AAMI Foundation Awards ECRI Grant to Research Safety, Effectiveness of Isolation Gowns

PLYMOUTH MEETING, PA- ECRI, the nation’s largest independent patient safety organization, has been awarded a $80,000 grant from The AAMI Foundation to investigate the significance of isolation gown barrier penetration and identify ways to improve the protective features for healthcare workers and patients.

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. In 2022, ECRI listed disposable gowns with insufficient barrier protection a Top 10 Health Technology Hazard. Subsequent research conducted in ECRI’s independent laboratory indicated that fluid can pass through the isolation gown’s protective barrier, potentially contaminating the wearer.

"Healthcare workers may be put in harm’s way by gowns meant to protect them,” says ECRI president and CEO Marcus Schabacker, MD, PhD. “We are grateful to the AAMI Foundation for supporting ECRI’s mission to advance effective, evidence-based healthcare through expanded research and stakeholder collaboration on gown safety.”

The ultimate goal of the research grant is to improve user understanding of gown protectiveness, ensure gown standards are realistic for healthcare, and motivate manufacturers to continue positive innovation and quality. Over the next year, ECRI will conduct a national survey of healthcare workers to quantify the incidence of gown strikethrough versus reporting. ECRI will also conduct comparative testing to determine whether current gown standards could be made more relevant to modern gown materials as well as to the healthcare environment.

“We want this research to generate discussion among end users, standards committees, and gown manufacturers to reevaluate what gown protectiveness means. 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,” says Karen Haberland, senior project officer with ECRI’s Device Evaluation team.

Haberland notes that the financial support this grant provides will enable ECRI to access the necessary equipment to expand testing and resources needed to collect real-world data.

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).

Steve Campbell, executive director of the AAMI Foundation, said 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,” say Campbell.

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 gowns@ecri.org.

About ECRI

ECRI is an independent, nonprofit organization improving the safety, quality, and cost-effectiveness of care across all healthcare settings. With a focus on technology evaluation and safety, ECRI is respected and trusted by healthcare leaders and agencies worldwide. For more than fifty years, ECRI has built its reputation on integrity and disciplined rigor, with an unwavering commitment to independence and strict conflict-of-interest rules.

ECRI is the only organization worldwide to conduct independent medical device evaluations, with labs located in North America and Asia Pacific. ECRI is designated an Evidence-based Practice Center by the US Agency for Healthcare Research and Quality. ECRI and the Institute for Safe Medication Practices PSO is a federally certified Patient Safety Organization as designated by the US Department of Health and Human Services. The Institute for Safe Medication Practices (ISMP) formally became an ECRI Affiliate in 2020. Visit www.ecri.org to learn more.

About The AAMI Foundation

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.

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