Jesús Rueda Rodríguez

Jesús heads the international affairs team. He continues to lead the regulatory debates that affect IVDs at EU level. Directly involved in the discussions on the revision and recast of the IVD Directive, he is also involved in the work at the international level acting as representative to WHO, ISO and as liaison to other associations on all regulatory matters.

In the last few weeks we have seen the emergence of a new global public health threat, the Zika Virus (ZIKV). Both the World Health Organization ( WHO ) and the European Centre for Disease Prevention and Control ( ECDC ) are monitoring the spread of the Zika, a mosquito borne arbovirus. The WHO recently declared the diseases linked to the Zika virus as a global public health emergency. Several Zika cases have been reported in Europe from people who have contracted the virus while travelling. The bigger risk however is when mosquito populations in Europe become infected and start acting as a vector for the disease. The map shows the distribution of Aedes albopictus which can become a carrier of Zika in Europe. At this stage, a lot of critical questions remain: What are the risks associated with Zika? Is there a potential link between Zika infections in pregnant women and microcephaly results in newborns? The Role of Diagnostics Developing adequate diagnostic tools becomes critical especially since Zika infections can display no symptoms or symptoms similar to other viral infections. In the short term, diagnostic tools will track the spread of the infection. Understanding how the epidemic spreads will be a critical step in controlling it. Accurate diagnostic tools will be needed to understand the relationship between Zika and microcephaly. Diagnostic tools, in the long term, will be essential in developing treatments and vaccines to combat Zika. If the link between Zika and microcephaly is confirmed, it will be equally critical to manage the potential risks during pregnancy. Detecting active Zika infections and determining the immune status of the mother with regards to Zika will be essential in reducing its impact during pregnancy. Precautionary measures are now being taken to ensure the safety of the blood donations – travellers...
When the European Parliament finalised their amendments for the Proposal for a Regulation on in vitro diagnostic medical devices in October 2013, they set the scene for a process that has continued through several Council Presidencies. The continued discussions are a reflection of the complexity of the file and the need for careful consideration of the technical aspects of the text, which should lead to the creation of a positive environment for innovation, safety and patient access across Europe.
Blood samples
Events which force us to confront our limitations are powerful experiences to learn from. They make us change our assumptions and, ultimately, can lead to actions that will impact our world. The Ebola outbreak of 2014 is showing the existing limitations of health systems around the world. Declared a Public Health Emergency of International Concern by the World Health Organization , by now the Ebola outbreak has claimed over a thousand lives and is yet to be brought under control. Effectively diagnosing Ebola patients is critical, as, in many diseases, rapid diagnosis followed by treatment increases the survival rate of patients. In the case of Ebola, a fast diagnosis will be critical in curbing the transmission of the disease. In vitro diagnostic testing is the only way to diagnose the disease, as the symptoms of Ebola are not specific: fever, headaches, muscle pain, sore throat… Shortcomings in diagnostic capacity for Ebola in West Africa, where there has never been an Ebola outbreak, were apparent from the start of the crisis. The WHO, in its recommendations, emphasises the need for diagnostic facilities near the outbreak. This makes for a faster diagnosis of Ebola patients. Ebola is no longer a concern just for West Africa However, Ebola is no longer a concern just for West Africa: the WHO after its announcement has recommended that every country needs to have access to diagnostic laboratories capable of diagnosing it, which will require deploying both material and human resources in order to ensure that any case can be adequately detected. But this Ebola outbreak does provide insights into how diagnostics can help in future health emergencies if adequate preparations are in place. Incentivise the development of rapid diagnostics – The public health benefit of rapid diagnostics for diseases like Ebola, which are highly infectious and...
Getting the timing right for the implementation of changes is essential to ensuring that the new regulations result in a better system for IVDs rather than a bureaucratic quagmire. The sweeping changes being made to risk classification will be complex and time-consuming. The lessons learned from similar overhauls in other markets show us that a period of transition is essential to optimise the implementation of changes for the new European IVD legal framework.
I have always found that no matter how much a person looks forward to a change, there is still that little tad of reluctance – a fear that things may not turn out for the better. The hesitation, even if momentary, manifests itself in the simple and mundane everyday tasks like clicking install for a computer software update or taking life’s big leaps, like getting married. The concern for what the change may bring is all the greater when you didn’t really mind the way things were in the first place. From my experience, some of us in the in vitro diagnostics (IVD) industry are also experiencing a bit of such reluctance when it comes to the revision of the IVD directive. Especially when it has worked fine since 1998, so why the change? A reasonable question, but considering the differences that have arisen between the healthcare context of the late 1990s and today, it’s time that our industry give the proposal careful consideration in the lead up to its approval, taking into account the impact of each of the legislation’s proposed aspects.