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Okay folks -- here is what really went wrong with the FDA approval process for ESWT

Posted by Ed Davis, DPM on 11/02/02 at 12:43 (099035)

Here is how the FDA classifies medical devices:

1) Class 1: External devices (surgical scissors, manual stethoscopes, etc.) are subject to general control only such as the current good manufacturing practices (cGMP), quality assurance and labeling.

2) Class 2: More invasive devices (x-ray machines, ultrasound devices, etc.) are subject to general controls and special controls, such as compliance and performance standards, postmarket surveilance (tracking), and addtional preclinical and clinical performance data as the FDA deems necessary.

3) Class3: Life support and life sustaining devices (heart valves, VAD's, etc.) are subject to general and special controls and require fromal premarket approval.

Think about it. Where would you classify an ESWT machine? They clearly belong in class 2, in my opinion. (The Orb-sone people may have pulled a 'fast one' when they treid to place their unit in class one status for a quick approval and thus the big brouhaha.) Some attorney eloquently argued to the FDA to move ESWT up to class 3, thereby delaying the approval process for new machines. Why? Maybe to quash competition and keep fees up. Folks-- it happens all the time in government! Just my speculation. What do y'all think?
Ed

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

rob a on 11/02/02 at 13:16 (099036)

The funny thing is that renal lithotripters are more invasive and have more serious consequences and they are class II devices. ESWT devices are a scaled down less powerful variation of these devices. You can potentially kill someone with renal lithotripters under normal operation (it has happened) but you would really have to go out of your way to due that with ESWT devices.

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

Ed Davis, DPM on 11/02/02 at 13:25 (099037)

Rob:
Excellent information!
Ed

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

john h on 11/02/02 at 14:00 (099040)

Dr. Ed: I would surely put in a class II. Many years ago my wife had a machine purchased over the counter called a 'Relaxasizor'. Spelling may be wrong here. It was a device with 6 or so electrodes much like a Tens unit. The theory was you placed these pads at various points on your body and turn on the adjustable voltage (110 volt machine) and it would cause the muscles to contract thereby you were exercising and losing fat. Sure, The unit was about 16' x 12' and could really put out some power. One day I hooked it up to myself with all 6 electrodes and slowly turned up the juice. Nothing! Eventually I had it at full power and nothing. Then all of sudden it kicked in and I think I found out what the electric chair is all about. Into the garbage can with that $300 unit. It was sold nationally and never subjected to any FDA testing. Is it not strange that 50,000 people are killed in auto accidents each year. hundres killed by lawn mowers, and other everyday devices and we have a problem getting approval on devices like ESWT equipment. Even when our FDA runs the machines through their process we frequenlty come up with different protocols and results than other countries. Why should we necessarily believe our process for testing is any better than in England, Canada, or Germany. My unprofessional opinion is that ESWT equipment for the foot in particular poses very minimal danger to anyone. Any product has a risk but with ESWT for the foot the FDA seems to have overdone it. It is not like blasting a kidney stone deep in the body in the area of vital organs. .

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

john h on 11/02/02 at 14:03 (099041)

Rob: I am amazed at the information you just posted. A lithotriptor is a Class II device and a Sonocur or Epos is a class III device? If there is not some politics or money involved in this then I would be amazed. Someone please explain this to me.

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

Dr. Z on 11/02/02 at 14:46 (099051)

I agree. but what do we do for ESWT and boney non-unions. My opinion is that ESWT for soft tissue ie plantar fasciitsi is class one so long as the company can show that it is safe. The proof that it works should be in the hands of the treating doctor.

ESWL was classified as a Class three device when it first came out. Now it has been reduced to a class two due to the many many years of treatments.

We are having a great time discussing this but the FDA made the rules and class three for pf is the standards and won't change. As Pauline first pointed out the company that first applied for Class three sets the standards and we can't change this.

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

rob a on 11/02/02 at 20:17 (099106)

Dr. Z is correct. Healthtronics applied for a class III labeling to extend the amount of time competitors would enter their market and to inflate reimburstments. They could have went for a class II but from a business stand point it was the more protectionist thing to do. Though in the long run, it is my opinion that it will back fire and cause resentment in the market and when reimburstments come down, many doctors will consider the smaller multitreatment devices due to their low operational cost. The only problem is that it may take a few years for all this to happen

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

Ed Davis, DPM on 11/02/02 at 22:11 (099116)

Rob:
Your point here is well taken. That is why I have to question the motives of those who are bashing Sonocur on the basis of delayed FDA approval. The delay is obviously political. There is more than enough evidence -- studies and experience to date combined to show the safety and efficacy of low energy ESWT for PF. The safety issue argument begs the ridiculous as low energy ESWT is even less likely than high energy ESWT to cause complications in treatment of PF. Bill takes the FDA issue to an extreme that few would consider reasonable. One can argue about the number and quality of studies to the point of irrelevancy.
Ed

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

Bill on 11/03/02 at 08:09 (099137)

Ed,

Are you suggesting the the FDA is intentionally delaying the approval of the Sonocur? What possible reason would there be? What are the political interests? If what you say is correct about its effectiveness and low price then I would think that insurance companies would be lobbying for its approval so they would have options.

Do you really think that government officials can be bought or do you just think that there is a conspiracy? It really undermines your crediability to accuse honest government officials of obviously political delays? What is your proof?

Come on. Its not approved because the FDA has not reviewed the studies either because the studies have not been completed, the studies don't show the results you claim or the studies have not reached the top of the pile.

I trust my government.

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

john h on 11/03/02 at 11:14 (099157)

Bill: I 'generally' trust my government but have been around long enough to know that politics and money play a big role in many things in government. A case in point is that for many years omphologist would prescribe glasses and then sell them to you. This could lead to a conflict of interest. Somewhere along the line it became prohibited. Today a nephrologist who is the doctor primarly involved in kidney dialysis can own chains of dialysis clincs and they in fact do. Something is wrong with this. Groups of Doctors own large numbers of specialized equipment such as catscans which are leased to hospitals they practice in. Where do you think they will refer their patients? Will the patient really need a catscan? In some hospitals they even own the TV's in the hospital patient rooms which are rented. At the testing level for ESWT are people who may have motivations beyond medicine so to think that if the FDA approves it and the protocol for its use it must be ok is just not true. When money is involved in FDA decisions you can bet the process is open to question.

Re: Re:Bill tells more about the studies

Dr. Z on 11/03/02 at 16:29 (099186)

Is the soncur eswt device applied for an FDA approval for Plantar fasciitis. I am not aware of any studies. Bill can you tell me more about these studies and where the studies are who is performing them in the USA

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

Ed Davis, DPM on 11/04/02 at 13:49 (099292)

Bill:
I am not going to play this game as you want me to. I am not going to comment, let alone guess on the 'intentions' of those responsible for the delay. In fact, it is likely that well intentioned FDA investigators have been led astray by political interests who have required the 'bar to be raised' for approval. Come on Bill -- Class 3 -- necessary to support human life? -- either you are playing a cynical game here or you really do not believe that readers have the ability to invoke common sense.
Ed

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

Ed Davis, DPM on 11/27/02 at 15:48 (101270)

'They who would give up an essential liberty for temporary security, deserve neither liberty nor security.'
Benjamin Franklin

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

rob a on 11/02/02 at 13:16 (099036)

The funny thing is that renal lithotripters are more invasive and have more serious consequences and they are class II devices. ESWT devices are a scaled down less powerful variation of these devices. You can potentially kill someone with renal lithotripters under normal operation (it has happened) but you would really have to go out of your way to due that with ESWT devices.

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

Ed Davis, DPM on 11/02/02 at 13:25 (099037)

Rob:
Excellent information!
Ed

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

john h on 11/02/02 at 14:00 (099040)

Dr. Ed: I would surely put in a class II. Many years ago my wife had a machine purchased over the counter called a 'Relaxasizor'. Spelling may be wrong here. It was a device with 6 or so electrodes much like a Tens unit. The theory was you placed these pads at various points on your body and turn on the adjustable voltage (110 volt machine) and it would cause the muscles to contract thereby you were exercising and losing fat. Sure, The unit was about 16' x 12' and could really put out some power. One day I hooked it up to myself with all 6 electrodes and slowly turned up the juice. Nothing! Eventually I had it at full power and nothing. Then all of sudden it kicked in and I think I found out what the electric chair is all about. Into the garbage can with that $300 unit. It was sold nationally and never subjected to any FDA testing. Is it not strange that 50,000 people are killed in auto accidents each year. hundres killed by lawn mowers, and other everyday devices and we have a problem getting approval on devices like ESWT equipment. Even when our FDA runs the machines through their process we frequenlty come up with different protocols and results than other countries. Why should we necessarily believe our process for testing is any better than in England, Canada, or Germany. My unprofessional opinion is that ESWT equipment for the foot in particular poses very minimal danger to anyone. Any product has a risk but with ESWT for the foot the FDA seems to have overdone it. It is not like blasting a kidney stone deep in the body in the area of vital organs. .

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

john h on 11/02/02 at 14:03 (099041)

Rob: I am amazed at the information you just posted. A lithotriptor is a Class II device and a Sonocur or Epos is a class III device? If there is not some politics or money involved in this then I would be amazed. Someone please explain this to me.

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

Dr. Z on 11/02/02 at 14:46 (099051)

I agree. but what do we do for ESWT and boney non-unions. My opinion is that ESWT for soft tissue ie plantar fasciitsi is class one so long as the company can show that it is safe. The proof that it works should be in the hands of the treating doctor.

ESWL was classified as a Class three device when it first came out. Now it has been reduced to a class two due to the many many years of treatments.

We are having a great time discussing this but the FDA made the rules and class three for pf is the standards and won't change. As Pauline first pointed out the company that first applied for Class three sets the standards and we can't change this.

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

rob a on 11/02/02 at 20:17 (099106)

Dr. Z is correct. Healthtronics applied for a class III labeling to extend the amount of time competitors would enter their market and to inflate reimburstments. They could have went for a class II but from a business stand point it was the more protectionist thing to do. Though in the long run, it is my opinion that it will back fire and cause resentment in the market and when reimburstments come down, many doctors will consider the smaller multitreatment devices due to their low operational cost. The only problem is that it may take a few years for all this to happen

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

Ed Davis, DPM on 11/02/02 at 22:11 (099116)

Rob:
Your point here is well taken. That is why I have to question the motives of those who are bashing Sonocur on the basis of delayed FDA approval. The delay is obviously political. There is more than enough evidence -- studies and experience to date combined to show the safety and efficacy of low energy ESWT for PF. The safety issue argument begs the ridiculous as low energy ESWT is even less likely than high energy ESWT to cause complications in treatment of PF. Bill takes the FDA issue to an extreme that few would consider reasonable. One can argue about the number and quality of studies to the point of irrelevancy.
Ed

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

Bill on 11/03/02 at 08:09 (099137)

Ed,

Are you suggesting the the FDA is intentionally delaying the approval of the Sonocur? What possible reason would there be? What are the political interests? If what you say is correct about its effectiveness and low price then I would think that insurance companies would be lobbying for its approval so they would have options.

Do you really think that government officials can be bought or do you just think that there is a conspiracy? It really undermines your crediability to accuse honest government officials of obviously political delays? What is your proof?

Come on. Its not approved because the FDA has not reviewed the studies either because the studies have not been completed, the studies don't show the results you claim or the studies have not reached the top of the pile.

I trust my government.

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

john h on 11/03/02 at 11:14 (099157)

Bill: I 'generally' trust my government but have been around long enough to know that politics and money play a big role in many things in government. A case in point is that for many years omphologist would prescribe glasses and then sell them to you. This could lead to a conflict of interest. Somewhere along the line it became prohibited. Today a nephrologist who is the doctor primarly involved in kidney dialysis can own chains of dialysis clincs and they in fact do. Something is wrong with this. Groups of Doctors own large numbers of specialized equipment such as catscans which are leased to hospitals they practice in. Where do you think they will refer their patients? Will the patient really need a catscan? In some hospitals they even own the TV's in the hospital patient rooms which are rented. At the testing level for ESWT are people who may have motivations beyond medicine so to think that if the FDA approves it and the protocol for its use it must be ok is just not true. When money is involved in FDA decisions you can bet the process is open to question.

Re: Re:Bill tells more about the studies

Dr. Z on 11/03/02 at 16:29 (099186)

Is the soncur eswt device applied for an FDA approval for Plantar fasciitis. I am not aware of any studies. Bill can you tell me more about these studies and where the studies are who is performing them in the USA

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

Ed Davis, DPM on 11/04/02 at 13:49 (099292)

Bill:
I am not going to play this game as you want me to. I am not going to comment, let alone guess on the 'intentions' of those responsible for the delay. In fact, it is likely that well intentioned FDA investigators have been led astray by political interests who have required the 'bar to be raised' for approval. Come on Bill -- Class 3 -- necessary to support human life? -- either you are playing a cynical game here or you really do not believe that readers have the ability to invoke common sense.
Ed

Re: Okay folks -- here is what really went wrong with the FDA approval process for ESWT

Ed Davis, DPM on 11/27/02 at 15:48 (101270)

'They who would give up an essential liberty for temporary security, deserve neither liberty nor security.'
Benjamin Franklin