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Blood Test Meters What the new ISO requirements mean to you

New ISO (International Organization for Standardization) performance requirements will come into effect in May 2016, requiring higher accuracy for blood glucose meters and for all of them to reach a specified standard.

Dartboard with missed darts_smallThe International Organization for Standardization (ISO) updated the standard relating to blood glucose monitors in May 2013 to reflect advances in technology. The transition period for implementation of the quality standards ends in May 2016, and healthcare professionals (HCPs) will be ensuring that patients are upgraded to compliant meters by that date.

ISO International Standards ensure that products and services are safe, reliable and of good quality. When you think about it, you would have thought that this would have happened a long time before now as blood testing being so central to Type 1 diabetes care. As it happens, all of the bigger blood test meter suppliers have always adhered to exacting standards, the competition between them on achieving excellent accuracy being what has driven accuracy standards in the past. The news that the standards (specifically ISO15197:2013) will be applied from next May will however change which meters HCPs can recommend to patients. The revisions that the new standards invoke mean that there are four criteria that all meters must now comply with by May 2016.

Big deal?
Man holds bullseye target in front of himself
To a great extent the imposition of these new standards won’t be a big deal for most blood testers, as your meter is likely to already conform to these standards, but some older meters will need to be upgraded as strips for these may no longer be available when the standards come into force. You can call the supplier of your blood test meter to see if it’s already within the necessary standards or ask your HCP for advice. With some meter upgrades you will barely notice the change or you could find that there is in fact no need to change at all, but do check!

For example, LifeScan’s OneTouch Verio and OneTouch Verio IQ meters already meet the tighter criteria for system accuracy, user performance, haematocrit and interfering substances before they become compulsory. If you have a meter using the OneTouch Ultra or OneTouch Vita test strip, you might be able to upgrade now to a OneTouch Verio or OneTouch VerioIQ meter for free. Dr Stefaan Wens, Regional Medical Affairs Lead, LifeScan EMEA, says of the company’s meter range, “LifeScan is proud that its meters already achieve the higher standards set by ISO, two years ahead of schedule. People with diabetes can take advantage of the many benefits offered by the OneTouch Verio family of meters, assured in the knowledge that they will remain unaffected by the upcoming guideline implementation.”

The case for standards
Vertical dart on dartboard
An article written for the ISO by Maria Lazarte states that diabetes patients will benefit from the latest version of an ISO standard for self-testing glucose monitoring systems. The standard requires that manufacturers of these systems provide even greater accuracy.

The newest ISO 15197:2013, In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus, differs from the previous 2003 version on the following points:

  • Increased accuracy for glucose meter systems, in particular for glucose values greater than 75 mg/dl (4,2 mmol/l)
  • Manufacturers of glucose meter systems must ensure their technology enables accuracy to improve from +-20% to +-15%
  • The new version accounts for 99% of results, as opposed to 95% for the previous one
  • For the first time, the standard provides formal acceptance criteria for accuracy as regards testing by patients and assessment of interferents (including hematocrit).

Project leader for ISO 15197, Dr. Alan Cariski, comments, “More accurate glucose measurements will help patients to better regulate their diabetes through more informed treatment decisions that may affect, for example, dietary intake and medication dose, especially insulin.”

This news item first appeared in Desang Diabetes Magazine, our free-to-receive digital journal. We cover diabetes news, diabetes management equipment (diabetes kit) and news about food suitable for a diabetic diet. Go to the top of this page to sign up – we just need your email address.

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