Category: medical devices

ISO 15197:2013 & #diabetes – will new stds for blood glucose meter accuracy affect what’s on the market?

Is the new ISO 15197:2013 for blood glucose meter accuracy likely to bump a few BG meters off the market? 

ISO 15197:2013: In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus”

The new (I say new, they came out last year but I’ve been out of the ‘diabetosphere’ for a while) guidelines can be found here but they cost CHF 154,000 which is a wee bit more than I want to cough up to read them. You can preview some of the document here.

The ISO’s own blog has written about this “More accurate self-testing results for diabetes patients with new ISO standard“.

Blood glucose meter and testing strips

See also

“The reliability of self-monitored glucose values is a prerequisite for an efficient and safe approach to treat patients to their target. Accuracy of SMBG, therefore, is a key aspect in this regard.9 Recently, accuracy requirements have been tightened. According to the revised ISO standard 15197:2013, 95% of the blood glucose (BG) results shall fall within ±15 mg/dl of the reference method at BG concentrations < 100 mg/dl and within ±15% at BG concentrations ≥ 100 mg/dl.10 The less restrictive ISO standard 15197:2003 loses its validity after a transitional period of 3 years.11

Source: Schnell and Erbach (2014) Impact of a Reduced Error Range of SMBG in Insulin-treated Patients in GermanyJournal of Diabetes Science and Technology February 5, 2014, doi: 10.1177/1932296813516206

There’s also been some discussion on the children-with-diabetes forum: Accuracy of blood glucose meters draws scrutiny childrenwithdiabetes (21 May 2013).

See also FDA to ISO 15197: Not good enough The Westgard Rules blog (15 January 2014)

“FDA believes that the criteria set forth in the ISO 15197 standard do not adequately protect patients using BGMS devices in professional settings, and does not recommend using these criteria for BGMS devices.” – quote excerpted from recent FDA draft guideline on blood glucose meters (line 277).