Massive stockpiling causes spot shortages of N95 respirators

Some hospitals face delays for current needs

Massive stockpiling of N95 respirators by major corporations preparing for pandemic influenza has caused supply problems for hospitals, which need N95s for current infectious disease hazards such as tuberculosis.

Spot shortages and delivery delays raise concerns about how hospitals would obtain respiratory protective equipment during an influenza pandemic. Most hospitals still rely on just-in-time delivery, which makes them vulnerable to supply disruptions, says David Naylor, vice president of sales for Thorofare, NJ-based Aramsco Inc., the world's largest distributor of N95 respirators.

Financial services, utilities, and other major companies are buying the respirators as part of a business continuity plan for pandemic preparedness, says Naylor. "The overall market is being consumed by Fortune 500 companies," he says. "You have companies that never bought an N95 before that now buy $10 million of them."

Yet hospitals, which are strapped for money and rely on federal or state grants for pandemic planning, haven't been able to create substantial stockpiles, Naylor says.

"Their day-to-day purchases are enough to keep the hospital running in normal conditions but would probably be a problem even in an unusual flu season," he says. In a worst-case scenario, he predicts, "it could be we'll find ourselves, like in the 1918 flu, wrapping linens across our face."

Inflexible purchasing policies compound the problem for hospitals, he says. For example, Aramsco doesn't sell to the health care market; the distributor maintains an inventory of 10 million respirators. But a hospital struggling with an N95 shortage might be unable to purchase from Aramsco because they aren't a part of the hospital's contracting system.

"We have contingency plans in case things don't go well," Naylor says. "These hospitals need to have the same."

Manufacturers struggle with capacity

The status of hospital supplies of N95s varies depending on the distributor, the manufacturer, and the model. Some hospitals have had a steady flow to meet their needs. Others have failed to receive their regular order. Switching products, even temporarily, requires re-fit-testing employees.

"Right now, there's a national shortage of respirators," says Michael Tapper, MD, chief of infectious diseases at Lenox Hill Hospital in New York City and a member of the Healthcare Infection Control Practices Advisory Committee, an expert panel that reports to the Centers for Disease Control and Prevention. Tapper shared his concerns with the FDA and U.S. Department of Health and Human Services.

"The stockpiling is going on for pandemic influenza preparedness, but in the interim there's an immediate shortfall of respirators for other diseases that are known to be airborne-transmitted," he says.

Demand spiked suddenly and sharply. The U.S. government plans to build its stockpile to almost 104 million by fall 2007. France is stockpiling 685 million respirators. Some state governments also are stockpiling.

Smaller purchases, such as hospitals', have encountered difficulties as manufacturers scramble to supply those large orders. "We are investigating the availability of the manufacturing resources for these products," says FDA spokes-woman Karen Riley.

The delays relate in part to distribution channels. Some distributors did not adapt to delays as manufacturers slowed deliveries, says Naylor.

Manufacturers such as 3M Corp. have been building new plants and adding to their existing capacity. "We're definitely committed to ensuring that our current distribution channels are getting the products that they need," says spokesperson Jacqueline Berry.

On its web site, 3M offered reassurances that it was addressing the needs of current customers:

"3M is attempting to ensure that N95 respirators go to the customers who need them most. We are prioritizing new and existing customers who are fulfilling the requirements of their occupational respiratory protection programs. We are protecting our current channel by not setting up any additional distribution. We are not prioritizing stockpiling except for when governments and states are increasing their readiness for natural disasters and a potential pandemic. For the most highly constrained products, we are building schedules to make sure that distributors have the most reliable supply of respirators possible."

For hospitals, there is a lesson to be learned from this shortage. Naylor calls it the "Yo-Yo plan"— as in, "You're On Your Own" if a pandemic or other emergency strikes.

"If you need to depend on someone to survive, you're putting yourself at risk," he says.