EU Device Safety Lax, Clinicians Concerned

EASD President Andrew Boulton Calls for Tighter Device Regulation in Europe

Andrew J.M. Boulton, MD, DSc


October 22, 2012

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I am Professor Andrew Boulton, President of the European Association for the Study of Diabetes, speaking from our annual meeting in Berlin. I want to briefly discuss a matter that has been a concern to many European physicians who are looking after people with diabetes. That matter pertains to the regulation of medical devices used not only in diabetes but in other areas. We were first drawn to the problems that exist by our colleagues in cardiology who, of course, use more invasive devices than we do, such as stents and so on, in coronary arteries.

The use of devices in diabetes is increasing and includes equipment for home blood glucose monitoring, continuous subcutaneous insulin infusion, insulin pumps, devices that continuously monitor blood glucose, and, more recently, more invasive devices (for example, those used in bariatric surgery). These are all classed as devices in Europe and also in the United States.

In Europe we do not have a central authority to register [or regulate] a device, such as the European Medicines Agency, or in America, the US Food and Drug Administration (FDA). Thus, a company that wants to bring out a new device or pump can choose any Notified Body in up to 70 locations across Europe. This Notified Body then examines the evidence, receives a fee from the company, and then gives them a Conformité Européenne [European health and safety product label], which is a CE mark -- basically a passport to manufacture and sell these devices in all European countries. There is no requirement for postmarketing surveillance, which is another concern, but a competent authority in the same country as the Notified Body is supposed to regulate and keep an eye on these devices when in use.

What we would like to see is the equivalent of the European Medicines Agency -- a centralized agency [responsible] for monitoring devices and appropriate postmarketing surveillance. For example, if you are using an insulin infusion pump, you can get diabetic ketoacidosis because of a problem with the insulin, which has to go through randomized controlled trials, postmarketing surveillance for safety, etc., or, because the pump has failed, a pump that is marketed across Europe after it has been assessed [only] by 1 Notified Body.

The situation in the United States is somewhat better, in that the FDA is responsible for devices [as well as medications]. We would like to see the European Union adopt a central regulatory body for the licensing and postmarketing monitoring of devices used in diabetes.

Thank you.