@Timothy , this is more for the rest of the folks since you are a long time ‘resident’ here at tuDiabetes. This is about wearing a Dexcom in locations outside those approved in writing to the prescribing endocrinologist. The patient should have a copy of the letter approving the variance based on significant research. Most of this was shared by my endo’s pump team.
First.
In early 2021, another placement reared itself. Child protective services were involved with a child after an unrelated emergency room visit for a trauma event. The CPS notice indicated an ER doctor notified CPS because the pump (brand not specified) & Dexcom were not placed according to standards. The conjecture related to placement is wide open. Take away, would site & sensor placement pass CPS scrutiny?
The rest of the information:
As far as the CGM sites are concerned in the USA, using a site outside those approved by the FDA following Dexcom research and development place you in peril of footing the bill if you lose a wire. Sure, G6 is approved in other countries for other locations beyond the abdomen. Here in the USA, you are limited to the belly.
Here’s why. From what is written about the way FDA does approvals, we are still in the post-thalidomide tragedy mentality of the early 1960’s. To some this may seem harsh, yet it is true. The US Congress and American people supported a “never again” mentality will anything be approved unless it is safe. The cases of phocomelia were horrible. Some say this is strong language, however, it is still used today in language related to FDA rationale, power, and need for authority.
Here in the states, everything must be checked and double checked and scientifically proven to be safe. Who knows, until proven otherwise, the placement of CGM sensor wires in the upper arm may provoke the growth of new hands in the upper harms (NOT).
The understanding the regulatory process is, if a prescriber wants to use something in a manner different than approved by the FDA (called off label), the prescriber must write to the manufacturer, describe the situation, and request off label approval. Many people are told by their prescribing doctors, “Oh, just go ahead and do it.”, not realizing the Pandora’s box which may be opened in a misadventure. I have seen local newspaper coverage in days past of malpractice lawsuits shining the light on such issues.
The purpose of this group is support. Sharing published regulatory & usage information is a form of support. Providing information from contradictory, inapplicable, & unfounded sources without substantiation is not supportive & may in the opinion of others be an undermining of veracity.
In regard to claims about sites, it is the savvy claims clerk in the insurance company that creates the problems related to off-label use.
When a claim comes in for the removal of a wire from, hypothetically, posterior upper arm, and the insurance clerk notifies the hospital or doctor making the claim, additional information is needed. What type of wire? If the response is a Dexcom CGM sensor wire, the clerk checks to see if the device was being used according to published standards.
If the device was not being used according to published standards, the insurance clerk should deny the claim as ‘device not used as prescribed’ (because the prescription is for an FDA regulated device to be used according to FDA authorization). Failure to use according to directions, without variance, constitutes negligent usage, placing the onus, and therefore the bill, on the user.
The point of my post about ‘proper placement’ is not what the patient would tell anyone. It is what the health care bill to the insurance company would reveal and the sequelae.
One additional item to remember is being told by a prescriber it is permissible to use an item outside FDA authorization or ‘off label’ in the case of devices requires the device manufacturer to be notified and acknowledge the variance in writing according to the FDA.
Anyone in this situation should verify and obtain copies of correspondence their physicians have had with Dexcom seeking approval of off label locations and the clinical reason for the requests.
The mountain of off-label requests will be the only impetus medical device manufacturers have to re-open the approval process and divert resources to current product situations. In the meantime, inspection of medical device companies’ prospectus (yes, the plural of prospectus is prospectus - see Oxford Dictionary) will show major investment in R&D (new product research & development [FDA required testing, etc])
BOTTOM LINE: As informed users of ‘restricted medical devices’ (restricted medical device includes but is not limited to a device & accessories requiring a physician’s prescription), we the users must learn the “Thalidomide era” safeguards and apply those same rules to have common sense brought to the forefront. Here is the link from the Dexcom website (make sure you are on the USA page):
Where can I insert my Dexcom? [link is for USA – country selection is in upper right of screen]
As an additional regulatory oddity, this is the same as connected INSULIN PUMPs on airplanes. I have yet to find in FAA regulations the full approval process demonstrating insulin pumps are safe to use on commercial aircraft and that the radio waves generated, or electromagnetic interference (EMI) will not cause the plane to crash. Twenty year ago, when CGMs were first making their appearance, there was rattle about the radio waves from the CGM transmitter being in the same frequency range as some important avionics. Use of items operating in those frequencies were unproven and deemed (by FAA regulation) dangerous until proven safe. (one of the reasons given 20+ years ago when I started pumping).
This is a long post. The picture is big. Let’s pull together and get the eyes opened so location in one country is good in another.
Hope this provides the sunshine needed. The comment is to illuminate the situation.
to test