Compact Nebulizer?

D

dasjsmum

New member
well, just to weigh in from a different country we can buy the eflow (for around $1500) here. I'm pretty sure insurance only covers it if you're insured for cf, which makes it almost impossible to get insurance. We have socialised medicine here.

Our clinic is providing the eflow to high school students so that their treatment burden can be lessened. That indicates to me that the eflow is effective and being emabraced here.

I dont know about the issues you have with insurance over there. From my pov the eflow is fantastic. I've seen all the tests on Amy's blog before she had a blog
and thought it would be great to have one.

Here's a link re clearance from the FDA.

<a target=_blank class=ftalternatingbarlinklarge href="http://www.prnewswire.com/cgi-...76356&EDATE
">"><a target=_blank class=ftalternatingbarlinklarge href="http://www.prnewswire.com/cgi-...002176356&EDATE
"><br "><a target=_blank class=ftalternatingbarlinklarge href="http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/05-18-2004/0002176356&EDATE
<br ">http://www.prnew...om...76356&...
</a></a>
</a>

Here's a link that explains the 510 (k) act.

<a target=_blank class=ftalternatingbarlinklarge href="http://www.devicewatch.org/reg/reg.shtml
">"><a target=_blank class=ftalternatingbarlinklarge href="http://www.devicewatch.org/reg/reg.shtml
<br ">http://www.devicewatch.org/reg/reg.shtml
</a></a>


Quote from above article: "Human data are usually not required for a 510(k) submission; this decision is made at the discretion of the FDA. Laboratory testing is almost always a requirement. Depending on the type of 510(k), the law gives the FDA either 30 or 90 days to clear the device, ask questions, or reject the application."

I think your both right here.

Amy is correct that this device requires clearance.

Nightwriter is correct in saying that people cant obtain it due to some quirk in your insurance companies policies.

Hope this helps others understand...woulndt want people to think that the eflow has not met medical standards <img src="i/expressions/face-icon-small-smile.gif" border="0">

Another link explains difference between approval and clearance:

<a target=_blank class=ftalternatingbarlinklarge href="http://www.emergogroup.com/services/us/fda-510k-consulting">http://www.emergogroup.com/ser...us/fda-510k-consulting</a>

Okay, here's another from the FDA site. apparently there are three categories. the eflow is categorised as class 11, and does not require clinical trials. According to this site, class 111 require clinical trials (eg. pace makers

<a target=_blank class=ftalternatingbarlinklarge href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm">http://www.fda.gov/MedicalDevi...e/Overview/default.htm</a>
 
D

dasjsmum

New member
well, just to weigh in from a different country we can buy the eflow (for around $1500) here. I'm pretty sure insurance only covers it if you're insured for cf, which makes it almost impossible to get insurance. We have socialised medicine here.

Our clinic is providing the eflow to high school students so that their treatment burden can be lessened. That indicates to me that the eflow is effective and being emabraced here.

I dont know about the issues you have with insurance over there. From my pov the eflow is fantastic. I've seen all the tests on Amy's blog before she had a blog
and thought it would be great to have one.

Here's a link re clearance from the FDA.

<a target=_blank class=ftalternatingbarlinklarge href="http://www.prnewswire.com/cgi-...76356&EDATE
">"><a target=_blank class=ftalternatingbarlinklarge href="http://www.prnewswire.com/cgi-...002176356&EDATE
"><br "><a target=_blank class=ftalternatingbarlinklarge href="http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/05-18-2004/0002176356&EDATE
<br ">http://www.prnew...om...76356&...
</a></a>
</a>

Here's a link that explains the 510 (k) act.

<a target=_blank class=ftalternatingbarlinklarge href="http://www.devicewatch.org/reg/reg.shtml
">"><a target=_blank class=ftalternatingbarlinklarge href="http://www.devicewatch.org/reg/reg.shtml
<br ">http://www.devicewatch.org/reg/reg.shtml
</a></a>


Quote from above article: "Human data are usually not required for a 510(k) submission; this decision is made at the discretion of the FDA. Laboratory testing is almost always a requirement. Depending on the type of 510(k), the law gives the FDA either 30 or 90 days to clear the device, ask questions, or reject the application."

I think your both right here.

Amy is correct that this device requires clearance.

Nightwriter is correct in saying that people cant obtain it due to some quirk in your insurance companies policies.

Hope this helps others understand...woulndt want people to think that the eflow has not met medical standards <img src="i/expressions/face-icon-small-smile.gif" border="0">

Another link explains difference between approval and clearance:

<a target=_blank class=ftalternatingbarlinklarge href="http://www.emergogroup.com/services/us/fda-510k-consulting">http://www.emergogroup.com/ser...us/fda-510k-consulting</a>

Okay, here's another from the FDA site. apparently there are three categories. the eflow is categorised as class 11, and does not require clinical trials. According to this site, class 111 require clinical trials (eg. pace makers

<a target=_blank class=ftalternatingbarlinklarge href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm">http://www.fda.gov/MedicalDevi...e/Overview/default.htm</a>
 
D

dasjsmum

New member
well, just to weigh in from a different country we can buy the eflow (for around $1500) here. I'm pretty sure insurance only covers it if you're insured for cf, which makes it almost impossible to get insurance. We have socialised medicine here.

Our clinic is providing the eflow to high school students so that their treatment burden can be lessened. That indicates to me that the eflow is effective and being emabraced here.

I dont know about the issues you have with insurance over there. From my pov the eflow is fantastic. I've seen all the tests on Amy's blog before she had a blog
and thought it would be great to have one.

Here's a link re clearance from the FDA.

<a target=_blank class=ftalternatingbarlinklarge href="http://www.prnewswire.com/cgi-...76356&EDATE
">"><a target=_blank class=ftalternatingbarlinklarge href="http://www.prnewswire.com/cgi-...002176356&EDATE
"><br "><a target=_blank class=ftalternatingbarlinklarge href="http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/05-18-2004/0002176356&EDATE
<br ">http://www.prnew...om...76356&...
</a></a>
</a>

Here's a link that explains the 510 (k) act.

<a target=_blank class=ftalternatingbarlinklarge href="http://www.devicewatch.org/reg/reg.shtml
">"><a target=_blank class=ftalternatingbarlinklarge href="http://www.devicewatch.org/reg/reg.shtml
<br ">http://www.devicewatch.org/reg/reg.shtml
</a></a>


Quote from above article: "Human data are usually not required for a 510(k) submission; this decision is made at the discretion of the FDA. Laboratory testing is almost always a requirement. Depending on the type of 510(k), the law gives the FDA either 30 or 90 days to clear the device, ask questions, or reject the application."

I think your both right here.

Amy is correct that this device requires clearance.

Nightwriter is correct in saying that people cant obtain it due to some quirk in your insurance companies policies.

Hope this helps others understand...woulndt want people to think that the eflow has not met medical standards <img src="i/expressions/face-icon-small-smile.gif" border="0">

Another link explains difference between approval and clearance:

<a target=_blank class=ftalternatingbarlinklarge href="http://www.emergogroup.com/services/us/fda-510k-consulting">http://www.emergogroup.com/ser...us/fda-510k-consulting</a>

Okay, here's another from the FDA site. apparently there are three categories. the eflow is categorised as class 11, and does not require clinical trials. According to this site, class 111 require clinical trials (eg. pace makers

<a target=_blank class=ftalternatingbarlinklarge href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm">http://www.fda.gov/MedicalDevi...e/Overview/default.htm</a>
 
D

dasjsmum

New member
well, just to weigh in from a different country we can buy the eflow (for around $1500) here. I'm pretty sure insurance only covers it if you're insured for cf, which makes it almost impossible to get insurance. We have socialised medicine here.

Our clinic is providing the eflow to high school students so that their treatment burden can be lessened. That indicates to me that the eflow is effective and being emabraced here.

I dont know about the issues you have with insurance over there. From my pov the eflow is fantastic. I've seen all the tests on Amy's blog before she had a blog
and thought it would be great to have one.

Here's a link re clearance from the FDA.

<a target=_blank class=ftalternatingbarlinklarge href="http://www.prnewswire.com/cgi-...76356&EDATE
">"><a target=_blank class=ftalternatingbarlinklarge href="http://www.prnewswire.com/cgi-...002176356&EDATE
"><br "><a target=_blank class=ftalternatingbarlinklarge href="http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/05-18-2004/0002176356&EDATE
<br ">http://www.prnew...om...76356&...
</a></a>
</a>

Here's a link that explains the 510 (k) act.

<a target=_blank class=ftalternatingbarlinklarge href="http://www.devicewatch.org/reg/reg.shtml
">"><a target=_blank class=ftalternatingbarlinklarge href="http://www.devicewatch.org/reg/reg.shtml
<br ">http://www.devicewatch.org/reg/reg.shtml
</a></a>


Quote from above article: "Human data are usually not required for a 510(k) submission; this decision is made at the discretion of the FDA. Laboratory testing is almost always a requirement. Depending on the type of 510(k), the law gives the FDA either 30 or 90 days to clear the device, ask questions, or reject the application."

I think your both right here.

Amy is correct that this device requires clearance.

Nightwriter is correct in saying that people cant obtain it due to some quirk in your insurance companies policies.

Hope this helps others understand...woulndt want people to think that the eflow has not met medical standards <img src="i/expressions/face-icon-small-smile.gif" border="0">

Another link explains difference between approval and clearance:

<a target=_blank class=ftalternatingbarlinklarge href="http://www.emergogroup.com/services/us/fda-510k-consulting">http://www.emergogroup.com/ser...us/fda-510k-consulting</a>

Okay, here's another from the FDA site. apparently there are three categories. the eflow is categorised as class 11, and does not require clinical trials. According to this site, class 111 require clinical trials (eg. pace makers

<a target=_blank class=ftalternatingbarlinklarge href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm">http://www.fda.gov/MedicalDevi...e/Overview/default.htm</a>
 
D

dasjsmum

New member
well, just to weigh in from a different country we can buy the eflow (for around $1500) here. I'm pretty sure insurance only covers it if you're insured for cf, which makes it almost impossible to get insurance. We have socialised medicine here.
<br />
<br />Our clinic is providing the eflow to high school students so that their treatment burden can be lessened. That indicates to me that the eflow is effective and being emabraced here.
<br />
<br />I dont know about the issues you have with insurance over there. From my pov the eflow is fantastic. I've seen all the tests on Amy's blog before she had a blog
and thought it would be great to have one.
<br />
<br />Here's a link re clearance from the FDA.
<br />
<br /><a target=_blank class=ftalternatingbarlinklarge href="http://www.prnewswire.com/cgi-...76356&EDATE
">"><a target=_blank class=ftalternatingbarlinklarge href="http://www.prnewswire.com/cgi-...002176356&EDATE
<br />"><br "><a target=_blank class=ftalternatingbarlinklarge href="http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/05-18-2004/0002176356&EDATE
<br /><br ">http://www.prnew...om...76356&...
</a><br /></a>
<br /></a>
<br />
<br />Here's a link that explains the 510 (k) act.
<br />
<br /><a target=_blank class=ftalternatingbarlinklarge href="http://www.devicewatch.org/reg/reg.shtml
">"><a target=_blank class=ftalternatingbarlinklarge href="http://www.devicewatch.org/reg/reg.shtml
<br /><br ">http://www.devicewatch.org/reg/reg.shtml
</a><br /></a>
<br />
<br />
<br />Quote from above article: "Human data are usually not required for a 510(k) submission; this decision is made at the discretion of the FDA. Laboratory testing is almost always a requirement. Depending on the type of 510(k), the law gives the FDA either 30 or 90 days to clear the device, ask questions, or reject the application."
<br />
<br />I think your both right here.
<br />
<br />Amy is correct that this device requires clearance.
<br />
<br />Nightwriter is correct in saying that people cant obtain it due to some quirk in your insurance companies policies.
<br />
<br />Hope this helps others understand...woulndt want people to think that the eflow has not met medical standards <img src="i/expressions/face-icon-small-smile.gif" border="0">
<br />
<br />Another link explains difference between approval and clearance:
<br />
<br /><a target=_blank class=ftalternatingbarlinklarge href="http://www.emergogroup.com/services/us/fda-510k-consulting">http://www.emergogroup.com/ser...us/fda-510k-consulting</a>
<br />
<br />Okay, here's another from the FDA site. apparently there are three categories. the eflow is categorised as class 11, and does not require clinical trials. According to this site, class 111 require clinical trials (eg. pace makers
<br />
<br /><a target=_blank class=ftalternatingbarlinklarge href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm">http://www.fda.gov/MedicalDevi...e/Overview/default.htm</a>
 
N

Nightwriter

New member
Jo,

I know you took time out of your busy day to find FDA regulations. The fact still remains that the eflow is cleared and eligible for approval pending further testing with an antibiotic. So in this case, approval would open the doors for more people to get their hands on the device.

FDA requires any pharmacy ditributing the eflow to apply this disclaimer:

*Disclaimer: The eFlow ® nebulizer has not undergone human clinical studies to determine its safety or efficacy and has not been approved by the FDA for use with tobramycin in the treatment of Pseudomonas aeruginosa in patients with cystic fibrosis. Compounded prescriptions are not evaluated by the FDA for safety or efficacy.

The eflow, like the Devilbiss Pulmoaide IS eligible to have the status changed to approved for use with a certain antibiotic once the testing is found to meet the FDA's testing.

This latest opportunity has just been lost.

Had the drug Atreonam which was being tested using the eflow been approved, the eflow would have been approved for use with that drug. So doctors who feel that the studies that have been too few or with populations as small as FIVE, it would assure them that the antibiotic would be delivered equal or superior to the piston driven compressors.

Once the eflow has been shown to deliver a drug with sufficient testing, the FDA approval will mean the insurance companies will have to pay for a medically necessary eflow for Atreonam and that will open the door for the other drugs to be dispensed in this manner at well.

Pari's website for the e-flow also states the e-flow (now called the Trio) is available on a limited basis.

The bottom line is this: Without approval (and this is not just semantics), as seen in this thread, many people's doctors will not prescribe it, and the insurance companies will not pay for it.
 
N

Nightwriter

New member
Jo,

I know you took time out of your busy day to find FDA regulations. The fact still remains that the eflow is cleared and eligible for approval pending further testing with an antibiotic. So in this case, approval would open the doors for more people to get their hands on the device.

FDA requires any pharmacy ditributing the eflow to apply this disclaimer:

*Disclaimer: The eFlow ® nebulizer has not undergone human clinical studies to determine its safety or efficacy and has not been approved by the FDA for use with tobramycin in the treatment of Pseudomonas aeruginosa in patients with cystic fibrosis. Compounded prescriptions are not evaluated by the FDA for safety or efficacy.

The eflow, like the Devilbiss Pulmoaide IS eligible to have the status changed to approved for use with a certain antibiotic once the testing is found to meet the FDA's testing.

This latest opportunity has just been lost.

Had the drug Atreonam which was being tested using the eflow been approved, the eflow would have been approved for use with that drug. So doctors who feel that the studies that have been too few or with populations as small as FIVE, it would assure them that the antibiotic would be delivered equal or superior to the piston driven compressors.

Once the eflow has been shown to deliver a drug with sufficient testing, the FDA approval will mean the insurance companies will have to pay for a medically necessary eflow for Atreonam and that will open the door for the other drugs to be dispensed in this manner at well.

Pari's website for the e-flow also states the e-flow (now called the Trio) is available on a limited basis.

The bottom line is this: Without approval (and this is not just semantics), as seen in this thread, many people's doctors will not prescribe it, and the insurance companies will not pay for it.
 
N

Nightwriter

New member
Jo,

I know you took time out of your busy day to find FDA regulations. The fact still remains that the eflow is cleared and eligible for approval pending further testing with an antibiotic. So in this case, approval would open the doors for more people to get their hands on the device.

FDA requires any pharmacy ditributing the eflow to apply this disclaimer:

*Disclaimer: The eFlow ® nebulizer has not undergone human clinical studies to determine its safety or efficacy and has not been approved by the FDA for use with tobramycin in the treatment of Pseudomonas aeruginosa in patients with cystic fibrosis. Compounded prescriptions are not evaluated by the FDA for safety or efficacy.

The eflow, like the Devilbiss Pulmoaide IS eligible to have the status changed to approved for use with a certain antibiotic once the testing is found to meet the FDA's testing.

This latest opportunity has just been lost.

Had the drug Atreonam which was being tested using the eflow been approved, the eflow would have been approved for use with that drug. So doctors who feel that the studies that have been too few or with populations as small as FIVE, it would assure them that the antibiotic would be delivered equal or superior to the piston driven compressors.

Once the eflow has been shown to deliver a drug with sufficient testing, the FDA approval will mean the insurance companies will have to pay for a medically necessary eflow for Atreonam and that will open the door for the other drugs to be dispensed in this manner at well.

Pari's website for the e-flow also states the e-flow (now called the Trio) is available on a limited basis.

The bottom line is this: Without approval (and this is not just semantics), as seen in this thread, many people's doctors will not prescribe it, and the insurance companies will not pay for it.
 
N

Nightwriter

New member
Jo,

I know you took time out of your busy day to find FDA regulations. The fact still remains that the eflow is cleared and eligible for approval pending further testing with an antibiotic. So in this case, approval would open the doors for more people to get their hands on the device.

FDA requires any pharmacy ditributing the eflow to apply this disclaimer:

*Disclaimer: The eFlow ® nebulizer has not undergone human clinical studies to determine its safety or efficacy and has not been approved by the FDA for use with tobramycin in the treatment of Pseudomonas aeruginosa in patients with cystic fibrosis. Compounded prescriptions are not evaluated by the FDA for safety or efficacy.

The eflow, like the Devilbiss Pulmoaide IS eligible to have the status changed to approved for use with a certain antibiotic once the testing is found to meet the FDA's testing.

This latest opportunity has just been lost.

Had the drug Atreonam which was being tested using the eflow been approved, the eflow would have been approved for use with that drug. So doctors who feel that the studies that have been too few or with populations as small as FIVE, it would assure them that the antibiotic would be delivered equal or superior to the piston driven compressors.

Once the eflow has been shown to deliver a drug with sufficient testing, the FDA approval will mean the insurance companies will have to pay for a medically necessary eflow for Atreonam and that will open the door for the other drugs to be dispensed in this manner at well.

Pari's website for the e-flow also states the e-flow (now called the Trio) is available on a limited basis.

The bottom line is this: Without approval (and this is not just semantics), as seen in this thread, many people's doctors will not prescribe it, and the insurance companies will not pay for it.
 
N

Nightwriter

New member
Jo,
<br />
<br />I know you took time out of your busy day to find FDA regulations. The fact still remains that the eflow is cleared and eligible for approval pending further testing with an antibiotic. So in this case, approval would open the doors for more people to get their hands on the device.
<br />
<br />FDA requires any pharmacy ditributing the eflow to apply this disclaimer:
<br />
<br />*Disclaimer: The eFlow ® nebulizer has not undergone human clinical studies to determine its safety or efficacy and has not been approved by the FDA for use with tobramycin in the treatment of Pseudomonas aeruginosa in patients with cystic fibrosis. Compounded prescriptions are not evaluated by the FDA for safety or efficacy.
<br />
<br />The eflow, like the Devilbiss Pulmoaide IS eligible to have the status changed to approved for use with a certain antibiotic once the testing is found to meet the FDA's testing.
<br />
<br />This latest opportunity has just been lost.
<br />
<br />Had the drug Atreonam which was being tested using the eflow been approved, the eflow would have been approved for use with that drug. So doctors who feel that the studies that have been too few or with populations as small as FIVE, it would assure them that the antibiotic would be delivered equal or superior to the piston driven compressors.
<br />
<br />Once the eflow has been shown to deliver a drug with sufficient testing, the FDA approval will mean the insurance companies will have to pay for a medically necessary eflow for Atreonam and that will open the door for the other drugs to be dispensed in this manner at well.
<br />
<br />Pari's website for the e-flow also states the e-flow (now called the Trio) is available on a limited basis.
<br />
<br />The bottom line is this: Without approval (and this is not just semantics), as seen in this thread, many people's doctors will not prescribe it, and the insurance companies will not pay for it.
<br />
<br />
<br />
 
S

saveferris2009

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Nightwriter</b></i>
The fact still remains that the eflow is cleared and eligible for approval pending further testing with an antibiotic. So in this case, approval would open the doors for more people to get their hands on the device.

</end quote></div>

Wrong. Wrong. Wrong. ANd wrong.

The eFLow can be used with ANY medication, per the FDA.

Again, medications are approved to be used with certain devices. Devices are NEVER approved to be used with specific medications.

THerefore the eFlow will NEVER be approved to be used with specific medications.

Rather medications, when submitting for FDA approved after PHase III trials, will be approved to be used with certain devices.






<div class="FTQUOTE"><begin quote>
The eflow, like the Devilbiss Pulmoaide IS eligible to have the status changed to approved for use with a certain antibiotic once the testing is found to meet the FDA's testing.

</end quote></div>

The Devilbiss wasn't approved to be used wtih TOBI. TOBI was approved to be used with the Devilbiss.

This is a <u> big difference </u> .

Are you using albuterol in your Devilbiss? Well, it was never "FDA APproved" per your criteria that you're misundersatnding in the Devilbiss.

THe process doesn't work that way.


<div class="FTQUOTE"><begin quote>

Had the drug Atreonam which was being tested using the eflow been approved, the eflow would have been approved for use with that drug. </end quote></div>

No!!!!!!!!!!!

Aztreonam would be approved for use with the eFLow. NOT THE OTHER WAY AROUND. There is a huge difference.


<div class="FTQUOTE"><begin quote>
Once the eflow has been shown to deliver a drug with sufficient testing, the FDA approval </end quote></div>

The eFLow has already been cleared to be used with any drug that a physician says is OK to use.

Hundres of doctors in the US are using the eFlow for their CFer's. Today.

The State of CA's publically funded plan, GHPP, even gives out eFLows.
 
S

saveferris2009

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Nightwriter</b></i>
The fact still remains that the eflow is cleared and eligible for approval pending further testing with an antibiotic. So in this case, approval would open the doors for more people to get their hands on the device.

</end quote></div>

Wrong. Wrong. Wrong. ANd wrong.

The eFLow can be used with ANY medication, per the FDA.

Again, medications are approved to be used with certain devices. Devices are NEVER approved to be used with specific medications.

THerefore the eFlow will NEVER be approved to be used with specific medications.

Rather medications, when submitting for FDA approved after PHase III trials, will be approved to be used with certain devices.






<div class="FTQUOTE"><begin quote>
The eflow, like the Devilbiss Pulmoaide IS eligible to have the status changed to approved for use with a certain antibiotic once the testing is found to meet the FDA's testing.

</end quote></div>

The Devilbiss wasn't approved to be used wtih TOBI. TOBI was approved to be used with the Devilbiss.

This is a <u> big difference </u> .

Are you using albuterol in your Devilbiss? Well, it was never "FDA APproved" per your criteria that you're misundersatnding in the Devilbiss.

THe process doesn't work that way.


<div class="FTQUOTE"><begin quote>

Had the drug Atreonam which was being tested using the eflow been approved, the eflow would have been approved for use with that drug. </end quote></div>

No!!!!!!!!!!!

Aztreonam would be approved for use with the eFLow. NOT THE OTHER WAY AROUND. There is a huge difference.


<div class="FTQUOTE"><begin quote>
Once the eflow has been shown to deliver a drug with sufficient testing, the FDA approval </end quote></div>

The eFLow has already been cleared to be used with any drug that a physician says is OK to use.

Hundres of doctors in the US are using the eFlow for their CFer's. Today.

The State of CA's publically funded plan, GHPP, even gives out eFLows.
 
S

saveferris2009

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Nightwriter</b></i>
The fact still remains that the eflow is cleared and eligible for approval pending further testing with an antibiotic. So in this case, approval would open the doors for more people to get their hands on the device.

</end quote></div>

Wrong. Wrong. Wrong. ANd wrong.

The eFLow can be used with ANY medication, per the FDA.

Again, medications are approved to be used with certain devices. Devices are NEVER approved to be used with specific medications.

THerefore the eFlow will NEVER be approved to be used with specific medications.

Rather medications, when submitting for FDA approved after PHase III trials, will be approved to be used with certain devices.






<div class="FTQUOTE"><begin quote>
The eflow, like the Devilbiss Pulmoaide IS eligible to have the status changed to approved for use with a certain antibiotic once the testing is found to meet the FDA's testing.

</end quote></div>

The Devilbiss wasn't approved to be used wtih TOBI. TOBI was approved to be used with the Devilbiss.

This is a <u> big difference </u> .

Are you using albuterol in your Devilbiss? Well, it was never "FDA APproved" per your criteria that you're misundersatnding in the Devilbiss.

THe process doesn't work that way.


<div class="FTQUOTE"><begin quote>

Had the drug Atreonam which was being tested using the eflow been approved, the eflow would have been approved for use with that drug. </end quote></div>

No!!!!!!!!!!!

Aztreonam would be approved for use with the eFLow. NOT THE OTHER WAY AROUND. There is a huge difference.


<div class="FTQUOTE"><begin quote>
Once the eflow has been shown to deliver a drug with sufficient testing, the FDA approval </end quote></div>

The eFLow has already been cleared to be used with any drug that a physician says is OK to use.

Hundres of doctors in the US are using the eFlow for their CFer's. Today.

The State of CA's publically funded plan, GHPP, even gives out eFLows.
 
S

saveferris2009

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Nightwriter</b></i>
The fact still remains that the eflow is cleared and eligible for approval pending further testing with an antibiotic. So in this case, approval would open the doors for more people to get their hands on the device.

</end quote>

Wrong. Wrong. Wrong. ANd wrong.

The eFLow can be used with ANY medication, per the FDA.

Again, medications are approved to be used with certain devices. Devices are NEVER approved to be used with specific medications.

THerefore the eFlow will NEVER be approved to be used with specific medications.

Rather medications, when submitting for FDA approved after PHase III trials, will be approved to be used with certain devices.






<div class="FTQUOTE"><begin quote>
The eflow, like the Devilbiss Pulmoaide IS eligible to have the status changed to approved for use with a certain antibiotic once the testing is found to meet the FDA's testing.

</end quote>

The Devilbiss wasn't approved to be used wtih TOBI. TOBI was approved to be used with the Devilbiss.

This is a <u> big difference </u> .

Are you using albuterol in your Devilbiss? Well, it was never "FDA APproved" per your criteria that you're misundersatnding in the Devilbiss.

THe process doesn't work that way.


<div class="FTQUOTE"><begin quote>

Had the drug Atreonam which was being tested using the eflow been approved, the eflow would have been approved for use with that drug. </end quote>

No!!!!!!!!!!!

Aztreonam would be approved for use with the eFLow. NOT THE OTHER WAY AROUND. There is a huge difference.


<div class="FTQUOTE"><begin quote>
Once the eflow has been shown to deliver a drug with sufficient testing, the FDA approval </end quote>

The eFLow has already been cleared to be used with any drug that a physician says is OK to use.

Hundres of doctors in the US are using the eFlow for their CFer's. Today.

The State of CA's publically funded plan, GHPP, even gives out eFLows.
 
S

saveferris2009

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Nightwriter</b></i>
<br /> The fact still remains that the eflow is cleared and eligible for approval pending further testing with an antibiotic. So in this case, approval would open the doors for more people to get their hands on the device.
<br />
<br /></end quote>
<br />
<br />Wrong. Wrong. Wrong. ANd wrong.
<br />
<br />The eFLow can be used with ANY medication, per the FDA.
<br />
<br />Again, medications are approved to be used with certain devices. Devices are NEVER approved to be used with specific medications.
<br />
<br />THerefore the eFlow will NEVER be approved to be used with specific medications.
<br />
<br />Rather medications, when submitting for FDA approved after PHase III trials, will be approved to be used with certain devices.
<br />
<br />
<br />
<br />
<br />
<br />
<br /><div class="FTQUOTE"><begin quote>
<br />The eflow, like the Devilbiss Pulmoaide IS eligible to have the status changed to approved for use with a certain antibiotic once the testing is found to meet the FDA's testing.
<br />
<br /></end quote>
<br />
<br />The Devilbiss wasn't approved to be used wtih TOBI. TOBI was approved to be used with the Devilbiss.
<br />
<br />This is a <u> big difference </u> .
<br />
<br />Are you using albuterol in your Devilbiss? Well, it was never "FDA APproved" per your criteria that you're misundersatnding in the Devilbiss.
<br />
<br />THe process doesn't work that way.
<br />
<br />
<br /><div class="FTQUOTE"><begin quote>
<br />
<br />Had the drug Atreonam which was being tested using the eflow been approved, the eflow would have been approved for use with that drug. </end quote>
<br />
<br />No!!!!!!!!!!!
<br />
<br />Aztreonam would be approved for use with the eFLow. NOT THE OTHER WAY AROUND. There is a huge difference.
<br />
<br />
<br /><div class="FTQUOTE"><begin quote>
<br />Once the eflow has been shown to deliver a drug with sufficient testing, the FDA approval </end quote>
<br />
<br />The eFLow has already been cleared to be used with any drug that a physician says is OK to use.
<br />
<br />Hundres of doctors in the US are using the eFlow for their CFer's. Today.
<br />
<br />The State of CA's publically funded plan, GHPP, even gives out eFLows.
<br />
<br />
<br />
 
N

Nightwriter

New member
Boy, it's just like in Fatal Attraction: No matter how many times Michael Douglas thought he killed Glen Close, she kept rising up out of that bathtub, LOL.

Shall I start to print the private messages that I am getting about this? I find your rudeness fun. Others don't appreciate you patrolling the boards and lashing out.

It doesn't matter if the chicken or the egg came first, my pet. Or if the chicken came with the egg, or the egg came with the chicken.

NO ONE CARES.

All they know is they will NOT be getting the eflow anytime soon. Unless YOU give us each 2000 BUCKS!

Again, many doctors won't precribe the eflow and most insurance companies won't pay for it, except under the circumstances previously described, because of the above stated reason.

Excuse me while I go get my pepper spray while waiting for the next blast...
 
N

Nightwriter

New member
Boy, it's just like in Fatal Attraction: No matter how many times Michael Douglas thought he killed Glen Close, she kept rising up out of that bathtub, LOL.

Shall I start to print the private messages that I am getting about this? I find your rudeness fun. Others don't appreciate you patrolling the boards and lashing out.

It doesn't matter if the chicken or the egg came first, my pet. Or if the chicken came with the egg, or the egg came with the chicken.

NO ONE CARES.

All they know is they will NOT be getting the eflow anytime soon. Unless YOU give us each 2000 BUCKS!

Again, many doctors won't precribe the eflow and most insurance companies won't pay for it, except under the circumstances previously described, because of the above stated reason.

Excuse me while I go get my pepper spray while waiting for the next blast...
 
N

Nightwriter

New member
Boy, it's just like in Fatal Attraction: No matter how many times Michael Douglas thought he killed Glen Close, she kept rising up out of that bathtub, LOL.

Shall I start to print the private messages that I am getting about this? I find your rudeness fun. Others don't appreciate you patrolling the boards and lashing out.

It doesn't matter if the chicken or the egg came first, my pet. Or if the chicken came with the egg, or the egg came with the chicken.

NO ONE CARES.

All they know is they will NOT be getting the eflow anytime soon. Unless YOU give us each 2000 BUCKS!

Again, many doctors won't precribe the eflow and most insurance companies won't pay for it, except under the circumstances previously described, because of the above stated reason.

Excuse me while I go get my pepper spray while waiting for the next blast...
 
N

Nightwriter

New member
Boy, it's just like in Fatal Attraction: No matter how many times Michael Douglas thought he killed Glen Close, she kept rising up out of that bathtub, LOL.

Shall I start to print the private messages that I am getting about this? I find your rudeness fun. Others don't appreciate you patrolling the boards and lashing out.

It doesn't matter if the chicken or the egg came first, my pet. Or if the chicken came with the egg, or the egg came with the chicken.

NO ONE CARES.

All they know is they will NOT be getting the eflow anytime soon. Unless YOU give us each 2000 BUCKS!

Again, many doctors won't precribe the eflow and most insurance companies won't pay for it, except under the circumstances previously described, because of the above stated reason.

Excuse me while I go get my pepper spray while waiting for the next blast...
 
N

Nightwriter

New member
Boy, it's just like in Fatal Attraction: No matter how many times Michael Douglas thought he killed Glen Close, she kept rising up out of that bathtub, LOL.
<br />
<br />Shall I start to print the private messages that I am getting about this? I find your rudeness fun. Others don't appreciate you patrolling the boards and lashing out.
<br />
<br />It doesn't matter if the chicken or the egg came first, my pet. Or if the chicken came with the egg, or the egg came with the chicken.
<br />
<br />NO ONE CARES.
<br />
<br />All they know is they will NOT be getting the eflow anytime soon. Unless YOU give us each 2000 BUCKS!
<br />
<br />Again, many doctors won't precribe the eflow and most insurance companies won't pay for it, except under the circumstances previously described, because of the above stated reason.
<br />
<br />Excuse me while I go get my pepper spray while waiting for the next blast...
<br />
<br />
 
You must log in or register to reply here.
Top