• Mikuš, P., Piešťanský, J., Dokupilová, S. 2018. Kvapalinová chromatografia, hmotnostná spektrometria a ich kombinácie vo farmaceutickej a biomedicínskej analýze, VEDA, Bratislava, 2018. 365 s.
• Mikuš, P., Piešťanský, J. 2014. Kapilárna elektroforéza, hmotnostná spektrometria a ich kombinácie vo farmaceutickej a biomedicínskej analýze, Učebnica pre farmaceutické fakulty a fakulty prírodovedného a technického smeru so zameraním na analytickú chémiu a farmaceutickú chémiu, VEDA, Bratislava, 2014. 312 s.
• Chromý, V. a kol. 2002. Bioanalytika, Analytická chemie v laboratorní medicíně. Masarykova Univerzita v Brně, 2002. 267 s.
• Králová, B., Fukal, L., Rauch, P. 2001. Bioanalytické metody. Praha : Vysoká škola chemickotechnologická, 2001. S. 254.
• Tekeľ, J., Mikuš, P. 2005. Vybrané kapitoly z analytickej chémie: analýza látok v biologických systémoch. Bratislava, Vydavateľstvo UK 2005, s. 194.
The content of the state exam of the Diagnostic Devices results from the syllabus related to analytical methodology of 17 thematic areas:
1. Analyzed samples in laboratory diagnostics.
2. Preparation of samples for instrumental analysis, their collection, transport, adjustment for analysis, prevention of deterioration of samples, analysis protocol.
3. Pre-analytical phase of laboratory diagnostics and devices in the pre-analytical phase of laboratory diagnostics
4. Types of reactions most often used in diagnosis (chemical, enzymatic, RIA methods). Features of analytical reagents.
5. Standardization in chemical diagnostics, errors of analytical methods, statistical evaluation of the results of analysis.
6. Methods and procedures in diagnosis according to the level of reliability. Definitive methods, reference methods, routine methods. Reference materials used in laboratory diagnostics.
7. Diagnostic kits (one- and two-stage method) and their manufacture. Diagnostic strips, visual evaluation, evaluation by instrumental methods. Automatic analyzers in clinical biochemical laboratories.
8. Chemical diagnostic aids in the determination of the most common analytes.
9. Use of in vitro medical diagnostic devices in clinical biochemistry.
10. Instrumental analytical methods in diagnosis.
11. Electrochemical methods (electrochemical methods of element analysis). Potentiometry, principle. The use of ion-selective electrodes in diagnostics.
12. Spectral methods (use of optical methods to evaluate the quality of diagnostic and medical devices)
13. Instrumental analytical methods of element analysis (RFA, AAS, AES), principle and their application.
14. Separation methods in the evaluation of chemical and diagnostic devices (chromatographic methods with UV and VIS detection, electromigration methods with spectrometric evaluation).
15. Nuclear characteristics of radionuclides. Nuclear analytical methods (determination of the basic characteristics of radionuclides, determination and identification of heavy metals by RRFA).
16. Radiopharmaceuticals, their production and properties. Characteristics and significance of radiopharmaceuticals, quality evaluation of radiopharmaceuticals.
17. Use of radionuclides of labeled substances in research, diagnosis and therapy. Imaging of organs and investigation of organ functions using radiopharmaceuticals (in vivo).
Conditions for passing the state exam: Successful completion of all compulsory subjects of the recommended Bc. study plan with a minimum number of 174 credits for subjects taken during the study
The content of the state subject Diagnostic Devices includes knowledge and basics in analytical methodology of 17 thematic areas:
1. Analyzed samples in laboratory diagnostics.
2. Preparation of samples for instrumental analysis, their collection, transport, adjustment for analysis, prevention of deterioration of samples, analysis protocol.
3. Pre-analytical phase of laboratory diagnostics and devices in the pre-analytical phase of laboratory diagnostics
4. Types of reactions most often used in diagnosis (chemical, enzymatic, RIA methods). Features of analytical reagents.
5. Standardization in chemical diagnostics, errors of analytical methods, statistical evaluation of the results of analysis.
6. Methods and procedures in diagnosis according to the level of reliability. Definitive methods, reference methods, routine methods. Reference materials used in laboratory diagnostics.
7. Diagnostic kits (one- and two-stage method) and their manufacture. Diagnostic strips, visual evaluation, evaluation by instrumental methods. Automatic analyzers in clinical biochemical laboratories.
8. Chemical diagnostic aids in the determination of the most common analytes.
9. Use of in vitro medical diagnostic devices in clinical biochemistry.
10. Instrumental analytical methods in diagnosis.
11. Electrochemical methods (electrochemical methods of element analysis). Potentiometry, principle. The use of ion-selective electrodes in diagnostics.
12. Spectral methods (use of optical methods to evaluate the quality of diagnostic and medical devices)
13. Instrumental analytical methods of element analysis (RFA, AAS, AES), principle and their application.
14. Separation methods in the evaluation of chemical and diagnostic devices (chromatographic methods with UV and VIS detection, electromigration methods with spectrometric evaluation).
15. Nuclear characteristics of radionuclides. Nuclear analytical methods (determination of the basic characteristics of radionuclides, determination and identification of heavy metals by RRFA).
16. Radiopharmaceuticals, their production and properties. Characteristics and significance of radiopharmaceuticals, quality evaluation of radiopharmaceuticals.
17. Use of radionuclides of labeled substances in research, diagnosis and therapy. Imaging of organs and investigation of organ functions using radiopharmaceuticals (in vivo).
0/100
After completing the course, the student gains an overview of the use of analytical chemistry and the analytical methods used in quantitative analysis of substances, laboratory skills in methods of quantitative analysis with an emphasis on instrumental analytical methods. The student gains theoretical and practical knowledge of materials and aids for analytical sampling, has got a know how to carry out analytical reactions allowing evaluation of the quality of the materials used, reactions for the evaluation of samples of biological origin in vitro, as well as in vivo.
•Hegyi L., Bielik I.: Základy verejného zdravotníctva, Herba 2011, s. 288, ISBN 978808917184
•Labudová, M., Puteková, S. 2021. Vybraté kapitoly z vnútorného lekárstva pre nelekárske odbory. Bratislava: Herba, 2021. 142 s. ISBN 978-80-8229-009-0
•Malovecká I., Mináriková D., Foltán V.: Zdravotnícke pomôcky – vybrané úlohy. Výdaj
zdravotníckych pomôcok na lekársky poukaz. FaF UK, 2015, on-line katalóg FaF, ISBN
978-80-223-3812-7
•Mináriková, D., et al. 2015. Zdravotnícke pomôcky. Legislatíva a regulácia. Vysokoškolská učebnica. Martin: Osveta, 2015. 1. vyd., 222 s. ISBN 978-80-8063-418-6
•Mináriková, D. a kol. 2018. Zdravotnícke pomôcky - princípy úhradovej kategorizácie.
Bratislava: Univerzita Komenského, 2018. Dostupné online, ISBN 978-80-223-4479-1.
- Rosina, J. Vránová, J., Kolářová. 2021. Biofyzika. Pro zdravotnické a biomedicínske obory. 2. doplnené vyd. Praha: Grada, 2021, 296 s. ISBN 978-80-271-2526-5
•Zamborský, R. 2020. problematika úrazov u geriatrického pacienta. Bratislava: Herba, 2020, 56 s. ISBN 978-80-8229-002-1
The student demonstrates a comprehensive knowledge of the importance of medical devices (MDs) as an integral part in prevention and curative health care in association with legislative requirements and resulting regulation. She/he deeply understands the definition and purpose of MDs, she/he can classify them , she/he is familiar with the standards of handling MD within the framework of preventive and therapeutic procedures. She/he bases his knowledge on quality and safety of MDs on technological aspects - material, production technology, MDs´handling throughout the entire life cycle. He/she has learned the basic principles of good clinical practice regarding MDs to be tested in clinical trials, he/she knows the requirements of good manufacturing practice and good distribution practice of the MDs.
The state examination in the subject Medical Device, part (a) and (b) is carried out orally and in person at the place of residence of the Faculty of Pharmacy of the Comenius University Bratislava.
a) Medical devices (MDs) in curative-preventive healthcare, definition, classification, standards of preventive and therapeutic procedures, technological aspects (material, manufacturing technology, handling of medical devices throughout the life cycle, including standards for medical devices for clinical investigations, ensuring good manufacturing practice and good distribution practice in MDs, decommissioning and disposal of MDs, including.
b) Regulatory aspects, European and national legislation in the field of medical devices, placing on the market of medical devices, regulation of the price and reimbursement of medical devices, handling, procurement and distribution of medical devices, prescription and dispensing of medical devices, vigilance over the safety of medical devices, health economy, financing of healthcare; health insurance system, position of medical devices in the context of social pharmacy, consumption, cost and pharmacoeconomic evaluation of medical devices, basics of public health, population health – position of medical devices in prevention and health promotion, ethics and legal aspects in the provision of health care and the exercise of the medical profession, health management, marketing in health care.
0/100
By completing the subject, the student has basic theoretical knowledge in the field of financing health care, understands the principles of health insurance, pricing and reimbursement of medical devices. He understands the importance of medical devices (MDs) in healthcare from prevention to monitoring the patient's treatment within different diagnoses. The student gets an overview of a wide range of MDs, she/he can classify and sort them according to the degree of a risk. She/he is familiar with the standards for handling MDs in their entirety, from R&D to clinical trials, placing on the market up to a disposing of them. Based on her/his knowledge of the MDs´materials, functionality and the correct application for patient, she/he can assess their quality and safety and thus ensure their place in the provision of health care at different levels of the health system.