Regulatory Open Forum

 View Only

  • 1.  Task force for PPE availability

    Posted 25-Mar-2020 11:23
    Do you want to help? Well now is the time. SBME has been inundated with calls asking for support.
    Here is the immediate need …
    - ASTM F2100 is the standard for masks. Is there a gown standard?
    - NYC front line folks are asking for face shields. What is this standard?
    - Who can test masks for efficacy quickly?
    - Acquisition of at least level 2 non-woven is very challenging since a huge supply was purchased by China in Nov. 2019. Does anyone have a source for this material domestically?
    #WeAreWorking
    #BePartoftheSolution
    #SBME



    ------------------------------
    Linda Braddon
    CEO
    Woodstock GA
    United States
    ------------------------------


  • 2.  RE: Task force for PPE availability

    Posted 25-Mar-2020 13:16
    What is the intended use of the masks?  ASTM F2100 does not seem to be the appropriate standard for PPE that is used respiratory protection, i.e. to prevent inhalation of an airborne virus such as COVID-19.

    ASTM F2100 This specification does not address all aspects of medical face mask design and performance, the effectiveness of medical face mask designs as related to the barrier and breathability properties, and respiratory protection, which may be necessary for some health care services.



    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 3.  RE: Task force for PPE availability

    Posted 26-Mar-2020 08:26
    A quick response at least for masks.  Nelson Labs, a test lab in Utah can test your masks. They also are a qualified biocomp lab, GLP and non-GLP.


    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 4.  RE: Task force for PPE availability

    Posted 26-Mar-2020 08:39
    Thanks.

    ------------------------------
    Linda Braddon
    CEO
    Woodstock GA
    United States
    ------------------------------

    Original Message


  • 5.  RE: Task force for PPE availability

    Posted 26-Mar-2020 09:45
    FDA just issued a guidance that addresses much of this - including specific types of requirements for masks, shields etc AND what is being waived at present.

    As for surgical gowns, yes there are standards - I don't know them off the top of my head, but probably if someone pulled a 510(k) or summary it would be mentioned. Heck, if you called 3M or another maker and asked what the standard is right now, they'd probably tell you.

    g-

    ------------------------------
    Ginger Glaser RAC
    Chief Technology Officer
    MN
    ------------------------------

    Original Message


  • 6.  RE: Task force for PPE availability

    Posted 27-Mar-2020 18:56
    Just for full disclosure I work for Daavlin, the company mentioned in this video about reducing the viral load on N95 masks.

    https://www.clickondetroit.com/health/good-health/2020/03/26/henry-ford-researchers-develop-protocol-to-sterilize-certain-masks/

    Its a start.

    ------------------------------
    Philip Reece
    Regulatory Affairs Director
    Belvidere IL
    United States
    ------------------------------

    Original Message


  • 7.  RE: Task force for PPE availability

    Posted 28-Mar-2020 00:01
    Edited by Julie Omohundro 28-Mar-2020 10:21

    There are many important details that are either unclear or omitted from the article, but I see a number of potential issues here, of which this one seems fundamental:

    "We use phototherapy equipment in our offices all the time to treat skin diseases."

    I'm not familiar with every use of phototherapy in dermatology, but those of which I am aware are treatment of skin conditions caused by genetic, lifestyle, and/or environmental triggers, not infections of the skin, which again, as far as I know, are always treated with antibiotics or antifungals, probably for good reason.  There is also potentially a big difference between killing microorganisms on non-biological surfaces, and treating someone with a disease caused by an infectious organism.  In short, I'm not clear that this experience is as relevant as these dermatologists might like to think it is.

    It seems unlikely they had time to research the topic much in the four days from idea to testing to protocol, but there is already established expertise and prior research in the field of decontamination of N95 masks for reuse, including with UV.  I think there is a good chance that one or more protocols are already available.




    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 8.  RE: Task force for PPE availability

    Posted 27-Mar-2020 20:15
    Edited by Adam Atherton 27-Mar-2020 20:17
    From FDA website https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns

    excerpts

    "American Society for Testing and Materials (ASTM) F2407 is an umbrella document which describes testing for surgical gowns:  tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission... 

    American National Standards Institute (ANSI) and the Association of the Advancement of Medical Instrumentation (AAMI): ANSI/AAMI PB70:2003 describes liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities."

    Guidance: Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings - Guidance for Industry and Food and Drug Administration Staff

    Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes

    Choosing appropriate gowns https://www.cdc.gov/HAI/pdfs/ppe/PPEslides6-29-04.pdf 

    ------------------------------
    Adam Atherton
    Farragut TN
    United States
    ------------------------------

    Original Message


Related Content