EH 2_2015

EUROPEAN HOSPITAL Vol 24 Issue 2/15 10 LABORATORY New IVD regulation planned for Europe ‘We will need a lot more regulators’ Report: Mark Nicholls European Hospital has already reported on the consequences of the new EU draft IVD regulation (December 2014 issue). Now, the new Directive proposed for Europe looks set to have major implica- tions for IVD manufacturers and laboratory-developed tests (LDTs). Replacing a current system that is inflexible, unresponsive and does not effectively protect patients, the new regulation will apply directly to all 28 EU countries and govern the manufacture and marketing of in vitro diagnostic devices (IVDs). Speaking ahead of the Advanced Diagnostics for Infectious Disease Conference in Lisbon, Portugal (April 15-16 April), Dr David Barton said the purpose of the new regula- tion would not only be to ensure that IVDs are safe and effective, but also to create a single market throughout the European Union so that devices ‘approved according to the rules and the regulation in one European country can be sold in all European countries’. However, Dr Barton, who is Chief Scientist at the National Centre for Medical Genetics in Ireland, warned that at the present stage it remained unclear when the new regulations will be in place, because there are on-going negotiations between governments and the European Parliament. However, once they are complete, it could be a further four years before the directive is fully implemented. Dr Barton will present the confer- ence with an update and analysis of the pending regulations, which will be based on a framework proposed by The Global Harmonisation Task Force (GHTF), a forum of indus- try and direct national regulators. ‘Under this framework,’ he said, ‘each IVD would be placed into a risk class from A-D with D being the highest risk class and A being the lowest, depending on the intended use of the device.’ Dr Barton explained that chal- lenges might arise over the regu- latory rollout in Europe; it sees a move from ‘very light touch regula- tion to a much more structured and hands-on form of regulation’. ‘Compliance with that will be a big burden for industry and also a big burden for the regulatory side,’ he added. ‘We’re going to need a lot more regulators and they’re going to need a lot more skills to carry out the new tasks they’ve been given.’ There are potential advantages of the new regulations, particularly for patients. Dr Barton: ‘Light touch regulation in an industry that does commercial IVD production is probably not in the best interest of patients. Clearly, just as with medicines, you want to make sure that your diagnostic devices are working well in order to protect the safety of patients. ‘From that point of view, more regulation should make things safer. We should also have a database of all approved IVDs, whether they are lab-developed tests or commercially approved IVDs.’ There will be more transparency, akin to the USA’s system, he added, although there is no direct link between Europe and the US in this respect, as they are different juris- dictions, but there are interesting parallels. In both cases the professional associations are making strong arguments for the continuation of the exemption of laboratory-devel- oped tests, built in to the current European legislation. As to how IVD manufacturers and clinical labs might prepare for the coming changes, Dr Barton concluded: ‘We’re hoping that, if the exemption for LDTs remains and is extended to all classes of device, the clinical labs won’t actually have to do very much. There will be recording of which LDTs are in use and reporting of adverse events and that’s quite proper.’ For industry, he foresees extra work and additional layers of regu- lation, inspection of their facilities, compliance, and production of clini- cal evidence in moving ‘from a very light touch regulation to regula- tion that’s more aligned with global norms’. Other topics at the Advanced Diagnostics For Infectious Disease Conference include the keynote presentation, ‘A Paradigm Shift of Diagnostic Medical Microbiology: Will It Finally Happen?’ by Dr Herman Goossens, Professor of Medical Microbiology at Antwerp University Hospital; the ESGMD/ ESCMID Roadmap of Bringing New Technologies into the Clinic, by Dr Eric Claas, Associate Professor of Medical Microbiology, Leiden University Medical Centre; and Molecular Diagnostics of Antimicrobial Resistance at Point- of-Care, by Dr Till Bachmann from the University of Edinburgh. Also on the agenda are point of care testing in infectious diseases, infectious disease applications of next-generation sequencing and mass spectrometry for infectious disease detection. David Barton is Chief Scientist (Director) of the Molecular Genetics Laboratory at the National Centre for Medical Genetics in Dublin, Ireland, and Adjunct Associate Professor at University College Dublin. He trained in Trinity College, Dublin, and The Queen’s University of Belfast and carried out medical genetics research at Yale and Cambridge Universities before setting up the NHS molecular genetics diagnostic laboratory in Cambridge. In 1995, he returned to Dublin to set up his current laboratory at the National Centre for Medical Genetics. The role of laboratory medicine in clinical IT communicatio fosters unified s Interview: Walter Depner Looking back, the founding fathers of laboratory medicine were doc- tors who carried out the historic medical practice of uroscopy in the Middle Ages, explains Professor Klaus Kohse MD, Director of the Institute for Laboratory Medicine in Oldenburg Clinical Centre at Oldenburg University Medical Faculty. ‘They drew conclusions about a patient’s state of health by analysing a person’s urine – an eas- ily accessible body fluid. The change to the use of blood for this type of analysis, along with improvements to analytics, was decisive for progress in this field, particularly in the last century,’ he adds. ‘This information carrier is trans- ported to all organs via the cir- culation and carries out an inten- sive exchange of substances. Examinations were carried out with increasingly sensitive procedures and extended to more and more physiological and pathological sub- stances with increasing complexity. The ability to determine concen- trations on a femtomolar level is no longer sensational, and for cells or genome equivalents the number required for safe quantitative and qualitative analysis can be counted on the fingers of just one hand.’ Where we are today ‘These days, the knack of laboratory medicine lies in the ability to process the enormous abundance of informa- tion from examinations. The ‘omics’, the entirety of genes, proteins, lipids, carbohydrates or metabolic param- eters can now only be captured with bio-informatic methods. Traditional assessment criteria, such as longitu- dinal studies or transversal studies, soon reach their limits. ‘Going forward, the aforemen- tioned, complex information will facilitate individual assessments along the lines of the much-heralded ‘personalised medicine’ – but only if we also realise that we are dealing with dynamic organisms, with any samples taken only giving us a snap- shot of a situation at this very point in time. Last, but not least, diagnos- tics will be advanced through the integration of clinical-chemical infor- mation with imaging procedures – such as functional NMR, PET and so on.’ Having been a member of vari- ous national and international com- mittees, associations and socie- ties, among others the Executive Committee of the IFCC Task Force on Paediatric Laboratory Medicine. With roles also including treasur- er of the European Communities Confederation of Clinical Chemistry and lecturer at the European Medical School Oldenburg-Groningen, the professor’s experience is pan-Euro- pean. How does he perceive this array of countries and cultures? ‘The development of Europe from a plethora of different national states has obviously led to a multitude of developments during the establish- ment of our discipline,’ he points out. ‘Clinical Chemistry, Clinical Biochemistry, Clinical Biology, Clinical Pathology, and Laboratory Medicine are terms that tend to be used on a mix and match basis. ‘The scope of diagnostic activ- ity is also extremely different. In one country the fields of haematol- ogy and microbiology are included, in another they are considered to be separate subjects. The medical degree courses also differ. There is human medicine on the one side and natural sciences, such as chemistry, biochemistry and pharmaceutics, on the other. The basic problem of how to deal with this continues to be an issue for the ‘community’. ‘This prevails despite the fact that there are European committees such as the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and Union Européenne des Médecins Spécialistes (UEMS), which have agreed on and compiled fun- damental documentation and com- petency descriptions, such as the term European Specialist in Clinical Chemistry and Laboratory Medicine, based on a ‘common platform’ type of catalogue.’ ‘The differences don’t stop at European borders, but have to be assessed differently as a matter of principle against the background Continued from page 9 Made to measure laboratories of stainless steel furniture, morgue refrigeration units and transport and storage equipment.’ Robert Karl is increasingly asked to take over the entire laboratory planning, so the firm is not only a supplier but also planner. Kugel’s customers include his- topathology labs, forensic centres, universities, hospitals, anatomy institutes and pharmaceutical firms plus veterinary pathologists. The firm has 130 international partners and 85% of its products are export- ed to 72 countries, including those in Europe, the Middle East, Russia, Asia and Australia. ‘This year, Kugel medical cel- ebrates its 20-year anniversary – for which Robert and Claudia Karl issued a statement that it is ‘an anni- versary that we are very proud of and which motivates us even more to develop and manufacture state- of-the-art solutions for our custom- ers around the world.’ Illuminated Down-draft Grossing table with accessories such as a corian cutting board and a monitor holder

EH 2_2015

Pages Overview