At a May 21, 2013 meeting hosted by the Diabetes Technology Society, diabetes investigators and representatives of the U.S. Food and Drug Administration (FDA) reviewed the results of studies examining the accuracy of several blood glucose monitoring systems currently available in the U.S. The FDA requires systems to meet minimum accuracy requirements as defined by the 2003 version of the International Organization for Standardization (ISO) that is currently being used by the FDA when assessing pre-market applications for these devices. Newer, tighter ISO criteria were released in May 2013 but the FDA has yet to announce whether it will adopt these or establish its own stricter criteria.
Independent investigators have found that twenty-five to forty-five percent of systems failed to meet the 2003 standards once released into the market. It can be assumed that even fewer systems will meet new, tighter requirements. The FDA’s post-marketing surveillance of meter system accuracy is limited by several factors, including the large number of adverse event reports (32,000 per year); the fact that many facilities manufacturing poorly performing meter systems are overseas (mainly in Asia), which limits the frequency of inspections; and the lower compliance of foreign manufacturers in filing accurate medical device reports.
Clinically, inaccurate glucose values could translate into incorrect insulin doses and/or failure to detect low blood glucose levels in those with hypoglycemic unawareness. It is important that elderly as well as younger patients have access to glucose monitoring devices that are accurate and reliable. Under recent changes in Medicare reimbursement for blood glucose testing supplies through the Competitive Bidding Program, Medicare beneficiaries must purchase blood glucose monitoring supplies from mail-order companies who are contracted with the Centers for Medicare and Medicaid Services. These companies are chosen based on their ability to offer equipment at the lowest price, potentially including blood glucose monitoring systems of concern. Physicians should review recent studies investigating the post-marketing accuracy of many (but clearly not all) available glucose meter systems (1-7) to help them in making informed decisions when prescribing meters.
Take Action: Stipulate the specific brand/model of the blood glucose meters you prescribe based on your assessment of what is best for the patient. Follow up with your local pharmacies to make sure prescriptions are filled as written.
Clinicians are urged to remain vigilant regarding any problems or adverse events associated with the blood glucose meters their patients are using.