The patient safety organization ECRI found half of the disposable gowns health systems purchased from international or non-traditional suppliers during the COVID-19 pandemic don't meet standards of protection.
The pandemic has strained the availability of disposable gowns, which are used by clinical staff when entering rooms with COVID-19 patients to protect themselves from splashes or spray. Some providers have responded to the shortage by purchasing from new vendors overseas. ECRI analyzed 170 of these gowns representing 34 models and found half of those that claimed a level of protection didn't meet standards for liquid barrier protection. Overall, 52% of gowns that didn't state any standards failed to meet the most basic protection levels.
"There are probably hundreds, if not thousands of vendors out there, so we aren't claiming any statistical relevance here, but it's clearly concerning that half of the products investigated aren't living up to relatively low standard levels," said Dr. Marcus Schabacker, CEO of ECRI.
ECRI received the gowns from its health system members that purchased them.
As the U.S. experiences a second wave of COVID-19 this fall, gowns may be in short supply for certain regions and ECRI is advising providers not to purchase from international or non-traditional suppliers. If the provider has no other options, ECRI is advising to only use these gowns in low-risk situations.
ECRI was interested in looking at this topic after working with a Philadelphia hospital that purchased gowns from a supplier outside the U.S. during the pandemic. When they arrived, they stated, "Not for medical use." Clinicians were worried and wanted them to be tested, which ECRI helped with.
Schabacker said the risk of COVID-19 contamination because of a substandard gown is low but it's still an unsafe situation for the clinician who may soil their scrubs with bodily fluids. "It's not as risky as a failing mask, which has a direct impact for the healthcare worker, but it's certainty not a desirable situation," he said.
ECRI has previous experience testing gowns for protection standards in its lab. ECRI uses the standards from the not-for-profit Association for the Advancement of Medical Instrumentation to determine if a gown is meeting protection levels or not. Schabacker said these standards are well-known and recognized in the industry.