The British In Vitro Diagnostics Association (BIVDA) and Diabetes UK are calling for healthcare professionals (HCPs) to take urgent action and check their patients’ blood glucose meter systems for compliance ahead of the implementation of ISO Standard 15197: 2013 in May.
To help ensure the accuracy and consistency of results for people with diabetes, revisions have been made to the ISO 15197: 2013 Standard for blood glucose monitoring. The revised standard will come into effect in May and as a result, some meter systems may be rendered non-compliant.
Up to a third of people diagnosed with diabetes are expected to be affected by the changes. As test strips will become unavailable for non-compliant meter systems, it is vital that HCPs check their patients’ meters and if necessary, upgrade them.
BIVDA has provided guidance for HCPs which outlines some of the changes to the revised ISO 15197: 2013 Standard and how to check if a meter system is compliant.
BIVDA’s Chief Executive, Doris-Ann Williams MBE, said:
“With the implementation deadline rapidly approaching, BIVDA is reminding HCPs to check their patients’ meter systems for compliance. If meter systems are not upgraded, individuals may find themselves unable to monitor their blood glucose as test strips may become unavailable for non-compliant meter systems.
“We strongly encourage HCPs to read our guidance and take action now to help ensure a smooth transition for patients”.
Simon O’Neill, Director of Health Intelligence and Professional Liaison at Diabetes UK, said:
“For people with diabetes, monitoring their blood glucose levels is key to them managing their condition well."
“It is therefore critical that healthcare professionals make their patients aware of the changes being made to the ISO 15197 Standard for blood glucose monitoring and also check that patients’ meter systems are compliant. If they are not, they must be upgraded. With test strips becoming unavailable for non-compliant meter systems, healthcare professionals must take action now to ensure that all people with diabetes can continue to manage their diabetes well and therefore have the best chance of living long and healthy lives.”
BIVDA’s guidance for HCPs can be viewed here.
Notes to Editor:
BIVDA is the industry association for manufacturers and suppliers of IVD tests. We represent over 100 members, ranging from British start-up companies to UK subsidiaries of multinational corporations. BIVDA member companies employ more than 8,000 people in the UK, with a total industry turnover of approximately £900 million.
For further information, please contact External Affairs Manager Emma Thomas at firstname.lastname@example.org or 0845 6188224.