Assessment of Stockpiled PPE Identifies Potential Quality Problems with Surgical Gowns
A NIOSH study intended to assess the effects of stockpiling on surgical gowns stored for use in future emergencies has revealed potential quality problems that may extend to gowns sold on the open market, according to a report available on the agency’s website.
From 2017 through 2019, NIOSH assessed a total of 1,040 Level 3 surgical gowns from six stockpile facilities. Level 3 gowns protect healthcare workers from microorganisms, body fluids, and particulate matter during surgical procedures. All the stockpiled gowns were manufactured in 2008 by either Medline or Cardinal Health. Testing evaluated the gowns’ resistance to spray impact, which measures how well the fabric resists strikethrough when fluids splash or spray onto the fabric, and resistance to hydrostatic pressure, which measures how well the fabric resists strikethrough when water pressure is applied to the fabric surface. These results were compared to those obtained from a control group of gowns purchased on the open market. All gowns in the control group were manufactured in 2018.
The testing focused on the gowns’ “critical zones,” which NIOSH defined as the chest area, the sleeve seams, and the tie attachment. ANSI/AAMI PB70:2012, Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, identifies pass/fail criteria for measurement of spray impact penetration and hydrostatic pressure. These criteria, which are intended for use by manufacturers to assess quality during production, specify the number of failures in critical zones allowed per lot of gowns.
According to NIOSH, testing results for resistance to hydrostatic pressure “strongly indicated” quality problems with one of the six stockpiled lots of Cardinal gowns. The agency also found potential quality problems with one of the two control lots of Cardinal gowns. For the Medline gowns, five of ten stockpiled lots did not meet performance requirements specified for hydrostatic resistance as specified in AAMI PB70.
While NIOSH cautions that the AAMI PB70 criteria were not intended to be used as applied in this study, the report concludes that “the data shows instances where both the stockpiled [. . .] and non-stockpiled [. . .] gowns may not offer the expected level of protection.” In addition, the agency recommends that guidance on post-market quality assurance sampling be added to AAMI PB70.
Read the full report on the NIOSH website.