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.
- By Jerry Laws
- Jul 01, 2009
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
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
Emergency use of those respirators meets the criteria
for issuing the authorization for three reasons,
(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
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
The European Centre for Disease Prevention
and Control issued guidance on May 19 ( www.ecdc.europa.eu/en/files/pdf/Health_topics/0905_Influenza_A(H1N1)_Personal_protective_measures.pdf )
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
"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
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
"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
This article originally appeared in the July 2009 issue of Occupational Health & Safety.