Do disposable isolation gowns adequately protect health care workers? Researchers at ECRI recently published two open-access papers in AAMI’s peer-reviewed journal Biomedical Instrumentation & Technology (BI&T) on strikethrough and barrier test methods that included troubling findings.
Karen Haberland, senior project officer at ECRI, presented these findings at the 2025 AAMI eXchange. This research was funded in part by an AAMI Foundation Mary K. Logan Research Award. As part of this research project ECRI researchers:
• Analyzed the rate of fluid strikethrough for disposable isolation gowns compared to incident reporting rates.
• Described aspects of isolation gown liquid barrier performance testing that do not align with healthcare workers’ needs.
• Recommended actionable steps to improve isolation gown selection, enhance reporting, and drive manufacturer quality.
Healthcare workers trust isolation gowns to keep them safe. If that trust is misplaced, whether because of a poor performing product or a misunderstanding about the product’s protections, it may create what Haberland called a “false sense of security.” Importantly, the authors stressed that the purpose of the research is not to discredit the personal protective equipment (PPE) manufacturers who are responsibly following industry best practices. Rather, the work highlights why and how there is significant room for improvement in those established practices to create effective PPE for the changing healthcare space.
Surveying Strikethrough Incidence
ECRI researchers adopted a two-pronged approach, issuing a national survey on gown selection and wearer experience and then conducting a lab analysis of disposable isolation gowns.
The survey was confidential, qualitative, and self-reported. It was distributed via survey link, social media, and email. ECRI researchers received 211 responses primarily from nurses, infection preventionists, and administrators. Most respondents worked at facilities like large acute care hospitals and ambulatory surgical centers. ECRI found that:
• 9% of gown wearers feel that they are provided adequate training on gown selection and use; 20.9% do not.
• Fewer than half of wearers understand gown levels.
• More than one-third of respondents have experienced gown strikethrough. For some, it is a daily or weekly occurrence.
• 6% of respondents stated that the strikethrough incidents they experienced were not reported.
Stated reasons for not reporting strikethrough included a lack of awareness about reporting requirements, reporting taking too much time, and the belief that strikethrough is not a risk to health. A very small number of respondents indicated that they did not report strikethrough incidents because they believe their management does not care. Per Haberland, “the fact that any wearer reports any amount of daily or weekly visible strikethrough is cause for concern and should prompt an investigation.”
Haberland stated that ECRI’s findings show a major opportunity for improvements in training for healthcare workers, as the survey shows that “fewer than half were trained.” She also expressed great concern about the reports of strikethrough and lack of reporting. That said, the survey data also showed that healthcare workers often have access to their preferred choice of gown – although it may not always be that the prefrred choice is the correct class of gown in a changing healthcare environment.
ECRI’s Lab Analysis
ECRI researchers also performed the two liquid barrier test methods, an impact and hydrostatic test, called for by ANSI/AAMI PB70:2022, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The research tests, Haberland notes, were far more of a robust test gauntlet than what is normally performed. The best practice for hospital gown testing, she added during an AAMI News interview, originated not from the healthcare space, but from textile and raincoat manufacturing. As such, testing is mostly performed with water rather than simulated body fluids, and the gowns are conditioned to humidity far higher than hospital standard. According to Haberland, she and her team hope their results will prompt a thorough reconsideration of how to validate safety and efficacy test methods.
The researchers varied preconditioning temperature, preconditioning relative humidity, test liquid, and liquid temperature. Each test was performed on two Level 2 isolation gowns. For Gown A, there were minor but statistically significant effects of liquid temperature on the occurrence strikethrough, regardless of preconditioning. This aligns with a greater potential for strikethrough due to body fluids that are warmer than the standard test temperature.
During the testing of Gown B, six out of 20 samples failed to meet the 1.0-gram maximum gain criteria. For the endpoint pressure test, both the first and second visible drops or sprays of fluid occurred below the minimum hydrostatic pressure threshold of 20cm H2O. While Gown A proved better than Gown B, it still exhibited points of leakage prior to the 20cm H2O threshold in all but one condition.
Protecting Healthcare Workers
Do disposable isolation gowns protect healthcare workers? “Not as well as they should.” Haberland offered several recommendations based on this research.
First, researchers should improve test methods by developing clinically relevant test protocols that reflect the circumstances of use. This can include using realistic fluids, temperatures, and preconditioning to simulate real-world conditions. Endpoint criteria should be refined using better metrics like the first point of leakage under pressure.
Second, policy alignment should be strengthened by revising and conforming with standards that require testing consistency. Haberland also recommended advocating for regulatory updates that reflect today’s healthcare challenges.
Last, Haberland stressed the need for accountability and transparency. This can include adopting standardized processes for monitoring and reporting gown failures and facilitating clear communication during investigations to ensure issues are addressed promptly. Gown designs and official performance requirements can also evolve to meet real-world clinical needs. In the short term, healthcare facilities can enhance education, ensure a range of gown options are in stock for all kinds of situations, and normalize incident reporting.
