ECRI finds more than half of disposable gowns fail safety standards

November 19, 2020

The non-profit organization conducted testing on 34 models of gowns from international or non-traditional suppliers.

New analysis from the Emergency Care Research Institute (ECRI), one of the country’s top patient safety organizations, has shown that more than 50% of disposable isolation gowns it tested failed to meet regulatory standards, according to a statement from the non-profit organization. This puts healthcare workers at risk of exposure to pathogens, including the SARS-CoV-2 virus.

52% of gowns with unstated levels of protection failed to meet the Association of the Advancement of Medical Instrumentation’s (AAMI) lowest level of protection, according to researchers at ECRI. These researchers tested gowns that claimed to have AAM-level protection but found that 50% did not meet the AAMI PB70 standard, a system for the evaluation and classification of liquid barrier performance.

The effectiveness of 34 models of disposable gowns from suppliers outside of the United States or from non-traditional suppliers has come into question after being evaluated by the ECRI. This assessment was conducted by ECRI’s quality assurance experts at the organization’s independent medical device laboratory according to the strictest product testing protocols, according to a statement from ECRI.

“[Healthcare facilities] have been ramping up their procurement of isolation gowns to protect workers from the novel coronavirus and we’re finding that many of the products they are buying simply do not meet basic protection standards,” said Marcus Schabacker, MD, PhD, ECRI’s president and chief executive officer. “Our research shows that you can’t judge the authenticity of the product based on its appearance, labeling, or packaging without product testing.”

Since the beginning of the SARS-CoV-2 pandemic, a lack of personal protective equipment (PPE) put the health care industry in a precarious position, forcing many providers to use alternative supply sources. Much of the PPE from international or non-traditional supplies are unsafe and ineffective, according to the ECRI. The organization released its report of imported masks in September, which found 70% of the Chinese KN95 respiratory masks failed to meet U.S. safety standards.

ECRI experts warn against the use of isolation gowns from outside of the United States or from non-traditional suppliers. If these products must be used because there are no other viable PPE options, they should only be used in extremely low-risk situations or undergo independent laboratory testing for liquid impact and hydrostatic penetration to verify barrier protection.

“As we have seen first-hand, manufacturer test reports or certificates are not a guarantee that these gowns are safe and effective,” said Michael Argentieri, vice president for technology and safety at ECRI. “We are advising our members against purchasing gowns that do not adequately protect healthcare workers, especially during the pandemic.”

Read ECRI’s full alert to healthcare providers here. For more information on the organization’s independent testing guidelines, email clientservices@ecri.org or call 610-825-6000 x5891, or visit ecri.org.