TIBBİ CİHAZLARDA SAĞLIK TEKNOLOJİLERİNİN DEĞERLENDİRİLMESİ

Yıl 2018, Sayı: 13, 116 - 146, 01.03.2018

Tuğba Yıldız

https://doi.org/10.21441/sguz.2018.62

Cited By: 2

Öz

Günümüzde sağlık harcamaları hızla artıyorken, karar vericiler, sağlığa erişim hakkı,

sağlıkta eşitlik ve seçim hakkı gibi temel ilkeleri gözeterek gelişen sağlık teknolojilerinin

finansmanı ve bütçe kısıtı arasında denge kurmaya çalışmaktadır. Bu doğrultuda

sağlık teknolojileri değerlendirmeleri (STD) birçok ülke için önemli bir sağlık

politikası aracı haline gelmiştir.

STD yöntemleri ve uygulamaları, birçok ülkede, ilaçlarla ilgili kararların verilmesinde

temel bir politika aracı haline gelmiştir. Tıbbi cihazlar için de STD uygulamaları,

ülkeler arasında hızla yayılıyor olmakla birlikte, henüz ilaçlarda olduğu kadar

yaygın bir uygulama alanına sahip değildir.

Bu çalışmanın amacı, ilaçlar için uygulanan STD yöntemlerinin birebir tıbbi cihazlara

uygulanamayacağına dikkat çekmek, tıbbi cihazlara ilişkin STD süreçlerinde tıbbi

cihazlara özgü özelliklerin göz önünde bulundurulmasının önemini ortaya koymak

ve tıbbi cihazların kendisine has özelliklerinin göz önünde bulundurulduğu STD süreçleri

konusunda önerilerde bulunmaktır. Çalışmada, genel olarak uygulanagelen

STD yöntemlerinin tıbbi cihazlar için de uygulanabilir olduğu ancak tıbbi cihazları

ilaçlardan ayıran farkların göz önünde bulundurularak STD süreçlerinin zenginleştirilebileceği

sonucuna varılmıştır.

Anahtar Kelimeler

Sağlık teknolojilerinin değerlendirilmesi, tıbbi cihaz, yinelemeli değerlendirme, klinik etkililik, maliyet etkililik

Kaynakça

• Borgonovi, E., Busse, R., & Kanavos, P. (2008). Financing Medical Devices in Europe: Current Trends and Perspectives for Research” . Eurohealth, 14(3), 1-3.
• Busse, R., Orvain, J., Velasco, M., Perleth, M., Drummond, M., Gurtner, F., Wild, C. (2002). Best Practice In Undertaking And Reporting Health Technology Assessments. International Journal of Technology Assessment in Health Care, 18(2), 361-422.
• Campbell, G. (2008). Statistics in the world of medical devices: the contrast with pharmaceuticals. Journal of Biopharmaceutical Statistics, 1(18), 4-19.
• Chalkidou, K., Lord, J., Fischer, A., & Littlejohns, P. (2008). Evidence-Based Decision Making: When Should We Wait For More Information? Health Affairs, 6(27), 1642-1653.
• Cook, J., Ramsay, C., & Fayers, P. (2004). Statistical evaluation of learning curve effects in surgical trials. Clin Trials, 1(5), 421-427.
• Council Directive 93/42/EC of 14 June 1993 Concerning Medical Devices. (2016, Mayıs 20). europa.eu: http://eur-lex.europa.eu/LexUriServ/LexUriServ. do?uri=CONSLEG: 1993L0042:20071011:en:PDF adresinden ulaşılmıştır.
• Coyle, D., & Lee, K.M. (2002). Evidence-based economic evaluation: how the use of different data sources can impact results, Evidence-based health economics: from effectiveness to efficiency in systematic review. London: BMJ Publishing Group.
• Drummond, M., Griffin, A., & Tarricone, R. (2009). Economic Evaluation for Devices and Drugs-Same or Different? Value in Health, 12(4), 402-404.
• Eldessoukı, R. (2011). Therapeutic and Diognastic Device Regulations. Therapeutic and Diognastic Device Outcomes Research (s. 41-43). USA: ISPOR.
• EUnetHTA. (2008). EUnetHTA Work Package & Handbook on Health Technology Assessment Capacity Building. Barcelona: EUnetHTA.
• EUnetHTA. (2015). Therapeutic medical devices guideline Austria. Austria: EUnetHTA. European Commission. (2012). Proposal por a Directive of the European Parliament and of the Council Relating to the Transparency of Measures Regulating The Prices of Medicinal Products For Human Use and Their Inclusion in the Scope of the National Health Insurance Systems. Sweeden: European Commission.
• FDA. (2016, Mayıs 20). Medical Device. FDA Web Sitesi: http://www.fda.gov/ medicaldevices/deviceregulationandguidance/howtomarketyourdevice/ adresinden ulaşılmıştır.
• Fraser, A. G., Daubert, J. C., Werf, F., Estes, M., Smith Jr, S. C., Krucoff, M. W., Komajda, M. (2011). Clinical Evaluation Of Cardiovascular Devices: Principles, Problems, and Proposals For European Regulatory Reform Report of a Policy Conference of the European Society of of Cardiology. European Heart Journal, 13(32), 1673-1686.
• GHTF. (2012). Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD). The Global Harmonization Task Force. Mayıs 20, 2016 tarihinde http:// www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n071-2012-definitionof- terms-120516.pdf adresinden ulaşılmıştır.
• Goodman, C.S. (2004). HTA 101 Introduction to Health Technology Assessment. Virginia: The Lewin Group.
• Henschke, C., Perleth, M., Busse, R., & Panteli, D. (2015). Taxonomy of Medical Devices in the Logic of Health Technology Assessment. International Journal of Technology Assessment in Healthcare, 31(5), 324-330.
• Higgins, J., & Green, S. (2016, Mayıs 20). Cochrane handbook for systematic reviews of interventions version 5.1.0 2011. Cochrane Web sitesi: http://handbook. cochrane.org/ adresinden ulaşılmıştır.
• INAHTA. (2006). Health Technology Assessment (HTA) Glossary. Stockholm: INAHTA.
• KCE. (2015). Towards a guided and phased introduction of high-risk medical devices in Belgium. Brussels: KCE.
• Konstam, M.A., Pina, I., Lindenfeld, J., & Packer, M. (2003). A Device Is Not a Drug. Journal of Cardiac Failure, 3(9), 155-157.
• Kristensen, F.B., & Sigmund, H. (2007). Health Technology Assessment Handbook. Copenhagen: Danish Centre for Health Technology Assessment.
• Lassen, K., Hoye, A., & Myrmel, T. (2012). Randomised Trials in Surgery: The Burden of Evidence. Reviews on Recent Clinical Trials, 3(7), 244-248.
• MEDDEV. (2010). Medical Devices: Guidance Document - Classification of Medical Devices. MEDDEV.
• Murphy, A.M. (2013). Economic evaluations for health. Economic evaluations for health technologies with an evolving evidence base: a case study of transcatheter aortic valve implantation. PhD thesistez. University of Glasgow.
• National Authority for Health. (2013). Methodological Choices for the Clinical Development of Medical Devices. Saint-Denis La Plaine : National Authority for Health.
• National Institute for Public Health and the Environment. (2015). Comparison of market authorization systems of medical devices in USA and Europe. Bilthoven: Netherlands National Institute for Public Health and the Environment.
• NICE. (2008). National Instutitute for Health and Care Excellence, Approval for Medical Devices Research Version 2. London: NICE.
• NICE. (2011). National Institute for Health and Clinical Excellence, Medical Technologies Evaluation Programme methods guide. London: NICE.
• Parquin, F., & Audry, A. (2012). Clinical evaluation of medical devices: main constraints and specificities. Therapie, 4(67), 311-318.
• Rochaix, L., & Xerri, B. (2009). National Authority for Health: France. The Commonwealth Fund, 48(1295), 1-10.
• Sculpher, M., Drummond, M., & Buxton, M. (1997). The iterative use of economic evaluation as part of the process of health technology assessment. Journal of Health Services Research and Policy, 1(2), 26-30.
• Siebert, M., Clauss, L. C., Carlisie, M., Casteels, B., Jong, P., Kreuezer, M., . . . Lang, A. W. (2002). Health technology assessment for medical devices in Europe. What must be considered? International Journal Technologies Assess Health Care, 3(18), 733-740.
• Simoens, S. (2009). Which Barriers Prevent the Efficient Use of Resources in Medical Device Sectors. Health Policy, 7(4), 209-217.
• Sorenson, C., Tarricone, R., Siebert, M., & Drummond, M. (2011). Applying health economics for policy decision making: do devices differ from drugs? Europace, 54- 58.
• Taylor, R. S., Cynthia , P., & Iglesias. (2009). Assesing the Clinical and Cost-Effectiveness of Medical Devices and Drugs: Are They Different? Value in Health, 12(4), 404-406.
• WHO. (2008). Ensuring Value for Money in Helth Care: The Role of Health Technology Assessment in European Union. UK: WHO.
• WHO. (2010a). Medical Devices: Managing the Mismatch an Outcome of the Priority Medical Devices Project. France: who.
• WHO. (2010b). World Health Organization, Clinical Evidence for Medical Devices: Regulatory Processes Focussing on Europe and the United States of America. A: WHO.