Am J Infect Control. 2023 Sep 8:S0196-6553(23)00608-9. doi: 10.1016/j.ajic.2023.09.003. Online ahead of print.
BACKGROUND: Recent epidemics and pandemics highlighted the need for effective personal protective equipment, including isolation gowns. The most critical property for an isolation gown is its ability to keep liquids and viruses from passing through the gown. Liquid and viral barrier penetration can be measured using laboratory test methods. AAMI PB70 standard defines isolation gown barrier performance levels and requirements.
OBJECTIVE: Twenty two disposable isolation gown models from six manufacturers were tested for liquid and viral penetration resistance.
METHODS: Standard test methods were used to evaluate water and viral penetration. Test results were evaluated using AAMI PB70 barrier performance criteria for four protection levels.
RESULTS: Seven of the 22 tested gown models did not pass liquid and viral penetration testing based on AAMI PB70 at the level claimed by manufacturer. The majority of these failures occurred at the seam and/or tie attachment areas.
CONCLUSIONS: The study findings underscore the need for improved processes surrounding activities such as premarket testing and post-market evaluation of gowns according to standardized test methods by third party laboratories. This study also supports the recent FDA guidance document that clarified the characteristics of isolation gowns considered to be class II and subject to FDA premarket review. Infection preventionists, hospital purchasers, and safety professionals should seek isolation gowns demonstrating conformance to industry standards from manufacturers.