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My motives about in office ESWT. by Dr. Z

Posted by Dr. Zuckerman on 4/06/01 at 10:10 (043809)

After learning that ESWT by the ossatron takes about 15 minutes, I have just figured the following out.

1. Dr. Z could do three per hour in the ASC.
2. I wouldn't have to worry about overhead, repairs,cost of owning any machine.

3. I just show up and do the procedure. I would get paid and not worry about anything concerning the machine. If it blows up not my problem.

Now why would I want to do this in the office. It is because the patients wins, the insurance company wins.

If the price and classification of these machines doesn't change in the future, then the patient's won't have choices. Dr. Z will have the choice of doing the procedure in an ASC without the hugh reponsiblity of taking care of a very complex machine.

In the near future I am hoping that I can say to the patient well you can do this in the ofice and walk out or we can go to the ASC and do it there.

Twenty years ago I did all of my procedure in the office with Ambulatory procedures. Today I am unable due to the high cost and the insurance companies not willing to pay for the over head costs involved in the office.

It stills amazes Dr. Z that with certain foot surgery they will pay an extra $1500 dollars to do this is the ASC but won't pay an extra $50 to pay for the supplies and sterile trays.

You control the insurance companies, you the pateint can control this same pattern that I am see developing with ESWT market. In the ASC only. I doubt that any doctor will be willing to pay a few hundred thousand dollars for an ESWT that will only pay the doctor whatever. It is what I call the coverup the patient don't see the up front bill because the insurance paids that extra ASC bill. On the back end that increase across the board insurance premium gets lost. I was alway told if you raise the fee alittle across the board no one notices and this is exactly what the insurance companies do to you. s

So if you want to know my solution speak up and I will be very happy to lead the way for you. Like I told you before this doesn't effect Dr. Z if effects you.

Re: My motives about in office ESWT. by Dr. Z

Julie on 4/06/01 at 10:18 (043810)

Yes, please Dr Z: tell us. It may not apply to me in the UK, but maybe I'm the only one up and about right now, or not at work. I'm sure everyone wants to know how to tackle this.

Re: My motives about in office ESWT. by Dr. Z

Beverly on 4/06/01 at 16:19 (043856)

Dr. Z.,

Thank you for sharing that. One related question I have is, how does the patient know the spark plugs have been changed? Does the machine just not work when it's time to change plugs? I ask that, because I could see it would be easy for something like that to slip through the cracks in the hospital with mulitple doctors all using the same machine.
Thanks,
Beverly

Re: My motives about in office ESWT. by Dr. Z

Lori E. on 4/06/01 at 18:57 (043876)

I don't know about other places but when they did my second foot at Dr. Z's the switched the plug.
Since my hubby is an electrical engineer, they showed us the plugs and we talked about them. One plug is used with each treatment with the orbasone.

Re: My motives about in office ESWT. by Dr. Z

Richard Perez, DPM on 4/06/01 at hrmin (043884)

With the Ossatron machine, the tech changes the spark plug after each treatment (about 1,500 - 2,000 shocks). Although, I think it has more life left in it. The spark plug is then sent back to HMT for reconditioning. It is my understanding that there is a new spark plug in development that would last for 10,000 shocks. This could help reduce the cost of the procedure.
Richard Perez, DPM

Re: My motives about in office ESWT. by Dr. Z

Dr. Zuckerman on 4/07/01 at 10:07 (043911)

Hi,

I have a spark plug that can last for 5000 shocks. In my office there is a complete check off list that must be signed before, during and after the procedure by the doctor, nurse, and techician. There is alot more that needs to be checked besides a spark plug. If you forget to change the plug you will either have poor quality of shocks, missed shocks, or no shocks.
It will be like a back firing of a car.

I still remember the first procedure I did after my training session for one week. The designer of the machine didn't change the plug after he was running the machine. Right in the middle of my first procedure without any instructor present, (they were all back in Europe) the machince started to backfire like a car. This was right in the middle of a TV filming. Well after about two minutes someone in the room made the remark that the it sounds like a car backfiring naybe it needs a tune-up. It then it hit Dr. Z
Someone didn't change the spark plugs. Five minutes later the plug was

changed and the backfiring stopped.

I don't think I will ever stop asking when I do a procedure is this a new spark plug. So there must be a check out list in my opinion for any procedure and especially for anything mechanical.

Re: My motives about in office ESWT. by Dr. Z

Dr. Zuckerman on 4/07/01 at 10:18 (043914)

Hi,
Your senators, congressmen or woman and especially the FDA must know and understand that with one machine in the market place the price is going to go up. The FDA has the power and the scientific information to change the classification of ESWT machine at any time they want . The public can and should e-mail members of the FDA to change the classification of all ESWT for soft tissue. Only when it is going to be use for bone should there it be class three. Did you know that lithotripy for renal stones is classificed in a lower class then ESWT for plantar fasciitis right at this moment.

As long as this classification stays the same the market will be small and the price of the machine will be up and the cost to the patients will go up.

You the patient can make a difference the question is do you want to

Re: My motives about in office ESWT. by Dr. Z

Kate on 4/08/01 at 21:16 (044035)

Dr.Zuckerman,
I think that doing ESWT in the office is notonly more convenient for the patient ( only one place to go for the eval / tx/ follow-up) but also the best way to offer the patient more individualized attention. Once ASC's are involved, you can lose so much of the 'personal-care experience.'

Re: My motives about in office ESWT. by Dr. Z

Pauline on 4/13/01 at 22:52 (044518)

My personal opinion is that if Norland wants it's classification changed for the Orbasone it should submit to the FDA the same docmentation that is required of all other Manufacturers of ESWT devices. It's a simple solution to a simple problem. Norland chose to go a different route. They knew the rules very well and chose to ignore them. They knew what they were doing when they applied for a different classification. Their purpose was to get their product to the market fast and it backfired. Are we to hate the FDA for holding them accountable for their own actions.

This is not poor Norland. It's play by the rules and do what is right. When the litigation is done Orbasone will be able to go out and play with the big boys until then let their device remain on the 'detained' FDA list.

Re: My motives about in office ESWT. by Dr. Z

Dr. Zuckerman on 4/14/01 at 10:44 (044567)

Well

Where did you get this information?. My understanding is the FDA knew about the orbasone. Applications were filled out, meetings took place. The company MIP, had professional consultants that were in contact with the FDA. The application were approved and then Healthronics started to protect their market. Did you know that healthronic and the ossatron initial applicaton wasn't for pf and that they changed directions in the middle of the process. If you truth I am sure that you wouldn't take this position. How would you like if you followed all the rules and then another company who may how. So get your facts straight before you make statements. Big companies don't like to have competition, and like to make the rules as they go along.

I saw the approval for FDA clearance for pain managment for the orbasone. There never was any misleading by MIP to the FDA about the use, what the orabasone was going to be used for, etc, etc.

Re: My motives about in office ESWT. by Dr. Z

JudyS on 4/14/01 at 12:07 (044583)

Pauline, how do you know that Norland didn't submit the same docs as HRT?
Where are you getting your information? Is it directly from Norland and/or the FDA? Do you have documentation? With all due respect, it would seem to me that the Dr.'s on this board who are the U.S. pioneers of ESWT for PF will have certainly done a good amount of their own research regarding the growth of the industry. If that's the case, how is it that your own varies so from Dr. Z's? I believe that someone here asked you a couple of weeks ago if you had some 'inside' knowledge of Norland and/or the FDA as your statements seem to reflect an information source not available to the rest of us. And, again with all due respect, can you tell us why you have a negative opinion about Norland? Do you know something that we don't? If so, I think it only fair that you share it here just as Dr. Z keeps us informed about the 'big business' of ESWT. We know that he has expertise in this area and I'm a little confused about the challenges you make of it. I would love it if you can reveal the source of your own expertise so that we can continiue to make balanced, informed decisions about our PF.

Re: My motives about in office ESWT. by Dr. Z

Pauline on 4/14/01 at 14:50 (044611)

I've been in research all my life and what I am experiencing on this board
is nothing new. Most of the information is public except for the litigation that is underway. My info comes from the acting head of the FDA. There is no doubt in my mind that an agreement will come out of the litigation which will make everything right with the world for Orbasone, but that day has not come yet.

Re: My motives about in office ESWT. by Dr. Z

Dr. Zuckerman on 4/14/01 at 16:43 (044616)

Hi,

I am not aware of any ligitation with regard to ESWT, orbsone, FDA or any
ESWT company. Are you?

Re: My motives about in office ESWT. by Dr. Z

Pauline on 4/14/01 at 20:48 (044631)

Dr. Z,
You keep up with lots, we can't expect you to know everything. That's why
attorneys have jobs. Researchers too.

Re: My motives about in office ESWT. by Dr. Z

Julie on 4/06/01 at 10:18 (043810)

Yes, please Dr Z: tell us. It may not apply to me in the UK, but maybe I'm the only one up and about right now, or not at work. I'm sure everyone wants to know how to tackle this.

Re: My motives about in office ESWT. by Dr. Z

Beverly on 4/06/01 at 16:19 (043856)

Dr. Z.,

Thank you for sharing that. One related question I have is, how does the patient know the spark plugs have been changed? Does the machine just not work when it's time to change plugs? I ask that, because I could see it would be easy for something like that to slip through the cracks in the hospital with mulitple doctors all using the same machine.
Thanks,
Beverly

Re: My motives about in office ESWT. by Dr. Z

Lori E. on 4/06/01 at 18:57 (043876)

I don't know about other places but when they did my second foot at Dr. Z's the switched the plug.
Since my hubby is an electrical engineer, they showed us the plugs and we talked about them. One plug is used with each treatment with the orbasone.

Re: My motives about in office ESWT. by Dr. Z

Richard Perez, DPM on 4/06/01 at hrmin (043884)

With the Ossatron machine, the tech changes the spark plug after each treatment (about 1,500 - 2,000 shocks). Although, I think it has more life left in it. The spark plug is then sent back to HMT for reconditioning. It is my understanding that there is a new spark plug in development that would last for 10,000 shocks. This could help reduce the cost of the procedure.
Richard Perez, DPM

Re: My motives about in office ESWT. by Dr. Z

Dr. Zuckerman on 4/07/01 at 10:07 (043911)

Hi,

I have a spark plug that can last for 5000 shocks. In my office there is a complete check off list that must be signed before, during and after the procedure by the doctor, nurse, and techician. There is alot more that needs to be checked besides a spark plug. If you forget to change the plug you will either have poor quality of shocks, missed shocks, or no shocks.
It will be like a back firing of a car.

I still remember the first procedure I did after my training session for one week. The designer of the machine didn't change the plug after he was running the machine. Right in the middle of my first procedure without any instructor present, (they were all back in Europe) the machince started to backfire like a car. This was right in the middle of a TV filming. Well after about two minutes someone in the room made the remark that the it sounds like a car backfiring naybe it needs a tune-up. It then it hit Dr. Z
Someone didn't change the spark plugs. Five minutes later the plug was

changed and the backfiring stopped.

I don't think I will ever stop asking when I do a procedure is this a new spark plug. So there must be a check out list in my opinion for any procedure and especially for anything mechanical.

Re: My motives about in office ESWT. by Dr. Z

Dr. Zuckerman on 4/07/01 at 10:18 (043914)

Hi,
Your senators, congressmen or woman and especially the FDA must know and understand that with one machine in the market place the price is going to go up. The FDA has the power and the scientific information to change the classification of ESWT machine at any time they want . The public can and should e-mail members of the FDA to change the classification of all ESWT for soft tissue. Only when it is going to be use for bone should there it be class three. Did you know that lithotripy for renal stones is classificed in a lower class then ESWT for plantar fasciitis right at this moment.

As long as this classification stays the same the market will be small and the price of the machine will be up and the cost to the patients will go up.

You the patient can make a difference the question is do you want to

Re: My motives about in office ESWT. by Dr. Z

Kate on 4/08/01 at 21:16 (044035)

Dr.Zuckerman,
I think that doing ESWT in the office is notonly more convenient for the patient ( only one place to go for the eval / tx/ follow-up) but also the best way to offer the patient more individualized attention. Once ASC's are involved, you can lose so much of the 'personal-care experience.'

Re: My motives about in office ESWT. by Dr. Z

Pauline on 4/13/01 at 22:52 (044518)

My personal opinion is that if Norland wants it's classification changed for the Orbasone it should submit to the FDA the same docmentation that is required of all other Manufacturers of ESWT devices. It's a simple solution to a simple problem. Norland chose to go a different route. They knew the rules very well and chose to ignore them. They knew what they were doing when they applied for a different classification. Their purpose was to get their product to the market fast and it backfired. Are we to hate the FDA for holding them accountable for their own actions.

This is not poor Norland. It's play by the rules and do what is right. When the litigation is done Orbasone will be able to go out and play with the big boys until then let their device remain on the 'detained' FDA list.

Re: My motives about in office ESWT. by Dr. Z

Dr. Zuckerman on 4/14/01 at 10:44 (044567)

Well

Where did you get this information?. My understanding is the FDA knew about the orbasone. Applications were filled out, meetings took place. The company MIP, had professional consultants that were in contact with the FDA. The application were approved and then Healthronics started to protect their market. Did you know that healthronic and the ossatron initial applicaton wasn't for pf and that they changed directions in the middle of the process. If you truth I am sure that you wouldn't take this position. How would you like if you followed all the rules and then another company who may how. So get your facts straight before you make statements. Big companies don't like to have competition, and like to make the rules as they go along.

I saw the approval for FDA clearance for pain managment for the orbasone. There never was any misleading by MIP to the FDA about the use, what the orabasone was going to be used for, etc, etc.

Re: My motives about in office ESWT. by Dr. Z

JudyS on 4/14/01 at 12:07 (044583)

Pauline, how do you know that Norland didn't submit the same docs as HRT?
Where are you getting your information? Is it directly from Norland and/or the FDA? Do you have documentation? With all due respect, it would seem to me that the Dr.'s on this board who are the U.S. pioneers of ESWT for PF will have certainly done a good amount of their own research regarding the growth of the industry. If that's the case, how is it that your own varies so from Dr. Z's? I believe that someone here asked you a couple of weeks ago if you had some 'inside' knowledge of Norland and/or the FDA as your statements seem to reflect an information source not available to the rest of us. And, again with all due respect, can you tell us why you have a negative opinion about Norland? Do you know something that we don't? If so, I think it only fair that you share it here just as Dr. Z keeps us informed about the 'big business' of ESWT. We know that he has expertise in this area and I'm a little confused about the challenges you make of it. I would love it if you can reveal the source of your own expertise so that we can continiue to make balanced, informed decisions about our PF.

Re: My motives about in office ESWT. by Dr. Z

Pauline on 4/14/01 at 14:50 (044611)

I've been in research all my life and what I am experiencing on this board
is nothing new. Most of the information is public except for the litigation that is underway. My info comes from the acting head of the FDA. There is no doubt in my mind that an agreement will come out of the litigation which will make everything right with the world for Orbasone, but that day has not come yet.

Re: My motives about in office ESWT. by Dr. Z

Dr. Zuckerman on 4/14/01 at 16:43 (044616)

Hi,

I am not aware of any ligitation with regard to ESWT, orbsone, FDA or any
ESWT company. Are you?

Re: My motives about in office ESWT. by Dr. Z

Pauline on 4/14/01 at 20:48 (044631)

Dr. Z,
You keep up with lots, we can't expect you to know everything. That's why
attorneys have jobs. Researchers too.