Disposable Gowns with Insufficient Barrier Protection Put Wearers at Risk

January 12, 2022 | Evaluations & Guidance


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Product selection errors and gown manufacturing flaws can lead to the use of medical protective gowns that do not adequately protect the wearer from body fluids and other potentially harmful substances. Gown wearers—which can include healthcare workers, nonclinical personnel, visitors, and others—can be put at risk of cross-contamination if the wrong type of gown is purchased and worn for the intended application, or if the gown does not provide the level of protection that is claimed.

Gown types include surgical gowns, isolation gowns, and cover gowns (sometimes called protective gowns). Each type is intended for different uses, and each use has different minimum protection requirements.

Selecting the appropriate gown for any given application, however, is not as simple as looking at its labeling. The nomenclature used by suppliers to designate the gown type or protection level is not consistent. Terms may be used interchangeably, or in a manner that does not align with how they are defined in applicable standards, such as the Association for the Advancement of Medical Instrumentation (AAMI) specifications for gown fluid resistance level (see Table 1). For example, product literature may describe a product as an "isolation gown," even though it doesn't meet the standard requirements for that type of gown. (Isolation gowns must provide 360° coverage from neck to knees, and must be at least minimally resistant to water spray, corresponding with AAMI Level 1.) The imprecise use of terms in marketing literature can make it difficult for purchasers to know the level of barrier protection that a gown will provide.

Similarly, the inconsistent descriptions and confusing terminology make it difficult for healthcare workers to select a gown that offers sufficient protection for a specific application. An example is choosing to wear a backless gown in an environment where infectious airborne particulates are present.

Finally, ECRI's testing of disposable gowns has raised concerns about manufacturing quality. In the latter half of 2020, ECRI's testing focused on disposable gowns from nontraditional suppliers (i.e., new or non-U.S. manufacturers). Healthcare facilities were purchasing gowns from these suppliers as a way to cope with supply shortages associated with the COVID-19 pandemic. Roughly half the gowns that we tested at that time failed to meet AAMI's fluid barrier requirements. ECRI is in the process of testing isolation gowns from some traditional, U.S.-based...

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