The current system of regulating medical devices could result in situations that may seriously threaten the lives of people with diabetes, says the European Association for the Study of Diabetes (EASD).
Medical devices such as blood glucose monitors and insulin pumps, are an essential element of successful diabetes care. However, the proper functioning of these devices is absolutely essential; malfunctions can have serious consequences and in some cases could result in death.
At present, there is a low level of regulation and control of medical devices in the EU. Although medical devices in the EU must have a CE Marking, obtaining this can in no way be compared to the rigorous processes required to gain approval for pharmaceutical products, and thereafter the post-marketing surveillance. Drugs are reviewed prior to admission onto the open market by the European Medicines Agency. EASD has previously called for an improvement of the current European system for device registration.
The CE Marking claims to guarantee the safety of the device being sold. However, it does not, in any respect, represent an independent confirmation of its quality. In addition, so-called “notified bodies”, located all over Europe, which are involved in the CE Marking process have little knowledge of diabetes care, diabetes treatment or in fact how a device which is being inspected will be used by a member of the public. The recent problems with hip implants and PIP breast implants have demonstrated the inefficiency of the current system.
The notified bodies do not control the fulfilment of the current ISO standard for blood glucose test systems. Furthermore, the new proposals from the European Commission for the improvement of the current system will, essentially, not change this unsatisfactory and insecure system of control.
EASD has stated that in order to protect people with diabetes, the following actions are essential:
- Firstly, since the procedure for obtaining a CE Marking and the role of notified bodies have proven to be ineffective, medical devices in diabetes care should be evaluated by independent research institutions. The standard of this evaluation should be the respective ISO-norm.
- Not only in vitro standards will have to be evaluated but also, and more importantly, real-life settings and situations.
- A continuous post-marketing surveillance of random samples should be a prerequisite.
The association warned that without substantial improvement to the present evaluation process established by the EU, disasters are likely to occur for people whose good health is reliant on accurate diabetes devices.
