How Many Respirators to Handle H1N1?

Is an enormous government stockpile the right strategy? Guidelines for the use of N95 respirators by the general public amid the flu outbreak demonstrate the critical public health role played by PPE manufacturers.

The American public's concern about potentially pandemic influenza A(H1N1) waned in early May as schools in some affected states reopened and Mexico appeared to have its outbreak in hand. The number of confirmed cases and cou ntries in which they were found continued to rise steadily, however, primarily in the Americas and Europe, the World Health Organization reported.

Then-acting Food and Drugs Commissioner Dr. Joshua M. Sharfstein on May 1 authorized the emergency use by the general public of surgical N95 respirators from the National Strategic Stockpile. Five companies' N95 respirators were covered by the authorization. Sharfstein's letter explained that the term "general public" included people performing workrelated duties, adding that anyone using a respirator while performing work-related duties must comply with OSHA's respiratory protection standard (29 CFR 1910.134).

Emergency use of those respirators meets the criteria for issuing the authorization for three reasons, Sharfstein wrote:

(1) Swine Influenza A can cause influenza, a serious or life-threatening disease or condition;
(2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that certain N95 respirators may be effective in preventing influenza by reducing wearer exposure to pathogenic biological airborne particulates, and that the known and potential benefits of certain N95 respirators, when used for the prevention of influenza, outweigh the known and potential risks of such products; and
(3) there is no adequate, approved, and available alternative to the emergency use of certain N95 respirators in the prevention of influenza.

The Emergency Use Authorization (EUA) followed a U.S. Department of Health and Human Services declaration on April 26 that a public health emergency existed— the A(H1N1) outbreak. And WHO Director-General Dr. Margaret Chan reiterated the gravity of the threat May 18, reminding her audience at the 62nd World Health Assembly in Switzerland that this flu strain was poised to strike the developing world's fragile health systems hard and possibly overwhelm them.

The European Centre for Disease Prevention and Control issued guidance on May 19 ( ) that did not recommend use by the public of surgical masks. The center's May 11 guidance for the health care sector included mask usage for all activities by health workers having close contact with patients, as part of comprehensive infection control recommendations.

Filling the U.S. Stockpile

What the EUA did not say is how many surgical N95 respirators are currently stockpiled or how many the U.S. government believes may be needed. Time magazine published an article May 19 explaining some of this, and respirator manufacturers supplied more details.

Respiratory protection manufacturers have discussed the stockpile for several years with the Bush and Obama administrations and specifically with officials working for an HHS unit named BARDA—the

"So the stockpile's in place," he said. "I think there was an assumption . . . that there was a lot more capacity and you could ramp up that capacity a lot more quickly." The largest manufacturers maintain excess capacity for just this type of situation, but it takes four to six weeks to scale up that equipment with the personnel in place to operate it, he explained.

He said a panel formed by CDC and FDA is re-examining the stockpile goal and what level of capacity from PPE manufacturers is realistic and necessary, eying a timeframe of three to five years to build the appropriate manufacturing capacity. Two leading trade associations for safety equipment. the International Safety Equipment Association and the Safety Equipment Distributors Association, are working with their members and involved in the conversation, which seeks creative ways for government, health care, and the private sector to join forces, Kates said.

Major Industry Groups Are Mobilized

Orders to buy protective respirators poured in when the influenza A(H1N1) outbreak was identified in late April. "I can't tell you the specifics, but I can tell you it was in excess of nine figures. That's how many inquiries we had on that Monday and Tuesday: nine figures in dollar value worth of inquiries over respirators. It was just a staggering, staggering number," Kates said.

Significantly, orders were not cancelled when the public began to lose interest. "By the end of that first week, everything became stable and the panic subsided quite a bit, but what we've seen—and the whole industry has seen—the orders haven't been canceled," he said. Customers in all of the big industry groups, from health care to pharmaceuticals, major public utilities, and private utilities, have increased orders.

"What I think this was for many of them was a stimulus for them to get back to their pandemic planning and their pandemic preparations," he said. Many companies have plans in place from the avian flu scare but had not invested money in protecting mission- critical employees. They're doing so because of A(H1N1), he said.

Strategic stockpiling by the government is only a beginning; government and private industry working together over the long term will yield the most significant progress, Kates said.

Guidance for the Public

The general public does not understand the concept of respiratory protection as occupational safety and health professionals understand it, of course. To that end, OSHA posted a series of Quick Cards and Fact Sheets to help its online audience understand how surgical masks and industrial respirators compare, which workers should wear respirators, how workers should protect themselves, and what employers can do to protect their employees.

One of the Quick Cards judges two large groups of workers as "high exposure risk": emergency responders transporting sick patients and doctors, nurses, and other hospital staffers who enter patients' rooms. The "very high exposure risk" category includes workers with high potential for exposure to known or suspected sources of pandemic virus during specific medical or lab procedures. Some dental procedures and laboratory work would qualify, according to OSHA.

CDC's best resources include its "Summary Fact Sheet for Disposable Respirators for Use During the Swine Flu Emergency," authorized by FDA on May 1 and explaining the EUA in plain English.

"You have been given a disposable respirator listed below to wear to help reduce your exposure to airborne germs during a public health emergency," it begins. "Reducing your exposure to airborne germs may reduce your risk of getting infected with flu. You can decide whether or not to use this respirator. If you are given the respirator at work, also talk to your employer.

"Whether or not you use a respirator, always follow infection control measures: wash hands, cover coughs and sneezes, stay home if you may be sick."

This article originally appeared in the July 2009 issue of Occupational Health & Safety.

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