Blood Glucose Testing and Implementation of ISO 2013 Accuracy Standards

27 June 2016

A new standard for accuracy of blood glucose testing meters and test strips will be coming into effect on 1st June 2016.

All blood glucose meters must conform to ISO 15197: 2013, and manufacturers will no longer be allowed to supply meters which do not meet these new standards after 31st May 2016.

These new standards are designed to ensure accuracy of testing and assurance that results are comparable to those produced by laboratory equipment. To be compliant results must be:

  • 95% results must fall within ± 0.83 mmol/L of laboratory results at concentrations of less than 5.6 mmol/L
  • 95% of results must fall within 15% of laboratory results at concentrations of 5.6 mmol/L or more.
  • The 2013 guidelines also now stipulate that 99% of readings must fall within zones A and B of the Consensus Error Grid for type 1 diabetes.

There may be a small number of patients still using a meter which is non-compliant with the new regulations, but because the manufacturers only need to update meters rather than test strips to ensure compliance, it is not straightforward to identify this group. However manufacturers have been busy ensuring any patient who has registered their device or calls for advice or supplies of consumables is using a compliant meter.

Any patients using a meter and strips which is not being updated by the manufacturer will need to be changed to a compliant device, however the numbers are likely to be small and it is anticipated there will be stock left in the supply chain meaning the process will happen over the coming months.

To check if a device is compliant, refer to the manufacturers information supplied with the product or contact their customer care line

There should not be large numbers of patients needing a new meter, but healthcare professionals are encouraged to:

  • Check with patients at their diabetes review/check-up that they are using an up to date meter
  • Ensure there are no non-compliant stocks of meters held in practices/clinics.

Further information on the ISO standards can be found at : http://www.iso.org/iso/catalogue_detail?csnumber=54976

The meters which have are approved for use in Tees are ISO 2013 compliant

Please speak to a your NECS MO practice support pharmacist/technician if you need more information