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FDA draft guidance speaks of Third Party Strips starting at line 990 of their draft guidance.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?
It is your diabetes. What do you think is sufficient to StripSafely?
Diabetes Mine‘s Mike H. has a full article with all kinds of interesting detail and reader comments on generics. Have a look.
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.