More than 1 million people have been infected in 168 countries. In the northern hemisphere, we are entering the second wave of H1N1.¹ It has been estimated that, in the United States, 30% to 50% of the population will become infected this fall and winter, with over half needing medical attention. Nearly 2 million hospital admissions are predicted, with over 300,000 patients requiring intensive care. Projections estimate that it could cause 30,000 to 90,000 deaths, with children and young adults as the hardest hit age groups.²

The 2009 influenza A (H1N1) virus differs from seasonal flu in some ways. With seasonal flu, about 90% of severe and fatal cases occur in people aged 65 years or older. The age groups most affected by the H1N1 flu virus are much younger. These patients may suffer respiratory failure, because the 2009 influenza A (H1N1) virus is much more efficient at replicating in the lungs.³ They may need intensive care, with long and costly stays.² Some countries reported that nearly 15% of hospitalized cases needed intensive care.²

The majority of infected people are experiencing only mild illness, although deaths do occur, particularly among children and young adults. Older people may have preexisting immunity to the 2009 H1N1 virus.⁴ MMWR cited a study that found "approximately one third of adults aged >60 years had cross-reactive antibody to 2009 pandemic influenza A (H1N1) virus detected, compared with none detected among children.⁵ Another factor is that younger people, such as teenagers, may have higher rates of contact with other people.⁶

We are so fortunate in that, thus far, it does not appear the H1N1 virus has mutated to a more virulent form, as so often happens with the progression of time. Of course, it is still early in the game.¹

Everyone wants to know how to protect themselves and their staff during the pandemic. The Centers for Disease Control and Prevention (CDC) offers guidance. Traditionally, for seasonal influenza, CDC recommended that healthcare personnel wear surgical masks for patient care. The H1N1 swine influenza, descended from the Spanish influenza of 19187, is different from seasonal influenza3; so, CDC’s recommendations for it are different. For protection against 2009 influenza A (H1N1) virus, CDC recommends "All healthcare personnel who enter the rooms of patients in isolation for swine influenza should wear a fit-tested, disposable N95 respirator or equivalent (eg, powered air-purifying respirator). Respiratory protection should be donned upon room entry."⁸

The recommendation for wearing N95 respirators recently was confirmed in a letter report from the Institute of Medicine Committee on Respiratory Protection for Healthcare Workers in the Workplace Against Novel H1N1 Influenza A.9 While noting a paucity of published data on use of masks versus respirators in preventing transmission of the influenza virus, the committee stated that laboratory studies have demonstrated that medical masks, because they do not create a seal against the face, are unlikely to be effective against airborne transmission.⁹

Michael Wang, marketing manager, Bio-Medical Devices Intl (BMDI), Irvine, CA, told Healthcare Purchasing News, "Current indication is that H1N1 influenza is spread primarily by contact, and therefore some suggest a respirator is unnecessary. At the same time, a common influenza symptom is coughing, and coughing is a common mechanism of aerosol generation."

The difference between a medical or surgical mask and a respirator, which may resemble a mask, is the level of protection offered against contaminants. A surgical mask primarily is intended to protect wearers from droplets, sprays, or splashes of blood and body fluids. With only 4% to 90% efficacy against airborne particles, masks offer little protection against respiratory hazards.9 An N95 respirator, being 95% to 99% efficient at filtering out particles, offers a higher level of protection.9 Some respirators are also fluid-resistant.

Jay Hexamer, general manager, North America medical supplies, Kimberly-Clark, Roswell, GA, noted: "Airborne infectious microbes less than 5 microns in size can only be trapped using an N95 respirator or higher." Unlike surgical masks, N95 respirators must be fit tested to create a seal against the face. Another difference is that surgical masks do not need to be NIOSH [National Institute for Occupational Safety and Health]-approved, as do respirators.

Wang outlined a third means of barrier protection: "Powered air-purifying respirators (PAPRs) are positive-pressure devices with full head coverage and 99.97% filtration efficiency. The PAPRs provide aerosol, droplet, and contact protection, covering all modes of influenza spread. The PAPRs are cool and comfortable verses the hot, uncomfortable, resistance-to-breathing N95s. Plus, N95s don’t protect the mucous membranes of the eyes. Adding goggles has the downside of fog-up from exhalation from the N95. With appropriate wipes or sprays, a hose-less PAPR is reusable and can be worn by different HCWs without need for fit testing."

Tronex N95 Mask - Fold Flat Style

Grant Rowe, product manager, respiratory protection, Bullard Company, Cynthiana, KY, added: "The CDC recommendations have been for healthcare workers to wear a respirator that offers the same protection as the N95 mask or higher. The PAPRs, with loose-fitting facepieces, still allow for the use of a stethoscope and offer higher protection, with assigned protection factors (APFs) of 25. The APF may be increased to 1,000 if the PAPR is configured with a full hood, but then stethoscope use would be impractical. Filtering facepiece respirators, such as N95 masks, appear to be the most economical at first glance, but they can soil quickly. PAPRs require a larger initial investment but can be used for much longer periods before requiring a new head covering."

Wang also believes there are financial advantages to using their PAPRs. "We have done many cost-analysis comparisons between MAXAIR and N95s and conventional PAPRs that demonstrate, under practical projections, MAXAIR is more cost-effective over time. The acquisition cost of the recommended quantity of MAXAIRs for emergency and routine use is less than the first year of N95 fit testing, and, each subsequent year, the cost is much less. Therefore, a MAXAIR program provides a comparative positive return-on-investment in 2.5 to 4.5 years over N95s and conventional PAPRs."

Some are predicting a shortage of personal protective equipment (PPE), including masks and respirators. It is a scary thought but not a new one, according to Rowe. "There have been many articles written that say we are not prepared. It is a foregone conclusion that there will be shortages of every kind of PPE should a widespread influenza pandemic hit our soil. The government does have a strategic stockpile, but it clearly will not be enough to satisfy the needs of all American citizens." (For more information on the Strategic National Stockpile, go to http://www.bt.cdc.gov/stockpile/.)

"Unfortunately, once the pandemic hits it will be too late to correct a shortage," said Rowe. He urged: "Buy early and often. Once the pandemic hits, it will be too late. Perhaps hospitals can pool resources, but it is human nature to be reluctant to share when items are scarce."

Hexamer believes his company offers an important benefit. "One of the benefits of being a vertically integrated company is that we have direct control over the manufacturing of our products, which is especially important during pandemic events. Kimberly-Clark’s ability to respond swiftly to a pandemic was recently demonstrated during the April 2009 H1N1 outbreak. We were quickly able to increase production of N95 respirators by 300%, allowing us to respond to the increased demand of the medical community."

Wang, BMDI, noted that their PAPRs have the added advantage of being able to be decontaminated for reuse, cutting down on the need for single-use respirators. "For a pandemic, an ‘average’ 300-bed facility can handle allocating 25% of beds for emergency with 50 to 75 MAXAIR systems. These can be on hand for routine isolation patient needs during ‘normal’ times and ready for an emergency. With these systems in place for routine use, plus the ability to decontaminate for reuse, when properly deployed, shortages for a hospital with a MAXAIR program wouldn’t be as likely versus one following recommended use and disposal with an N95 program."

Kimberly-Clark FluidShield PFR95 N95 Respirator Singles are individually wrapped.

What sorts of planning are needed to ensure adequate barrier supplies during a pandemic? Are there guidelines as to how many masks or respirators are needed each day per staff member in the event of an influenza pandemic?

"The CDC recommends that healthcare facilities consider stockpiling enough consumable and durable supplies for the duration of a pandemic wave, which is estimated to be between 6 and 8 weeks," stated Hexamer. He stressed the importance of also planning for "factors that would be present during a pandemic, such as an increased number of employees and volunteers donning PPE, a higher level of infection control precautions observed, and an increased use of respirators."

"Some hospitals have fallen into the trap of only purchasing one N95 mask per employee," said Rowe, "which obviously does not take into account the disposability factor. Some experts believe that the pandemic may be up to three waves of 2 to 3 weeks each. If this is true, then the HCW would need to have enough PPE for 60 or more days."

"With PAPRs, the guidance isn’t any clearer," observed Rowe, "but I’ve seen the following trends: 1 PAPR for every 10 hospital beds; 1 PAPR for every HCW who has a beard or has difficulty passing N95 fit testing; 3 PAPRs for every isolation room (1 per shift); and most PAPR blowers are shared, with loose-fitting facepieces personally issued to the HCWs."

Wang, BMDI, also commented on estimates for PAPRs. "Our experience is that stocking about 20% extra is appropriate. Three to five MAXAIR systems per infectious patient at any given time is typical. When placed on mobile carts, each can be moved strategically as needed, serving multiple patients at the same time in a reasonable proximity, and then stored."

Rowe, Bullard Company, cited the experience of one large hospital during the height of the SARS outbreak in Toronto. He said that, each day, the hospital consumed 3,000 disposable gowns, 14,000 pairs of gloves, 18,000 N95 respirators, 9,500 ear-loop masks, and 500 pairs of goggles. This same report from the Occupational Safety and Health Administration also stated: "In the first week of the SARS outbreak, the hospital purchased $1 million worth of supplies, although their annual hospital budget was only $50 million per year."10

Clearly, healthcare facilities need help in determining their needs before they need them. The CDC can help. Their FluSurge software is a free, downloadable, spreadsheet-based model that provides help in reaching estimates of the number of hospitalizations and deaths during an influenza pandemic. It also compares the number of persons hospitalized, the number of persons requiring ICU care, and the number of persons requiring ventilator support during a pandemic. To download FluSurge, go to http://www.cdc.gov/flu/tools/flusurge.

Industry is ready to help out, too. It helps not only the healthcare facilities but their suppliers to anticipate needs in a pandemic.

Kimberly-Clark developed the PPE Demand Analysis Tool "to help facilities determine how much PPE supplies they would need to consider stockpiling," said Hexamer. "This analysis tool begins with outputs from CDC’s FluSurge program. The tool estimates outpatient visits, using the same planning assumptions. Combined with the facility’s current average PPE use, this creates a baseline of information to estimate PPE use-rates per outpatient visit, per admission, per hospital bed, and per employee." For more information, go to http://www.kchealthcare.com/pandemicflu/PPE Demand Calculator.asp.

Hexamer also urged planning for how and where supplies will be stored and to consider practical accessibility of those supplies. "You may need to consider working with your distributor partner or renting a storage facility that will provide you quick access to your supply. Your facility will also need to consider a system to rotate the inventory to ensure product is not expired when needed."

Kimberly-Clark offers yet more assistance, said Hexamer. "We developed a pandemic preparedness website that offers information on PPE solutions, pandemic planning resources, a PPE stockpile calculator, a respiratory etiquette program, and a hospital preparedness checklist, as well as respiratory protection program that provides proper donning and testing fitting of N95 respirator masks." Check it out at www.kchealthcare.com/pandemicflu. Also check out Kimberly-Clark’s HAIwatch.com, which offers accredited clinical education on pandemic preparedness for nurses and physicians, available for free.

References

1. World Health Organization. Preparing for the second wave: lessons from current outbreaks. http://www.who.int/csr/disease/swineflu/notes/h1n1_second_wave_20090828/en/index.html

2. National Conference of State Legislatures. H1N1 state and federal response. Updated September 3, 2009. http://www.ncsl.org/?TabId=18061

3. University of Wisconsin. Swine flu: H1N1 virus more dangerous than suspected except to survivors of the 1918 pandemic flu virus. ScienceDaily 14 July 2009. Retrieved September 3, 2009, from http://www.sciencedaily.com/releases/2009/07/090713212231.htm

4. Centers for Disease Control and Prevention. 2009 pandemic influenza A (H1N1) virus infections—Chicago, Illinois, April—July 2009. MMWR 2009;58(33);913-918. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5833a1.htm

5. Centers for Disease Control and Prevention. Serum cross-reactive antibody response to a novel influenza A (H1N1) virus after vaccination with seasonal influenza vaccine. MMWR 2009;58:521—4. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5833a1.htm

6. Nishiura H, Castillo-Chavez C, Safan M, Chowell G. Transmission potential of the new influenza A(H1N1) virus and its age-specificity in Japan. Euro Surveill 2009 June 4;14(22). pii:19227.

7. Kansas State University. 1918 flu resulted in current lineage of H1N1 swine influenza viruses. ScienceDaily. 1 May 2009. Retrieved September 3, 2009, from http://www.sciencedaily.com/releases/2009/04/090430111640.htm

8. Centers for Disease Control and Prevention. Interim guidance for infection control for care of patients with confirmed or suspected novel influenza A (H1N1) virus infection in a healthcare setting. 13 May 2009. Retrieved September 3, 2009, from http://www.cdc.gov/h1n1flu/guidelines_infection_control.htm

9. Institute of Medicine. 2009. Respiratory protection for healthcare workers in the workplace against novel H1N1 influenza A: a letter report. Washington, DC: National Academies Press. http://books.nap.edu/openbook.php?record_id=12748&page=3.

10. Occupational Safety and Health Administration. Pandemic influenza preparedness and response guidance for healthcare workers and healthcare employers. OSHA 3328-05R; 2009. http://www.osha.gov/Publications/OSHA_pandemic_health.pdf