e-flow

[NoExcuses]

1. There seems to be a large misunderstanding regarding how medications and delivery devices go through FDA approval. So let me explain. To bring a drug to the market, the manufacturer uses a delivery device. Pulmozyme used various traditional nebs & compressors because that's what was on the market in the early 90s. There is no requirement for the manufacturer's of Pulmozyme to do tests for the eFlow. Pulmozyme is already FDA approved. The eFlow, on the same token, does not have to come to the market with a drug. It's simply a drug delivery device.

Here's another example. Albuterol came to the market prior to the traditional nebs/compressors we use today. But the traditional nebs/compressors that we use today didn't have to come to market being tested for albuterol. On the same token, the manufacturer of albuterol didn't have to conduct studies for the new nebs/compressors we use today.

2. Studies have been done, so smack your lawyer friend Jen. In fact, blood samples as well as sputum samples have been done using the eFlow comparing blood and sputum samples with traditional nebs (this is how dose efficacy is measured). So your lawyer friend is grossly misinformed. Colistin is studied and many use the eFlow with Colistin and Pulmozyme and we aren't dead. I would never decide to not use a med or delivery device based on a sensationalized story that I don't know the details of.

3. Using Tobramycin or Colistin is not "off label." Labels, aka what the FDA states in prescribing information, is for types of diseases the drug is indicated for. Switching a delivery device for a medication is not off label. In fact, if you're waiting for the FDA to get involved in approving drugs for the eFlow after the drugs have received approval to market (Pulmozyme, tobramycin, Colistin) you are going to be waiting in perpetuity. That is not how the FDA works.

So, as Jen said, <b> do you due dilligence </b> as opposed to listening to random stories people say and/or not reading published clinical studies.

If you wish to view the eFlow studies with Pulmozyme, tobramycin and colistin, visit my blow. Scroll down to the left and under categories, click "eFlow."


Skye, in terms of your use for EAP, I would stick with what they tell you because you're in a clinical trial. They are concerned about the proper cleaning and regulation of eFlow use. I don't think using the eFlow with other meds is a big deal, but for the integrity of the study, I would hold off.

 

[NoExcuses]

1. There seems to be a large misunderstanding regarding how medications and delivery devices go through FDA approval. So let me explain. To bring a drug to the market, the manufacturer uses a delivery device. Pulmozyme used various traditional nebs & compressors because that's what was on the market in the early 90s. There is no requirement for the manufacturer's of Pulmozyme to do tests for the eFlow. Pulmozyme is already FDA approved. The eFlow, on the same token, does not have to come to the market with a drug. It's simply a drug delivery device.

Here's another example. Albuterol came to the market prior to the traditional nebs/compressors we use today. But the traditional nebs/compressors that we use today didn't have to come to market being tested for albuterol. On the same token, the manufacturer of albuterol didn't have to conduct studies for the new nebs/compressors we use today.

2. Studies have been done, so smack your lawyer friend Jen. In fact, blood samples as well as sputum samples have been done using the eFlow comparing blood and sputum samples with traditional nebs (this is how dose efficacy is measured). So your lawyer friend is grossly misinformed. Colistin is studied and many use the eFlow with Colistin and Pulmozyme and we aren't dead. I would never decide to not use a med or delivery device based on a sensationalized story that I don't know the details of.

3. Using Tobramycin or Colistin is not "off label." Labels, aka what the FDA states in prescribing information, is for types of diseases the drug is indicated for. Switching a delivery device for a medication is not off label. In fact, if you're waiting for the FDA to get involved in approving drugs for the eFlow after the drugs have received approval to market (Pulmozyme, tobramycin, Colistin) you are going to be waiting in perpetuity. That is not how the FDA works.

So, as Jen said, <b> do you due dilligence </b> as opposed to listening to random stories people say and/or not reading published clinical studies.

If you wish to view the eFlow studies with Pulmozyme, tobramycin and colistin, visit my blow. Scroll down to the left and under categories, click "eFlow."


Skye, in terms of your use for EAP, I would stick with what they tell you because you're in a clinical trial. They are concerned about the proper cleaning and regulation of eFlow use. I don't think using the eFlow with other meds is a big deal, but for the integrity of the study, I would hold off.

 

[NoExcuses]

1. There seems to be a large misunderstanding regarding how medications and delivery devices go through FDA approval. So let me explain. To bring a drug to the market, the manufacturer uses a delivery device. Pulmozyme used various traditional nebs & compressors because that's what was on the market in the early 90s. There is no requirement for the manufacturer's of Pulmozyme to do tests for the eFlow. Pulmozyme is already FDA approved. The eFlow, on the same token, does not have to come to the market with a drug. It's simply a drug delivery device.

Here's another example. Albuterol came to the market prior to the traditional nebs/compressors we use today. But the traditional nebs/compressors that we use today didn't have to come to market being tested for albuterol. On the same token, the manufacturer of albuterol didn't have to conduct studies for the new nebs/compressors we use today.

2. Studies have been done, so smack your lawyer friend Jen. In fact, blood samples as well as sputum samples have been done using the eFlow comparing blood and sputum samples with traditional nebs (this is how dose efficacy is measured). So your lawyer friend is grossly misinformed. Colistin is studied and many use the eFlow with Colistin and Pulmozyme and we aren't dead. I would never decide to not use a med or delivery device based on a sensationalized story that I don't know the details of.

3. Using Tobramycin or Colistin is not "off label." Labels, aka what the FDA states in prescribing information, is for types of diseases the drug is indicated for. Switching a delivery device for a medication is not off label. In fact, if you're waiting for the FDA to get involved in approving drugs for the eFlow after the drugs have received approval to market (Pulmozyme, tobramycin, Colistin) you are going to be waiting in perpetuity. That is not how the FDA works.

So, as Jen said, <b> do you due dilligence </b> as opposed to listening to random stories people say and/or not reading published clinical studies.

If you wish to view the eFlow studies with Pulmozyme, tobramycin and colistin, visit my blow. Scroll down to the left and under categories, click "eFlow."


Skye, in terms of your use for EAP, I would stick with what they tell you because you're in a clinical trial. They are concerned about the proper cleaning and regulation of eFlow use. I don't think using the eFlow with other meds is a big deal, but for the integrity of the study, I would hold off.

 

[NoExcuses]

1. There seems to be a large misunderstanding regarding how medications and delivery devices go through FDA approval. So let me explain. To bring a drug to the market, the manufacturer uses a delivery device. Pulmozyme used various traditional nebs & compressors because that's what was on the market in the early 90s. There is no requirement for the manufacturer's of Pulmozyme to do tests for the eFlow. Pulmozyme is already FDA approved. The eFlow, on the same token, does not have to come to the market with a drug. It's simply a drug delivery device.

Here's another example. Albuterol came to the market prior to the traditional nebs/compressors we use today. But the traditional nebs/compressors that we use today didn't have to come to market being tested for albuterol. On the same token, the manufacturer of albuterol didn't have to conduct studies for the new nebs/compressors we use today.

2. Studies have been done, so smack your lawyer friend Jen. In fact, blood samples as well as sputum samples have been done using the eFlow comparing blood and sputum samples with traditional nebs (this is how dose efficacy is measured). So your lawyer friend is grossly misinformed. Colistin is studied and many use the eFlow with Colistin and Pulmozyme and we aren't dead. I would never decide to not use a med or delivery device based on a sensationalized story that I don't know the details of.

3. Using Tobramycin or Colistin is not "off label." Labels, aka what the FDA states in prescribing information, is for types of diseases the drug is indicated for. Switching a delivery device for a medication is not off label. In fact, if you're waiting for the FDA to get involved in approving drugs for the eFlow after the drugs have received approval to market (Pulmozyme, tobramycin, Colistin) you are going to be waiting in perpetuity. That is not how the FDA works.

So, as Jen said, <b> do you due dilligence </b> as opposed to listening to random stories people say and/or not reading published clinical studies.

If you wish to view the eFlow studies with Pulmozyme, tobramycin and colistin, visit my blow. Scroll down to the left and under categories, click "eFlow."


Skye, in terms of your use for EAP, I would stick with what they tell you because you're in a clinical trial. They are concerned about the proper cleaning and regulation of eFlow use. I don't think using the eFlow with other meds is a big deal, but for the integrity of the study, I would hold off.

 

[NoExcuses]

1. There seems to be a large misunderstanding regarding how medications and delivery devices go through FDA approval. So let me explain. To bring a drug to the market, the manufacturer uses a delivery device. Pulmozyme used various traditional nebs & compressors because that's what was on the market in the early 90s. There is no requirement for the manufacturer's of Pulmozyme to do tests for the eFlow. Pulmozyme is already FDA approved. The eFlow, on the same token, does not have to come to the market with a drug. It's simply a drug delivery device.

Here's another example. Albuterol came to the market prior to the traditional nebs/compressors we use today. But the traditional nebs/compressors that we use today didn't have to come to market being tested for albuterol. On the same token, the manufacturer of albuterol didn't have to conduct studies for the new nebs/compressors we use today.

2. Studies have been done, so smack your lawyer friend Jen. In fact, blood samples as well as sputum samples have been done using the eFlow comparing blood and sputum samples with traditional nebs (this is how dose efficacy is measured). So your lawyer friend is grossly misinformed. Colistin is studied and many use the eFlow with Colistin and Pulmozyme and we aren't dead. I would never decide to not use a med or delivery device based on a sensationalized story that I don't know the details of.

3. Using Tobramycin or Colistin is not "off label." Labels, aka what the FDA states in prescribing information, is for types of diseases the drug is indicated for. Switching a delivery device for a medication is not off label. In fact, if you're waiting for the FDA to get involved in approving drugs for the eFlow after the drugs have received approval to market (Pulmozyme, tobramycin, Colistin) you are going to be waiting in perpetuity. That is not how the FDA works.

So, as Jen said, <b> do you due dilligence </b> as opposed to listening to random stories people say and/or not reading published clinical studies.

If you wish to view the eFlow studies with Pulmozyme, tobramycin and colistin, visit my blow. Scroll down to the left and under categories, click "eFlow."


Skye, in terms of your use for EAP, I would stick with what they tell you because you're in a clinical trial. They are concerned about the proper cleaning and regulation of eFlow use. I don't think using the eFlow with other meds is a big deal, but for the integrity of the study, I would hold off.

 

[NoExcuses]

Per the FDA:

The FDA has cleared the eFlow for use "with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult and pediatric patients."

 

[NoExcuses]

Per the FDA:

The FDA has cleared the eFlow for use "with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult and pediatric patients."

 

[NoExcuses]

Per the FDA:

The FDA has cleared the eFlow for use "with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult and pediatric patients."

 

[NoExcuses]

Per the FDA:

The FDA has cleared the eFlow for use "with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult and pediatric patients."

 

[NoExcuses]

Per the FDA:

The FDA has cleared the eFlow for use "with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult and pediatric patients."

 

[Chaggie]

<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Giggles</b></i>

ALso, my doc explained that how the eflow works is the medications are put into the eflow and it is electrically charged and formed into a mist and then SUPER fast delivery. Well nobody knows if this electric charge CHANGES the molecules and makeup of the med and therefore who knows if it changes it, damages it, enhances it. I did not want to take a chance of using the Eflow with meds like Tobi and Pulmozyme if it is not approved with the Eflow. He did say you should be all right with ALbuterol cause it is a big molecule and probably does not change much. </end quote></div>


Giggles, that isn't how the flow works. it has a vibrating mesh screen with thousands of holes that turns it into a mist, no electricity comes in contact with the medication.

Sorry a little off on that. It not the screen that vibrates it's the vibration element that vibrates the mesh in the domed aperture is moved up and down by the vibrating element. but again the med does not come in contact with electricity.

Here's a description on the technology <a target=_blank class=ftalternatingbarlinklarge href="http://www.touchbriefings.com/pdf/14/lth031_t_Omron.pdf">http://www.touchbriefings.com/pdf/14/lth031_t_Omron.pdf</a>


Interestingly other nebulizers are using the same technology, areogen is one of them

 

[Chaggie]

<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Giggles</b></i>

ALso, my doc explained that how the eflow works is the medications are put into the eflow and it is electrically charged and formed into a mist and then SUPER fast delivery. Well nobody knows if this electric charge CHANGES the molecules and makeup of the med and therefore who knows if it changes it, damages it, enhances it. I did not want to take a chance of using the Eflow with meds like Tobi and Pulmozyme if it is not approved with the Eflow. He did say you should be all right with ALbuterol cause it is a big molecule and probably does not change much. </end quote></div>


Giggles, that isn't how the flow works. it has a vibrating mesh screen with thousands of holes that turns it into a mist, no electricity comes in contact with the medication.

Sorry a little off on that. It not the screen that vibrates it's the vibration element that vibrates the mesh in the domed aperture is moved up and down by the vibrating element. but again the med does not come in contact with electricity.

Here's a description on the technology <a target=_blank class=ftalternatingbarlinklarge href="http://www.touchbriefings.com/pdf/14/lth031_t_Omron.pdf">http://www.touchbriefings.com/pdf/14/lth031_t_Omron.pdf</a>


Interestingly other nebulizers are using the same technology, areogen is one of them

 

[Chaggie]

<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Giggles</b></i>

ALso, my doc explained that how the eflow works is the medications are put into the eflow and it is electrically charged and formed into a mist and then SUPER fast delivery. Well nobody knows if this electric charge CHANGES the molecules and makeup of the med and therefore who knows if it changes it, damages it, enhances it. I did not want to take a chance of using the Eflow with meds like Tobi and Pulmozyme if it is not approved with the Eflow. He did say you should be all right with ALbuterol cause it is a big molecule and probably does not change much. </end quote></div>


Giggles, that isn't how the flow works. it has a vibrating mesh screen with thousands of holes that turns it into a mist, no electricity comes in contact with the medication.

Sorry a little off on that. It not the screen that vibrates it's the vibration element that vibrates the mesh in the domed aperture is moved up and down by the vibrating element. but again the med does not come in contact with electricity.

Here's a description on the technology <a target=_blank class=ftalternatingbarlinklarge href="http://www.touchbriefings.com/pdf/14/lth031_t_Omron.pdf">http://www.touchbriefings.com/pdf/14/lth031_t_Omron.pdf</a>


Interestingly other nebulizers are using the same technology, areogen is one of them

 

[Chaggie]

<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Giggles</b></i>

ALso, my doc explained that how the eflow works is the medications are put into the eflow and it is electrically charged and formed into a mist and then SUPER fast delivery. Well nobody knows if this electric charge CHANGES the molecules and makeup of the med and therefore who knows if it changes it, damages it, enhances it. I did not want to take a chance of using the Eflow with meds like Tobi and Pulmozyme if it is not approved with the Eflow. He did say you should be all right with ALbuterol cause it is a big molecule and probably does not change much. </end quote>


Giggles, that isn't how the flow works. it has a vibrating mesh screen with thousands of holes that turns it into a mist, no electricity comes in contact with the medication.

Sorry a little off on that. It not the screen that vibrates it's the vibration element that vibrates the mesh in the domed aperture is moved up and down by the vibrating element. but again the med does not come in contact with electricity.

Here's a description on the technology <a target=_blank class=ftalternatingbarlinklarge href="http://www.touchbriefings.com/pdf/14/lth031_t_Omron.pdf">http://www.touchbriefings.com/pdf/14/lth031_t_Omron.pdf</a>


Interestingly other nebulizers are using the same technology, areogen is one of them

 

[Chaggie]

<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Giggles</b></i>

ALso, my doc explained that how the eflow works is the medications are put into the eflow and it is electrically charged and formed into a mist and then SUPER fast delivery. Well nobody knows if this electric charge CHANGES the molecules and makeup of the med and therefore who knows if it changes it, damages it, enhances it. I did not want to take a chance of using the Eflow with meds like Tobi and Pulmozyme if it is not approved with the Eflow. He did say you should be all right with ALbuterol cause it is a big molecule and probably does not change much. </end quote>


Giggles, that isn't how the flow works. it has a vibrating mesh screen with thousands of holes that turns it into a mist, no electricity comes in contact with the medication.

Sorry a little off on that. It not the screen that vibrates it's the vibration element that vibrates the mesh in the domed aperture is moved up and down by the vibrating element. but again the med does not come in contact with electricity.

Here's a description on the technology <a target=_blank class=ftalternatingbarlinklarge href="http://www.touchbriefings.com/pdf/14/lth031_t_Omron.pdf">http://www.touchbriefings.com/pdf/14/lth031_t_Omron.pdf</a>


Interestingly other nebulizers are using the same technology, areogen is one of them

 

[Skye]

You guys rock! Thanks for all the great replies. I intend to stay with just the AL for now in use with the e-flow. I was just very curious what others are doing who own the e-flow and what the future might be for me as AL becomes approved for the market and I am not bound by their guidelines. Some exciting stuff in the pipeline for all of us, so keep pushin and takin care of yourselves! Thank you all again.

 

[Skye]

You guys rock! Thanks for all the great replies. I intend to stay with just the AL for now in use with the e-flow. I was just very curious what others are doing who own the e-flow and what the future might be for me as AL becomes approved for the market and I am not bound by their guidelines. Some exciting stuff in the pipeline for all of us, so keep pushin and takin care of yourselves! Thank you all again.

 

[Skye]

You guys rock! Thanks for all the great replies. I intend to stay with just the AL for now in use with the e-flow. I was just very curious what others are doing who own the e-flow and what the future might be for me as AL becomes approved for the market and I am not bound by their guidelines. Some exciting stuff in the pipeline for all of us, so keep pushin and takin care of yourselves! Thank you all again.

 

[Skye]

You guys rock! Thanks for all the great replies. I intend to stay with just the AL for now in use with the e-flow. I was just very curious what others are doing who own the e-flow and what the future might be for me as AL becomes approved for the market and I am not bound by their guidelines. Some exciting stuff in the pipeline for all of us, so keep pushin and takin care of yourselves! Thank you all again.

 

[Skye]

You guys rock! Thanks for all the great replies. I intend to stay with just the AL for now in use with the e-flow. I was just very curious what others are doing who own the e-flow and what the future might be for me as AL becomes approved for the market and I am not bound by their guidelines. Some exciting stuff in the pipeline for all of us, so keep pushin and takin care of yourselves! Thank you all again.