Legislative and ethical aspects of introducing new technologies in medical care for senior citizens in developed countries

. 2016 ; 11 () : 977-84. [epub] 20160721

Jazyk angličtina Země Nový Zéland Médium electronic-ecollection

Typ dokumentu časopisecké články, přehledy

Perzistentní odkaz   https://www.medvik.cz/link/pmid27499618

INTRODUCTION: The majority of developed countries are currently experiencing demographic aging. The most frequently expressed concerns related to the changing age structure are the increased costs of social and medical care, a lack of labor force in the job market, and financial sustainability of the pension system. These concerns are often based on the pessimistic view of population aging. This view understands aging as a prolonged period of illness and suffering. On the other hand, optimists believe that a longer life span is a result of increased quality of life and better health care. The quality of life may be improved not only by medicaments, but also by rapidly developing area of medical devices, which allow better care for seniors in many areas. AIM: This contribution aims to assess the legislative environment and ethical questions related to the use of medical devices, especially medical devices, in medical care for senior citizens. METHODS: The methods used in this study are literature reviews of legislative and ethical environment in the European Union (EU) and the US. RESULTS: Main findings of this study result from assessing the state of medical device regulations in Europe and the US. Namely, the US regulation seems to be better arranged, which is probably due to the fact that there is only one responsible body - the US Food and Drug Administration, which is responsible for all medical device regulations. On the other hand, in the EU, talks about new legislation are led by ministers from all the EU member states and it may take a long time before all the EU countries come to an agreement.

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Maresova P, Mohelska H, Kuca K. Economics aspects of ageing population. Procedia Econ Finance. 2015;23:534–538.

Maresova P, Kacetl J, Stemberková R, Kuca K. Care for Czechś Ageing Population; Proceedings of the 19th International Conference Current Trends in Public Sector Research, Brno, Czech Republic; Brno, Czech Republic: 2015. pp. 250–258.

Mckee K, Matlabi H, Parker SG. Older people’s quality of life and role of home-based technology. Health Promot Perspect. 2012;2(1):1–8. PubMed PMC

Horgas A, Abowd G. In: Pew RW, Van Hemel SB, editors. The impact of technology on living environments for older adults; Technology for Adaptive Aging; National Research Council (US) Steering Committee for the Workshop on Technology for Adaptive Aging; Washington (DC): National Academies Press (US); 2004. p. 9.

Gustafson DH, Sr, McTavish F, Gustafson DH, Jr, et al. The effect of an information and communication technology (ICT) on older adults’ quality of life: study protocol for a randomized control trial. Trials. 2015;16:191. PubMed PMC

Baig MM, Gholamhosseini H. Smart health monitoring systems: an overview of design and modeling. J Med Syst. 2013;37(2):9898. PubMed

Reiss A, Stricker D. Aerobic activity monitoring: towards a long-term approach. Universal Access Information Society. 2014;13(1):101–114.

Wootton R, Bahaadinbeigy K, Hailey D. Estimating travel reduction associated with the use of telemedicine by patients and healthcare professionals: proposal for quantitative synthesis in a systematic review. [Accessed December 14, 2015];BMC Health Serv Res. 2011 11:185. Available from: http://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-11-185. PubMed DOI PMC

Maresova P, Penhaker M, Selamat A, Kuca K. The potential of medical device industry in technological and economical context. Ther Clin Risk Manag. 2015;11:1505–1514. PubMed PMC

WHO Medical devices full definition. 2016. [Accessed December 14, 2015]. Available from: http://www.who.int/medical_devices/full_deffinition/en/

Chao KZ, Riskin DJ, Krummel TM. A patient-centered, ethical approach to medical device innovation. Virtual Mentor. 2010;12(2):91–95. PubMed

Registrar Corp [homepage on the Internet] U.S. FDA Medical Device Regulations. [Accessed December 14, 2015]. Available from: http://www.registrarcorp.com/fda-medical-device/registration/?lang=en.

FDA.gov [homepage on the Internet] Medical devices. [Accessed December 14, 2015]. Available from: http://www.fda.gov/MedicalDevices/default.htm.

HHS.gov [homepage on the Internet] About HHS. Department of Health & Human Services; [Accessed December 14, 2015]. Available from: http://www.hhs.gov/about/index.html.

GPO [homepage on the Internet] Electronic Code of Federal Regulations. [Accessed December 14, 2015]. Available from: http://www.ecfr.gov/cgi-bin/text-idx?SID=997ee953cbebe663b8b9cc29,87c67076&mc=true&tpl=/ecfrbrowse/Title21/21chapterI.tpl.

Center for Devices and Radiological Health . Regulatory Science Priorities (FY2016) Center for Devices and Radiological Health; 2015. [Accessed July 5, 2016]. p. 9. Available from: http://www.fda.gov/downloads/MedicalDevices/ScienceandResearch/UCM467552.pdf.

European Commission (EC) [homepage on the Internet] Medical devices. [Accessed December 14, 2015]. Available from: http://ec.europa.eu/growth/sectors/medical-devices/index_en.htm.

Holtzman Y, Gorkhover G, Ganz M. The U.S. Medical Device Industry: Strengths, Weaknesses, Opportunities, and Threats. MD+DI, Medical Device and Diagnostic Industry; 2015.

Obelis [homepage on the Internet] Europe moves forward on new and emerging technologies. [Accessed December 14, 2015]. Available from: http://obelismedical.net/europe-moves-forward-on-new-and-emerging-technologies.

IMDRF . UDI Guidance Unique Device Identification (UDI) of Medical Devices. IMDRF; 2013. [Accessed November 13, 2015]. Available from: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-udi-guidance-140901.pdf.

Citron P. Ethics considerations for medical device R&D. Prog Cardiovasc Dis. 2012;55(3):307–315. PubMed

Meskó B. The Guide to the Future of Medicine: Technology and the Human Touch. Berlin: WEbicina Kft; 2014. p. 274.

Logothetidis S. Nanotechnology in medicine: the medicine of tomorrow and nanomedicine. Hippokratia. 2006;10(1):7–21.

FDA FDA forecasts medical device technology trends for next decade. 2011. [Accessed November 14, 2015]. Available from: http://www.dicardiology.com/content/fda-forecasts-medical-device-technology-trends-next-decade#sthash.zawYs9DD.dpuf.

Sharkey A, Sharkey N. Granny and the robots: ethical issues in robot care for the elderly. Ethics and Information Technology. 2012;14(1):27–40.

Ng T. Ethics in the age of medical device technologies. Virtual Mentor. 2007;9(2):83–85. PubMed

Ikonen V, Kaasinen E. Ethical Assessment in the Design of Ambient Assisted Living. Proceedings of Assisted Living Systems—Models, Architectures and Engineering Approaches, Schloss Dagstuhl, Germany. 2008. pp. 14–17.

Kriewall TJ. Ethics of medical device safety. J Long Term Eff Med Implants. 2008;18(2):167–174. PubMed

Chao KZ, Riskin DJ, Krummel TM. A patient-centered, ethical approach to medical device innovation. Virtual Mentor. 2010;12(2):91–95. PubMed

Friedman B, Kahn PH. Human Values, Ethics and Design. University of Washington; 2003. pp. 1177–1201.

Friedman B, Kahn PH., Jr Human agency and responsible computing: implications for computer system design. J Syst Softw. 1992;17(1):7–14.

Mittelstadt B, Fairweather NB, McBride N, Shaw M. The ethical implications of personal health monitoring. Int J Technoethics. 2014;5(2):37–60.

Memon M, Wagner SR, Pedersen CF, Beevi FHA, Hansen FO. Ambient assisted living healthcare frameworks, platforms, standards, and quality attributes. Sensors. 2014;14:4312–4341. PubMed PMC

United Nations . Charter of the United Nations. The Statute of the International Court of Justice. San Francisco, CA: United Nations; 1945.

United Nations The Universal Declaration of Human Rights. [Accessed December 14, 2015]. Available from: http://www.un.org/en/universal-declaration-human-rights/index.html.

Keselman A, Tang X, Patel VL, Johnson TR, Zhang J. Institutional decision-making for medical device purchasing: evaluating patient safety. Stud Health Technol Inform. 2004;107(Pt 2):1357–1361. PubMed

Herman WA, Devey GB. Future Trends in Medical Device Technologies. The U.S. Food and Drug Administration;

World Medical Association World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Postgrad Med. 2002;48(3):206–208. PubMed

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