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    Volume 50, Issue 1 (July 2021)

    Development of a Standard Test Method for Assessing Mechanical Penetration of Personal Protective Equipment Material to Test Soils by Simulating Actual Use

    (Received 1 March 2021; accepted 1 June 2021)

    Published Online: 21 July 2021

    CODEN: JTEVAB

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    Abstract

    Preventing healthcare worker exposure to dangerous pathogens is a crucial factor in sustaining the fight against Ebola, Coronaviruses, and other microorganisms that may cause infectious diseases. It is critical that personal protective equipment (PPE) used to protect healthcare workers be safe and effective in meeting labeled performance claims for barrier resistance to deadly viruses such as Ebola (Zaire ebolavirus) and severe acute respiratory syndrome coronavirus 2. The aim of this study is to develop a readily reproducible and standardized simulated use test for gown and drape materials using a blood test soil to evaluate the ability of the materials to prevent penetration of clinically relevant test soils at clinically relevant pressures. We designed and constructed a simulated use “elbow lean” apparatus based on the apparatus in ASTM F1819, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood Using a Mechanical Pressure Technique, that applies a physiologically relevant load to PPE material. We developed a test protocol for our proposed method and used the apparatus on a variety of PPE materials to assess penetration of a blood test soil. The testing demonstrated that the new apparatus can be used to assess penetration of a blood test soil through PPE materials under conditions that are more clinically relevant than those in ASTM F1670, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood, and ASTM F1671, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System. The apparatus and procedure detailed in this study will be proposed for use in the development of a new standard test method for assessing mechanical penetration of PPE to test soils that better simulate clinical use conditions.

    Author Information:

    Schwerin, Matthew R.
    Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, US Food and Drug Administration, Silver Spring, MD

    Lucas, Anne D.
    Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, US Food and Drug Administration, Silver Spring, MD

    Woods, Terry O.
    Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, US Food and Drug Administration, Silver Spring, MD


    Stock #: JTE20210144

    ISSN:0090-3973

    DOI: 10.1520/JTE20210144

    Author
    Title Development of a Standard Test Method for Assessing Mechanical Penetration of Personal Protective Equipment Material to Test Soils by Simulating Actual Use
    Symposium ,
    Committee F23