I had mentioned an upcoming editorial about glucose standards. That editorial has now been published and appears to be freely available.
I have argued that glucose specifications (ISO 15197 and CLSI POCT12-A3) should have goals for 100% of the data, not 98 or 99%. A manufacturer might argue that this is not needed because …
- The actual occurrence of dangerous glucose meter results, due to a failure of a glucose meter may not occur at all.
- To have goals for 100% of the data, meaning that 0% of the data should not be allowed in certain error regions would be too burdensome.
My responses would be: to 1), yes this may be true but does not mean the goal should be abandoned. As for 2), one should realize that one cannot prove the occurrence of zero failures – the FDA knows this – thus there is no reason that a zero failure rate goal for dangerous errors would be burdensome.
So the way the glucose meter standards are written looks bad – it’s time to change things.