PPE CASE – Performance of Stockpiled Level 3 Surgical Gowns Sampled from Six Stockpile Facilities
NPPTL Report Number P2022-0101
End user protections will be enhanced by revisions to AAMI PB70 to define minimum critical zone boundaries and include guidance for post-market quality assurance sampling and data interpretation for third party entities.
In 2017, NIOSH established a PPE Stockpile Partnership consisting of 1) federal agencies and the SNS; 2) state, county, and city stockpiles; 3) hospital-related stockpile entities; and 4) a manufacturer trade association to inform the design and execution of an empirical study to evaluate stockpiled air-purifying respirators (APR) and surgical gowns from ten US stockpile facilities, where this study was conducted in accordance with the study design outlined in Greenawald et al. 2021. The APR performance results can be found on NIOSH’s PPE CASE Reports website. This report summarizes the performance testing results of two stockpiled Level 3 surgical gowns models including Medline Proxima Aurora and Cardinal Health Astound. A total of 1,040 Level 3 surgical gowns were sampled from six facilities. Being one level out of four (Level 1 being the least protective to Level 4 being the most protective), Level 3 surgical gowns are worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate matter [FDA 2021].
NIOSH PPE CASE: Performance of Stockpiled Level 3 Surgical Gowns Sampled from Six Stockpile Facilities. By Lee A. Greenawald, Susan M. Moore, Selcen Kilinc-Balci, Patrick L Yorio. Pittsburgh, PA U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, NPPTL Report Number P2022-0101.