Guest guest Posted May 12, 2009 Report Share Posted May 12, 2009 There is reference after reference paper after paper and case after case that shows HBOT to be benificial we all know that. Still we sit here day in and day out argueing the fact. If it is a portable a tin can or who gives a rats ass... As long as we see teh benifits. Now do you know why this is not approved as a indication as of yet..... NO why don't you... Because we are to damn stubborn to realize the issue. It is published in books papers and so forth. There is more comming soon. But I will give you and insite because the UHMS and others out there say it first must be shown to be cost effective You get it cost effective not that it works. So the cost effectiveness part fo HBOT is what is causeing it not to be approved. I'm sure I will get someone to chime in on thsi soon to give you the full story. I like to shed the light a little see how many of you are really willin to dig up the resources and find the truth. I'll give you a clue look at your text books it is around page 145... You will see for an indication to be approved it first has to be shown to be cost effective not that it works cost effective. ITS ABOUT HE ALLMIGHTY DOLLAR not the fact that our kids are doing better. So in the meantime you will have clinics blowing people up in accidents etc untill they realize this is an issue and start approving what we knwo to work. Darin Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 12, 2009 Report Share Posted May 12, 2009 It is always about the money. However, I think you might be missing the point as to why this is so difficult to get approval for certain applications... FDA approvals are usually driven by the medical device manufacturer (or drug manufacturer, or whoever stands to make money from it). Since the manufacturers of the large units have already sold them for wound and diabetes use, what incremental sales will they derive from getting HBOT approved for more uses? It costs money to do those 510k submissions - and lots of it. That's how I currently earn a living (I'm a medical device engineer who helps write the submissions for 510k approvals), so I can't complain. (And while I think of it, as for the occasional chamber that catches on fire and kills someone, that is allowable risk per the FDA as long as it only happens once in a while. So don't expect safety to change any time soon unless it happens several more times). But back to the money...What about the portable units - are the manufacturs getting plenty of sales from the loving parents? (who tend to pay out of pocket waaaayy more than the insurance companies, particularly medicare, will reimburse - so they would have to sell 2 or 3 units instead of one to make the same profit if it were covered by insurance, if they could sell any at all because insurance would likely make you go to the clinic to obtain reimbursement). ly, I would not be surprised if the device makers were busy lobbying AGAINST getting FDA approval for HBOT for autism, CP, etc. JMHO. - > > > There is reference after reference paper after paper and case after case that shows HBOT to be benificial we all know that. Still we sit here day in and day out argueing the fact. If it is a portable a tin can or who gives a rats ass... As long as we see teh benifits. > Now do you know why this is not approved as a indication as of yet..... > > NO why don't you... Because we are to damn stubborn to realize the issue. > > > It is published in books papers and so forth. There is more comming soon. But I will give you and insite because the UHMS and others out there say it first must be shown to be cost effective You get it cost effective not that it works. So the cost effectiveness part fo HBOT is what is causeing it not to be approved. > > I'm sure I will get someone to chime in on thsi soon to give you the full story. I like to shed the light a little see how many of you are really willin to dig up the resources and find the truth. I'll give you a clue look at your text books it is around page 145... You will see for an indication to be approved it first has to be shown to be cost effective not that it works cost effective. ITS ABOUT HE ALLMIGHTY DOLLAR not the fact that our kids are doing better. So in the meantime you will have clinics blowing people up in accidents etc untill they realize this is an issue and start approving what we knwo to work. > > > Darin > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 12, 2009 Report Share Posted May 12, 2009 I know that Oxy health puts money towards the re imbursnent of HBO that is. Why I support them so strongly truth be known they do this and it jepordizes there very exsistance Sent from my Verizon Wireless BlackBerry [ ] Re: When will you all see the Big Picture.. It is always about the money. However, I think you might be missing the point as to why this is so difficult to get approval for certain applications... FDA approvals are usually driven by the medical device manufacturer (or drug manufacturer, or whoever stands to make money from it). Since the manufacturers of the large units have already sold them for wound and diabetes use, what incremental sales will they derive from getting HBOT approved for more uses? It costs money to do those 510k submissions - and lots of it. That's how I currently earn a living (I'm a medical device engineer who helps write the submissions for 510k approvals), so I can't complain. (And while I think of it, as for the occasional chamber that catches on fire and kills someone, that is allowable risk per the FDA as long as it only happens once in a while. So don't expect safety to change any time soon unless it happens several more times). But back to the money...What about the portable units - are the manufacturs getting plenty of sales from the loving parents? (who tend to pay out of pocket waaaayy more than the insurance companies, particularly medicare, will reimburse - so they would have to sell 2 or 3 units instead of one to make the same profit if it were covered by insurance, if they could sell any at all because insurance would likely make you go to the clinic to obtain reimbursement). ly, I would not be surprised if the device makers were busy lobbying AGAINST getting FDA approval for HBOT for autism, CP, etc. JMHO. - > > > There is reference after reference paper after paper and case after case that shows HBOT to be benificial we all know that. Still we sit here day in and day out argueing the fact. If it is a portable a tin can or who gives a rats ass... As long as we see teh benifits. > Now do you know why this is not approved as a indication as of yet..... > > NO why don't you... Because we are to damn stubborn to realize the issue. > > > It is published in books papers and so forth. There is more comming soon. But I will give you and insite because the UHMS and others out there say it first must be shown to be cost effective You get it cost effective not that it works. So the cost effectiveness part fo HBOT is what is causeing it not to be approved. > > I'm sure I will get someone to chime in on thsi soon to give you the full story. I like to shed the light a little see how many of you are really willin to dig up the resources and find the truth. I'll give you a clue look at your text books it is around page 145... You will see for an indication to be approved it first has to be shown to be cost effective not that it works cost effective. ITS ABOUT HE ALLMIGHTY DOLLAR not the fact that our kids are doing better. So in the meantime you will have clinics blowing people up in accidents etc untill they realize this is an issue and start approving what we knwo to work. > > > Darin > Quote Link to comment Share on other sites More sharing options...
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