Health Hazard Evaluation Report: HETA-2010-0044-3109, California Occupational Safety and Health Administration, Division of Occupational Safety and Health, Oakland, California, May 2010. NIOSH Investigation of 3M Model 8000 Filtering Facepiece Respirator as Requested by the California Occupational Safety and Health Administration, Division of Occupational Safety and Health

摘要

The CDPH established a stockpile of respirators for use by healthcare personnel during an outbreak of pandemic influenza. The stockpile included an assortment of FFRs including approximately 32 million 3M Model 8000 N95. The CDPH's stockpile of respirators was made available for healthcare worker use during an outbreak of pandemic influenza in Fall, 2009. In addition to the CDPH's reserves, the CDC distributed a supplement of approximately 4 million 3M Model 8000 N95 FFRs to the CDPH from the federal government's Strategic National Stockpile, which is maintained and managed by CDC. Healthcare facilities within California that were experiencing shortages of respirators for the protection of healthcare personnel received respirators distributed from the CDPH stockpiled respirators, including this 3M model. On December 23, 2009, NIOSH received a request for assistance from Cal/OSHA. Cal/OSHA was concerned that a large healthcare organization was unable to successfully fit test their healthcare workers with the 3M Model 8000 N95 FFR received from the California stockpile. The healthcare organization conducted the initial set of fit tests using the Bitrex qualitative fit test protocol, and none of the approximately 20 workers who were fit tested obtained an acceptable fit (pass rate of 0%). A second group of 20 workers were reported to have obtained a fit test pass rate of 40% (8 of 20) with fit tests conducted by 3M representatives using the TSI PortaCount with N95 Companion quantitative fit test protocol. The California experience with these devices raised questions about whether the subject units had a defect of some type whereby they may have been non-conforming to the NIOSH approval. SMEs from the NIOSH NPPTL conducted the technical assistance investigation. The purpose of the NIOSH investigation was to determine whether the fit test pass rate reported at the various facilities of a California healthcare organization resulted from any defect in the units' characteristics on which the product was certified (e.g., filter efficiency at the N95 criteria, workmanship, or quality of manufacture) as believed by Cal/OSHA and CDPH.