More than 50% of the disposable isolation gowns that ECRI tested failed to meet standard levels of protection, putting healthcare workers at risk of exposure to bloodborne or other pathogens including SARS-CoV-2, according to the nonprofit organization.
ECRI’s researchers found that 52% of gowns with unstated levels of protection failed to meet the Association for the Advancement of Medical Instrumentation’s (AAMI) lowest level for protection.
ECRI also tested gowns that claimed AAMI-level protection and found that 50% 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 US 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 evaluation was done according to rigorous product-testing protocols conducted by ECRI’s quality assurance experts at the organization’s independent medical device laboratory, according to ECRI.
“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 CEO.
“Our research shows that you can’t judge the authenticity of the product based on its appearance, labeling, or packaging without product testing,” said Schabacker.
Since the pandemic began, healthcare providers across the nation have struggled to procure personal protection equipment (PPE), including isolation gowns and N95 masks, ECRI said.
Dire circumstances, supply chain shortages, and a lack of a centralized approach to dealing with the crisis are forcing healthcare systems in the United States to find alternative supply sources, ECRI added.
Many PPE products from nontraditional and international suppliers are unsafe and ineffective, ECRI said. In September, ECRI released its analysis of important masks and found that 70% of the Chinese KN95 respiratory masks it tested failed to meet US standards.
ECRI experts warn against healthcare organizations using isolation gowns from outside the United States or from nontraditional suppliers. If using these products is the only option, they must only be used in only in extremely low-risk circumstances or undergo independent laboratory testing for liquid impact and hydrostatic penetration to verify barrier effectiveness. Sterile gowns are necessary during invasive procedures.
“As we have seen firsthand, 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,” Argentieri said.
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