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A New Standard Explains Critical Performance and Design Properties for Medical Gowns

  • Saturday, 11 January 2025
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A New Standard Explains Critical Performance and Design Properties for Medical Gowns

A medical gown that can ward off the splatter of bodily fluids during procedures such as blood draws, suturing and injections is crucial to healthcare worker (HCW) safety. However, a recent academic study, published to little notice amid the pandemic, found that many disposable isolation gowns used in hospitals across the country have failed to meet industry standards and may be putting HCWs at greater risk than advertised.

Disposable isolation gowns are designed to be worn once and discarded after each use. They can be made of a variety of fabric materials, including polypropylene, polyester, and polyethylene, and utilize a number of fiber-bonding technologies to achieve desired properties such as strength, durability, moisture management, and liquid barrier performance.

Gowns are also designed with a range of features, such as an open back design, sewn seams, and front or rear break-away capabilities to make it easy for HCWs to remove the gowns during critical tasks like administering medication and providing care to patients with high-risk conditions. Additionally, the garments are usually constructed to provide a good degree of airflow while allowing for coverage of HCWs’ hands.

Unlike surgical gowns, which undergo a rigorous approval process under the FDA’s premarket notification program, the agency recognizes standards for isolation gowns established by three groups and leaves oversight to the gown companies themselves. As a result, the industry has not been able to establish uniform testing methods to ensure that gowns sold in the U.S. are meeting these standards.

In a recent study, laboratory tests conducted by a company that provides medical products and services to healthcare organizations showed that most of 22 isolation gowns tested allowed more fluid strikethrough than the industry standard. The researchers say that the results indicate the need to impose rigorous standards on manufacturers of isolation gowns to prevent ongoing problems with fluid penetration.

This problem is exacerbated by the fact that most of the leading isolation gown manufacturers in the U.S. market operate abroad, with several of them based in China, where the U.S. government has flagged some companies for connections to forced labor of the Uyghur population, raising concerns about whether these firms have violated the Make PPE in America Act. A new standard document that explains critical performance and design properties for isolation gowns could aid end users in selecting the right level of protection for their procedures, and can help reduce the risks of exposure to infectious diseases.

ECRI is asking healthcare facilities to report their experiences with disposable isolation gowns, so that we can collect data about how well these products perform in the real world and identify areas where improvements can be made. We will share our results with the healthcare community, and encourage you to take a moment to participate in this survey now. It is available online. The survey will close on May 31, 2022. Thanks for your participation. ECRI is an independent, non-profit research organization that promotes patient safety and quality in health care.

Tags:disposable chemotheraphy isolation gown

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