Summary of what’s wrong with the ISO 15197 2013 glucose meter standard

March 24, 2019

  1. Minimum system accuracy performance criteria (6.3.3) – I previously commented that the word “minimum” is silly. One either meets or does not meet the requirements. But the big problem is Notes 1 and 2 in this section that says that the test is not to be carried out by actual users. Thus, the protocol is biased by excluding user error. In the section where users are included, the acceptance criteria (8.2) drop the requirement for 99% of the results to be within the A and B zones of an error grid. The requirement for 95% of the results to be within ± 15 mg/dL below 100 and within ± 15% above 100 remain. Thus 5% of the results are unspecified, same as the 2003 version. This means that for people who test 3 times daily, they could have a dangerous error for their meter once a week in spite of their meter meeting the ISO 15197 standard.
  2. Safety and Reliability Testing (Sections 5) – A hallmark of reliability testing is the frequency of failures to obtain a result. There is nothing in this section (or elsewhere in the standard) to tally the frequency of failed results or specified limits for percent failures. This makes no sense for a standard about a POC test that is needed emergently. Failure to obtain a result is a frequent event in the FDA adverse event database for glucose meters.
  3. If you want to see who wrote the standard, you can’t. As with all ISO standards, there is no list of authors or members who served on the committee.