ECRI Research Team Wins National Award for Uncovering Hidden Risks in Disposable Isolation Gowns
Study found that standard liquid barrier tests may underestimate real-world failure risk, raising new questions about how healthcare facilities validate protective apparel
A research team at ECRI received the AAMI Publication Award for Best Research Article from the Association for the Advancement of Medical Instrumentation (AAMI), a prestigious recognition in healthcare technology research. The award honors the team's peer-reviewed investigation into whether the standard tests used to verify disposable isolation gowns are rigorous enough to protect healthcare workers and patients in real clinical environments.
The winning study, "Evaluating Disposable Isolation Gown Liquid Barrier Test Methods for Relevance to Healthcare," was published in Biomedical Instrumentation & Technology (BI&T), by Karen Haberland, MS with ECRI co-authors Julie Miller, MS; Jeremy Suggs, ScD; James Davis, MSN, RN, CIC, HEM, FAPIC; Mukui Mutunga, PhD; with support from Shaniya Gohel and Basil Roy from Drexel University.
What ECRI’s Research Found
Isolation gowns are a frontline defense against infection transmission in hospitals, worn by clinicians during procedures where exposure to bodily fluids or other contaminants is likely. Their safety is evaluated using two liquid barrier tests: the impact penetration test and the hydrostatic pressure test required under ANSI/AAMI PB70:2022, the national standard governing liquid barrier performance and classification of protective apparel and drapes used in healthcare.
The ECRI team went significantly further than standard testing protocols. Their analysis found that current liquid barrier test methods for disposable isolation gowns may underestimate the risk of barrier failure in actual clinical use, a finding with direct implications for healthcare worker safety and infection prevention programs.
A companion study published in the same journal, "Clinical Experience with Disposable Isolation Gown Selection, Strikethrough, and Reporting," reinforced those conclusions by documenting how gown failures are experienced and reported at the point of care.
Together, the two studies make a case for reconsidering how the industry validates the efficacy of isolation gowns before they reach clinical settings.
Why It Matters
Patient and healthcare worker safety depend on the assumption that available personal protective equipment performs as labeled under real-world conditions. When the tests used to certify that equipment don't reflect the stresses of clinical practice, a gap opens between what a product is believed to do and what it actually does when a nurse or physician is caring for an infectious patient.
AAMI, whose standards shape how medical devices and healthcare equipment are evaluated globally, recognized the study for its contribution to advancing safety and quality in healthcare.
Top Researcher Leverages ECRI Lab
ECRI is the only independent nonprofit organization worldwide to conduct independent medical device evaluations. Karen Haberland, MS, is a Senior Project Officer of Device Safety at ECRI where she has led PPE and vaccine administration technology investigations since 2020.
"This work underscores the need for rigorous, relevant testing methods to protect healthcare workers and patients alike," said Haberland, who accepted the award on behalf of the team. “I look forward to continuing this mission. Thank you to AAMI for the honor and for supporting research that helps advance safety and quality in healthcare.”
Learn More
ECRI's research on disposable isolation gowns, including an expert interview with the team, is available on the AAMI website. Visit AAMI to learn more: “ECRI Research Shows When Isolation Gowns May Fall Flat.”
