Page:NIOSH DM DFM respirator evaluation draft.pdf/66

it should be acceptable public health practice to permit as many as one (or more) wearers in twenty to unknowingly receive less than the designated minimum protection level (i.e., class APF)? The Institute is considering basing its APF determinations on a substantially lower maximum control-failure rate (e.g., 0.1 to 1 users per 100 users). Confidence levels should be set at 95% or 99%. A confidence level as low as 90% is unacceptable because possibility of erroneous decisions (10%) is unacceptably high. Most importantly, if this type of APF-determination method is used, both purchasers and users must be fully informed that this control method is expected to fail to achieve APF-level protection in a specified proportion of wearers. Additionally, they should be informed that in many cases the employer and wearers are unable to know who these inadequately-protected wearers are. The issue of informed consent given by respirator users should be investigated if this approach is considered.
  More importantly, NIOSH concludes that respirator manufacturers and suppliers have not routinely informed respirator purchasers and users that a significant number of users are expected to unknowingly fail to attain APF-level protection, even under optimal use conditions due to excessive face-seal leakage. That is, neither supplier purchase guidance nor respirator-user instructions for NIOSH-certified masks routinely inform purchasers and users of this situation. Purchasers and users have not been provided with appropriate instructions regarding how to identify and adequately protect those wearers with facepieces failing to attain APF-level protection so as to permit the safe and effective use of NIOSH-certified respirators. NIOSH concludes that APF values recommended by the Institute possibly may create a false sense of security in respirator users. In their use of NIOSH RAPFs, purchasers and users might erroneously assume that 100 in 100 respirator wearers will receive APF-level or better protection under typical usage conditions. Purchasers might then purchase NIOSH-certified respirators for use in conditions where they are less than effective for all wearers. This could create a hazard for those wearers that could receive inadequate protection.