How to go about requesting a new or revised Monograph for Oxygen

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  • Wednesday, September 11, 2019 9:39 PM
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    Reply # 7877011 on 7868351
    Dane Robertson

    Carsten,

    Thank you for your input. The reality is Oahu could be another Hurricane Katrina or Fukashima waiting to happen someday. A direct hit will have very serious consequences. It would be a big benefit to remote locations like Guam, Puerto Rico, Bahamas, Military facilities, and other remote hospitals to allow them the opportunity to succeed with this innovative technology.The Pros far outweigh the Cons in these situations.


    Mark,

    An endorsement for medical gas mechanical systems would be the correct direction in my opinion. It would be wise to require the manufacturers to approve and certify the technicians working on their equipment. Is it feasible?


    Your comments and questions are very admirable.


    I was unaware that the ISO code was replaced. Thank you for the lead and I will try and acquire the ISO 7396-1 document.


    With a properly designed system and the right application, I strongly feel that allowing concentrators to run and allow blending of the economizer circuit from the liquid would be the best of both worlds. If it makes sense to turn the concentrator off at night to prevent short cycling, that could work also.
  • Wednesday, September 11, 2019 9:44 PM
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    Reply # 7877012 on 7868351
    Dane Robertson
    Back to the original question.... What is the process to start the ball rolling and submit a new monograph. Is it safe to say there isn't one and our case should be submitted to each regulatiing body simultaneously until told otherwise?!
  • Thursday, September 12, 2019 5:32 AM
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    Reply # 7877335 on 7868351
    Mark Allen

    Dane - your're right!  In all our musings we lost sight of your original question!! 

    Truth is I don'tknow that answer.  I will as the detecticve says "institute inquiries" and see is if I can find out!
  • Thursday, September 12, 2019 9:28 AM
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    Reply # 7877593 on 7868351
    Robert Sutter

    Hello Dane,

    It is a lot more complicated than just getting it into various codes and standards. The FDA would possibly look at this as a new drug. In that case they would require someone to do a new drug application along with trials to develop the scientific evidence supporting the drug and identifying its strengths and weakness. Up until recently (2012, I believe) oxygen along with the other medical gases were classified as unapproved drugs. They had been around before drug trials were required. The FDA was looking to eliminate all unapproved drugs and removed many drugs from the market. They realized that medical gases were different and that no one was going to do drug studies on these products. They were accepted as drugs by Federal Legislation. The following link will take you to the Federal Regulation regarding medical gases. Look at Part G - Medical Gases.

    Medical Gas Regulations

    Under section §360ddd–1. Regulation of medical gases you will find how to submit a new medical gas.
  • Thursday, September 12, 2019 6:33 PM
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    Reply # 7878414 on 7868351
    Don Holden

     I love MGPHO!

     This is what I have concluded so far with all my readings. 

    1.  Medical air compressors and oxygen generators are medical devices that do not need FDA approval to be sold. 

    2.  Medical air compressors and oxygen generators need to meet USP monographs to be used. 

    3.  You are allowed to blend USP oxygen and NF nitrogen to produce

    USP air. 

    4.  NFPA 99 2018 5.1.3.5.11.1 Oxygen concentrator supply units for use with medical gas pipelines shall produce oxygen meeting the requirements of oxygen 93 USP or oxygen USP. 

    5.  You can blend oxygen 93 USP with oxygen USP as long as you’re blend is between 90% oxygen through 96% oxygen or 98 percent oxygen to 100% oxygen.  (You can not blend to 97% oxygen.)

    6.  We cannot give 93 USP oxygen to civilians but we’re allowed to give military personnel and there families 93 USP oxygen. (Exception to this rule would be a federally declared emergency.)

    7.  All the medical gases we have been delivering to patients up until 2012 have been unapproved drugs. 

    8.  It’s a very complex and difficult venture to add or change a monograph. 


     Please let me know where I have gone wrong in my summary. 

    Last modified: Thursday, September 12, 2019 7:37 PM | Don Holden
  • Friday, September 13, 2019 6:17 AM
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    Reply # 7879098 on 7868351
    Mark Allen

    Thanks Bob.  That helps.

     

    Don,  

    I agree with all but this one.  Specifically:

    "6.  We cannot give 93 USP oxygen to civilians but we’re allowed to give military personnel and their families 93 USP oxygen. (Exception to this rule would be a federally declared emergency.)"

    - not so, because homecare operators routinely use oxygen 93 (or even less if we're honest) from domiciliary concentrators.  It is the central systems which are in question, not oxygen 93 itself.  Carsten may see it a bit differently.

     

    But the reality in this context is that the divide between "Oxygen" and "Oxygen 93" is entirely a pharmacolegal fairy castle.  We are in all cases delivering to the clinician oxygen. The FiO2 percentage is a patient specific clinical question outside our competence.  This is the basis of the Canadian approach to the question - quacks like a duck, itsa duck.

     

    and your point 5.  Now there would be a strange bit of kit.  Nice example of how bad regulation can lead to strange technology.
  • Friday, September 13, 2019 7:11 AM
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    Reply # 7879158 on 7868351
    Robert Sutter

    Aloha Don,

    On #5 the USP has no compendia for oxygen that falls in the range greater than 96% and less than 99%.

    FYI, when air USP is produced by compression (as opposed to reconstituting (blending)) and offered for sale. The organization manufacturing that product needs to register with the FDA as an original manufacture as opposed to a repacker. 
  • Friday, September 13, 2019 2:36 PM
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    Reply # 7879941 on 7868351
    Dane Robertson

    That is quite an ironic summary by Don.


    Bob, Thank you for the Federal Regulation document. That was very helpful.


    Just to make sure I understand your last comment correclty.....as long as a medical gas is produced on site and not for sale, you don't need to be registered with FDA, correct? That is why Medical Air equipment and other similar USP equipment doesn't need FDA approval, correct?
  • Saturday, September 14, 2019 9:01 AM
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    Reply # 7880706 on 7868351
    Al Moon (Administrator)

    IN MY OPINION / IT'S ALWAY FOR SELL:


    By the fact that it can only can be administered by a physician prescription.

    (i.e. its a billable item)
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