EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2014

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materials measures, if not carefully prepared, may result in fatal incidences. As reported in a series of publications in 2001 and 2002, 23 dialysis patients died in Croatia as a consequence of a dialysis filter performance test for leaky capillary membranes with the perfluorocarbon-5070 liquid 8,9 . Following a dialyzer repair process performed by the manufacturer, residual amounts of PF5070 stayed in the filter and were rinsed out later by the perfusing blood during dialysis therapy. PF5070 slowly accumulated in the heart and lungs of the patients, ultimately causing death several hours later upon foam formation. Conclusion Leachables and extractables from poly- mers, biomaterials and medical devices should be carefully assessed when they are exposed to bodily fluids in long-term clini- cal applications. Associated adverse events may range from severe allergic reactions to death. The amount of residual extractables in medical devices should, thus, be kept as low as possible. Questions still remain, however. What are the threshold levels for leachables below which no adverse events can be detected? And, how do you control the release of leachables in long-term, chronically ill patients? As long as these questions remain unanswered, careful clinical observations and an understanding of the underlying mechanisms are imperative. References 1. Nakai S et al; Overview of regular dialysis treatment in Japan as of 31. December 2011. Ther Aph Dial, 17:567- 611 (2013) 2. ISO 10993-1: Biological evaluation of medical devices: Part 1. Evaluation and testing within a risk management process. 4th Edition 2009 3. ISO 10993-12: Biological evaluation of medical devices: Part 12. Sample preparation and reference materials. Corrected 2nd Edition 2003. 4. ISO 10993-17: Biological evaluation of medical devices: Part 17. Establishment of allowable limits for leachable substances. 1st Edition, 2002 5. ISO 10993-7: Biological evaluation of medical devices: Part 7. Ethylene-oxide sterilization residuals. Edition 2009. 6. Commission regulation (EU) Nr. 143/2011 of 17. February 2011. Official Journal of the European Union, L44/2 from February 18, 2011. 7. Hutter J et al; Acute onset of decreased vision and hearing traced to hemodialysis treatment with aged dialysers. JAMA, 283:2128-2134 (2000) 8. Gasparovic V et al; Sudden death of Croatian hemodialysis patients in October 2001. Croatian Med J, 42:606-610 (2001) 9. Canaud B et al; Performance liquid test as a cause for sudden deaths of dialysis patients: perfluorohydrocarbon, a previously unrecognized hazard for dialysis patients. ephrol Dial Transplant, 17:545-548 (2002) Prof. Dr. Jörg Vienken Board Member of Nephro-Solutions AG Harvesterhuder Weg 49 20148 Hamburg e-mail: vienken@nephro- solutions.de Presented by: Interested in Sponsoring? Contact medicalsales@ubm.com The Medtech Industry's Premier Awards Program Transforming Healthcare— One Innovation at a Time 2014 MDEA Ceremony When: June 11, 2014 When: MD&M East Event Jacob K. Javits Center, New York You're Invited! See Who Wins RSVP TODAY! mdeawards.com/rsvp @mddionline #mdea14 ES433752_EMDT1405_052.pgs 05.01.2014 21:49 UBM black yellow magenta cyan

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