Editorial by HFE President John Bowis
After two years of debate, the Council is close to finalizing its’ position on the medical devices directive. The MDD, as it’s known to most, was proposed in the aftermath of a scandal where patients were harmed due to fraud and lack of oversight in the approval of silicone breast implants (PIP). At the time of its proposal, Health First Europe called for a balanced approach to the legislation in order to ensure protection from patients from undue harm, but without sacrificing the accessibility of patients to the innovative technologies they need and want.
We now sit at a crucial point in the legislative process because the Member States are very close to agreeing their position on this highly important dossier for patients. In fact, it has been reported that the ‘general approach’ of the Council will be agreed on 19 June and will open the way to start negotiations with the Parliament soon. However, given the intense and difficult discussions around many points, it now seems that, when it comes to the issues of patient safety, Member States have forgotten the scandal that made the MDD revision so very important. One eye-catching example is how Member States want to organize the secondary use of devices.
Different safety standards for patients
The Council want to allow different sets of safety rules for reusing devices that are originally intended to be used only once. This is surprising when bearing in mind that the whole purpose of the regulation is to ensure a high level of safety for patients. With this approach to so-called ‘reprocessing’, the Council allows different re-processors to apply different levels of standards. The patient safety concerns raised by this particular situation are typical of the challenges for patient safety as a whole in the MDD. As a patient, how will I know which type of device is being used on me? To whom can I direct my redress in the event of a problem? And where will issues be reported so that it doesn’t continue to happen to other patients?
The current text does not foresee any requirements mandating information to patients about the differing standards of devices that could be used in their treatment. This is in contradiction to the recent Council Conclusions adopted by Member States on patient safety and quality of care which call for prioritising greater information to patients…not less.
Think about yourselves
As individuals discussing whether to support this position on behalf of your governments, I would ask you to think about yourself. Think about whether you want to wonder in the midst of a medical procedure whether the innovations that should help to heal you, could actually harm you. And consider whether this regulation is achieving what we all aimed for it to do – protect patients and support innovation.
You may discover that there is more work to be done.