External Quality Assessment of Blood Glucose Monitors: Measurement Quality of Blood Glucose Meters: Is There a Need for an Institution with an Unbiased View?

摘要

The quality of self-monitoring of blood glucose (SMBG) with modern blood glucose meters is considered by many as not being a relevant topic anymore. However, in reality, a number of open questions about the quality of the measurement exists. Even if the meters fulfill the established quality criteria when they receive approval, there is no independent institution that performs a regular, critical comparison of the quality of the measurement of all blood glucose meters after their approval. Such an institute could also evaluate the quality of the different batches of test strips. In addition, it can evaluate the impact of other factors that are known to have an impact on the quality of measurement, e.g., the ambient temperature and the hematocrit. Such an institution will be very helpful to counterbalance complaints by the patients, physicians and authorities about an industry that earns a lot of money but does not provide solutions for the topics raised.