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

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  • Friday, September 06, 2019 6:11 PM
    Message # 7868351

    I'm trying to identify what is the best starting point to propose a new or revised oxygen monograph. In one of Mark Allen's papers called "Oxygen On Site", he mentioned europe has discussed creating a thrid monograph for Oxygen 90+. This makes a lot of sense if we want to blend Oxygen 93 with Oxygen 99. Is anybody familar with the process? Should I start with FDA, United States Pharmacopeia, or NFPA 99?


  • Saturday, September 07, 2019 7:53 AM
    Reply # 7868799 on 7868351
    Al Moon (Administrator)

    I'm still a little lost on the subject of Oxygen for Patient Use In Healthcare within the USA.


    The FDA is the ruling order for Healthcare right ?

    They have guidelines and regulations (i.e. maybe laws) for Oxygen use in Healthcare for Human Consummation right ?


    Well NFPA 99, is only a Document for Installation, Testing and Maintenance of Medical Gases and Vacuum Systems right ?

    It a guideline on how to preform those listed items, if the items are approved by the FDA right ?


    In my opinion, and with just a few hours of review. I can only find that the FDA has only approval the use of Oxygen Concentrators 93 USP, during times of government emergency use only. 

     

    I do believe in Oxygen Concentrators 93 USP and its healthcare efficacy.


    But should we not be quoting FDA documents numbers and not NFPA 99 ? 


  • Saturday, September 07, 2019 12:05 PM
    Reply # 7868924 on 7868351

     Both the FDA and NFPA have approved liquefied oxygen and oxygen created by a concentrator. 

     They have not approved the blending of the two at present time considering they’re two different drugs.  So why can’t we have a third drug of the two blended like we do for many other gases?  Does anyone know the approval process for blended gases? 


     To add to the confusion we give carbon monoxide to patients and it’s not an approved drug. We are allowed to blend nitrogen and oxygen and that is an approved drug. 

    Last modified: Saturday, September 07, 2019 12:13 PM | Don Holden
  • Saturday, September 07, 2019 5:26 PM
    Reply # 7869406 on 7868351
    Al Moon (Administrator)

    NFPA 99 does not approved anything.


    I would love to debate on how and when USP 93 Oxygen is approved for Standard Healthcare Facilities in the USA. Just think the Federal Government via CMS is only working from NFPA 99 the 2012 Edition. Oxygen Concentrators (i.e. USP 93 Oxygen ) has only been listed within NFPA 99 for the 2018 Edition.


    This and other fun topics in Las Vegas NV / at the Annual MGPHO meeting / Sept 30 - Oct 3. / Sign Up Today:


     

  • Saturday, September 07, 2019 6:00 PM
    Reply # 7869414 on 7868351

     FDA approved 93% oxygen before 2012. 

     I thought at one time I had shown you (Al MOON) the documentation. 


     The question is how do you get a blended gas approved with the FDA? 

     Keep in mind I can blend 93 and 99 and get and maintain 95 to 96% oxygen which would meet the 93% criteria other than its blended. 

    Last modified: Saturday, September 07, 2019 6:06 PM | Don Holden
  • Sunday, September 08, 2019 8:50 AM
    Reply # 7869809 on 7868351
    Al Moon (Administrator)

    Please direct me or list the documents per the FDA - for the area, section, paragraph and verse. That specifically addresses Oxygen use on human in daily healthcare for standard hospital use, in regards to Oxygen USP 93. Then we can start the debate in Las Vegas. 

  • Sunday, September 08, 2019 11:35 AM
    Reply # 7869990 on 7868351

    The FDA enforces and NFPA recommends is my understanding, correct me if I am wrong.


    To my current knowledge FDA has approved 93% oxygen centralized concentrator supply for:

    1. NEMA emergency hospitals erected during and for a Federally declared emergency.

    2. US Active Duty Military Hospitals.


    Any other suggested use has not been approved by FDA as an acceptable method of centralized oxygen supply.


    There are sound clinical reasons why the FDA has taken this stance at this point in time.


    There are many things MGPHO could do as far as advocating for it's membership. 

    Since MGPHO is not a clinical based/oriented organization I suggest we stay of this one.


    But, that said we certainly need to stay current on the trending of this topic and I will look up the CFR again ruling this FDA enforcement and see if anything has changed regarding the exceptions.


    A hospital based in the world where liquid and gaseous oxygen supply is not practical or cumberson where frequent outages could be federally mandated a declared emergency.


    BUT, keeping a studied eye on what diagnosies admitted to the hospitals and are allowed to stay for long periods needs to be addressed by the clinical professional organizaitons. 


    In the words of G. D. McA. " I shall return" on this subject with CFR language in hand. The spin stops there.



  • Sunday, September 08, 2019 12:03 PM
    Reply # 7870068 on 7868351

    Editting is required: 


    The FDA enforces and NFPA recommends is my understanding, correct me if I am wrong.


    To my current knowledge FDA has approved 93% oxygen centralized concentrator supply for:

    1. NEMA emergency hospitals erected during and for a Federally declared emergency.

    2. US Active Duty Military Hospitals.


    Any other suggested use has not been approved by FDA as an acceptable method of centralized oxygen supply.


    There are sound clinical reasons why the FDA has taken this stance at this point in time.


    There are many things MGPHO could do as far as advocating for it's membership. 

    Since MGPHO is not a clinical based/oriented organization I suggest we stay out of this one.


    But, that said we certainly need to stay current on the trending of this topic and I will look up the CFR again ruling this FDA enforcement and see if anything has changed regarding the exceptions.


    A hospital based somewhere in the world where cryogenic liquid and gaseous oxygen supply is neither practical nor dependable leading to frequent outages should be reviewed and considered a federally declared emergency.


    BUT, keeping a studied eye on which diagnosies are allowed admission for prolonged care to these hospitals shall be a prerequisite to any change in the current CFR exception for 93% oxygen central supply concentrators. A list of diagnosies where only accute care shall be allowed needs to be addressed by the clinical professional organizaitons. 


    If this does not get addressed from a clinical perspective first the original CFR for 99% oxygen could go in the direction of the Oxygen Bar in the Flamingo Hotel & Casino regarding the FDA enforcement.


    In the words of G. D. McA. " I shall return" on this subject with CFR language in hand. The spin stops there.


  • Sunday, September 08, 2019 1:36 PM
    Reply # 7870221 on 7868351

    Thanks for taking this up all - it is a subject of great interest to quite a few people, and any information we can get circulated is useful. 

     

    To earlier comments: Yes, in Europe, the Germans had been discussing getting the European Phamacopeia to include a monograph for Oxygen 90+ to deal with the question of "mixing" in a piped system.  As Don points out, there is no clinical problem here, only the pharmacolegal problem of making an "off spec" pharmaceutical (oxygen between 96 and 99%).  I don't know how far they got.

     

    The two uses mentioned need to be supplemented by a third: remember that in Alaska there are several hospitals who are using oxygen from concentrators everyday.  They are neither active duty military nor under any particular emergency, and they are under regular inspection from FDA, so there is at least one other category of "acceptability".

     

    Let me throw the cat among the pigeons and disagree with Carsten on one very essential point: I disagree that there are any "sound clinical reasons" any more.  Concentrators are being used in so many places and under such a variety of conditions that in essence, the testing has been done.  There are objections still raised, but I am not aware of any objection that has support of informed clinicians anymore. The residual objections appear to all come from equipment manufacturers who have some concerns about their kit.

     

    As to the respective jurisdictions of FDA and NFPA, I will remind you that we have been manufacturing a drug for decades with nothing more than the USP in one hand and the NFPA in the other - and FDA takes no interest at all.   Medical Air, the only drug made in your hospital under the sole supervision of the maintenance mechanics.

     

    Health Canada is treating concentrator installations in pretty much the same way.  Compliance with the Z7396-1 is sufficient.  What reason is there for FDA to act otherwise?

  • Sunday, September 08, 2019 5:01 PM
    Reply # 7870473 on 7868351



    Forgive my lack of intimate knowledge Mark but if I understand you the transition to 96% and 93% Oxygen is transitioning using the community standard model approach and not a scientific method for this transition.


    Again, I lack any knowledge of any periodicals addressing this change from Europe or the Germans


    As I stated it makes sense in some areas of the world to have the lower oxygen concentration if conventional supply is not a dependable source.


    I can see it is rather easy to mix a lower concentration with air and nitrous oxide until you get into some high risk pathophysiologies requiring very high concentrations (FiO2) of oxygen for treatment. These would be limited to most teaching facilities where heart transplants and heart/lung transplants are performed.


    I have not had time to research this subject intimately and I am motivated to "ping" my curious mode. Nice kitty.


    I am not for or against anything here except a clear and logical transition period for the clinical community in a facility currently using the 99% USP Oxygen. This transition should be based upon  documented risk management case studies determined by clinicians in conjunction with the other disciplines already engaged in the code changes addressing the concentrator technology.


    The times are a changing where a community standard is the process over the historically reliable scientific standard has been the practice in the past. That said neither method is totally infallible. These two methods do compliment each other during the period of change.


    I take it there is no study documented from a clinical perspective?


    Nice hairball!

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