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Soncur . The American Society Foot and Ankle Shockwave Group

Posted by Dr. Zuckerman on 8/18/02 at 08:03 (092818)

RE: ESWT Device (Brian Kiel, DPM)
From: John Moroney

The Siemens device is called the Sonocur. It is a low power ESWT
device that has performed well in Europe according to published
studies.

According to my sources at the FDA, the Sonocur was given sales
marketing approval by the FDA for the treatment of lateral
epicondylitis (tennis elbow). The device, therefore cannot be sold
to podiatrists, yet. However, it could be used by a podiatrist who
is in a practice with an orthopedic or other medical group and be
used 'off label.' Independent use should be checked with ones legal
counsel and Liability carrier although the onus seems to be upon
Siemens rather than the DPM.

John Moroney, Executive Director
American Society of Foot & Ankle Shockwave Treatment (ASFAST)
Chicago, IL
(email removed)

Re: To Dr. Z

Pauline on 8/18/02 at 11:56 (092836)

Dr. Z,
Is there an agency responsible for certifing x-ray machines in the field and other things like mammogram machines? What do they check for? What other type of medical devices have to be checked and certified? Do ESWT machines fall into the catagory that also would need this?

Re: To Dr. Z

Dr. Zuckerman on 8/18/02 at 12:15 (092839)

That a very good question, especially with ESWT machines. Firstly with x-ray equipment they have to be certified by the state. In New Jersey we
have to have our equipment tested both on a daily and yearly time frame . Logs of quality assurance have to be kept. It is very similiar to OSHA regulations.

With ESWT machines a very interesting road block has come up in some states. The doctors, ASC etc have to get a certificate of need in order to place the ESWT machine in an ASC. I know this has happened in Pa. and in Virginia. Not sure of the other states. I guess they are following the exact same protcol as was the state regulations for kidney ESWL

What are some of the things that are checked with X-ray equipment.

1. Proper calibration.
2. acceptable limits of x-ray exposure
3. Quality and efficiency of the x-ray processor. I believe you must have an x-ray processor no hand tanks allowed
4 Quality of the films taken
5. Ratio of re-take of x-rays due to proper quality .

See you later its hot and I am going for a swim

Re: Soncur . The American Society Foot and Ankle Shockwave Group

Ed Davis, DPM on 8/20/02 at 19:11 (093017)

Not really sure who this group is. I have sent them an email but recieved no response.
Ed

Re: Soncur . The American Society Foot and Ankle Shockwave Group

Dr. Zuckerman on 8/20/02 at 22:18 (093037)

Ed,

It was formed by Dr. Weil . It is a group of podiatrists in the USA. They will repond to you.

Re: Soncur . The American Society Foot and Ankle Shockwave Group

Pauline on 8/22/02 at 08:57 (093192)

Where is this group headquartered and are they formally registered anywhere?

Re: Soncur . The American Society Foot and Ankle Shockwave Group

Dr. Zuckerman on 8/23/02 at 08:13 (093299)

They are in Chicago. I would call Dr. Weil's office . He could tell you everything you are requesting

Re: To Dr. Z

Pauline on 8/18/02 at 11:56 (092836)

Dr. Z,
Is there an agency responsible for certifing x-ray machines in the field and other things like mammogram machines? What do they check for? What other type of medical devices have to be checked and certified? Do ESWT machines fall into the catagory that also would need this?

Re: To Dr. Z

Dr. Zuckerman on 8/18/02 at 12:15 (092839)

That a very good question, especially with ESWT machines. Firstly with x-ray equipment they have to be certified by the state. In New Jersey we
have to have our equipment tested both on a daily and yearly time frame . Logs of quality assurance have to be kept. It is very similiar to OSHA regulations.

With ESWT machines a very interesting road block has come up in some states. The doctors, ASC etc have to get a certificate of need in order to place the ESWT machine in an ASC. I know this has happened in Pa. and in Virginia. Not sure of the other states. I guess they are following the exact same protcol as was the state regulations for kidney ESWL

What are some of the things that are checked with X-ray equipment.

1. Proper calibration.
2. acceptable limits of x-ray exposure
3. Quality and efficiency of the x-ray processor. I believe you must have an x-ray processor no hand tanks allowed
4 Quality of the films taken
5. Ratio of re-take of x-rays due to proper quality .

See you later its hot and I am going for a swim

Re: Soncur . The American Society Foot and Ankle Shockwave Group

Ed Davis, DPM on 8/20/02 at 19:11 (093017)

Not really sure who this group is. I have sent them an email but recieved no response.
Ed

Re: Soncur . The American Society Foot and Ankle Shockwave Group

Dr. Zuckerman on 8/20/02 at 22:18 (093037)

Ed,

It was formed by Dr. Weil . It is a group of podiatrists in the USA. They will repond to you.

Re: Soncur . The American Society Foot and Ankle Shockwave Group

Pauline on 8/22/02 at 08:57 (093192)

Where is this group headquartered and are they formally registered anywhere?

Re: Soncur . The American Society Foot and Ankle Shockwave Group

Dr. Zuckerman on 8/23/02 at 08:13 (093299)

They are in Chicago. I would call Dr. Weil's office . He could tell you everything you are requesting