Our Blog / the diabetes online community on accuracy

FDA considers a glucose meter and strips a complete system. When a third party manufacturer makes test strips for a meter, who do you think should be responsible for a problem: the meter company, the strip company or the patient for not seeing the fine print and matching the meter with the correct production date corresponding to the strips?

FDA draft guidance speaks of Third Party Strips starting at line 990 of their draft guidance. They say:

Third party test strips refer to test strips manufactured and distributed by a company other than the company that manufactures and distributes the glucose meter. Third party strip manufacturers should ensure that they are aware of any design changes to the meter, because such changes could affect compatibility of the strip with the meter. We strongly recommend that agreements between the third party strip manufacturer and the meter manufacturer are in place to ensure that the third party strip manufacturer is made aware of any design changes to the meter. In cases where this is not possible, the third-party strip manufacturers should sufficiently address, in their submission, how they will mitigate the risk of incorrect results due to meter design changes.

Think that is an academic issue?

Until there is a clarification of who is responsible for adverse event reporting due to an inaccurate reading using a third party strip manufacturer, do you feel that you can strip safely?

Amazon sells two different third party brand strips. One  requires a OneTouch® meter, “purchased before October 2012,” the other,purchased before July 2010.” That is not readily apparent at Amazon.

It is your diabetes. What do you think is sufficient to StripSafely?

CLICK HERE TO COMMENT ON THIRD PARTY STRIP ACCOUNTABILITY

 

Update 4/17:
Diabetes Mine‘s Mike H. has a full article with all kinds of interesting detail and  reader comments on generics. Have a look.
http://www.diabetesmine.com/2014/04/here-come-generics-test-strips-etc.html

Our view is all systems need to come up to the new guidance accuracy levels and that standard should be mandatory. Generics must have agreements in place with the device manufacturer so patients know who is accountable for what.

Bennet Dunlap

11 Comments

  1. To my knowledge, I have never used a test strip from a third-party manufacturer? I’ve always used the same brand as the meter — in this case One Touch for my One Touch Animas Meter. I do think the “buyer beware” should be a part of this discussion. However, I would agree that third party strip accountability rests with the Strip manufacturer.

    We strongly recommend that agreements between the third party strip manufacturer and the meter manufacturer are in place to ensure that the third party strip manufacturer is made aware of any design changes to the meter. In cases where this is not possible, the third-party strip manufacturers should sufficiently address, in their submission, how they will mitigate the risk of incorrect results due to meter design changes.

    Mike
    werthecure.com

    Reply
  2. Brigid O'Donnell

    I submitted comments for a second time to the FDA. Thank you for crafting the comments so succinctly.
    I am wondering if people who use the 3rd party manufacturer are ones without insurance or can’t afford the name brand strips. Also,is it true that Medicare doesn’t cover strips for it’s members? If so, then I can understand why seniors or others with less income may be have no other option then to buy strips that are more affordable. I may be incorrect in assuming that 3rd party strips are less expensive though.

    Reply
    • Thanks! Glad to hear it was easy to comment. That is our goal.

      Every voice counts!

      Cost certainly is an issue. At StripSafely take the position that a reasonably accurate systems (and our definition of reasonable is very close to what FDA is proposing, ISO 2013 plus better in hypos) have value. A system that fails to achieve that does not.

      Papers have identified that some systems for sale in the US fail to achieve the level of accuracy for which they were approved. See the “QUIZ” and “ISSUE” links at the top of each StripSafely page.

      To be clear we are not suggesting these generics are worse or better than any other system.

      We want all systems to be reliably accurate so we the PWD don’t need to worry about it. We want clear acceptability that helps.

      Best

      Reply
  3. This issue is more important than is generally recognized. Right now, there are TWO makers of generic test strips for use with the J&J OneTouch Ultra system, one being owned by InstaCare Corp’s subsidiary Pharma Tech Solutions, Inc., which is based near Los Angeles and sells the Shasta GenStrip product (see http://prn.to/PudvGD). More recently, a Taiwan-based company whose U.S. operation is based in North Carolina (known as UniStrip Technologies, LLC) received FDA approval for its UniStrip1™ test strip product (see the press release at http://prn.to/1ig0VHU). J&J has responded by efforts to eliminate OneTouch Ultra from existence with its new Verio product line using strips that do not fit into OneTouch Ultra meters (although fundamentally, Verio has no new underlying chemistry involved, its merely designed to be incompatible with the electrical contacts being in different locations).

    Reply

So, what do you think ?