Fit-test problems raise questions about pandemic N95 respirators

California 'recalls' 3M 8000s due to poor fit of HCWs

The release of millions of N95 filtering facepiece respirators during the novel H1N1 pandemic has revealed a potentially serious problem in preparedness: N95 respirators have different fit characteristics, and not all of them can be successfully fit-tested on health care's predominantly female work force.

In January, California "recalled" millions of respirators in its pandemic stockpile after Kaiser Permanente complained that the 3M 8000 model could not be successfully fit-tested. All the employees initially failed the fit-test, and even after technical assistance from 3M, 60% failed the quantitative fit-tests. Even those who passed the fit-test lost an effective face seal during routine movements, California officials say.

The California Department of Public Health (CDPH) asked 3M to replace the 3M 8000s, a model that has since been discontinued, with the 3M1860 or 1860s, popular models in health care. "It is now evident that contrary to the representations of 3M representatives in 2006, the Model 8000 Particle Respirator will not adequately protect health care workers, and that the state's entire inventory of Model 8000 Particle respirators is not suitable for its intended purpose," CDPH director Mark Horton, MD, said in a letter to 3M. (This issue involves only the 3M 8000, not a series of models; for example, the 3M 8210 and 8511 have very different fit characteristics.)

3M spokeswoman Jackie Berry emphasized that the 3M respirators are not defective. "When properly used and fitted it does reduce exposure to the H1N1 virus. There are absolutely no performance issues with the product," she says.

The concerns about fit still were being addressed when Hospital Employee Health went to press. "We take any concerns related to the products very seriously. We're in discussions with [the California Department of Public Health] to try to reach some type of resolution," says Berry.

Meanwhile, the National Institute for Occupational Safety and Health (NIOSH) conducted an evaluation of the 3M 8000. Initial tests showed that it still passed the agency's certification requirements, which primarily involve filtration capability. NIOSH also was testing the fit on a panel of 40 individuals.

NIOSH has proposed adding fit-characteristics — a "total inward leakage" test — to the certification requirements for N95 filtering facepiece respirators. Still, even if the rule is adopted swiftly, the new criteria would be phased in and would not become fully effective for at least a couple of years, says Roland Berry Ann, deputy director of the NIOSH National Personal Protective Technology Laboratory in Pittsburgh.

When planning a stockpile of protective gear for health care workers, it's important to have more than one model of respirator, safety experts say. A respirator may fit certain facial sizes or characteristics but not others. Ideally, a respirator that fits a wide range of facial features and is available in multiple sizes is the best choice for a stockpile.

Those involved in purchasing decisions also should consult occupational health professionals and industrial hygienists who can provide technical expertise, safety experts say.

In 2006, the California Department of Public Health used federal pandemic preparedness funds to build its stockpile of respirators. CDPH requested the 3M 1860 or 1860s but was told that the respirator wasn't available in sufficient quantity, says CDPH spokesman Michael Sicilia.

"3M was involved in advising the state of California in the purchase," he says. "We were assured by 3M that this was a perfectly good respirator [for health care workers]."

The 32.4 million 3M 8000 respirators represented about 60% of the state's stockpile of 50 million respirators and cost about $7.4 million, reports Sicilia. About 8.5 million respirators from the stockpile, including 5.1 million of the 3M 8000, were shipped to 34 local health departments and 61 health care facilities to protect health care workers from the novel H1N1.

The 3M 8000 is a respirator with few features, says Deborah Gold, MPH, CIH, senior safety engineer in the research and standards health unit at Cal-OSHA in Oakland. For example, it has only one strap and no padding at the nose bridge. CDPH did not consult with the California Division of Occupational Safety and Health (Cal-OSHA) in the purchase.

It's important for stockpiled respirators in pandemic planning to fit the typically smaller female face, since the health care work force is predominantly female, says Gold. "It's important to have some idea that a stockpile of respirators is likely to fit a high percentage of all individuals or a significant percentage of a certain type of individuals," she says. "To ask health care facilities to fit-test 100 people with little chance that even half are going to be able to use this respirator is a big use of resources."

Roger Richter, senior vice president of professional services with the California Hospital Association in Sacramento, told HEH that he was not aware of other hospitals or health systems that had problems with the 3M 8000. However, by late fall, H1N1 cases had declined and hospitals may have been relying on their own supplies of respirators, he says. The 3M 8000 was not a model that was commonly used in health care, he says.

The Centers for Disease Control and Prevention in Atlanta also purchased millions of the 3M 8000 model for its national strategic stockpile, but CDC has not had any complaints, says spokesman Richard Quartarone.

Some 18.2 million of the 76 million N95 respirators distributed from the national stockpile were the 3M 8000, he says. In all, the 3M 8000s made up 30% of the N95s respirators in the 100 million stockpile.

"When the N95 respirators were purchased by the Strategic National Stockpile, in order to get the number they needed, they had to go to a wide variety of manufacturers and get a wide variety of respirators," Quartarone says.

Concerns about the 3M 8000 underscore the need for fit-testing to ensure that respirators are protective, says Berry Ann. "It does highlight the importance of fit-testing to be sure that the respirator fits [an individual], and you need to have an assortment [of models] because no respirator fits everyone," he says. "If you're one of the people it fits . . . you would be protected."