Over Half of Isolation Gowns Fail to Meet Protective Standards

Ken Terry

November 11, 2020

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

More than half of the disposable isolation gowns tested by ECRI, a leading national patient safety organization, failed to meet standard levels of protection, according to a high-priority hazard alert that ECRI issued on Tuesday.

The substandard isolation gowns are "putting healthcare workers at risk of exposure to bloodborne or other pathogens, as well as SARS-CoV-2, the virus that causes COVID-19," an ECRI news release said.

The organization, which has advised hospitals, other healthcare stakeholders, and government agencies on product safety for decades, found that 52% of the gowns that lacked labels stating levels of protection failed to meet even the lowest level of protection set by the Association for the Advancement of Medical Instrumentation (AAMI). Fifty percent did not meet the AAMI standard for liquid barrier performance.

ECRI researchers evaluated 34 models of disposable gowns from suppliers outside the United States or from nontraditional suppliers that had had no prior experience in manufacturing personal protective equipment (PPE).

"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, in the press release. "Our research shows that you can't judge the authenticity of the product based on its appearance, labeling, or packaging without product testing."

ECRI's alert recommends that healthcare providers consider using isolation gowns from outside the United States or from nontraditional manufacturers "only as a last resort when established models of isolation gowns with a known and confirmed AAMI level are unavailable." Even then, the alternative gowns should be used by staff only in low-risk areas of hospitals, ECRI says.

Before purchasing these gowns, ECRI advises, providers should request samples for evaluation, and those samples should be tested by an independent lab for impact and hydrostatic penetration to verify barrier effectiveness.

ECRI further suggests that providers procure PPE from nontraditional suppliers only after due diligence, which includes obtaining background information on the company and requesting samples for evaluation. If the manufacturer claims its product has been tested, the provider should ask for copies of test reports.

Masks Also Problematic

Isolation gowns are not the only PPE products that ECRI has found lacking. In September, ECRI released its analysis of imported masks, which found that 70% of the Chinese KN95 respiratory masks it tested failed to meet US standards, as reported by Medscape Medical News.

Problems have also been reported with Chinese masks in other countries. In March, for example, Dutch authorities recalled 600,000 face masks made in China, according to BBC News. In May, The Wall Street Journal reported that federal and state regulators had found a significant number of imported N95-style masks failed to meet federal certification standards.

The US Food and Drug Administration (FDA) regulates the marketing of isolation gowns in this country. But, recognizing the shortage of PPE during the first stage of the pandemic, the FDA on May 22 issued a blanket emergency use authorization (EUA) for these and other items.

The use of these products, the FDA said, is intended only for "low or minimal-risk level situations to prevent the spread of COVID-19." The EUA allows the agency to waive "good manufacturing practice requirements" and some labeling requirements.

However, an isolation gown must be labeled as a nonsurgical gown, the types of healthcare settings where it may be used must be indicated, and it must be specified whether it is intended for single use or reuse after decontamination.

"Not Intended for Medical Use"

The vagueness of this blanket EUA "opened doors for maybe not the most professional or sincere players," ECRI's Schabacker told Medscape Medical News. US Customs, the only federal agency besides the FDA that regulates imported PPE, looks mainly for counterfeits and for products that are not intended for medical use, he said.

Even so, some of the latter slip through. A Philadelphia-area hospital that's a member of ECRI bought a container of imported isolation gowns, Schabacker recalled. Only after its staff opened the container did they notice that it was labeled, "not for medical use." The hospital then asked ECRI to test the gowns, "and we found that some of those weren't sufficient even to meet AAMI level 1 criteria," he said.

Because of what he called the "chaotic supply chain" for PPE, it isn't entirely clear how many of these products are being imported, rather than being made by nontraditional suppliers in the United States. He said that ECRI estimates that Chinese manufacturers accounted for 50% to 65% of the gowns it tested. Another 7% to 20% were probably made by nontraditional domestic producers, he added.

PPE shortages continue to be reported across the country. A spokesman for Get Us PPE, a volunteer organization that matches available PPE supplies to healthcare providers, told the New York Times that 70% of providers that requested help last month reported being completely out of one type of protective gear.

With the number of COVID-19 cases rising across the country, Schabacker expects the PPE shortages to worsen. When that happens, he said, "providers will be seeking alternatives to traditional suppliers for both gowns and masks.

"Given the situation we see right now, we expect to get into crunch time again."

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