The Insidious Dangers of Disposable Isolation Gowns—and How to Address

Isolation gowns are a longstanding infection control tool across hospital settings. These garments are intended to safeguard patients and clinicians by preventing the spread of disease-causing microorganisms. But do today’s disposable gowns provide the degree of protection healthcare workers assume? Not necessarily.

ECRI believes there is a disparity between healthcare workers’ perceptions and actual gown performance. Consider, for example, this 2012 survey of infection preventionists. It found that about one-quarter of these professionals encountered strikethrough and 45% encountered tearing of gowns. What’s more, while a sizable portion had seen issues related to disposable gowns, half lacked the training to understand why.

The 2012 survey findings led to a review of gown standards. Despite that, ECRI’s Problem Reporting system continues to be notified of contamination, leakage, and tearing in hospitals across the United States.

We believe the nature of today’s gowns may be partly to blame. By 2018, disposable gowns had grown to at least 80% market share. These gowns are made of nonwoven materials—not the traditional woven materials available during development of original test methods.

In more recent years, supply chain shifts during the pandemic may have spurred ongoing quality issues. That’s a topic we addressed in a November 2020 ECRI Exclusive Hazard Report, Use of isolation gowns purchased from non-traditional manufacturers without independent lab validation may put healthcare workers at risk for blood and fluid exposure.

Based on our ongoing evaluation, we have identified three key questions for infection prevention and other hospital leaders to explore:

Long-term Strategies for Improvement

To address risks to healthcare workers and patients, ECRI is pursuing a two-pronged goal: greater awareness among individual workers and reinvigorated discussion at the industry level.

We are taking steps to educate more workers on the protective differences in medical protective gowns. That includes generating greater awareness of gown standards (ASTM F3352 and ANSI/AAMI PB70-2022) so that purchasers know which physical properties and fluid barrier characteristics will best meet their facilities’ needs. At the same time, healthcare workers need to become familiar with gown Levels to ensure they select the right amount of protection relative to fluid exposure risk for the procedure at hand.

We are also working to reinvigorate industry discussion about the need to revise gown standards and testing. Current test methods were not developed for the healthcare industry and may not reflect the realities of hospital environments. Gowns need to be tested under the humidity and other conditions present in healthcare facilities. In addition, they need to be tested against media that more closely mimic bodily fluids. There also needs to be a greater focus in gown design to help prevent issues with fit, coverage, and barrier protection.

What Steps Can Hospitals Take Today?

As the industry collaborates on long-term solutions, teams can take these steps in the short term:

Further research is needed to quantify the current rate of fluid strikethrough in healthcare facilities. ECRI is actively seeking facilities willing to share a survey with their staff who purchase or use disposable isolation gowns. This research is funded by a grant from AAMI Foundation’s Mary K. Logan Research Awards.

Take the Disposable Isolation Gown User Experience Survey now.

Written by Karen Haberland, Senior Project Officer

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Who is performing incoming inspections of gowns?Have gowns been tested for hydrostatic pressure resistance?How do gowns perform during doffing?Long-term Strategies for Improvement