set of stakeholders before developing a standard .
● Coordination of Stakeholders : A multitude of stakeholders — including materials suppliers , manufacturers , users , and government agencies — impact the PPE supply chain . While participation from all stakeholders is encouraged , coordinating and ensuring that all relevant stakeholders understand and are engaged in the standards development process can be challenging .
● Dissemination of Standards : The end users of PPE standards are diverse and geographically dispersed , making it difficult to not only reach them but also provide standards in a format they can effectively and efficiently use .
● Timeframe for Standards Development : Because it takes approximately nine months to develop a voluntary consensus standard using the ASTM process , new standards may only have limited impact during the current pandemic wave . To be more responsive , standards development needs to be forward-looking and anticipate future needs and challenges .
Additionally , the whitepaper outlines the need for new and modified standards across infection control PPE that seek to address high-priority gaps that ASTM International and other standards-development organizations ( SDOs ) can pursue .
In September 2020 , ASTM International held a workshop on fast-tracking standards development to address PPE shortages due to COVID-19 . The focus of the workshop was to outline the current state of the industry , identify gaps in standardization , and encourage participants to get involved in modifying existing standards and creating new standards . The workshop provided a forum for engineers , scientists , and medical professionals worldwide to exchange ideas and identify areas for needed standards development . The workshop addressed everything from protective clothing and face shields , respirators and face masks , to reprocessing and reuse of PPE , conformity assessments , modeling and additive manufacturing .
The workshop identified the need for new and modified standards across several categories of infection control PPE . These standards address high-priority gaps that ASTM and other SDOs can pursue to support PPE quality and availability . These gaps include :
➊ Respirators and Face Masks
● Respirator filtration testing per NIOSH mandatory standard — sampling methodology , mounting of respirators / masks methodology , handling of samples , pressure threshold limits
● Particle filtration efficiency testing
● Physical characterization , including pressure drop
● Specification of face velocities and neutralization in ASTM F2299
● Use of surfactant-free polystyrene latex ( PSL ) particles
● Optical particle counter ( OPC ) detector limits and alternative detection methods
● Specification of initial colony forming units ( CFU ) concentration in ASTM Standard F2101 , including more details on culture conditions
➋ Protective Clothing and Face Shields
● Guidance on manufacturing of isolation gowns
● Design guidance for face shields
● Basic requirements and definitions for face shields for healthcare use and material selection guidance
● ( cleanability , disinfection )
➌ Reprocessing and Reuse of PPE
● Standardization and guidance relevant to emergency re-use of PPE , and harmonization of test methods
● across agencies
● Overlying guidance document for testing of reprocessed PPE
● Standard reference materials and guidance on residuals
● Impact of disinfectants on filtering facepiece respirators ( FFRs ), with regulatory input
● Automated colony counting and specification of initial bacterial concentration in ASTM F2101
● Expanded single-use methods to include reusable devices with different requirements
➍ Conformity Assessment
● Conformity testing for respirator fit capability
● Testing to identify counterfeit materials , kits , and devices
● Other “ fit-for-purpose ” methodologies
➎ Modeling and Additive Manufacturing
● Verification check based on flow visualization for mask fit quality , or to validate another fit test
● Guidance document for computational modeling of aerosol leakage through 3D face masks ( scope provided along with details of standard )
● Modeling and simulation standards to test PPE designs prior to 3D printing
● Computational test methods to augment physical testing
● Physical test methods
References :
ASTM International . Whitepaper : Global Collaboration to Advance
Personal Protective Equipment ( PPE ) Safety , Quality , and Innovation . February 2021 . Bielicki JA , Duval , X , et al . Monitoring approaches for healthcare workers during the COVID-19 pandemic . The Lancet Infect Dis . July 23 , 2020 . DOI : https :// doi . org / 10.1016 / S1473-3099 ( 20 ) 30458-8
Jefferson T , Del Mar CB , et al . Physical interventions to interrupt or reduce the spread of respiratory viruses . Cochrane Database Syst Rev . Nov . 2020 . doi : 10.1002 / 14651858 . CD006207 . pub5
Society for Healthcare Epidemiology of America ( SHEA ). COVID-19 Research Agenda for Healthcare Epidemiology . January 2021 .
Verbeek JH , Rajamaki B , et al . Personal protective equipment for preventing highly infectious diseases due to exposure to contaminated body fluids in healthcare staff . Cochrane Database Syst Rev . 2020 ; 4 : CD011621 .
World Health Organization ( WHO ). Keep health workers safe to keep patients safe . Sept . 17 , 2020
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There is a need for large , welldesigned RCTs addressing the effectiveness of many of these interventions in multiple settings and populations , especially in those most at risk of acute respiratory infections ( ARIs ).”