TIBBİ CİHAZLARDA SAĞLIK TEKNOLOJİLERİNİN DEĞERLENDİRİLMESİ

Öz Günümüzde sağlık harcamaları hızla artıyorken, karar vericiler, sağlığa erişim hakkı,sağlıkta eşitlik ve seçim hakkı gibi temel ilkeleri gözeterek gelişen sağlık teknolojilerininfinansmanı ve bütçe kısıtı arasında denge kurmaya çalışmaktadır. Bu doğrultudasağlık teknolojileri değerlendirmeleri (STD) birçok ülke için önemli bir sağlıkpolitikası aracı haline gelmiştir.STD yöntemleri ve uygulamaları, birçok ülkede, ilaçlarla ilgili kararların verilmesindetemel bir politika aracı haline gelmiştir. Tıbbi cihazlar için de STD uygulamaları,ülkeler arasında hızla yayılıyor olmakla birlikte, henüz ilaçlarda olduğu kadaryaygın bir uygulama alanına sahip değildir.Bu çalışmanın amacı, ilaçlar için uygulanan STD yöntemlerinin birebir tıbbi cihazlarauygulanamayacağına dikkat çekmek, tıbbi cihazlara ilişkin STD süreçlerinde tıbbicihazlara özgü özelliklerin göz önünde bulundurulmasının önemini ortaya koymakve tıbbi cihazların kendisine has özelliklerinin göz önünde bulundurulduğu STD süreçlerikonusunda önerilerde bulunmaktır. Çalışmada, genel olarak uygulanagelenSTD yöntemlerinin tıbbi cihazlar için de uygulanabilir olduğu ancak tıbbi cihazlarıilaçlardan ayıran farkların göz önünde bulundurularak STD süreçlerinin zenginleştirilebileceğisonucuna varılmıştır.

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 TechnologyAssessments. International Journal of Technology Assessment in Health Care, 18(2),361-422.

Campbell, G. (2008). Statistics in the world of medical devices: the contrast withpharmaceuticals. Journal of Biopharmaceutical Statistics, 1(18), 4-19.

Chalkidou, K., Lord, J., Fischer, A., & Littlejohns, P. (2008). Evidence-Based DecisionMaking: When Should We Wait For More Information? Health Affairs, 6(27),1642-1653.

Cook, J., Ramsay, C., & Fayers, P. (2004). Statistical evaluation of learning curveeffects 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 useof different data sources can impact results, Evidence-based health economics: fromeffectiveness to efficiency in systematic review. London: BMJ Publishing Group.

Drummond, M., Griffin, A., & Tarricone, R. (2009). Economic Evaluation for Devicesand Drugs-Same or Different? Value in Health, 12(4), 402-404.

Eldessoukı, R. (2011). Therapeutic and Diognastic Device Regulations. Therapeuticand Diognastic Device Outcomes Research (s. 41-43). USA: ISPOR.

EUnetHTA. (2008). EUnetHTA Work Package & Handbook on Health TechnologyAssessment Capacity Building. Barcelona: EUnetHTA.

EUnetHTA. (2015). Therapeutic medical devices guideline Austria. Austria: EUnetHTA.European Commission. (2012). Proposal por a Directive of the European Parliamentand of the Council Relating to the Transparency of Measures Regulating The Pricesof Medicinal Products For Human Use and Their Inclusion in the Scope of the NationalHealth Insurance Systems. Sweeden: European Commission.

FDA. (2016, Mayıs 20). Medical Device. FDA Web Sitesi: http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/ adresindenulaşılmıştır.

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 Conferenceof 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 MedicalDevices in the Logic of Health Technology Assessment. International Journal of TechnologyAssessment in Healthcare, 31(5), 324-330.

Higgins, J., & Green, S. (2016, Mayıs 20). Cochrane handbook for systematic reviewsof 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 devicesin Belgium. Brussels: KCE.

Konstam, M.A., Pina, I., Lindenfeld, J., & Packer, M. (2003). A Device Is Not aDrug. 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 Burdenof Evidence. Reviews on Recent Clinical Trials, 3(7), 244-248.

MEDDEV. (2010). Medical Devices: Guidance Document - Classification of MedicalDevices. MEDDEV.

Murphy, A.M. (2013). Economic evaluations for health. Economic evaluations forhealth technologies with an evolving evidence base: a case study of transcatheteraortic valve implantation. PhD thesistez. University of Glasgow.

National Authority for Health. (2013). Methodological Choices for the Clinical Developmentof Medical Devices. Saint-Denis La Plaine : National Authority for Health.

National Institute for Public Health and the Environment. (2015). Comparison ofmarket 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 forMedical Devices Research Version 2. London: NICE.

NICE. (2011). National Institute for Health and Clinical Excellence, Medical TechnologiesEvaluation Programme methods guide. London: NICE.

Parquin, F., & Audry, A. (2012). Clinical evaluation of medical devices: main constraintsand specificities. Therapie, 4(67), 311-318.

Rochaix, L., & Xerri, B. (2009). National Authority for Health: France. The CommonwealthFund, 48(1295), 1-10.

Sculpher, M., Drummond, M., & Buxton, M. (1997). The iterative use of economicevaluation as part of the process of health technology assessment. Journal of HealthServices 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 MedicalDevice Sectors. Health Policy, 7(4), 209-217.

Sorenson, C., Tarricone, R., Siebert, M., & Drummond, M. (2011). Applying healtheconomics for policy decision making: do devices differ from drugs? Europace, 54-58.

Taylor, R. S., Cynthia , P., & Iglesias. (2009). Assesing the Clinical and Cost-Effectivenessof 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 TechnologyAssessment in European Union. UK: WHO.

WHO. (2010a). Medical Devices: Managing the Mismatch an Outcome of the PriorityMedical 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.