1310 - The Insidious Dangers of Disposable Isolation Gowns

Session Description: Most disposable isolation gowns (Level 1 and 2) are Food and Drug Administration (FDA) Class I products, meaning they are not required to send performance testing data to FDA for review, furthermore manufacturers have very little oversight in terms of production quality. Previous studies have shown that some isolation gowns do not meet the manufacturer’s claimed performance standard. We will present our study results and our testing methodology that has been externally reviewed by our contacts at The National Institute for Occupational Safety & Health (NIOSH). Studies performed by our facility’s biomedical engineers have shown that some disposable gowns from traditional and non-traditional suppliers were sub-par as measured by key performance indicators. We will also review our facility’s de-identified risk management information system events related to isolation gown failures. Gowns that fail to meet their stated fluid barrier protection level or that tear easily during clinician use pose an elevated risk of exposure to the user and potential infection spread. There is not enough pressure to ensure manufacturers meet industry standards or maintain quality. Healthcare facilities must improve reporting of gown strikethrough, and follow-up with documentation if exposure or infection occurs as a result. This presentation will highlight how infection preventionists and purchasing committees can start to evaluate isolation gown types and what questions to ask manufacturers, including requiring documented key performance indicator data. The target audience is infection preventionists, those members of purchasing committees, and others who work with or have an interest in Personal Protective Equipment (PPE) selection. The content is appropriate for all experience levels and career stages.