FDA Page on Dexcom SEVEN
The Food and Drug Administration has published a page with background information about the Dexcom SEVEN approval.According to the page the Dexcom SEVEN was approved on May 31st, and a pointer to the approval letter(PDF) is provided. So Dexcom really didn't delay at all before telling us about it.
It's interesting to see the history of the Dexcom filing with the FDA
Filed: June 9, 2006I don't think this amount of filing is unusual, but it gives some insight into the amount of work needed for FDA approval.
Amended: July 11, August 4, November 21, November 24, and November 28,
2006, and February 9, April 20, and April 23, 2007
There's also an indirect pointer to the 74-page Dexcom SEVEN user manual(PDF).
Two points in the background notice jump out for me. The first I already knew and the second is a little vague:
- Use of acetaminophen-containing medication when the STS-7 sensor is inserted may affect the performance of the device.
- The Dexcom STS-7 System must be removed prior to MRI
Does this mean that I need to remove the sensor and the transmitter before an MRI, or that I just need to remove the transmitter? I'll have to clarify that one with Dexcom. Update: I exchanged emails with Dexcom customer support. When having an MRI I need to remove the transmitter and sensor and leave the entire system in another room.
If the FDA only points out issues with acetaminophen, then it appears that use of other drugs doesn't cause issues. That's good, because I've already seen the impact of acetaminophen on the Dexcom STS that I'm wearing and it's not good.
I'm still waiting on my Dexcom SEVEN. I hope to see it in a week or so.
Note: I currently own some shares in Dexcom, I work not to let this ownership influence what I say about the company or its products.
posted by Bernard @ 6:11 AM
5 Comments:
Bernard,
There is a list of drugs that the FDA looks at when approving new devices and drugs. It does not include all drugs, just some very common ones like Tylenol, blood thinners, and those that are removed from the body using specific cytochromes.
So it is possible other drugs may have an effect. If you notice a change in results after starting a new drug, you may have to challenge test it to find out if it is causing the problem.
Re the MRI I read something about this very recently, but can't find it. It said that exposure to the MRI could break the Dexcom, so I'd assume it is the main unit, not the sensor. It also said that exposure to weaker magnetic fields in the environment weren't a problem.
Any metal near an MRI machine would be attracted by the magnet.
Lots of information on MRI's on the IP email list lately because Minimed got recalled.
yeah I'm sure the 1.5+ Tesla magnetic field in an MRI would screw up the electronics in the sensor. Same thing for a pump--I would never wear my pump in an MRI. I doubt that the MRI tech would even let you.
I wonder if the 3-day sensor is also affected by acetomenophen.
And can you tell anywhere whether the 7-day sensor is any different from the 3-day? I am just suspecting that they showed the 3-day could last longer at this point...
Even worse - if there is metal in the transmitter that is under your skin it could be ripped out during an MRI. A couple years ago a kid was killed during an MRI at Northern Westchester when the technician didn't remove an oxygen tank from the MRI room.
Bernard,
I think the sensor needs to be removed from the skin prior to an MRI, rather than just disconnecting the transmitter and leaving the receiver in another room.
I had an MRI around two weeks after starting to use CGM last July, and as I wasn't sure, (and neither was anyone else, never having seen such a thing) I pulled the entire lot. If there is anything ferromagnetic within the sensor it will, as Wingman said, be pulled out of your skin to the magnet in the scanner. It isn't worth the risk to find out.
Non-ferromagnetic metals are fine with MRI, but anything computer based, such as a CGM receiver or pump, will likely be corrupted, which is why there is such heavy duty screening between the scanner and the computer control room!
X-rays, on the other hand, seem not to have affected any of the Medtronic transmitters I've owned (Guardian RT, original Paradigm and Minilink). All have been exposed to CT and been fine.
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