European diabetes device regulation is in need of “radical change,” according to president of the European Association for the Study of Diabetes, professor Andrew Boulton, MD.
The approval process and regulation of diabetes devices has been an issue of debate in Europe due to a number of high-profile medical device failures that have occurred in recent years. And though an announcement on the subject was issued by the European Commission on Sept. 26, 2012, the EASD says the concerns were not addressed sufficiently, according to a press release.
“The general public, including diabetes patients, were rightly extremely concerned when the various medical device scandals came to light earlier this year,” Boulton said during a press conference. “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?”
In a letter published in the European diabetes journal Diabetologia, Boulton and Stefano Del Prato, MD, of the department of endocrinology and metabolism, Section of Diabetes and Metabolic Diseases in Pisa, Italy, addressed their concerns, citing multiple medical device failures, including the “spontaneous rupture” of silicone gel breast implants, “dangers of metal-on-metal hip implants and deaths caused by the likely failure of implantable cardioverter-defibrillator leads.” Though such device failures have not, to date, been reported in the management of diabetes, the use of devices in diabetes treatment continues to grow and Boulton believes there is an “urgent need for reform of the entire [device registration and monitoring] process.”
Device approval procedure
Currently, the process for approval of medical devices in Europe is less rigorous compared with that required for the approval of new drugs. Manufacturers must receive the Conformite Europeenne (CE) mark to obtain approval of new devices. The CE is awarded by a “Notified Body” (NB), usually an independent organization supported partially by fees paid by the device manufacturing companies, according to Boulton.
Companies who wish to register a new continuous glucose monitor can choose any NB they want and pay them a fee to ensure their device meets specified requirements set by the European Union Council. A CE mark is then affixed to the device and the manufacturer can market their device throughout Europe, without the need for independent studies or trials. In addition, neither the national nor the European health authorities enforce any post-marketing vigilance system, Boulton wrote in his letter.
Increase in diabetes devices
The use of diabetes devices such as home blood glucose monitors, continuous subcutaneous insulin infusion and continuous glucose monitoring has increased rapidly worldwide. According to Boulton, the widespread use of such devices increases the risk for human error and device failure.
In 2005, literature published in Diabetologia demonstrated that a post-marketing reliability study of a non-invasive continuous glucose monitor found the device inaccurate. According to the study, there was a >50% mean absolute difference between the glucose readings on the device and those on the patients’ home blood glucose monitor. Furthermore, >4% of the incorrect readings were potentially dangerous, Boulton wrote.
Call for ‘radical change’
In their letter, Boulton and Del Prato endorse a proposal made by the European Society of Cardiology stating that, “similar to the EMA, which oversees medications, there should be a single, coordinated European system to oversee the evaluation, approval and post-marketing surveillance of medical devices; there could, for example, be a sub-division for device regulation within the EMA.”
They have little belief, however, that the current revisions being made to the European Union directives on medical devices will result in the institution of a central European device registry, due to the current financial limits within Europe.
“The safety of our patients with diabetes who use devices in their day-to-day treatment and monitoring is of paramount importance: hence the EASD has organized a symposium on this topic at its 2012 meeting and has established working committees on devices in diabetes,” they wrote.
The EASD plans to submit their solutions in 2013, but hope, in the meantime, that “the EU will reform the functioning of existing NBs and establish both surveillance and vigilance procedures for medical devices in Europe.”
Disclosure: Boulton and Del Prato report no relevant financial disclosures.