RIVM expressed concerns on the effects of bisphenol a (BPA) on the immune system in a report issued in March 2016. Consequently, the Dutch minister of Health, Welfare and Sport, Edith Schippers, requested EFSA to consider this issue. EFSA states that the new evidence highlighted by RIVM adds to the indication already reported in 2015 that BPA might affect the immune system in animals, but is too limited to draw conclusions on human health.
In 2015, reports in the media questioned the performance of blood glucose meters for patients with diabetes available on the Dutch market. They suggested that new, cheaper blood glucose meters were of lower quality. Some patients were required to switch to a different blood glucose meter than they were used to, because the reimbursement policies of health insurance companies had changed. Therefore, the Dutch Health Care Inspectorate requested RIVM to investigate blood glucose meters.
Research
RIVM assessed technical documentation of 20 blood glucose meters that were on the Dutch market on January 1st, 2015. This collection of documents contains technical information about the meters. RIVM assessed documentation of meters from manufacturers that have been active on the Dutch market for a considerable period as well as from relatively new manufacturers on the market.
Furthermore, RIVM analysed data provided by seven Dutch laboratories that compare laboratory-determined blood glucose values with blood glucose measurements performed by the patients. Finally, RIVM consulted experts in diabetes care about factors that may influence the accuracy of blood glucose measurements, and about potential consequences of inaccurate blood glucose measurements for patients with diabetes.
Results
The submitted documentation of blood glucose meters showed shortcomings. The information about the accuracy of the meters and the method for gathering user experiences was insufficient. However, shortcomings in the documentation do not necessarily mean that the meter is inaccurate or unsafe.
Laboratory comparisons showed that about one fifth of patients’ blood glucose measurements differed from the laboratory measurement. However, comparison of data between different laboratories was difficult, as laboratories each applied their own criteria. Moreover, some of the laboratories indicated that the percentage of measurements that deviates decreases considerably when the patient repeats the measurement while paying special attention to correct use of the blood glucose meter. This shows that besides accuracy of the meter itself, the way it is used is also an important factor for accuracy of the blood glucose measurement.
Shortcomings in the technical documentation and inaccurate measurements were found for meters of manufacturers that have been active on the Dutch market for a considerable period as well as for meters of manufacturers that recently entered the Dutch market.
Consequences for patients
Inaccurate measurements do not necessarily lead to long-term complications for patients, concludes RIVM based on interviews with experts. The system for diabetes management in the Netherlands ensures that patients can rely on different health care professionals and regular checks. However, it is important that patients are well informed about these checks built into the system.
Special attention should be paid when patients switch to other blood glucose meter. Patients and health care providers need to be aware of possible significant differences between the measurements with the old and the new meter. Therefore, adequate supervision by the health care professional during the switch is of utmost importance.