'Inadequate' change in diabetes device regulation will not protect patients
The European Commission vote to approve new legislation, which would supposedly tighten medical device regulation and improve patient safety 'will not protect patients with diabetes', says the European Association for the Study of Diabetes (EASD).
The system used to approve medical devices in Europe is considerably less rigorous than that which is used to approve new pharmaceuticals, and is also less stringent than the process used in the USA.
To obtain consent for a medical device in Europe, manufacturers must be awarded the Conformité Européenne (CE) stamp, which is overseen by a Notified Body (NB), often a private organisation operating under the authority of a 'competent authority' or regulator for the EU country in which they are based.
For example, in the case of a new blood glucose monitor a manufacturer must choose an NB in any country, to which it will pay relevant fees.
The duty of the Notified Body is then to ensure that the device meets required standards and specifications, and once approved it can be marketed across Europe with a CE approval mark.
However, Dr. Deborah Cohen, Investigations Editor at the British Medical Journal has found that this system is subject to various abuses. For example, some companies 'shop around' to find the NB most likely to authorise their device, and some receive inappropriate advice from their NB about how to get their product through the process and onto the market.
Alarmingly, in conjunction with a major UK newspaper she was able to process a completely fictional device through the majority of the approval stages with completely fabricated data.
The main focus of the legislation changes are on Class III devices, which are the most complex and often implantable. Diabetes pumps and all other diabetes devices fall either in Class I or in Class II, and are therefore not subject to the new rules.
EASD President Professor Andrew Boulton said: “These changes will do little to improve Europe’s antiquated regulations for regulating devices, that were brought in for electric toothbrushes and stethoscopes - not the wide range of medical devices vital for diabetes patients today.”
He adds: “We are talking here about devices that people depend on for their lives, such as insulin pumps and technology that monitors blood glucose.”
Professor Boulton commented during the annual meeting of the EASD in Barcelona, Spain: “Just as with drugs, devices can provide major benefits to patients but can also cause major harm when things go wrong".
In tandem with the European Society of Cardiology (ESC), the EASD is advocating a central European Device Agency (EDA), similar to that which already exists for pharmaceuticals in the case of the European Medicines Agency (EMA).
However, revised proposals by the European Commission are rumoured to have been 'watered down' due to intensive lobbying by industry members and EU states, and it is currently understood that EDA proposals are not being discussed.
Other proposals, such as the designation of 'Special Notified Bodies' for Class III devices, and stricter requirements in terms of training and qualifications for these Notified Bodies have been brought forward.
In addition, it is proposed that these special NBs should form a collective network to ensure that their practice converges and conforms to a level of transparency.
Final voting on the draft legislation is expected to take place at the end of October.
“Diabetes care has progressed massively thanks in many ways to improved device technology, but the regulation has not kept up with these advances,” concludes Professor Boulton.
“We desperately need a system in place that protects diabetes patients from potential harm. Or must we wait for another major device scandal before the European authorities take the appropriate action?”.
Dr. Cohen added: “These changes are the bare minimum required to really ensure the safety and effectiveness of medical devices and protect patients. It leaves patients across Europe in a position where some are more protected than others.
'It’s unclear how these new regulations will impact on the devices involved in diabetes or other class II devices, though it appears to be good news for those with most complex, highest risk devices, such as hips and other implants. I hope that the current proposals are not watered down further by lobbying".