healthcare textiles & laundry
By Gregory Gicewicz
Navigating Our New World of Reusable Protective Gowns for Use by Healthcare Personnel
In addition to clear environmental advantages , reusable gowns offer superior performance and protection as well as more predictable availability .
COVID-19 is permanently transforming many practices in our healthcare world . One of these transformations is the dramatic switch from disposable to reusable protective gowns for use by healthcare personnel ( HCP ). During the last decade , most single-use protective HCP gowns were manufactured overseas . Recently , many of these single use gowns have been plagued by quality issues and supply chain disruptions . Concurrently , demand has skyrocketed due to COVID-19 . Consequently , the availability and performance of HCP gowns have become a chronic issue in healthcare settings .
Fortunately , reusable HCP protective gowns are coming to the rescue . In addition to clear environmental advantages , reusable gowns offer superior performance and protection as well as more predictable availability . Their cost per use is typically far below single-use gowns and they support local jobs to reprocess in preferably accredited healthcare laundries . Conversely , disposable gowns are discarded in our landfills after one use and typically do not employ local workers in their reprocessing .
The following seeks to inform healthcare practitioners on how to navigate the world of reusable protective gowns for use by HCP . We will explain protective gown terminology and regulations ; provide guidance on how to align the correct protective gown to its required purpose ; identify key areas to investigate before selecting the protective gown ; and finally how to care for and maintain the investment to ensure quality and patient safety . Discussion is limited to reusable gowns making liquid barrier protection claims and that are intended for use in healthcare settings . Other hospital staff apparel such as scrubs , lab coats , masks , and gloves are not included in the discussion , nor are non-healthcare protective gowns .
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Definitions , Regulations and Standards
The Food and Drug Administration ( FDA ) broadly defines two different categories of protective gowns : those claiming minimal or low levels of barrier protection and those claiming moderate to high barrier protection . More specifically , minimal or low-barrier protection gowns are broken down
into ANSI / AAMI PB70 Levels 1 or 2 protection or equivalent standards . Moderate or high barrier protection gowns are broken down into ANSI / AAMI PB70 Levels 3 or 4 protection or equivalent standards .
The FDA classifies protective gowns as either class I devices or class II devices . Class I devices are typically lower risk and are “ exempt ” from the rigorous premarket notification procedures . Class II devices are higher risk and require special controls as well as FDA premarket notification procedures . It is best to think of Class I gowns as non-surgical gowns and class II gowns as surgical gowns . Per the FDA , a class I “ non-surgical gown ” must meet all the following criteria :
➊ It is labeled as a gown other than a surgical gown ( e . g ., isolation gown )
➋ It is not described in its labeling as a surgical gown
➌ If it has statements relating to barrier protection , such statements are for only minimal or low barrier protection .
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