Abstract
The engineer in charge with developing, producing and marketing of medical devices has to be a specialist in many interdisciplinary realms, ranging from natural sciences to finances and ethics. This requires both curiosity, knowledge and the capability of finding compromises in terms of cost and time. Current main issues represent the following questions: (1) “How to test a device adequately?” (2) How to cope and avoid extractables from polymers and medical devices? (3) How to achieve a reasonable biocompatibility? A good understanding of physiological pathways and processes in the body of a human being helps to answer these questions during conception, research and development of devices for medical application. Last but not least, the bioengineer has to be communicative, because many questions can only be answered in a cooperation between scientists and engineers from both academia and industry.
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References
Sanderson K (2021) Electronic skin: From flexibility to a sense of touch. Nature 591:685–687
Willet F, Avansino D, Hochberg L, Henderson J, Shenoy K (2021) High performance brain-to-text communication via handwriting. Nature 593:249–254
von Gersdorff G, Usvyat L, Marcelli D, Grassmann A, Marelli C, Etter M et al (2013) Monitoring dialysis outcomes across the world – The MONDO global database consortium. Blood Purif 36:165–172
Usvyat L, Barth C, Bayh I, Etter M, von Gersdorff G, Grassmann A et al (2013) Interdialytic weight gain, systolic blood pressure, serum albumin, and C-reactive protein levels change in chronic dialysis patients prior to death. Kidney Int 84:149–157
Dekker M, Marcelli D, Canaud B, Carioni P, Wang Y, Grassmann A et al (2017) Impact of fluid status and inflammation and their interaction on survival: A study in an international hemodialysis patient cohort. Kidney Int 91:1214–1223
Samples R (2001) Mummy has a wooden toe. Science 291:243
Becker C (1914) Die Wunderheilung der Ärzteheiligen Cosmas und Damian. Dtsch med Wschr 40:27–28
Hans von Wechtlich (1517) Feldtbuch der Wundartzney. Strassburg 1517
Check E (2007) The hard copy. Nature 446:485–486
Freedman et al (2015) The economics of reproducibility in preclinical research. PLoS Biol 13(6):e1002165
International Standard Organisation (2009) (DIN EN ISO) 10993–4. Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood
Braune S, Fröhlich G, Lendlein A, Jung F (2015) Effect of temperature on platelet adherence. Clin Hemorheol Microcircul 61:681–688
Braune S, Groß M, Walter M, Zhou Z, Dietze S, Rutschow S, Lendlein A, Tschöpe C, Jung F (2016) Adhesion and activation of platelets from subjects with coronary artery disease and apparently healthy individuals on biomaterials. J Biomed Mater Res Part B 104:210–217
Zhang Y, Ma K, Gong Y, Wang G, Hu Z, Liu L, Lu J, Chen PP, Lu CC, Ruan X, Liu BC (2018) Platelet microparticles mediate glomerular endothelial injury in early diabetic nephropathy. J Am Soc Nephrol 29:2671–2695
Cantaluppi V, Gatti S, Medica D, Figliolini F, Bruno S, Deregibus M, Sordi A, Biancone L, Tetta C, Camussi G (2012) Microvesicles derived from endothelial progenitor cells protect the kidney from ischemia–reperfusion injury by microRNA-dependent reprogramming of resident renal cells. Kidney Int 82:412–437
Vienken J (2010) Biomaterials for medical devices: are current hemo- or biocompatibility tests adequate? Mat Wiss u Werkstofftech 41:1081–1085
Mueller X, Tevaearai H, Jegger D, Tucker O, von Segesser L (2001) Hemolysis and hematology profile during perfusion: Inter-species comparison. Int J Artif Organs 24:89–94
Dahms K, Sharkova Y, Heitland P, Pankuweit S, Schaefer R (2014) Cobalt intoxication diagnosed with the help of Dr. House. Lancet 383:574–575
Nitta K, Goto S, Masakane I, Hanafusa N, Taniguchi M, Hasegawa T, Nakai S, Wada A, Hamano T, Hoshino J, Joki N, Abe M, Yamamoto K, Nakamoto H (2020) Annual dialysis data report for 2018, JSDT Renal Data Registry: survey methods, facility data, incidence, prevalence, and mortality. Ren Replacem Ther 6:41
ISO 10993-1 (2009) Biological evaluation of medical devices: Part 1. Evaluation and testing within a risk management process
ISO 10993-12 (2003) Biological evaluation of medical devices: Part 12. Sample preparation and reference materials
ISO 10993-17 (2002) Biological evaluation of medical devices: Part 17. Establishment of allowable limits for leachable substances. (New ISO under development 2021)
ISO 10993-7 (2009) Biological evaluation of medical devices: Part 7. Ethylene-oxide sterilization residuals. Edition 2009
Commission regulation (EU) Nr. 143/2011 of 17 February 2011. Off J European Union, L44/2 from February 18, 2011
Hutter J, Kuehnert M, Wallis R, Lucas A, Sen S, Jarvis W (2000) Acute onset of decreased vision and hearing traced to hemodialysis treatment with aged dialysers. JAMA 83:2128–2134
Canaud B, Aljama P, Tielemans C, Gasporovic V, Gutierrez A, Locatelli F (2002) Performance liquid test as a cause for sudden deaths of dialysis patients: perfluoro-hydrocarbon, a previously unrecognized hazard for dialysis patients. Nephrol Dial Transplant 17:545–548
ISO-Standard 10993–4 (1993) Biological evaluation of medical devices
Erlenkötter A, Endres P, Nederlof B, Hornig C, Vienken J (2008) Score model for the evaluation of dialysis membrane hemocompatibility. Artif Organs 32:962–968
Gwinner W, Menne J, Lonnemann G, Bahlmann F, Koch K, Haller H (2005) Life-threatening complications of extracorporeal treatment in patients with severe eosinophilia. Int J Artif Organs 28:1224–1227
Tielemanns C, Madhoun P, Lenaers M, Schandene L, Goldman M, Vanherweghem JL (1990) Anaphylactoid reactions during hemodialysis on AN69 membranes in patients receiving ACE inhibitors. Kidney Int 38:982–984
Kammerl M, Schaefer R, Schweda F, Schreiber m, Riegger G, Krämer B (2000) Extracorporeal therapy with AN69 membranes in combination with ACE-inhibition causing severe anaphylactoid reactions: still a current problem? Clin Nephrol 53:486–488
Vienken J (2001) Polymers in dialysis: characteristics and needs. Med Device Technol 12:18–27
Vienken J, Bowry S (2002) Quo vadis dialysis membrane? Artif Organs 26:152–159
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Vienken, J. (2022). The Role of the Engineer and Technology in Healthcare. In: Boccato, C., Cerutti, S., Vienken, J. (eds) Medical Devices. Research for Development. Springer, Cham. https://doi.org/10.1007/978-3-030-85653-3_2
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