NIOSH Respirator Standards Combat TB Resurgence
BY Susan English
The National Institute for Occupational Safety and Health (NIOSH) has announced the first in a series of planned revisions to the federal regulations that govern filter testing and certification for air-purifying respirators. The new standard for manufacturers of respirators, filters and filtration media was developed to take advantage of advancements in respirator technology geared toward protecting hospital employees caring for patients with infectious tuberculosis–a disease which has shown a marked upswing in the past few years.
All new respirators will meet the performance criteria recommended by the government`s Centers for Disease Control for respiratory devices used in health care settings for protection against Mycobacterium tuberculosis (Mtb), the infectious agent that causes TB. NIOSH 42 CFR, Part 84 will permit the marketing of a new generation of respirator filters that feature less leakage, more efficiency and easier breathing–all at a dramatically lower price tag. The culmination of two decades of work in respiratory protection technology, and the first upgrade in more than 60 years, the new standards incorporate advanced testing technology pioneered by TSI Inc., (St. Paul, MN) in its recently introduced automated filter testers.
Price estimates for the first round of respirators are from $1 to $3 vs. $8 for the old model. This is less than HEPA-filtered respirators and is expected to translate into considerable savings for the health care industry. Exact savings are hard to predict, but a recent cost analysis of the 159 acute care in-patient Department of Veterans Affairs facilities in the U.S. suggests the VA alone may save up to $16 million annually. According to Department of Health and Human Services` Secretary Donna Shalala, “The health care industry in particular has anxiously awaited this regulation, which will advance the protection of doctors and nurses who treat patients with infectious disease while interfering less with patient care. Other industries and workers will also benefit from the improved respirators that can be certified under these updated regulations.” Hospital workers, miners, firefighters and painters are among the 7 to 10 million American workers who rely on NIOSH-certified respirators for protection against workplace hazards.
The first in a series of planned revisions that govern filter testing and certification for air-purifying respirators, the new regulation replaces the previous standard (30 CFR, Part 11). Last August, NIOSH certified the first 13 respirators under its new testing and certification requirements. The new standards define nine classifications of non-powered air purifying respirators, each representing a different level of protection. They were actually developed to take advantage of the new filter inspection technology employed in TSI`s CertiTest Model 8127 and Model 8130 automated filter testers, which provide a range of verification capabilities for testing all nine filter categories identified in the standards. Under the new particulate filter tests, NIOSH will certify three classes of filters to accommodate the varying characteristics of liquid and solid particles, with a 200 mg filter loading challenge: N–for salt (NaCl) test aerosols, which will be tested against a mildly degrading aerosol of sodium chloride, and the R and¥series filters, which will be tested against a highly degrading aerosol of dioctylphthalate (DOP). Filters will be classified under three levels of efficiency–95 percent, 99 percent and 99.97 percent, and tests will employ the most penetrating aerosol size–0.3 µm.
The new regulations will carry a three-year phase-in period, with extensions, allowing improvement to be implemented “on a safety and health priority basis.” In reality, because the regulation has been 10 years in the making, many respirator manufacturers have already submitted their test data to NIOSH, which has been backlogged in its certification efforts since publicizing the final rule last June.n