The AAMI Foundation has awarded an $80,000 grant to the independent nonprofit patient safety organization ECRI to investigate the significance of isolation gown barrier penetration and how to improve the protective features for healthcare workers and patients. In 2022, ECRI named disposable gowns with insufficient barrier protection a Top 10 Health Technology Hazard.

Isolation gowns are personal protective equipment worn by healthcare workers to protect themselves and their patients by providing a barrier to fluid and particulate contamination. But previous research indicates that gown strikethrough—wherein fluid passes through the isolation gown’s protective barrier, contaminating the wearer—is an ongoing issue and an example of avoidable harm.

ECRI’s research, funded by the AAMI Foundation’s Mary K. Logan Research Program, will examine the extent of the problem that has been further exacerbated by recent pandemic-related supply chain changes and the widespread use of nonwoven materials. 

Over the next year, ECRI will conduct a national survey of healthcare workers to quantify the incidence of gown strikethrough versus reporting. Researchers will also complete an observational analysis on healthcare workers’ assumptions versus correct gown levels for a given task. They will also conduct comparative testing in parallel to determine if current gown standards could be made more relevant to modern gown materials as well as to the healthcare environment.

“The financial support this grant provides will enable us to access the necessary equipment to expand our testing and to the resources needed to collect real-world data,” says Karen Haberland, senior project officer with ECRI’s Device Evaluation team.

Steve Campbell, executive director of the AAMI Foundation, says the foundation is pleased to support the research, which was selected by a Research Review Committee from several applications received this year and approved by the AAMI Foundation Board of Directors. “We’re anxious to share the results of the researchers’ work with the entire healthcare community,” says Campbell.

This AAMI Foundation grant program, which was named in honor of AAMI’s former president and CEO Mary Logan, was established in 2016 with a gift from the Association for the Advancement of Medical Instrumentation (AAMI).

The AAMI Foundation is dedicated to advancing the professional development of health technology professionals and the safety of technology to improve health. The foundation achieves this vision through the awarding of scholarships, awards, grants, and other endeavors to strengthen the knowledge of health technology professionals.

According to Haberland, ECRI researchers “hope to quantify the rate of gown strikethrough in healthcare facilities and determine if it is higher than currently reported, and we also aim to generate an actionable list of inconsistencies between current gown test methods and the healthcare environment.”

“We want this research to generate discussion amongst end users, standards committees, and gown manufacturers to reevaluate what gown protectiveness means. The bottom line is that, for many possible reasons, isolation gowns may not be protecting healthcare workers in the way users think or hope they are. And that problem won’t improve without much more investigation,” she says.

Moreover, the goal of the research is to improve user understanding of gown protectiveness, ensure gown standards are realistic for healthcare, and motivate manufacturers to continue positive innovation and quality.

Researchers have already started developing the survey, which will be distributed soon. Survey results will inform bench testing. Researchers are also in the process of acquiring equipment needed to condition samples to both current standard requirements and more realistic hospital temperature and humidity for our proposed comparative testing. If all goes according to plan, researchers will have initial results by next spring, and may be shared at the AAMI eXchange conference in 2024.

Haberland says healthcare workers who use disposable isolation gowns can participate in the work by distributing the survey and/or by sharing their concerns about isolation gowns by contacting researchers at [email protected].

“We are truly grateful for the trust and confidence that the AAMI Foundation has placed in us, and we are committed to gaining a better understanding of gown strikethrough and reinvigorating industry discussion to improve barrier protection,” says Haberland.