Disposable hospital gowns can expose healthcare workers to infection

Disposable gowns designed to deflect splashes of body fluids used in thousands of U.S. hospitals have performed poorly in recent and ongoing laboratory tests and may not meet safety standards, leaving healthcare workers at greater risk of infection than advertised.

A peer-reviewed academic study, published unnoticed amid the coronavirus pandemic, found that isolation gowns commonly worn in medical wards or intensive care units tear too easily and allow about four to 14 times the expected amount of fluid to seep through them , when sprayed or splashed.

“I’m amazed that facilities use them,” study co-author Elizabeth Easter, a textile expert at the University of Kentucky, said of the thinnest disposable gowns. “Because, technically, you can see through the fabric.”

Now, a similar study is underway at ECRI, a nonprofit organization focused on health care safety that began testing disposable isolation gowns after receiving anecdotal reports of “leakage of blood or other bodily fluids,” said the engineering director of ECRI Chris Lavanci. He told KHN that preliminary test results raise concerns that the disposable gowns may not meet safety standards.

Isolation gowns are worn by hospital workers to cover their torsos and hands before entering rooms with infectious patients, blocking the splash of fluids that might otherwise stick to the workers’ clothing and get into their eyes or mouths. Germs are thought to rarely penetrate gowns and make the wearer sick, but with gowns in constant use in hospitals every day, even a small gap in protection can be magnified a millionfold.

“An expected principle of infection control is that you don’t want that body fluid to go through it,” Lavanci said. “It’s a very reasonable expectation that if you get fluids, there’s a risk.”

Lavanchy declined to provide further details on ECRI’s findings, stressing that tests are ongoing. The organization is in discussions with dress companies, who will be given the opportunity to question or challenge the findings before the full report is published, planned for later this year. Neither ECRI nor the academic study identified the specific gowns or brands that were tested, but officials involved in both studies said the gowns were purchased from some of the major suppliers to US hospitals.

KHN reached out to three of the largest suppliers of hospital gowns for comment. No one answered.

The testing of isolation gowns comes as the coronavirus pandemic has dramatically heightened concerns about infection control in hospitals and constraints on supply chains for personal protective equipment, including gowns. Disposable gowns were a scarce resource in the first year of the pandemic, forcing some nurses to resort to carrying trash bags and some hospitals to hastily buy from manufacturers with no experience with gowns or foreign suppliers that did not meet U.S. standards. ECRI’s tests showed that many of these gowns offered insufficient protection, drawing attention to the lack of quality control in the gown industry, which ultimately motivated the organization’s ongoing testing of gowns from more traditional suppliers.

Supply shortages and questions about the quality of single-use gowns may persuade some hospitals to reconsider reusable isolation gowns, which can be washed about 75 times. Several studies and pilot programs have shown that reusable gowns offer at least as much protection and lower costs, and are much better for the environment. Additionally, reusable gowns are readily available during the pandemic, allowing hospitals to avoid supply shortages and price spikes.

Inova Health System, near Washington, D.C., switched two of its hospitals to reusable gowns in 2021 to insulate itself from supply chain issues, and hopes to introduce the gowns to its remaining three facilities by the end of this year. Before the change, Inova used about 3 million disposable gowns a year, creating 213 tons of waste, company officials said.

“There was a lot of trial and error in this process,” said Michelle Penninger, Inova’s assistant vice president for infection prevention and control. “But it will all pay off in the end.”

Chana Luria, who has worked as a nurse in California for about 30 years, said she long preferred the washable gowns that were common in the first decade of her career. They felt thicker, safer and far less wasteful, she said. The liquid splashed on those dresses slides onto the floor — sometimes creating a slip hazard — but never penetrates her clothes or skin, she said.

Many nurses prefer disposable gowns because they have a reputation for being cooler and more breathable, Luria said, but infection control should be a priority over comfort. “I’d rather sweat in a big bag and have some real protection,” Luria said. “It’s called personal protective equipment. If it doesn’t protect you, it’s a waste of time.

“We used to spend millions of dollars on dresses”

Whether washed or discarded, isolation gowns are often worn in just minutes.

And all those minutes add up. At UCLA Health, a four-hospital chain in the Los Angeles area that switched to reusable gowns over the past decade, one liver transplant unit once used up to 1,000 disposable gowns a day, said Norm Lantz, senior director of general services. “We were spending millions of dollars on dresses,” Lantz said. “And then we realized that with all that money, what we’re buying is filling landfills.”

Most isolation gowns are classified as either “level one” gowns, intended for use in standard medical wards and during basic care, or as slightly thicker “level two” gowns, which are worn in intensive care units and during of drawing blood and suturing, according to the FDA. The agency recognizes standards for isolation gowns created by three organizations — the American National Standards Institute, the Association for the Advancement of Medical Instruments and ASTM International — but has no independent verification to ensure the gowns meet those standards.

Unlike surgical gowns, which are subject to greater scrutiny, isolation gowns are classified by the FDA as low-risk medical devices that are exempt from government review before sale. Dress companies are largely responsible for their own quality control.

But disposable isolation gowns fell well short of industry standards 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. The tests were conducted in 2018. , before the pandemic, shortages eroded the quality of dresses available.

To test the gowns’ ability to repel body fluids, the researchers sprayed them with water using something similar to a shower and determined whether the weight of the absorbent paper on the other side of the protective material increased.

Level 1 disposable gowns were found to leak an average of 16.2 grams of fluid, far more than the standard 4.5 grams, according to the study. Tier 2 disposable gowns weighed an average of 13.5 grams but had to leak no more than 1 gram.

Both levels of disposable gowns also did not meet a tensile strength standard that was not recognized by the FDA at the time of testing but has since been recognized. The dresses were expected to withstand at least 7 kilograms of force. But when widthwise pressure was applied, level one dresses tore with less than 1 pound of force, and level two dresses tore with less than 5, according to the study.

Several brands of reusable dresses passed both tests by comfortable margins, even after being washed 75 times.

Meredith McQuarrie, head of the Florida Textile Testing Laboratory, who co-authored the study, said the failures of disposable gowns show the effect of standards “not being fully enforced.”

“One hundred percent this should not be just further research,” she said. “This should definitely raise some alarm in the medical profession in terms of PPE concerns.”

ECRI is now undertaking a separate study at its Philadelphia lab that will replicate the academic’s tests. In addition, ECRI said it will launch a survey through which healthcare workers can report failed gowns. The organization also named “insufficient” disposable gowns as one of its “Top 10 Health Technology Threats for 2022.”

Tim Brown, ECRI’s vice president of supply chain solutions, said alarm bells began to sound amid supply shortages at the start of the pandemic, as desperate hospitals turned to gowns of questionable quality, often imported from Chinese companies .

In 2020, ECRI tested 34 models of gowns from foreign and “non-traditional” suppliers and found that about half the gowns did not meet the claimed level of protection, and half did not meet even the lowest standard, according to documents provided by the organization.

“There were more fraudulent products on the market than ever before,” Brown said, “and that really raised the level of concern from a quality standpoint.”

“We didn’t carry garbage bags”

While supply chain issues in 2020 have cast doubt on single-use gowns, they’ve been vindicating for hospitals that switched to reusable alternatives years ago.

Officials at UCLA Health and Carilion Clinic, a seven-hospital chain based in Virginia, both of which are outspoken proponents of reusable gowns, said they have no shortage and are simply washing faster to keep up with pandemic demand.

Hospital groups also said they were insulated from the price spike, which at times raised the cost of a single-use gown from about 80 cents to nearly $3.

Lantz said UCLA Health has prevented approximately 1,200 tons of waste and is now saving $450,000 a year after switching inpatient and emergency rooms to reusable aprons.

At Carilion Clinic, reusable gowns were saving hospitals about 40 cents per use even before the pandemic, said Jim Buchbinder, the company’s director of laundry services.

“Forty cents per dress when we’re using 120,000 dresses a week during the pandemic — that’s significant,” Buchbinder said. Besides, we had to wear them. We didn’t bring bin bags to Carilion.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism on health issues. Along with policy analysis and polling, KHN is one of the three main operational programs at KFF (Kaiser Family). KFF is a charitable, non-profit organization providing information on health issues to the nation.

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