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Coronavirus Resources from the Field

As the COVID-19 crisis unfolds, AAMI is providing this curated collection of resources to assist the health technology field. While AAMI finds these sources to be credible and has compiled this collection as a service to the field, these references are not endorsed by AAMI and the inclusion of any reference or resource should not be construed as endorsement, promotion, or support of any organization.

To request new or updated information, resources and links, please contact Bradley Schoener at bschoener@aami.org. 

  • Updates on AAMI Training and Events
  • COVID-19 Emergency Guidance
  • COVID-19 Town Halls and Webinars
  • AAMI COVID-19 News
  • Coronavirus Resources for the Field
  • On-Demand HTM Emergency Management Webinar Series

If you need guidance around standards, FDA’s Emergency Use Authorization (EUA) process, or other quality assurance and regulatory affairs issues, we would be happy to connect you with AAMI faculty who have indicated they would be willing to work with new clients, some on a pro bono basis. Please contact Bradley Schoener at, bschoener@aami.org for more information.

 

Ventilators/Resuscitators/CPAP/BiPAP

These guidance documents have been developed by the AAMI COVID-19 Response Team, made up of manufacturers, clinicians and FDA representatives, to respond to the ventilator shortage emergency.

  • AAMI CR501:2020, Emergency Use Ventilator (EUV) Design Guidance (8 April 2020, Revision 1.2)
  • AAMI CR502:2020, End User Disclosures for Emergency Use Ventilators (EUVs) (17 April 2020, Revision 1.2)
  • AAMI CR503:2020, Emergency Use Resuscitator Systems Design Guidance (8 April 2020, Revision 1)
  • AAMI CR504:2020, End User Disclosures for Emergency Use Resuscitator Systems (17 April 2020, Revision 1.1)
  • AAMI CR505:2020, Emergency Use CPAP/BiPAP Design Guidance (15 April 2020, Revision 1)
  • AAMI CR506:2020, End User Disclosure for CPAP/BiPAP (17 April 2020, Revision 1.1)
  • AAMI CR507:2020, Basic Safety of Emergency Use Medical Devices (6 May 2020, Revision 1)
  • AAMI CR511:2020, Emergency use Guidance for Remote Control of Medical Devices (16 December 2020, Revision 1.1)
  • DRAFT Test report for Emergency Use Ventilators 
  • DRAFT Test report for Emergency Use Resuscitator Systems
  • DRAFT Test report for Emergency Use CPAP/BiPAP

Previous versions, for reference:

  • AAMI CR502:2020, End User Disclosures for Emergency Use Ventilators (EUVs) (8 April 2020, Revision 1.1)
  • AAMI CR504:2020, End User Disclosures for Emergency Use Resuscitator Systems (8 April 2020, Revision 1)
  • AAMI CR506:2020, End User Disclosure for CPAP/BiPAP (15 April 2020, Revision 1)

The ISO and IEC standards referenced in these guides have been made freely available by ANSI and can be obtained through this link.

 

 

    Regulations
    • FDA GUIDANCE DOCUMENT--Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff March 2020
    • Ventilator Supply Mitigation Strategies: FDA Letter to Health Care Providers
    • Emergency Use Authorization for Ventilators
    Standards
    • FDA List of Recognized Standards for Ventilators
    • ISO and IEC standards for ventilators available from ANSI through this surveymonkey url:  https://www.surveymonkey.com/r/62DZ6TD
    Design Guidance

    • Medtronic's site for its PB560 Ventilator
    • MIT E-Vent | MIT Emergency Ventilator—Emergency ventilator design toolbox

    Other Guidance & Non-U.S. Specifications
    • United Kingdom Medicines and Healthcare products Regulatory Agency--Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak
    • BSI Standards related to ventilators
    • APSF/ASA Guidance on Purposing Anesthesia Machines as ICU Ventilators
    • Report: “Co-Ventilating Patients During a Critical Ventilator Shortage: A Method for Implementation” by FEMA’s Washington DC COVID-19 Co-Ventilation Task force 
    • “Strategies to Mitigate Ventilator Shortages”by ECRI
    • “Working Protocol for Supporting Two Patients with a Single Ventilator” by Greater NY Hospital Association
    • oneSource offers a free COVID-19 Database that contains all the relevant IFUs and Service Manuals for respirators, ventilators, bypass machines
    • CDC COVID-19 Vaccine Equipment Storage and Handling presentation – Benjamin Roberts,MS, CBET, North Seattle College
      • Other resources listed within this video. Roberts, B. K. (2021, January 13). Vaccine storage and handling 2020 with COVID
    • Vaccine Storage and Handling Toolkit Updated with COVID-19 Vaccine Storage and Handling Information. (2020, November 20). Retrieved January 03, 2021
    • Vaccines Storage and Handling Toolkit. (2019, July 11). Retrieved January 03, 2021
    • Vaccine Storage Temperature Monitoring Guidelines. (2015, April). Retrieved January 03, 2021
    • Adult Vaccine Program. (2020, December). Retrieved January 03, 2021
    • WA DoH Publications. (n.d.). Retrieved January 03, 2021
    • OHA Vaccines and Immunization. (n.d.). Retrieved January 03, 2021

    PPE Regulations, Specifications & Standards

    General Recommendations
    • FDA guidance on PPE
    • FDA guidance on emergency use of medical devices
    • CDC interim recommendations and FAQs
    • WHO recommendations (broadly applicable to the categories below)
    • FDA Guidance: Conservation Strategies for Medical Gloves and Surgical Masks and Gowns
    • CDC Guidance: Strategies for Optimizing the Supply of Isolation Gowns; Facemasks; and N95 Respirators
    • JAMA Network Guidance on Conservation of PPE
    • FDA EUA for Face Masks
    • oneSource offers a free COVID-19 Database that contains all the relevant IFUs and Service Manuals for reusable gowns and other materials
    Non-surgical Masks
    • FDA 3D printing FAQs 
    • Dept. of Veterans Affairs Innovation Ecosystem connector site
    • America Makes COVID-19 site: Connecting Manufacturers and Healthcare entities
    • National Institutes of Health 3D Print Exchange COVID Collection
    • Design Templates for face shields, masks and scrubs: Medical Device Data displayed should include: Manufacturer, Make, Model, and Serial Number of device only and a general physical location of the device (e.g.: name Healthcare System or 3rd Party Servicer). No IT information should be displayed for any device.
    Surgical Masks and N95 Respirators
    • FDA GUIDANCE DOCUMENT--Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff March 2020 
    • FDA information on “N95 Respirators and Surgical Masks (Face Masks)
    • ASTM F3387-19 Standard Practice for Respiratory Protection 
    • CDC Strategies for Optimizing the Supply of N95 Respirators 
    • CDC/NIOSH Recommended Guidance for Extended Use and Limited Reuse of N95 Filtering Facepiece Respirators in Healthcare Settings 
    • ECRI statement on extended use and reuse of N95 respirators 
    Surgical Mask Standards
    • ASTM F2299/F2299M-03(2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres 
    • ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus 
    • ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks 
    • ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) 
    • ASTM F1494-14 Standard Terminology Relating to Protective Clothing 
    Face Shields
    • NIOSH Face Shield Recommendations
    • Design Templates for face shields, masks and scrubs
    Mask Reprocessing
    • Varies by manufacturer (IFUs)— some have issued letters to clients
    • AAMI ST65:2008/(R)2018. Processing of reusable surgical textiles for use in health care facilities.
    Tech Packs
    • The Gerber PPE Task Force is helping manufacturers switch to production of masks, labels & other personal protective equipment. 
    • The Gerber Task Force Patterns, Markers, and Tech Pack 
    • Design Templates for face shields, masks and scrubs: Medical Device Data displayed should include: Manufacturer, Make, Model, and Serial Number of device only and a general physical location of the device (e.g.: name Healthcare System or 3rd Party Servicer). No IT information should be displayed for any device.

    Gowns and Surgical Drapes

    Standards
    • ANSI/AAMI PB70:2012 , Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
    • AAMI TIR11:2005/(R)2015 Selection and use of protective apparel and surgical drapes in health care facilities
    • ASTM F1494-14 Standard Terminology Relating to Protective Clothing 
    • ASTM F2407 - 06(2013)e1 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities 
    • ASTM F1671 / F1671M - 13 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 
    • ASTM F1868 - 17 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate 
    • ASTM D751 - 19 Standard Test Methods for Coated Fabrics 
    • ASTM D1683/D1683M-17(2018) Standard Test Method for Failure in Sewn Seams of Woven Fabrics 
    • ASTM D1776/D1776M-20 Standard Practice for Conditioning and Testing Textiles 
    • ASTM D5034-09(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) 
    • ASTM D5587-15(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure 
    • ASTM D5733 - 99 Standard Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure (Withdrawn 2008) 
    • ASTM D6701-16 Standard Test Method for Determining Water Vapor Transmission Rates Through Nonwoven and Plastic Barriers
    • ANSI site for international standards related to COVID-19 including biological evaluation of medical devices; protective clothing used in health care settings; and business continuity management, security, and resilience  
    Guidance
    • CDC Considerations for Selecting Protective Clothing used in Healthcare for Protection against Microorganisms in Blood and Body Fluids 
    • FDA Surgical Mask and Gown Conservation Strategies - Letter to Healthcare Providers 

    Gloves

    Related Standards
    ANSI site for international standards related to COVID-19 including biological evaluation of medical devices; protective clothing used in health care settings; and business continuity management, security, and resilience 

    Infusion Pumps

    Guidance
    FDA Guidance for infusion pumps

    Sterilization and Disinfection

    Guidelines
    • Article: Can N95 respirators be reused after disinfection? And for how many times?
    • Article: Disposable N95 Masks Pass Qualitative Fit-Test But Have Decreased Filtration Efficiency After Cobalt-60 Gamma Irradiation
    • FDA guidance on Sterilizers and disinfectant devices
    • AAMI TIR68:2018 Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces
    • ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities [NOT a free public resource]
    • ANSI/AAMI ST58:2013/(R)2018 Chemical sterilization and high-level disinfection in health care facilities
    • ANSI/AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities
    • OSHA COVID-19 processing recommendations 
    • CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
    • OSHA SARS disinfection guidance 
    • EPA regulations on disinfectants
    • Steris Resources: Decontamination Solutions for compatible N95 or N95-equivalent Respirators

    Extracorporeal Blood Purification Devices

    Guidance
    • FDA EUAs for Extracorporeal Blood Purification Devices
    • CDC, Interim Additional Guidance for Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed COVID-19 in Outpatient Hemodialysis Facilities

    Clinical Thermometers

    Guidance
    • FDA Guidance for Clinical thermometers
    • FDA – “Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” 
    • FDA Non-contact Infrared Thermometers fact sheet
    Nasopharyngeal (NP) swabs
    • Northwell Health had developed a design for 3D printing of NP swabs.  They are releasing the design to anyone with a Formlabs printer. To request the design files and protocols fill out this form: https://www.northwell.edu/3d-design-innovation

    Testing and Testing Labs

    Test Lab Contact List
    Test Labs Contact List as of 4.7.2020

    FEMA Logistics and Shipping

    Useful Links
    • FEMA Leads Whole-of-America Coronavirus Operations 
    • FEMA Industry Liaison Program 

    FDA Contacts

    Email Contact List
    • CDRH-EUA-Templates@fda.hhs.gov
    • CDRH-NondiagnosticEUA-Templates@fda.hhs.gov
    • DeviceShortages@fda.hhs.gov
    • COVIDManufacturing@fda.hhs.gov
    • CDRH-COVID19-Ventilators@fda.hhs.gov
    • FDA Center for Devices and Radiological Health (CDRH) - News and Updates

    Materials for Devices - Production, Textiles, Skilled Labor Production

    Production

    National Association of Manufacturers and Business Roundtable launched a survey for businesses to identify specific ways they can provide or produce the supplies that are in high demand. They are working closely with federal agencies, including FEMA, to ensure that it captures the supply information they need. https://brt.nam.org/?_zs=TlDad1&_zl=suEe6

     

    Textiles
    • The National Council of Textile Organizations, representing the complete domestic textile supply chain, provides the latest information from the federal government on issues impacting this industry along with a directory manufacturers available to meet the needs of textile-related healthcare supplies and PPE.
      • COVID-19 RESPONSE - Follow this link for the latest guidance from various government agencies on textile-related questions associated with the COVID-19 pandemic.
      • COVID-19 TEXTILE-RELATED SUPPLY & PPE DATABASE - The full spectrum of the U.S. textile industry, from fiber though finished products, has been at the forefront of efforts to deploy resources to address the critical need for personal protective equipment and other medical and sanitation supplies in the fight against coronavirus.  Follow this link to access a directory of finished goods manufacturers and input producers for textile-related healthcare supplies and PPE.  
    • The International Safety Equipment Association (ISEA) has provided a list of members that employ skilled workforces and have technical capability to cut-and-sew a wide range of gloves and garments needed in response to the COVID-19 pandemic. A list of members is available at www.safetyequipment.org/publichealth.com
    Additional Resources
    • WHO - CED Critical COVID19 Topics Townhall: Oxygen Delivery Systems, Tuesday, 5 May, 2:00-3:00 pm CET Geneva time; Register here: https://us02web.zoom.us/webinar/register/WN_MhkdUp9qQZClrpkbi5G_lw 
    • CED CE Monthly Competency Webinar Series: Quality & Safety: Improving Health Technology-Related Quality & Safety for Patients and Medical Staff, Wednesday, 13 May, 11 am - Noon New York time  Register here:  https://us02web.zoom.us/webinar/register/WN_bTTbSXj8S9GgQ2GGg_6FKw
    • Special COVID19 Issue of Global CE Journal: https://globalce.org/downloads/Flipping_Special_Issue3/mobile/index.html (full Issue)
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