The Insidious Dangers of Disposable Isolation Gowns—and How to Address Them. Written by Karen Haberland, Senior Project Officer.

The Insidious Dangers of Disposable Isolation Gowns—and How to Address Them. Written by Karen Haberland, Senior Project Officer. Published online 2024 February 6. ECRI. 

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:

1. Who is performing incoming inspections of gowns? It’s important to ensure that gown packaging makes people aware of coverage, size, and Association for the Advancement of Medical Instrumentation (AAMI) protection Level. Also, the 2022 version of American National Standards Institute (ANSI)/AAMI PB70 now requires gown packaging to include an expiration date. Inspections can help to confirm that gown packaging includes that information to aid in proper gown usage and to report problems, should any arise.
2. Have gowns been tested for hydrostatic pressure resistance? Hydrostatic pressure testing is one of two methods for determining the barrier protection Level of a gown. This test measures resistance to penetration by steadily increasing hydrostatic pressure per AATCC TM 127. It’s critical that testing covers seams and tie attachment sites, as these can be weaker than full material samples (especially if they feature sewn seams or lack seal coating).
3. How do gowns perform during doffing? Manufacturers’ instructions for use often specify that workers remove the gowns by breaking the ties. However, rather than seeing gowns pop at the designed breakpoints, ECRI volunteers often observe tearing of the gown material along the shoulders or on the chest. This failure in construction could lead to contamination of the user’s clothing, as well as time lost in cleanup and changing. 

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:

1. Encourage infection preventionist involvement in personal protective equipment (PPE) selection.
2. Review the facility’s current gown selection to ensure the Level aligns with typical exposure risks. (For additional information, see ECRI’s Medical Protective Gowns: Key Features and Guidance for Selection.)
3. Hold manufacturers accountable. Request fluid barrier testing data prior to purchase, and push for the Levels and quality you want to see.
4. When gown problems occur, document and report them to patient safety organizations like ECRI.  

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.