Are these approved in Canada?

[tabitha]

Are home monitoring kits available in Canada? When I spoke with the Aortic Clinic here in Ottawa, I was told that they are not approved so I can't get one and it's to the lab I go....However, the more I read here, the more I see that some Canadians do have one. Anyone know the deal?

 

[Greg a]

Freddie in Edmonton uses one and BINA near you does as well I think....heck Freddie said she even saw Costco doing a demo on them

 

[Freddie]

Correction Greg: Freddie is in Saskatoon.
Answer to you question Tabitha: ignorance

In 2008 I e-mailed Health Canada in regards of the Coagucheck XS being licensed in Canada, only because my doctor insisted they were not licensed (I later got a prescription from my Cardio to get the unit).

**Please note that this Len Yuc may no longer be the Regulatory Information Officer**

Here is the response I received from Health Canada:

The manufacturer, Roche Diagnostics GMBH, currently holds a Medical Device Licence (#73487) to import/sell the Coaguchek XS Plus Monitor (Device Identifier 04800842190) in Canada. We cannot provide you a copy of the licence. However, you (and your doctor) can view this information on the Medical Devices Active Licence Listing website at www.mdall.ca.

If you have further licensing questions, please feel free to contact our office again.

Sincerely,
Yen Luc
Regulatory Information Officer
Regulatory & Scientific Information Section
Device Licensing Services Division
Medical Devices Bureau
Health Canada
Phone: (613) 952-9154
Fax: (613) 957-6345

 

[Greg a]

oooooooooops

 

[Freddie]

BTW Tabitha, these units are also being used in Alberta and B.C. in hospitals and clinics.

 

[bdryer]

Hi

I have a couagcheck xs. In Alberta you can purchase the device through either the co-op or London drugs. A prescription is required.

Co-op is pretty much unique to Alberta. London drug outlets are available in the 4 western provinces.

 

[tabitha]

hmmm, interesting. SOmething I'll definitely have to talk to my surgeon or cardiologist more about, eh?

 

[AgilityDog]

Sounds like your LAB doesn't approve of home testing because it cuts into their business.

 

[Bina]

Are home monitoring kits available in Canada? When I spoke with the Aortic Clinic here in Ottawa, I was told that they are not approved so I can't get one and it's to the lab I go....However, the more I read here, the more I see that some Canadians do have one. Anyone know the deal?

Tabitha, the person you spoke with at your Clinic needs to be updated on the status of INR home monitors in Canada !!
The monitor we use is the Coaguchek XS.....it is manufactured and imported from Germany, a leader in medical devices.
Even the small medical lab where I go for other blood tests knew about the machine and wanted one for her clinic.

Anyway, what I did first was to call Roche Diagnostics in Laval, Quebec. 1-877-426-2482 and a nice customer service rep sent me
a pamphlet in the mail. I showed it to my regular GP doctor, he was impressed and wrote me a prescription.
I called back Roche, they gave me the closest pharmacy that would order the monitor for me.
2 weeks later the monitor arrived, I got the call, went for a 20 minute training session, paid the $500 and was on my way.
It is that simple when we take matters into our own hands.
Let me know how it goes. I'm not too far from Ottawa

 

[sarahsunshine]

You'll get more information from others no how to do it, but we were given ours on loan from the clinic starting in 2002 (I think). Then we bought our own (covered by Blue Cross Insurance with a prescription from the doctor) in 2008. I doubt Blue cross would cover if it was illegal!

Anyway, Don't just get one, call your insurance company to see if they will cover it. Blue Cross also covers the strips at 100%, so that's a plus too. My DH's insurance sometimes covers the strips at 80% and sometimes doesn't. It's hit and miss (SunLife).

Ooops... we're in Edmonton.

 

[sarahsunshine]

I just found a list of Coagucheck certified pharmacies in Canada online (from 2009)- and there are 4 in Ottawa with phone numbers. Try here:
rochecanada.com/fmfiles/re7234008/Docs/pharmacies.pdf

Medical Art Dispensary 160 Elgin St. Ottawa ON K2P 2P7 (613) 232-4854
Parkway Pharmacy 311 Mcarthur Avenue Ottawa ON K1L 6P1 (613) 749-2324
Shoppers Drug Mart #631 Rideau Centre-50 Rideau Street Ottawa ON K1N 9J7 (613) 236-2533
White Cross Dispensary 264 Elgin ST Ottawa ON K2P 1M2 (613) 233-4029

 

[ottagal]

I'm surprised to hear that as I heard of a few people in Ottawa who were home testing (and were patients at the Heart Institute). I know the surgeon/cardio wanted them to initially get a blood draw at the clinic until they were satisfied with their INR levels.

 

[Bev]

The Coaguchek units are available in Hamilton. It seems like a lot of lab people are not well informed about self-testing. My sister in BC was told by a lab tech that the self-testing units are only used in Europe. (Really??) I look forward to getting my own machine soon.

 

[Bina]

Whatever you do, (in Canada), keep your receipts. Most private insurances will cover 80% of the test strips, but not the monitor.
However, both the monitor and test strips are accepted under medical expenses on your yearly tax return.

 

[tabitha]

I spoke with the surgeon and he stresses that they are not approved in north america! Interesting. He did say that a lot of people use them, but they are not recommended by health canada for sure. I still have to check with my insurance to see if they'd cover something, but if it's not approved by HC, I can't see how it would be covered?

I know my regular pharmacist doesn't carry them, and he said for the same reason (HC) but that he could order one in for me if I wanted him to.

If I get one, I know I'd still go to the lab for a loooooong time as I'm pretty paranoid that way

 

[Roberta]

This is interesting. A friend of mine (who had a mechanical valve implanted) went to two heart surgeons for pre surgical consults (at the same hospital). One surgeon brought up the home testing and encouraged it (along with hospital monitoring) and the other said no to it.

That's a head scratcher. :confused2:

Tabitha, when you say they are not approved in North America that would include the US. However, the US uses the FDA for approval. I wonder if they are FDA approved?

 

[Roberta]

[Tabitha, when you say they are not approved in North America that would include the US. However, the US uses the FDA for approval. I wonder if they are FDA approved?[/QUOTE]



I found the answer. Coagucheck is FDA approved.
http://www.coaguchek.com/com/index.php?target=/en/professionals/products/coaguchek_xs_system

 

[Freddie]

Tabitha; copy and paste in your Word document the following and show it to your surgeon and doctors - just leave out the name Yen Luc as I am not sure if she/he is still the Regulatory Information Officer. My doctor(GP) said the same thing that "these devices were not licensed in Canada" and got VERY upset with me......until I showed my doctor the following e-mail (darn near threw the copy in their face). Now to keep the doc happy I go to the lab about once a month or so and self test every two, because the doc wants their money too.

This is proof that they are licensed by Health Canada. Keep a copy for yourself and give one to every doctor you see. My cardio took my word for it and gave me the prescription for the home monitor. Good man he is, didn't have to show him any proof.
This is evidence and it will also give your doctors something to research if they still don't believe you.

Here is the response I received from Health Canada:

The manufacturer, Roche Diagnostics GMBH, currently holds a Medical Device Licence (#73487) to import/sell the Coaguchek XS Plus Monitor (Device Identifier 04800842190) in Canada. We cannot provide you a copy of the licence. However, you (and your doctor) can view this information on the Medical Devices Active Licence Listing website at www.mdall.ca.

If you have further licensing questions, please feel free to contact our office again.

Sincerely,
Yen Luc
Regulatory Information Officer
Regulatory & Scientific Information Section
Device Licensing Services Division
Medical Devices Bureau
Health Canada
Phone: (613) 952-9154
Fax: (613) 957-6345

 

[sarahsunshine]

Copied and pasted from the above web page:

Manufacturer
Company ID: 114999
ROCHE DIAGNOSTICS GMBH
Sandhofer Strasse 116
Mannheim, DE, 68305



Full Active Licence Listings of ROCHE DIAGNOSTICS GMBH


Licence No.: 73487 Type: Device Family

Licence Section
Device Class First Issue Date End Date Licence Name
3 2007-02-28 PROTHROMBIN TIME (PT) MONITOR



Device Section
First Issue Date End Date Device Name
2007-02-28 COAGUCHEK XS PLUS MONITOR

Identifier Section
First Issue Date End Date Device Identifier
2007-02-28 04800842190



Device Section
First Issue Date End Date Device Name
2011-01-10 COAGUCHEK XS PRO MONITOR
Identifier Section
First Issue Date End Date Device Identifier
2011-01-10 05530199190

 

[sweetmarie]

You'll get more information from others no how to do it, but we were given ours on loan from the clinic starting in 2002 (I think). Then we bought our own (covered by Blue Cross Insurance with a prescription from the doctor) in 2008. I doubt Blue cross would cover if it was illegal!

Anyway, Don't just get one, call your insurance company to see if they will cover it. Blue Cross also covers the strips at 100%, so that's a plus too. My DH's insurance sometimes covers the strips at 80% and sometimes doesn't. It's hit and miss (SunLife).

Ooops... we're in Edmonton.

sarasunshine: I'm with Sunlife too. Just out of curiosity, who do you mean by your DH?
Thanks, SM