Access

Safe and accurate In Vitro Diagnostics (IVDs) are essential to a safe, efficient and effective healthcare system. Policymakers recognise this and that’s why they have included a clinical evidence requirement in the upcoming revision of the IVD Directive (IVDD). Because IVDs play such a pivotal role in the treatment pathway of patients, we, the IVD […]

When most people think about chronic conditions, certain disease areas come to mind – diabetes, heart disease, obesity, asthma, allergies…the list goes on.  However, it is unlikely that you think about chronic wounds as being part of that list.  Why is that?  Given that wounds impact 4 million Europeans per year (more than cancer and […]

Access to quality healthcare and medical technologies has risen to the top of the international health agenda. In this regard, diabetes is a particular challenge as good management relies on continuous access to both medicines and medical devices. In its latest study, IDF Europe found that hundreds of thousands of people living with diabetes in Europe do not have access to the treatment they need, putting their health at risk.

In Europe, health data are considered so sensitive that processing them is generally prohibited in the EU, unless that processing follows specific guidelines. For example, the prohibition does not apply when sharing data is essential to providing healthcare, where those data are handled by a Healthcare Professional (HCP) subject under national law and subject to professional secrecy laws. With the rapid growth in diversity of medical technologies though, more and more medtech companies are processing health data on behalf of HCPs. 

In my article in the newsletter of last August, I told you about the standard rehabilitation support I receive as outpatient of spinal cord injury (SCI), and how I have had to work for access to more personalised treatment, which has brought to where I am today. However, be that as it may, my current state of rehabilitation remains insufficient and my search for better alternatives continues. 

The revision of the IVD and MDD Directives has ensured that the last quarter has been a really colourful, hectic and interesting one. The revision process has now entered a new phase where Council will need to agree on a position, after which it will have to negotiate this position with Parliament. That negotiation should then lead to the final texts for IVDs and devices. In terms of timelines, the Parliament is set on finalising both processes before the European elections of May 2014. Until then, I’m sure the evolutions will provide me with plenty to blog about.

Imagine walking for most of the day to get to the health center nearest your community, carrying your young child who is very ill. When you arrive, the doctor takes a sample from your child to perform a diagnostic test. You then learn that it will take a month or more to receive the results, as only a specialised laboratory can perform the necessary test to obtain a diagnosis. This sort of unnecessary delay can be the difference between life and death. It is still, nevertheless, the reality in many countries, especially in limited resource settings where diagnostic testing is centralised, and most patients live far from testing sites.

The rapid ageing of the European population has urged the need for prevention and proper treatment of age-related diseases. Amongst these priorities and priority diseases, Cataract is today the major cause of vision impairment of senior citizens worldwide, responsible of 48 % of blindness around the globe.

Hockey, sailing, golf, football … As an avid sports fan, I used to enjoy all those kinds of activities with great enthusiasm – until the day I became paralysed. Some of you may remember me from the European MedTech Forum in 2011 or from this video on which I told my story after I made my comeback. For those who don’t: my name is Hylke Sieders, I am 37 and suffered from a sudden spinal cord bleeding between the C2 and C3 vertebrae (in the neck) in 2009 which left me almost entirely paralysed.  Almost, since I am able to stretch my arms and use 3 ½ fingers from my left hand. But I don’t have movement in the rest of my body although my legs are not completely devoid of sensation (current status C5-C6).