Disposable gowns designed to deflect body fluid splatters used in thousands of U.S. hospitals have performed poorly in recent and ongoing laboratory tests and may meet safety standards, with healthcare workers having a higher risk of infection than advertised.
A peer-reviewed academic study published at the slightest notice in the coronavirus epidemic found that isolation gowns usually worn in medical units or intensive care units are easily torn and allow four to 14 times the expected amount of fluid to come out when sprayed. splashed
“I’m amazed at the benefits they’re using,” said study co-author Elizabeth Easter, a textile expert at the University of Kentucky, in the thinnest disposable gown. “Because, technically, you can see through the fabric.”
A similar study is now underway at ECRI, focusing on protecting a nonprofit healthcare provider that began testing disposable isolation gowns after receiving “stories of leaks through blood or other body fluids,” said Chris Lavanchi, ECRI’s engineering director. She told KHN that preliminary test results expressed concern that disposable gowns could not meet safety standards.
Isolation gowns are worn by hospital staff to cover the torso and arms of infectious patients before entering the room, blocking liquid sprays that may otherwise stick to staff clothing and end up in their eyes or mouth. Germs rarely enter gowns and are thought to make the wearer sick, but gowns are used regularly in the hospital every day, even a small gap in protection can be millions of times longer.
“It’s an expected principle of infection control that you don’t want body fluids to go through it,” Lavanchi said. “A very reasonable expectation is that there is a risk if you drink fluids.”
Lavanchy declined to give further details about the ECRI results, insisting that the test is ongoing. The company is in talks with gown companies who will have the opportunity to question or debate the results in advance of the release of a full report planned later this year. Neither ECRI nor academic studies identified the specific gowns or brands that were tested, but officials involved in both studies said the gowns were purchased from U.S. hospital primary suppliers.
KHN has reached out to the three largest suppliers of hospital gowns for comment. No one responded.
The testing of isolation gowns comes at a time when coronavirus epidemics have dramatically raised concerns about infection control in the hospital and the limitations of the supply chain of personal protective equipment, including gowns. Disposable gowns were a scarce resource in the first year of the epidemic, forcing some nurses to wear trash bags and some hospitals rushing to buy gowns from inexperienced manufacturers or foreign suppliers who do not meet U.S. standards. ECRI tests have shown that many of these gowns provide poor protection, which draws attention to the lack of quality control in the gown industry, ultimately inspiring the company in current testing of gowns from more traditional suppliers.
Lack of supplies and questions about the quality of disposable gowns may prompt some hospitals to reconsider reusable isolation gowns, which can be laundered about 75 times. A handful of studies and pilot programs recommend that reusable gowns offer at least as much protection and low cost and are better for the environment. In addition, reusable gowns are readily available throughout the epidemic, allowing hospitals to avoid supply shortages and increased costs.
Innova Health Systems, near Washington, D.C., has transformed two of its hospitals into reusable gowns in 2021 to keep itself away from supply chain problems and hopes to launch gowns at the remaining three facilities by the end of this year. Prior to the change, Innova used about 3 million disposable gowns a year, generating 213 tons of waste, company officials said.
“There were a lot of trials and errors through this process,” said Michelle Penninger, Inva’s assistant vice president of infection prevention and control. “But it will all pay off in the end.”
Chana Luria, who has worked as a nurse in California for nearly 30 years, says she prefers long-washable gowns that were common in the first decade of her career. They feel denser, safer and much less wasteful, he said. The liquid spilled on that gown would have gone to the floor – sometimes creating the risk of slipping – but never penetrated her clothes or skin, she said.
Many nurses favor disposable gowns because they have a reputation for being cooler and more breathable, Luria said, but infection control should take precedence over comfort. “I’d rather sweat in a heavy bag and get some kind of real protection,” Luria said. “It’s called personal protective equipment. If it doesn’t protect you, it’s a waste of time. “
‘We were spending millions of dollars on gowns’
Whether they are washed or trashed, isolation gowns are often worn for a few minutes.
And add all those minutes. At UCLA Health, a four-hospital chain in the Los Angeles area that has been transformed into reusable gowns over the past decade, a single liver transplant unit used 1,000 disposable gowns once a day, said Norm Lantz, senior director of the General Service. “We were spending millions of dollars on gowns,” Lantz said. “And then we realized, out of all that money, what we were buying was filling the landfills.”
Most isolation gowns are classified as “Level One” gowns, designed to be worn in the standard medical unit and during primary care, or slightly thicker “Level Two” gowns, which are used in the ICU and during blood transfusions and stitches. Is worn, FDA. The agency recognizes the standards of isolation gowns made by three organizations – the American National Standards Institute, the Association for the Advancement of Medical Instruments, and ASTM International – but there is no independent check to ensure the gowns comply with these standards.
Unlike surgical gowns, which are further vetted, isolated gowns are classified by the FDA as low-risk medical devices that are exempt from official review prior to sale. Gown companies are largely responsible for their own quality control.
But in a recent academic study conducted by Easter and a textile-testing expert at Florida State University and published in the American Journal of Infection Control in 2021, disposable isolation gowns fell far short of industry standards. Tests were performed in 2018 before the epidemic eroded the available gown standards.
To test the ability of the gown to repel body fluids, the researchers sprayed with water using something like a showerhead and determined whether the weight of the blotter paper on the other side of the protective material increased.
Level One disposable gowns found an average of 16.2 grams of liquid, much higher than the 4.5-gram standard, the study found. Level-two disposable gowns should have weighed an average of 13.5 grams but not more than 1 gram.
Both layers of the disposable gown failed to meet a standard for tensile strength, which was not recognized by the FDA at the time of testing but has been since. The gowns were expected to withstand at least 7 pounds of strength. But when pressure is applied to the width, the Level One gown breaks less than 1 pound, and the Level Two gown breaks less than 5 pounds, according to the study.
Reusable gowns from several brands have passed both tests at comfortable margins even after washing 75 times.
Meredith McQuery, supervisor of the Florida State Textile Testing Lab, who co-authored the study, said the failure of disposable gowns to demonstrate the impact of the criteria “is not being fully implemented.”
“One hundred percent it shouldn’t just form further studies,” he said. “This will certainly cause some apprehension in the medical profession in terms of PPE concerns.”
Now, ECRI is conducting a separate study in its Philadelphia laboratory that will repeat academic examinations. Also, the ECRI said it would launch a survey through which healthcare workers would be able to report gown failure. The company also named an “inadequate” disposable gown among the “Top 10 Health Technology Risks for 2022”.
Tim Brown, vice president of ECRI at Supply Chain Solutions, said alarms were sounding amid supply shortages at the start of the epidemic as desperate hospitals turned into questionable quality gowns, often imported from Chinese companies.
In 2020, ECRI tested 34 gown models from foreign and “unconventional” suppliers and found that nearly half of the gowns did not meet their claimed safety standards and half failed to meet even the minimum standards, according to documents provided by the company.
“There were a lot more fraudulent products on the market than ever before,” Brown said, “and that’s what really raised the level of concern from a quality perspective.”
‘We didn’t wear trash bags’
Although 2020 supply chain issues raised suspicions about disposable gowns, they were reiterating the need to transform them into reusable options for hospitals.
Officials at UCLA Health and Carelion Clinic, a seven-hospital chain based in Virginia, are outspoken advocates of both reusable gowns, saying they have no shortage and have been quickly laundered to keep pace with epidemic demand.
Hospital groups also said they were insulated from the price of the waves, which sometimes ranged the price of a single disposable gown from about 80 cents to about ড 3.
Lantz said UCLA Health has saved about 1,200 tons of waste and now saves $ 450,000 a year after converting its inpatient units and emergency rooms into reusable gowns.
At the Carillion Clinic, reusable gowns were saving about 40 cents per use per hospital even before the epidemic, said Jim Butchbinder, director of the company’s laundry service.
“Forty cents a gown when we use 120,000 gowns a week during an epidemic – that’s enough,” Butchbinder said. “Plus, we had to wear them. We weren’t after the trash bag in Carleton.”
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