The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS) announces a notice of request for information and comment. This request for information was published in the Federal Register in an effort to:
- enhance harmonization of the FDA clearance and NIOSH approval process for surgical N95s
- solicit information regarding the potential to augment the current NIOSH requirements with additional testing to potentially streamline the approval process
- determine if there are gaps in the current process to more effectively meet the needs of healthcare workers
- provide evidence regarding the effectiveness of the current particulate filter tests.
NIOSH is requesting information and comments on the following:
1. Do healthcare stakeholders anticipate expanding the use of respiratory protective devices (RPDs) to include elastomeric air purifying respirators and/or Powered Air Purifying Respirators (PAPRs)?
2. For protections appropriate for RPDs to be used in surgical and/or nonsurgical healthcare environments, should NIOSH consider adding tests and requirements to the 42 CFR Part 84 conformity assessment process for splash/spray protection (fluid resistance) per ASTM F1862:2000a, or other appropriate standards? NIOSH seeks evidence related to the performance of existing products (NIOSH-approved, but not FDA-cleared as a medical device) against this standard and the prevalence and characteristics of actual sprays/splashes faced by healthcare workers during non-surgical patient care.
3. For RPDs to be used in surgical and/or non-surgical healthcare environments, should NIOSH consider adding requirements and tests beyond those provided in 42 CFR Part 84 for protection against flammability hazards per 16 CFR 1610, UL 2154, or other appropriate standards? NIOSH seeks evidence related to the performance of existing products (NIOSH-approved, but not FDA-cleared as a medical device) against this standard and the prevalence and characteristics of actual flammability hazards faced by healthcare workers during patient care (i.e., non-surgical activities).
4. For RPDs to be used in surgical and/or non-surgical healthcare environments, should NIOSH consider adding optional, supplemental filtration testing (e.g., ASTM F2101–01 (Bacterial Filtration Efficiency) and ASTM F1215:1989 (Particulate Filtration Efficiency)) in addition to the existing NIOSH filter requirements in 42 CFR Part 84? NIOSH requests evidence related to the performance of existing products (NIOSH-approved, but not FDA-cleared as a medical device) against these alternative filter test methods and the prevalence and characteristics of airborne exposures faced by healthcare workers during patient care (i.e., non-surgical activities). NIOSH seeks comparative results for testing against such candidate supplemental standards versus test
results achieved in the existing filter efficiency tests of 42 CFR Part 84.
Individuals wishing to submit comments to the docket should do so by April 14, 2014. Information requests can also be submitted by email to [email protected]. You may submit comments identified by CDC–2014–0005 and Docket Number NIOSH–272 by either of the two following methods:
• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
• Mail: NIOSH Docket Office, Robert A. Taft Laboratories, MS–C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
All information received in response to this notice must include the agency name and docket number [CDC–2014–0005; NIOSH–272]. All relevant comments received will be posted without change to www.regulations.gov, including any personal information provided. All electronic comments should be formatted as Microsoft Word. For access to the docket to read background documents or comments received, go to www.regulations.gov.
NIOSH will determine next steps after all comments are reviewed and assessed. NIOSH intends to provide an entry to the docket regarding next steps no later than June 30, 2014.