We have been kindly asked here at Diabetes Insight by LifeScan, part of the Johnson & Johnson Family of Diabetes Companies to share the following information and make people with diabetes more aware of the changes ahead for recommending blood glucose monitors.
Latest generation of blood glucose meters comply with new ISO standards two years before they become compulsory
LifeScan, part of the Johnson & Johnson Family of Diabetes Companies, is proud to announce that its latest generation of blood glucose meters meet the international performance standard ISO 15197:2013, two years before it is expected to become compulsory, and are available immediately for use.1,2
The 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 is expected to end in May 2016, and healthcare professionals (HCPs) should plan to ensure that their patients are upgraded to compliant meters within this period. This may have potentially significant resource implications as most patients are currently using non-ISO 2013 compliant meters, meaning HCPs should start planning early to manage this transition.
The new ISO standards mean meters will only be compliant if they meet the updated criteria for system accuracy, user performance, haematocrit and interfering substances.1 These revisions will change which meters HCPs can recommend to patients, due to test strips becoming unavailable over time for those meters that do not meet the requirements. HCPs need to take this into account when reviewing preferred meter lists in order to avoid formularies becoming invalid after May 2016 and patients suddenly having to switch meters.
LifeScan is staying ahead of this transition as its latest generation of blood glucose monitors already meet the stricter performance requirements.1,2 The currently available OneTouch® Verio® family of meters is based on a recent technology platform, and includes the OneTouch® Verio® and the OneTouch® Verio® IQ blood glucose monitoring systems.
Dr Stefaan Wens, Regional Medical Affairs Lead, LifeScan EMEA, said: “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.”
OneTouch is ready to partner with you during this period, and to help alleviate the significant resource implications of the transition through its comprehensive Customer Care service. To find out more, please call OneTouch® Customer Care on 0800 279 4142 or visit www.lifescan.co.uk
- ISO 15197, In vitro diagnostic test systems-Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
- OneTouch® Verio® performance vs ISO 15197:2013. Data on file