2021 FDA Science Forum
Development of an Easily Constructed Simulated Use Test Fixture and Method for Assessing Mechanical Permeability of PPE Materials
- Authors:
- Center:
-
Contributing OfficeCenter for Devices and Radiological Health
Abstract
Preventing healthcare worker exposure is a crucial factor in sustaining the fight against 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 impermeability to these deadly and contagious viruses. The aim of this study is to develop an easily constructed and readily reproducible simulated use test for assessing the ability of PPE gown and drape materials to resist 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 International’s ASTM F1819 (Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood Using a Mechanical Pressure Technique). The simulated elbow fixture is placed in a universal testing machine and used to apply a physiologically relevant load to a sample of PPE material challenged by a test soil. The apparatus was used to test a variety of PPE materials to assess penetration of a blood test soil while using two different elbow test heads, one rigid and one tissue-mimicking test head made of ballistics gelatin. 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/F1671. The new method will be provided to ASTM Committee F23 on Personal Protective Clothing and Equipment for development as a more clinically relevant standard.
