European medical device regulations are woefully inadequate to protect people with diabetes: EASD

The European Association for the Study of Diabetes (EASD) expressed its concern in relation to medical devices used in diabetes care. The statement, made by Professor Andrew Boulton (University of Manchester, UK), President, EASD was made during the annual meeting of EASD.

A number of recent high profile scandals involving medical devices (for eg. hip replacements, breast implants) have put a spotlight on the European Union directives that regulate all such devices. Repeated calls have been issued by EASD and other major European medical associations to extensively improve these regulations. EASD says the recent European Commission announcement on this subject has not addressed these concerns sufficiently.

Boulton said, “The general public, including diabetes patients, were extremely concerned when the various medical device scandals came to light earlier this year. The European Commission appears to have missed its opportunity to tighten up these regulations. Without tougher rules governing approval and surveillance for medical devices, how can we ensure the public has confidence in the system?”

Medical devices are playing an increasingly important role in diabetology, specifically in improving the quality of care of people with diabetes. Blood-glucose monitors have become a cornerstone of care, as have insulin pumps. Subcutaneous sensors are increasingly being used to help achieve optimal control of blood sugar and predictions are that, in the near future, closed-loop systems may be able to automatically adjust insulin infusion rates delivered by insulin pumps. Moreover, more invasive devices are also increasingly used in diabetes, such as those used in bariatric surgery. Clearly, any major fault or problem has the potential for tragic consequences in people with diabetes.

The system for approving medical devices in Europe is far less rigorous than that required for approving new drugs, and is also less stringent than the system used to approve devices in the US. To obtain approval for a medical device in Europe, manufacturers must be given the Conformité Européenne (CE) mark, awarded by so-called ‘Notified Bodies’ (NB), which are generally independent organisations under the auspices of the competent authority of the European Union member state in which they are based. To register a new glucose monitoring device, a manufacturer can choose any notified body in any country, to which it will pay a fee. The NB then ensures the device meets the required specifications. Once the device has gone through this single process, it will receive the CE mark and can be marketed across Europe without any restriction or further scrutiny.

Critics of the system say that the wide variation in quality of NBs across Europe means that manufacturers could target the NB most likely to give rapid approval to their device. Since NBs are in effect competing with each other for device manufacturers’ business, the system could be open to abuse with NBs being less rigorous to secure this business. There are also substantial variations in the price NBs charge within and between EU member states.

Crucially, there is currently no obligation for independent studies or trials before a device is put on the market. There is also a very notable absence of long-term monitoring of these devices. The EASD believes the best solution would be to have the manufacturing companies ordered to fulfill the respective internationally accepted standard (ISO) for devices measuring blood glucose. Although EASD and others (including the European Society of Cardiology) have called for a new centralised agency falling under the European Medicines Agency (EMA) to coordinate such monitoring, indications from the European Commission are that such an agency is unlikely to be created.

Boulton added, “This monitoring should at the very least be controlled by independent central laboratories with specific expertise. The manufacturers of insulin pumps, sensors, and in the future, closed-loop systems to control blood glucose in diabetes, should be obliged to enter data into national registries from patients treated with these devices in order to have an independent evaluation of quality.”

EASD, in collaboration with device manufacturers, wishes to establish conventional standards and calls upon the European Union to implement them in the near future. “The European Association for the Study of Diabetes feels responsible to undertake the necessary steps to ensure a proper quality of medical devices in diabetology and is in discussions as to the best way to go about this,” said Boulton.

Among the measures being considered are the use of an EASD quality-approval mark that would supercede the CE mark, enabling health authorities across Europe to see a device has been approved to EASD standards (based on the ISO quoted above) before deciding whether or not to reimburse it. The EASD would appoint facilities within Europe to conduct the approval process, and would also propose random sampling of approved devices in the years post-approval to ensure they continue to meet required standards. Finally, each device model (in the case of glucose monitoring) would be individually coded so that adverse event data can be recorded in registries and problems detected at the earliest possible stage.

EP News Bureau