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

  • Sunday, September 08, 2019 6:02 PM
    Reply # 7870508 on 7868351
    Al Moon (Administrator)

    OMG and WOW


    Again where are the double blind studies and white papers on the use of ups 93 against ups 99.99 on human consumption in any standard USA healthcare facility?


    Where is George Scott (i.e. Where's Waldo)  


    Where are the documentations the listings and code numbers from the FDA:


    My battle cry ( VIVA LAS VEGAS ) 

  • Monday, September 09, 2019 5:46 AM
    Reply # 7871097 on 7868351

    Carsten, you are quite right.  This is very much a "community standard" question at the moment.  That said there has been some work done by the University of Karlsruhe I believe (not sure if it was finished or if it has been published - I will have to ask) which I understood looked into the question of high concentration therapy and there are several papers cited in the ISO standard (many from Canada).  Too many derive from a single researcher however.

     

    The information I have seen suggests that the saturation curve is quite flat at the top concentrations, which means that there is not a large difference between 90% and 100% in ability to attain an oxygen saturation in the blood, but let me quickly point out that my medical degree is non existent, so I readily and happily defer to the doctors/RRTs (Al?) /etc.

     

    Regrettably, I doubt there is a great deal of interest in doing any studies on the subject - not really cutting edge medical stuff.  The Karlsruhe study was a "labor of love" by a professor who I believe is now retired.  Don't know who sponsored it.

     

     

  • Monday, September 09, 2019 11:08 AM
    Reply # 7871528 on 7868351

    Thank you Mark. I always "follow the money" when it comes to periodicals. Learned that a long time ago.

    I figured there would be little motivation to put money into this research but I do recall a number of papers written in the 1960s and 1970s on the subject of oxygen toxicity in the clinical setting that may be applicable.


    I think, at this point in time, addressing the implementation of the lower oxygen percent by volume delivery systems replacing the high percent by volume oxygen sources needs be discussed extensively.


    I understand your reference of the medical air. Medical air is not manufactured from a raw material but is dried and filtered to USP specifications. The removal of CO is required only when outside source of air to be compressed is consistently above the 10 ppm level and the CO2 is likewise to be removed if above 500 ppm levels along with any other hydrocarbons.

     The track record of keeping medical air dew point levels at an acceptable level is dismal at best in my past 27 years of medical gas verifications and preventive maintenance support in these hospitals.


    This experience the hospitals currently possess does not qualify them, in my opinion, to manufacture oxygen percent volumes dependably over a long period of time. This is taking a raw material and converting it's content to 4.5 times it's concentration in it's raw state.


    This leads to my other concern of WHO is TRAINED and HOW are they TRAINED to be completent to service and maintain these large oxygen concentrators?


    NFPA 99 addresses this? ASSE addresses this? 

  • Monday, September 09, 2019 5:00 PM
    Reply # 7872348 on 7868351

    Great conversation. The concept of USP Medical Air being an on site self made drug is a great example. Who approved it and when? NFPA, FDA, or USP? How can we start this process for a new Oxygen 90+ monograph.


    Attached is an Oxygen Concentrator supply system schematic from ISO 10083:2006(E). I interpret this schematic as allowing cryogenic oxygen being mixed with an Oxygen concentrator. Can't we have NFPA 99 state the same thing?


    Gentlmen, we recently had one of two liquid oxygen plants go down on Oahu. The plants are to small to provide the entire state alone and it is cost prohibitive for them to increase their capacity. Long story short, multiple healthcare facilities had an Oxygen supply low alarm and the company with the down plant was frantically shipping (and flying) truckloads of liquid Oxygen to Hawaii from CA.


    Now add the following thoughts:

    1. Hawaii is one of the most remote heavily populated land masses in the world.

    2. All outer islands have liquid O2 shipped to them.

    3. Hawaii has a very high risk for huricanes, earthquakes, and tsunami's. (FYI, both plants are in the Tsunami zone)


    Self sustainability with a critical gas is much more important than the % of the product being off by a couple percentage points. Also, if the clinical staff community does not have any substatial concerns, it makes our case even stronger.


    Al, reference FDA 510(k) No. K100957 approval date was 1/21/2011.


    Best regards,

    Dane


    1 file
    Last modified: Monday, September 09, 2019 5:05 PM | Dane Robertson
  • Monday, September 09, 2019 7:31 PM
    Reply # 7872534 on 7868351
    Al Moon (Administrator)

    FDA 510K are mostly about devices.


    In a debate listing several numbers with out the written text, is a default. 

  • Monday, September 09, 2019 7:36 PM
    Reply # 7872569 on 7868351

     Typical compressed medical gases classified as drugs are medical air USP, oxygen USP, nitrous oxide USP, carbon dioxide USP, helium USP, nitrogen NF, and mixtures of these gases. Oxygen and nitrogen produced by pressure swing absorption or vacuum swing absorption are classified as oxygen 93% USP and nitrogen 97% NF when use as medical gases. This is a well established fact. The abbreviations USP and NF indicate that the product conforms to the requirements of the United States Pharmacopeia/National Formulary. In the United States, compressed medical gases classified as medical devices include lung diffusion mixtures, blood gases, and laser gas mixtures. Gas mixtures use for artificial atmospheres and calibration of medical equipment are also classified as medical devices.  Gas apparatus such as medical regulators, flow meters, anesthesia machines, and concentrators are classified as medical devices. 


     It is unquestionable that this medical device known as an oxygen concentrator (generator) has extreme benefits around the world. So the question is what is the process to have a new monograph of 90% plus oxygen USP.


     In my humble opinion the same as it took a while for NFPA to write in to their healthcare facilities code (oxygen generators) so it is that the industry is slow in adjusting to the various uses and applications of these  medical devices.

  • Monday, September 09, 2019 7:59 PM
    Reply # 7872604 on 7868351

    Very interesting factoids about Hawaii and it's outer islands.


    Keeping the focus on the inconsistent source of supply of cryogenic oxygen for your health facilities appears to be a medical emergency in your state.


    This is the one area I thought this FDA Code for 93% USP should allow the oxygen concentrator supply for your facilities to be consider legitimate.


    Whether it would be allowed only on the short term or a long term solution is hard to predict. 


    How long has this been a reality?

  • Monday, September 09, 2019 9:54 PM
    Reply # 7872763 on 7868351

     This has been a reality for the 50 years I have been doing business in the islands and longer. 

     This recent incident lasted for a month. Previous incidences have only been for a week or two and we have learned to compensate. 

     This is never been listed or talked about as a emergency so as not to scare the the public. 

     It is obvious that we cannot fly helicopters from California to give relief to the islands 2000 miles away. 

     The hospitals that have our oxygen generators we’re very grateful that they did not have to worry about this crisis. (Some of these facilities also have the capability of pumping their own cylinders.)  It was so bad this time that we could not supply the industrial industry with oxygen. 

     If we  we were to blend 95% oxygen with 99% oxygen we would be able to make their supplies last a little longer.  If we were to follow the code, then the hospitals that can pump their own cylinders would not be able to help the facilities with 99% oxygen. 

     We would like to comply with the FDA, NFPA, ASSE and all other regulatory agencies if at all possible, but it is more important to service the patients in these facilities with oxygen 96-97%. Unlike what happened in India. 

  • Tuesday, September 10, 2019 9:00 AM
    Reply # 7873456 on 7868351

    I understand your frustration Don but, getting the FEMA folks to comply is a matter of filing.


    Scaring the public is never a great idea and usually is counter productive at best.


    But, that said, getting this done legitimately is the best path to get what you want and that is recognition of the 93% USP for these remote facilities under the current FDA guidelines.


    Scaring the public is an interesting and understandable reaction.


    I guess I am too close to the forest to see the trees. 

  • Tuesday, September 10, 2019 11:02 AM
    Reply # 7873734 on 7868351

    Very useful conversation all!

     

    Couple of small points raised in here that I think we as MGPHO ought to be discussing (maybe they need their own thread):

     

    WHO is training and HOW are they trained?  Is this not the raison d'etre for 6040?  Should 6040 have an "endorsement" for operation of a concentrator source like 6010 has an "endorsement" for Lokring/Medlok?

     

    What is the "medical device" here (if any)?  Is it not the complete, operating and tested medical gas system?  For me as a manufacturer to absorb the burden (and pass on the costs) of making a fancy "black box" under the medical device regulations seems a pointless excercise.  Unlike a domicilliary concentrator, which is usable "out of the box", a central supply concentrator is of no use at all until installed, started up and tested in the context of the complete installed system.

     

    FDA appears to have taken this position (whether by default or intent does not matter) and medical air is the precedent.  Oxygen may be more emotionally charged but in a pharmacolegal sense there is no difference.

     

    Which is my reflection on Carsten's question: "NFPA 99 addresses this? ASSE addresses this?"  Should not MGPHO be addressing this?  We ARE the final line - we are the ones who write the document that says the "medical device" is ready to be used.  Our's IS the dog in this fight.  Yet we have no unified position to suggest if FDA came asking.

     

    And they may.  In Europe, major changes are underway that will bring European medical device practice much closer to and maybe beyond where FDA is today.  This will almost certainly cause FDA to consider it's position too at some point.

     

    Does MGPHO, should MGPHO, have a role in representing our industry?  if so, what do we want it to be and what positions should be promoted?

     

    Dane - just a note of caution - remember that the ISO 10083 has been withdrawn.  The 7396-1 replaced it. It is rarely a good idea to use a concentrator as a backup for liquid (or vice versa) and I would always advise against it.  Concentrators want to run (they don't take nicely to being short cycled) and liquid of course is a "use it or lose it" proposition, so the two together are a bit of an engineering "contradiction in terms".  Not saying it can't be done, but you want to know what you are about.

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