presentation by Brenda Hayden, RN, and Robert C. Huebner, PhD, “Discussion with Respirator Protection Device Manufacturers on Preparedness and Surge Capacity,” given to Prestige Ameritech last November, the agency touches on several important items: there will be a “significant increase” in the need for respiratory protection devices (RPDs) during an influenza pandemic; this need will be all across all sectors including healthcare, public safety, business, government and the public; and industrial surge capacity of RPD will not be able to meet the need and supplies will be short during a pandemic. The DHHS presentation addressed N95 supply issues by reporting that annually, about 900 million N95s per year are available in the U.S. (most are used in non-medical settings). Of those, 25 percent to 30 percent are produced overseas. About 10 percent to 20 percent of annual sales are going to stockpiling, and the SNS represents about 2 percent of the emergency stock needed. In terms of surgical mask stockpiles, the HHS presentation reports that the SNS has a stock representing 0.2 percent of the emergency stock needed.

The answer to PPE shortfalls during a pandemic, it might seem, rests on two action plans: increased stockpiling and increased domestic manufacturing. Within the last several years, then-HHS secretary Mike Leavitt announced that the supplies within the Strategic National Stockpile (SNS) would be boosted with the addition of 73 million N95 respirators with another 32 million ordered, and 37.4 million surgical masks with another 14 million ordered.

For those skeptical of the federal and state stockpiling and distribution process, stepping up domestic manufacturing of PPE items is the single best way to be prepared for a pandemic or other emergency event.

“Masks and respirators are vital to the protection of Americans during a pandemic, but the U.S. government and healthcare systems continue to buy foreign made masks,” Bowen says. “Prestige Ameritech has been very vocal about the dangers of relying on foreign countries for masks and respirators. With the exception of DHHS, our warnings have been met with ambivalence. DHHS fully understands the seriousness of the situation, but has yet to do anything to change it.” Bowen continues, “Currently, the materials to make face masks and respirators are made in the U.S. It is our belief that soon, this will not be true, and that like others before them, the raw materials will follow the manufacturing operations to Asia. When this happens, it will not longer be possible for America to protect its fact mask and respirator supplies. Now is the time to act.”

Prestige Ameritech’s proposed solution is for the country to embrace American manufacturing again. Bowen says that all healthcare GPOs should designate masks, respirators and other “pandemic medical countermeasures” as a special class of products that must be made in the U.S., and that all American healthcare institutions — from large healthcare systems down to small clinics and physician offices — should buy American-made PPE products exclusively. This purchasing exclusivity should be adopted by the U.S. government as well, Bowen emphasizes, adding that this plan will give the U.S. a stockpile to draw from during a pandemic and will ensure that the mask supply cannot be cut off by foreign governments. “Existing mask companies will grow, new mask companies will form, and mask companies who have left America will return,” Bowen says. “A few years ago, the French government discovered that in a pandemic, they would be reliant on China for masks. To remedy the problem, they issued government contracts for hundreds of millions of French-made masks. This spurred the creation of new face mask companies in France, thus solving the problem.”

Bowen says he is confident the U.S. will adopt a made-in-the-USA policy sooner rather than later. “Homeland Security Presidential Directive 21 directed the Department of Homeland Security to identify and remedy gaps in America’s pandemic preparedness plans,” he says. “The Biomedical Advanced Research and Development Authority (BARDA) of the DHHS has identified the problem and is in the beginning stages of coming up with a remedy. We firmly believe that mask production will come back to America and are making preparations for it.”

Bowen reports that political inroads are being made. “We’re been very active politically, and support for American-made masks is growing. Recently, U.S. Congressmembers Kay Granger, Joe Barton, and Michael Burgess wrote a letter to Mike Leavitt about American-made masks. We have heard that Pat Leahy of Vermont supports American masks as well. We have very been successful garnering support from many of our Texas state representatives, including Jane Nelson, who chairs Texas’ Senate committee for the Texas Department of Health and Human Services, and Tom Craddick, the speaker of the Texas House of Representatives. We will continue our vigorous effort to gain political support for American-made masks. Protecting America is a bi-partisan concern and politicians are listening.”

At press time, many on Capitol Hill are consumed with the presidential election and the state of the economy, and may not have pandemic planning on their minds. Bowen says the feds can’t afford to take another misstep, adding, “The federal government got a black eye over how it handled the Katrina disaster. Homeland Security Presidential Directive 21 was a result. The Feds have identified this problem as a national security threat. Now that the issue has been identified as such, they cannot simply ignore it. I see massive government stockpiling of masks on the horizon, as well as political pressure on the GPOs and healthcare systems to purchase American-made masks in order to rebuild America’s mask manufacturing infrastructure.”

In the worst-case scenario — if the foreign pipeline closes and domestic manufacturers can’t meet quotas, and we can’t stockpile enough disposable face masks — can we reuse RPDs? In the presentation supplied to Prestige Ameritech, the DHHS noted, “There are several RPD options (re-usable devices, etc.) that can be employed to meet the projected needs” and that “All sectors must contribute to efforts to prepare in order to meet the needs for RPD during a pandemic.” While the DHHS presentation did not specify which RPDs can and should be reused, medical face masks and N95 respirators are the most likely items.

Currently, medical masks are recommended by the CDC for use in healthcare settings for routine patient care, while the National Institute for Occupational Safety and Health (NIOSH) recommends certified N95 respirators be used in high-risk activities such as aerosol-generating procedures in healthcare settings where SARS and tuberculosis could lurk. However, most medical masks and disposable N95 filtering face-piece respirators have a limited effective life span, according to the CDC: “Once worn, they can become damaged or deformed or develop intolerable levels of breathing resistance from moisture buildup. If worn in an environment with high probability of exposure to infectious agents, they can become contaminated.”2

The reuse of RPDs was the subject of scrutiny in January 2006 when DHHS asked the Institute of Medicine (IOM) to convene the IOM Committee on the Development of Reusable Facemasks for Use During an Influenza Pandemic to conduct a 90-day assessment of measures that can be taken that would permit the reuse of disposable N95 respirators in healthcare settings, as well as the need for and development of reusable face masks for healthcare providers and the public. The committee met in January and March 2006 to convene public workshops and develop a report, available through the National Academies Press, on an analysis of the potential for respirator and medical mask reuse.2

The first issue addressed in the report concerns measures taken to permit the reuse of disposable N95 respirators, and issues such as what modifications can be made in the manufacturing process that would permit these respirators to be reused without increasing the likelihood of infection with the flu virus, and what practices in caring for, wearing, and cleaning could be implemented to safely extend the effective lifetime of disposable N95 respirators. Another issue is the need for reusable masks for healthcare providers and the general public. The IOM committee report states, “In the event of an extended pandemic, there will be the inevitable increasing demand by the public for masks, which cannot be met by the current, or even ramped-up U.S. production of disposable masks. Examples of the types of questions related to design of reusable masks that will be considered include: what materials would be effective; what would be an acceptable level of fluid resistance and filtration efficiency (e.g., individual to prevent respiratory droplets from being dispersed, and to reduce exposure to potentially infectious material, that is, to ensure that reusable masks for non-infected individuals filter inflowing air to minimize exposure to the flu virus, and reusable masks for compliance with existing standards and legal requirements, but the committee acknowledges that there may be difficulty in meeting such standards during a pandemic situation.”2

Many agencies and professional societies have weighed in on reuse issues and most recommend one-time use and disposal of medical masks and filtering face-piece respirators or, at the least, that a wearer change the device when it becomes moist. Generally, medical masks should be changed between uses and whenever they become moist. The FDA and World Health Organization (WHO) recommend disposal of medical masks after one use by one patient, and that HCWs don a new medical mask or respirator each time they come into contact with a new patient. Because laundering disposable medical masks will destroy their barrier properties, there is no way to disinfect them. The IOM committee heard from manufacturers who said that currently marketed disposable medical masks are made of materials that are likely to deteriorate with the usual methods of disinfection. And because medical masks are intended for disposal (and are submitted to FDA with that labeling), manufacturers have no incentive to develop methods for decontamination. Additionally, manufacturers said they would incur increased liability if devices designed and intended for disposal were recommended for reuse.2

The IOM report states, “If a sufficient supply of respirators is not available, NIOSH and CDC recommend that healthcare facilities may consider reuse as long as the device has not been obviously soiled or damaged (e.g., creased or torn). Reuse may increase the potential for contamination; however, this risk must be balanced against the need to provide full respiratory protection to healthcare personnel. The agency recommends that if disposable N95 respirators are reused for contact with SARS patients, institutions should implement a procedure for safer reuse to prevent contamination through contact with infectious droplets on the outside of the respirator.”2

The IOM committee examined various forms of respiratory protection and suggests that N95 filtering face-piece respirators that are NIOSH-certified and properly fit-tested are likely to provide the best protection against influenza to the extent that it may be spread via an airborne route. As well, the committee suggests a closely fitting, high-efficiency medical mask is likely to provide appropriate protection against droplets, whereas a surgical N95 will provide protection against both droplets and aerosols. The IOM report notes, “While recognizing the methodological and data limitations regarding the efficacy of medical masks as a form of respiratory protection against avian influenza, and in the absence of data to the contrary, the committee concluded that masks are likely to provide far less protection against aerosols than an N95 filtering face-piece but may offer better protection than cotton masks, homemade alternatives such as handkerchiefs and scarves, or no protection at all. No device is fail-safe, and its effectiveness depends on fit, level of exposures, and appropriate use. Finally, none of these devices protects against contact transmission, and appropriate hand hygiene is necessary when using and after removing these devices.”2

The IOM committee also acknowledges that during a pandemic, PPE usage may be far from ideal: “With adequate time and planning, stockpiling or ramping up production, or both, would ensure that there would be enough respirators or medical masks for all those who may need them, but with limited resources and time, supplies are likely to be insufficient. Thus, reality may require that disposable N95 respirators and medical masks be pushed beyond their approved uses in the hope that they can offer some level of protection beyond their intended limits of use. Moreover, individuals with no access to respirators or masks, even disposables, may feel driven to invent their own respiratory protection measures; for example, they may don woven masks not approved for medical uses in the United States, or use household items such as towels or sheets.”2

References:

1. Pandemic Influenza Plan of the Department of Health and Human Services. Accessed at: http://www.hhs.gov/pandemicflu/plan/

2. National Academies Press (NAP). Committee on the Development of Reusable Facemasks for Use During an Influenza Pandemic. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. 2006.

13. Chettle CC. Are you prepared for a flu pandemic? Available at: http://www.nurse.com/ce/anthology.html?CCID=4599&Chapter=3833&ChapNum=4

4. Gihring T. The pandemic prophecy. Minnesota Monthly. April 2006. Available at: www.minnesotamonthly.com/articles/pandemicProphecy.html.