More than 50% of disposable isolation gowns tested by the nonprofit advocacy organization ECRI fail to meet standard levels of protection.
The results from the recent analysis released Monday comes as new surges of COVID-19 have put additional stress on the personal protective equipment supply chain. ECRI issued a high-priority hazard alert to healthcare organizations outlining its concerns.
“Our research shows that you can’t judge the authenticity of the product based on its appearance, labeling, or packaging without product testing,” said Marcus Schabacker, ECRI’s president and CEO, in a statement.
ECRI examined 34 models of isolation gowns made outside the U.S. or from non-traditional suppliers.
It found that 52% of gowns with unstated levels of protection failed to meet even the lowest protection standards developed by the group Association for the Advancement of Medical Instrumentation (AAMI), which creates standards on medical equipment.
“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,” the group added in a release on the findings.
ECRI issued a hazard report to warn providers of the potential problems. The report said that systems should only rely on isolation gowns from outside the U.S. or from nontraditional manufacturers with little experience in the medical space as a last resort.
It also calls for providers to properly evaluate any gowns they do get from outside the U.S. before they are used.
To avoid paying for a product that could not be used, providers should ask for a sample from a manufacturer that is overseas or a nontraditional manufacturer.
Providers may be forced to use gowns from overseas or from manufacturers new to the healthcare space. Providers and even some members of Congress have questioned the overreliance of the PPE supply chain on foreign manufacturers.
“Despite the increase in both domestic and outside-the-U.S. manufacturing of isolation gowns, ECRI is still receiving notification of widespread limits on quantities that can be purchased,” the hazard report said.
A recent survey of healthcare systems conducted by Premier Inc. found that 10% of the systems are still having trouble getting enough isolation gowns.
This alert from ECRI comes after the group also raised concerns in September about the effectiveness of KN95 masks, which hospitals have turned to due to the scarcity of N95 masks.