A new analysis by ECRI, a patient safety organization, shows that more than 50 percent of the disposable isolation gowns it tested failed to meet standard levels of protection, putting healthcare workers at risk of exposure to bloodborne or other pathogens, as well as SARS-CoV-2, the virus that causes COVID-19, according to a press release.
Researchers at ECRI, a nonprofit organization that advises hospitals, government organizations and other healthcare stakeholders on product safety, found that 52 percent of gowns with unstated levels of protection failed to meet even the Association for the Advancement of Medical Instrumentation’s lowest level for protection. ECRI also tested gowns that claimed AAMI-level protection and found that 50 percent did not meet the AAMI PB70 standard, a system for the evaluation and classification of liquid barrier performance.
ECRI issued a high-priority hazard alert to warn U.S. healthcare organizations about its safety concerns after evaluating 34 distinct models of disposable gowns from suppliers outside the United States or from non-traditional suppliers. The ECRI said the evaluation was done according to product-testing protocols conducted by ECRI’s quality assurance experts at the organization’s independent medical device laboratory.
“Hospitals 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.”
In September, ECRI released its analysis of imported masks and found 70 percent of the Chinese KN95 respiratory masks it tested failed to meet U.S. standards.
“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.”
