Others doubt credibility of Tom Fox.

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From NeuroHBOT/message/15365

Re: ASME PVHO approval for Oxyhealth Chambers - not true!!!!!

Tom,

Please explain to me about the Vitaeris failure. I know a number of

people who have Oxy Health chambers, and not one of them has ever had

a problem. If there has been a failure, surely you have some

evidence of this failure that you can share with everyone?

I have been following a number of list serves, as I believe that

hyperbarics have a lot to offer to a lot of people. However, there

are only two things I have found out over the course of the last six

months.

1) There are a number of people out there with " high pressure "

machines in a clinic setting. From my observations, it would appear

that these are the only folks that have a problem with the soft

chambers. Could this be because of the fact that those with hard

chambers fear that their financial status is in jeopardy? I believe

so. Anyone with any intelligence is able to see that. If I am

wrong, please inform me why it is that you think I am wrong!

2) Tom Fox has a personal vendetta against Oxy Health. Why this is,

I have no idea. But it is perfectly obvious. I would like to know

why this is. Tom continues to make claims against Oxy Health

(failures, etc) but has offered up no evidence of such failures, or

or evidence that their chambers are unsafe. It is obvious that he

has something to lose. Tom, please feel free to prove me wrong! If

you have evidence or proof supporting the claims you make, then feel

free to share. Your statements are of little value unless you have

some type of evidence to support them (and hearsay is not evidence).

If not, quit making these claims as you are mis-informing a number of

individuals who might be benefitting from hyperbarics, but will not

because of what you tell them. As far as I know, and I have done the

research, there has never been a safety issue nor has anyone ever

submitted to any authorities that the chambers made by Oxy Health are

made of " unsafe " material. If you have evidence that the material is

unsafe, please feel free to share that as well.

I have done the research, and soft chambers are not required to

conform to the ASME PVHO standards. Also, Oxy Health's chamber was

FDA approved prior to the formation of the ASME PVHO standards.

However, they do have FDA approval, and realistically the ASME PVHO

certifications don't really amount to a hill of beans. Now, why

would anyone submit to the ASME PVHO certification when the cards are

stacked against them? The ASME PVHO organization should be

supporting the public, and obviously they are more interested in

supporting their own agendas. If I were Oxy Health, I would not

submit to these certifications, either. It would be suicide to

submit to these when everyone on the board wants to stamp out soft

chambers.

Now, with all that being said, I think it is a crying shame that

people are so obsessed with making a buck that they are trying to

stamp out a therapy modality that is beneficial, and the only cost

effective method, for many people across the country. I live in the

upper midwest, and soft chambers are the only possibly means of

receiving HBOT in area. Most people cannot afford to travel 1000's

of miles to receive treatment. All this talk about " a second

mortgage " and such to purchase a soft chamber is ridiculous. It

would cost me much more to travel to one of the " high pressure "

clinics for a period of time than it would to purchase a soft chamber.

In closing, I have witnessed a number of people who have gotten much

better by using a soft chamber, and I have never witnessed anything

that is even a indication of a safety problem. The soft chamber

companies would be absolutely stupid if they were to sell a chamber

that was not safe. This would leave them open to huge lawsuits that

would do more than just end their business.

Now, I am not saying that " high pressure " chambers aren't

beneficial. Obviously they are. However, they are not the " only " ,

or in my mind the preferred, method of treatment. If everyone would

quit worrying about their pocketbooks, and would focus on making

patients better, these ridiculous arguments would all stop. However,

I am sure that we can all agree on the fact that this will never

happen. Until then, I would suggest that everyone does their own

homework when checking out hyperbarics, and ignore those who make

claims with no evidence to back them up.

P.S. If the soft chambers are so bad, why are many studies out there

starting to show that 1.3 ATA is the best for treatment of a majority

of the conditions out there?

Szymonski

>

> NOTE FROM THE MODERATOR: I AM GOING TO APPROVE THE FOLLOWING POST

BECAUSE DAVID FREELS HAS MADE ACCUSATIONS TOWARDS MR. FOX ABOUT TOM

MAKING THE SOFT CHAMBERS BE ABLE TO GO TO A HIGHER PRESSURE. RECENT

EVENTS AT THE SYMPOSIUM WITH DAVID FREELS CLAIMS AND MR. FREELS WILL

NOT ALLOW TOM FOX TO REPLY ON THE MEDICADE LIST SO I AM GOING TO

ALLOW IT HERE. PLEASE KEEP IN MIND THAT WHEN YOU FIND RANTINGS BY

DAVID FREELS, HE IS A CLOSE FRIEND OF SAMIR PATEL OF OXYHEALTH AND

DEFENDS THEM AND PROMOTES THE SOFT CHAMBERS. AT THE SYMPOSIUM HE

CAUSED A BIG STIR BECAUSE OXYHEALTH WAS NOT ALLOWED TO PARTICIPATE.

I AM IN TOTAL AGREEMENT WITH NOT LETTING THEM IN WITH ALL THE FALSE

CLAIMS THEY MAKE. TOM, WITH ALL DUE RESPECT, I DO NOT WANT THIS LIST

TO TURN INTO THE LUNACY WHICH GOES ON IN THE OTHER LIST, BUT I FEEL

YOU HAVE A RIGHT TO PUBLICLY DEFEND YOURSELF. ROBERT

> --------------------------------------------------------------------

---

>

> By now those of you who know me are well aware of my position of

the soft

> " chambers " . Lord knows they have enough safety issues Without

modifying them

> to go to a greater pressure than they were designed to go to. I

have never

> worked on nor would I ever work on these chambers. And those

representing this

> are misinformed or just plain lying. None of the soft " chambers,

Oxyhealth,

> Performance or the new Healing Dive " chamber " have not complied

with ASME

> PVHO standards for safety. Mr would know this because

he is on the

> committee. None of the Oxyhealth Chambers currently sold have

ever been

> submitted for evaluation of design and construction. In late 2007

the 2 ATA

> chamber was submitted for evaluation and is the prelminary stages

of that

> process. The SOS hyperlite code case, the only soft hyperbaric

chamber approved

> by the ASME PVHO committee, took 6 years to complete.

>

> Congratulations to Oxyhealth, according Mr they have now

distributed

> 7000 non compliant soft bags given the very rough estimate

Oxyhealth has taken

> $133,000,000 primarily from families of children with special

needs. You

> complain about the expense of demonstrating the safety of your

devices in a

> code case looks like you should have made enough to fund your

code case for

> all devices currently sold. By the way, speaking about safety, a

serious

> incident report on the the Vitaeris was never filed as required by

the FDA. The

> compressor failure that resulted in a child exposed to smoke under

pressure in

> the Oxyhealth soft " Chamber " . Should look at this guys could

cause the FDA

> premarket approval 510 k to be recinded

>

> Interestingly Mr Freels never asked me for anything from me. If

he had

> asked for references, I would tell him I am publishing this in

collaboration

> with Dr. Cuau and the references would be held pending

that

> publication. The presentation presented here is the result of

three years investigation.

> Claims being made by Mr. Freels on another list are baseless.

His ability

> to get basic facts right are very questionable and driven by his

desire to

> please Mr. Patel and those behind Oxyhealth. For being a

researcher you need

> to get your facts straight.

>

> According to ASME PVHO members, non of the Oxyhealth chambers

have been

> presented for a

> code case evaluation. Only one soft full pressure chambers has

been approved

> by ASME PVHO committee. Check with Mr. the manufacturer of

Oxyhealth

> Chambers is on the Committee. Yet he chooses not to present

Oxyhealth's other

> chambers. Why is this?? ASME PVHO committee has 23 members of

which 4 are

> members of the UHMS. Not the majority and certainly not a quarum.

Does not

> sound like how Mr Freels presented on the other list.

>

> Best Regards,

> Tom Fox

>

> This is presented in response to :

> Mr Freels previously published this:

>

>

> The FDA is required by law to not allow medical devices to be

marketed

> unless they are first proven (1) safe and (2) effective.

Historically, FDA has

> decided efficacy and has hired ASME-PVHO to decide safety of

hyperbaric

> chambers.

>

> ASME-PVHO decided 20+ years ago the 1.3 ATA Gamow bags (now

marketed as

> Oxyhealth) did not require the extensive testing as is typical of

other

> hyperbaric chambers and instead approved the Oxyhealth/Gamow bag

chambers as-is.

> Oxyhealth chambers may not have an ASME-PVHO " stamp " but they've

been approved by

> ASME-PVHO nonetheless--otherwise they would never have been

approved by the

> FDA and received a 510k clearance.

>

> Over 6,000 Oxyhealth chambers have been sold and if just 50% are

in daily

> use, that means there are more Oxyhealth chambers in daily use

than all other

> hyperbaric chambers combined. ASME-PVHO was correct in their

original

> decision, as the Oxyhealth chambers have an impeccable (and

apparently enviable)

> safety record.

>

> Given that ASME-PVHO committee members are also (1) hard-shell

chamber

> manufacturers and (2) members of the Undersea and Hyperbaric

Medical Society

> (UHMS), because of the commercial success of Oxyhealth, there is

an effort to

> force Oxyhealth to submit to acquiring an ASME-PVHO " stamp. "

>

> However, Oxyhealth has a 2 ATA, 100% oxygen portable chamber in

its catalog

> that ASME-PVHO has refused to approve for nearly 10 years. It used

to cost

> around $20,000 but is now probably closer to $35,000 if it were to

receive

> ASME-PVHO approval. ASME-PVHO constantly changes the requirements

for approval,

> evidently so as to not approve it.

>

> Given this open animosity by ASME-PVHO toward Oxyhealth, it is

> understandable why Oxyhealth declines to submit its product line to

ASME-PVHO stamping

> when it is unnecessary. Only an FDA 510k is required to sell a

hyperbaric

> chamber.

>

> Tom Fox is well aware of the ASME-PVHO history of refusal to

approve the 2

> ATA Oxyhealth chamber and the potential for Oxyhealth to go out of

business if

> they submitted the rest of their product line to ASME-PVHO

stamping--even

> though they already have a 510k and an impeccable safety record. I

have

> personally explained it to him and his wife on two or three

occasions.

>

> Neither the has an ASME-PVHO stamp--yet listserv

member Tom

> Fox refuses to file an FDA complaint against all soft chamber

vendors with

> whatever specific complaints he has. His ability to participate on

this forum

> was suspended until he files such specific complaints and

then " cc:'s " his

> post here, at which time he will be allowed to post unmoderated.

Freels

2948 Windfield Circle

Tucker, GA 30084-6714

770-491-6776 (phone)

404-725-4520 (cell)

815-366-7962 (fax)

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