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Oxygen Generators

  • Wednesday, July 29, 2015 7:27 PM
    Message # 3457029

    Can an FDA approved oxygen generator be used as the primary source of oxygen in a level I facility meeting all the requirements of a level I?

    Last modified: Wednesday, July 29, 2015 10:10 PM | Anonymous
    Moved from Medical Gas Codes & Standards: Wednesday, July 29, 2015 10:10 PM
  • Wednesday, July 29, 2015 7:34 PM
    Reply # 3457037 on 3457029

    When did the FDA approve Oxygen Concentrators as source equipment for oxygen piping distribution systems for humans in the United States?

  • Wednesday, July 29, 2015 9:45 PM
    Reply # 3457092 on 3457029
    Anonymous

     About two years ago but that's not the question.

  • Wednesday, July 29, 2015 9:48 PM
    Reply # 3457094 on 3457029
    Anonymous

     Not all oxygen generators are FDA approved.

  • Thursday, July 30, 2015 7:48 AM
    Reply # 3457574 on 3457029
    Al Moon (Administrator)

    We have a statement from the entity "Anonymous" that about two years ago oxygen generators were approved by the FDA for human consumption. Can you supply the reference document, section number and year of the document for our review? 


    Thank you, in advance, for the information.

    Last modified: Tuesday, August 04, 2015 9:38 PM | Anonymous
  • Thursday, July 30, 2015 8:02 PM
    Reply # 3458433 on 3457029

    Correct me if I am wrong. The FDA approved oxygen concentrators for individual use in home care. I am not aware of FDA approval for oxygen concentrators as source equipment for piping distribution systems serving acute care human hospitals.


    I have seen concentrators used as source equipment for veterinary hospitals.


    So, the answer is NO to category 1 healthcare facilities without a variance from the FDA, at this time.

    Last modified: Tuesday, August 04, 2015 9:41 PM | Anonymous
  • Friday, July 31, 2015 11:33 PM
    Reply # 3460059 on 3457029

    As Don Holden suggests, the generator USP oxygen (90 - 96%) may be used as a supplemental supply, such as an EOSC source, in the event of a catastrophic loss of the primary supply of the conventional USP oxygen (99 - 100%) remote bulk supply.


    Thanks to Don Holden, I was able to learn some of these facts from a letter from HHS dated January 7, 2011 with an "Indications for Use" attachment. This letter states that the generator USP oxygen is "substantially equivalent" only as it applies to the conditions in the attached "indications for use".


    In addition, as I read the attached "Indications for Use" attachment, the military is allowed to use this generator USP oxygen in times of war and peace.


    This is my "read" and I am grateful to Don for bringing this to my attention.


    Last modified: Tuesday, August 04, 2015 9:39 PM | Anonymous

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