hold48398
04-08-2008, 09:42 PM
I sent the following to my CDE about a week ago:
Hi Chris,
[...] I have a question about a small disclaimer on the Navigator website, which states:
"A portion of the membrane polymer will remain in the skin each time the sensor is removed. Although no health effects were observed or reported in clinical studies, the long term effects of the sensor membrane fragments remaining in the skin have not been determined"
How will this affect the skin's healing, site rotation etc? It concerns me to think that there is a piece of sensor left in Mia's skin every time we change the sensor. How do you feel about this??
Thanks,
Marisa
Btw my CDE was completely FLOORED by the disclaimer, and she immediately sent this to both endos in our practice and noone (and I mean not a single person) had EVER mentioned this to them at any time, not during any conversation, any training or any presentation, so this caught them off guard big big time. They are speculation that this may have also been why the Navigator was sitting at FDA for so long...anyhow this is the reply from Abbott addressing our concern about any membrane left behind:
Hi, Chris,
Good question.
Our sensor technology uses a very thin layer of membrane (commonly used in glucose sensor technologies) to control the movement of glucose in order to measure glucose reliably. When examining sensors from clinical studies under high power microscope, our scientists discovered tiny spots on a small portion of the sensors. This led us to believe that tiny fragments of the membrane material may be left behind after sensor removal from the body. After the finding, we shared the information with the FDA.
Independent testing done even before this finding established that our polymer membrane is biocompatible (a biocompatible material has favorable body response when in contact with body tissue and does not result in toxic or harmful effects) and that it meets the requirements of the standards for medical devices (AAMI/ANSI/ISO standard 10993). Experts on this matter who reviewed our membrane data have also expressed the opinion that membrane remaining in the skin is safe – the membrane does not show any signs of toxicity, biodegradation (break-down inside the body) or adverse reactions. We have also been able to confirm this after active analysis of data from over 194 different subjects. We have identified ways to eliminate the loss of membrane from our sensors and these will be implemented very soon.
The good news the way I see it is that Abbott has found a way to eliminate the possibility for any membrane to be left behind and they will implement "very soon"....Given that the shipment of Navigators will be a few months yet (as per my CDE they are hoping to get complete Navigator training in June/July and start shipping thereafter), I am hopeful that by then the new membranes/sensors will be released, and we don't have to worry about any fragments left behind under Mia's sites...which is not a pretty thought imo, so that is good news. Depending on the timeframes involved, we may or may not delay the purchase of the Navigator system but more likely than not, we will go ahead either way asap. We have money set aside in our Flex Spending Account for this technology this year.
Anyways, I just wanted to provide everyone with an update as I have been told it.:rolleyes:
Hi Chris,
[...] I have a question about a small disclaimer on the Navigator website, which states:
"A portion of the membrane polymer will remain in the skin each time the sensor is removed. Although no health effects were observed or reported in clinical studies, the long term effects of the sensor membrane fragments remaining in the skin have not been determined"
How will this affect the skin's healing, site rotation etc? It concerns me to think that there is a piece of sensor left in Mia's skin every time we change the sensor. How do you feel about this??
Thanks,
Marisa
Btw my CDE was completely FLOORED by the disclaimer, and she immediately sent this to both endos in our practice and noone (and I mean not a single person) had EVER mentioned this to them at any time, not during any conversation, any training or any presentation, so this caught them off guard big big time. They are speculation that this may have also been why the Navigator was sitting at FDA for so long...anyhow this is the reply from Abbott addressing our concern about any membrane left behind:
Hi, Chris,
Good question.
Our sensor technology uses a very thin layer of membrane (commonly used in glucose sensor technologies) to control the movement of glucose in order to measure glucose reliably. When examining sensors from clinical studies under high power microscope, our scientists discovered tiny spots on a small portion of the sensors. This led us to believe that tiny fragments of the membrane material may be left behind after sensor removal from the body. After the finding, we shared the information with the FDA.
Independent testing done even before this finding established that our polymer membrane is biocompatible (a biocompatible material has favorable body response when in contact with body tissue and does not result in toxic or harmful effects) and that it meets the requirements of the standards for medical devices (AAMI/ANSI/ISO standard 10993). Experts on this matter who reviewed our membrane data have also expressed the opinion that membrane remaining in the skin is safe – the membrane does not show any signs of toxicity, biodegradation (break-down inside the body) or adverse reactions. We have also been able to confirm this after active analysis of data from over 194 different subjects. We have identified ways to eliminate the loss of membrane from our sensors and these will be implemented very soon.
The good news the way I see it is that Abbott has found a way to eliminate the possibility for any membrane to be left behind and they will implement "very soon"....Given that the shipment of Navigators will be a few months yet (as per my CDE they are hoping to get complete Navigator training in June/July and start shipping thereafter), I am hopeful that by then the new membranes/sensors will be released, and we don't have to worry about any fragments left behind under Mia's sites...which is not a pretty thought imo, so that is good news. Depending on the timeframes involved, we may or may not delay the purchase of the Navigator system but more likely than not, we will go ahead either way asap. We have money set aside in our Flex Spending Account for this technology this year.
Anyways, I just wanted to provide everyone with an update as I have been told it.:rolleyes: