Systematization of information for identifying similar cardiovascular implantable devices
Otto, Christina Carvalho; Freire, Sergio Miranda; Almeida, Rosimary Terezinha de
http://dx.doi.org/10.1590/2446-4740.0629
Res. Biomed. Eng., vol.31, n1, p.70-77, 2015
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Views: 903
Abstract
Introduction: The lack of a terminology to compare medical devices together with the arbitrary and opaque nature of product registration systems are major obstacles to a more informed decision process regarding the use and acquisition of new medical devices. This paper describes the systematization of information to help in the identifi cation of similar cardiovascular implantable devices. Methods: The systematization was developed in four stages: defi nition of the technical attributes of each device group; classifi cation of a sample of devices; implementation of the proposed systematization in Protégé; and evaluation of the application. The systematization dealt with a set of common attributes – indication of use, anatomic location, manufacturer, device model and lifetime; and a set of attributes specifi c for each type of device. Results: The systematization was performed by means of a hierarchy of classes with the respective properties in Protégé, which support three basic functions: data entry, query, and maintenance. 38 queries were designed to allow the identifi cation of similar devices according to their technical characteristics. The users’ evaluation showed that the application fulfi lled the requirements to monitor the price of these devices on the market. Conclusions: Protégé was a useful tool for the systematization of cardiovascular implantable devices that can be used for the post-market vigilance of medical device safety. To better fulfi ll this aim, other attributes may be incorporated to better characterize the safety aspects of these devices.
Keywords
Medical devices, Price monitoring, Post-market vigilance, Management, Protégé.
References
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Bernstein AD, Daubert JC, Fletcher RD, Hayes DL, Lüderitz B, Reynolds DW, Schoenfeld MH, Sutton R, North American Society of Pacing and Electrophysiology, British Pacing and Electrophysiology Group. The revised NASPE/BPEG generic code for antibradycardia, adaptive-rate, and multisite pacing. Pacing and Clinical Electrophysiology 2002; 25(2):260-4. http://dx.doi.org/10.1046/j.1460-9592.2002.00260.x. PMid:11916002.
Brasil. Agência Nacional de Vigilância Sanitária – ANVISA. Consulta a banco de dados: produtos para a saúde. Brasília; 2003 [cited 2009 Dec 15]. Available from: http://www.anvisa.gov.br/scriptsweb/correlato/correlato_rotulagem.htm.
Brasil. Agência Nacional de Vigilância Sanitária - ANVISA. RDC nº 185, de 13 de outubro de 2006. Diário Oficial da União, Brasília, out. 2006.
Brasil. Agência Nacional de Vigilância Sanitária - ANVISA. Stents farmacológicos e stents metálicos no tratamento da doença arterial coronariana. Boletim Brasileiro de Avaliação de Tecnologias em Saúde 2009a; IV(8).
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Calil SJ. Situação dos hospitais brasileiros: panorama da distribuição e dos custos de manutenção de (alguns) equipamentos médicos para diagnóstico. In: Workshop Anvisa; 2004; Rio de Janeiro, Brazil.
Chin JP, Diehk VA, Norman KL. Development of an instrument measuring user satisfaction of the human-computer interface. In: Proceedings of the SIGCHI conference on Human Factors in Computing Systems; 1988 May 15-19; Washington, USA. p. 213-8.
Cohen D, Billingsley M. Europeans are left to their own devices. British Medical Journal 2011; 342:d2748. http://dx.doi.org/10.1136/bmj.d2748. PMid:21572130.
Departamento de Informática do Sistema Único de Saúde - DATASUS. 2011 [cited 2011 Nov 21]. Available from: http://www2.datasus.gov.br/DATASUS/index.php?area=02.
Deconinck E, Sohier J, De Scheerder I, Van den Mooter G. Pharmaceutical aspects of drug eluting stents. Journal of Pharmaceutical Sciences 2008; 97(12):5047-60. http://dx.doi.org/10.1002/jps.21356. PMid:18384155.
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Emergency Care Research Institute - ECRI. Universal Medical Device Nomenclature System™. 2009 [cited 2009 Oct 27]. Available from: https://www.ecri.org/Products/Pages/UMDNS.aspx.
França AHG, Pereira AH. Atualização sobre endopróteses vasculares (stents): dos estudos experimentais à prática clínica. Jornal Vascular Brasileiro 2008; 7(4):351-63. http://dx.doi.org/10.1590/S1677-54492008000400010.
Global Harmonization Task Force Study Group 1 - GHTF. GHTF/SG1/N29R16: information document concerning the definition of the term “Medical Device”. The Global Harmonization Task Force; 2005.
Global Medical Device Nomenclature Agency - GMDN. The Global Medical Device Nomenclature. 2005 [cited 2009 Oct 27]. Available from: http://www.gmdn agency.org/.
Heart Rhythm Society. 2012a [cited 2012 Aug 05]. Available from: http://www.hrsonline.org/.
Heart RhythmUK. 2012b [cited 2012 Aug 05]. Available from: http://heartrhythmuk.org.uk/.
HoffmanG. 1958: primeiro implante de marca-passo. 2009 [cited 2012 Aug 05]. Available from: http://www.dw-world.de/dw/article/0,967232,00.html.
International Health Terminology Standards Development Organization – IHTSDO. Systematized Nomenclature of Medicine-Clinical Terms. 2009 [cited 2009 Sep 21]. Available from: http://www.ihtsdo.org/snomed-ct/.
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo – HCFMUSP
Orientações ao portador de cardioversor desfibrilador implantável. 2009 [cited 2009 Oct 27]. Available from: http://www.incor.usp.br/marca-passo/orientacao_cdi.html.
Kalil C, Nery PB, Bartholomay E, Albuquerque LC. Tratamento com cardioversor-desfibrilador implantável e ressincronização cardíaca: isolados ou associados? Revista Brasileira de Cirurgia Cardiovascular2006; 21(1):85-91. http://dx.doi.org/10.1590/S0102-76382006000100015.
Kingsley PA. Health care practitioners’ medical device information and labeling needs. 1995 [cited 2011 Nov 21]. Disponível em: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/HumanFactors/ucm126024.pdf.
Kramer DB, Xu S, Kesselheim AS. Regulation of medical devices in the United States and European Union. The New England Journal of Medicine 2012; 366(9):848-55. http://dx.doi.org/10.1056/NEJMhle1113918. PMid:22332952.
Martinelli MF. Terapia de ressincronização cardíaca (TRC). Jornal Diagnósticos em Cardiologia 2008; 38:1-14.
National Cancer Institute - NCI. National Cancer Institute Thesaurus. 2011 [cited 2011 Feb 18]. Available from: http://ncit.nci.nih.gov/.
Nelken N, Schneider PA. Advances in stent technology and drug-eluting stents. The Surgical Clinics of North America 2004; 84(5):1203-36, v. http://dx.doi.org/10.1016/j.suc.2004.05.003. PMid:15364552.
Noy N, McGuinness D. Ontology development 101: a guide to creating your first ontology. Palo Alto: Stanford University; 2001. Stanford Knowledge Systems Laboratory Technical Report KSL-01-05 and Stanford Medical Informatics Technical Report SMI-2001-0880.
Otto CC, Freire SM, Almeida RT. Terminologias para produtos para a saúde – revisão e análise crítica. In: Anais do XXII Congresso Brasileiro de Engenharia Biomédica; 2010 Nov; Tiradentes, Brazil. p. 21-5.
Otto CC. Sistematização de informações sobre os produtos para a saúde de uso cardiovascular utilizando o Protégé [dissertation]. Rio de Janeiro: Programa de Engenharia Biomédica, Universidade Federal do Rio de Janeiro; 2011.
Pauly MV, Burns LR. Price transparency for medical devices. Health Affairs 2008; 27(6):1544-53. http://dx.doi.org/10.1377/hlthaff.27.6.1544. PMid:18997210
Protégé. 2011 [cited 2011 Nov 21]. Available from: http://protege.stanford.edu/.
Rubin DL, Noy NF, Musen MA. Protégé: a tool for managingand using terminology in radiology applications. Journal of Digital Imaging 2007; 20(Suppl 1):34-46. http://dx.doi.org/10.1007/s10278-007-9065-0. PMid:17687607.
TsakonasG, PapatheodorouC. Exploring usefulness and usability in the electronic information services. Journal of Information Science 2006; 32(5):400-19. http://dx.doi.org/10.1177/0165551506065934.
World Health Organization - WHO. Medical devices: managing the mismatch. 2010 [cited 2011 Nov 21]. Available from: http://whqlibdoc.who.int/publications/2010/9789241564045_eng.pdf.
World Health Organization - WHO. First WHO global forum on medical devices: context outcomes and future actions. 2011 [cited 2011 Nov 21]. Available from: http://www.who.int/medical_devices/gfmd_report_final.pdf.
Andrade JC, Avila Neto V, Braile DM, Brofman PRS, Costa ARB, Costa R, Galvão Filho SS, Gauch PR, Lucchese FA, Martinelli Filho M, Medeiros PT, Mateos JC, Pimenta J, Takeda RT. Diretrizes para o implante de cardioversor desfibrilador implantável. Arquivos Brasileiros de Cardiologia 2000; 74(5):481-2. http://dx.doi.org/10.1590/S0066-782X2000000500010. PMid:10951840.
Araújo OFN. Proposta de uma rede de compartilhamento de habilidades no ambiente da Manufatura [thesis]. Campinas: Universidade Estadual de Campinas; 2003.
Association Internationale de la Mutualité - AIM. Medical devices: an entire overhaul of the European authorisation and surveillance system for high-risk Medical Devices is urgently needed. Brussels; 2012 [cited 2012 Aug 05]. Available from: http://www.ikkev.de/uploads/media/AIM-ESIP-ISDBMiEF_position_paper_on_reform_Medical_device.pdf.
Bernstein AD, Camm AJ, Fisher JD, Fletcher RD, Mead RH, Nathan AW, Parsonnet V, Rickards AF, Smyth NPD, Sutton R, Tarjan PP. North American Society of Pacing and Electrophysiology policy statement. The NASPE/BPEG defibrillator code. Pacing and Clinical Electrophysiology 1993; 16(9):1776-80. http://dx.doi.org/10.1111/j.1540-8159.1993.tb01809.x. PMid:7692407.
Bernstein AD, Daubert JC, Fletcher RD, Hayes DL, Lüderitz B, Reynolds DW, Schoenfeld MH, Sutton R, North American Society of Pacing and Electrophysiology, British Pacing and Electrophysiology Group. The revised NASPE/BPEG generic code for antibradycardia, adaptive-rate, and multisite pacing. Pacing and Clinical Electrophysiology 2002; 25(2):260-4. http://dx.doi.org/10.1046/j.1460-9592.2002.00260.x. PMid:11916002.
Brasil. Agência Nacional de Vigilância Sanitária – ANVISA. Consulta a banco de dados: produtos para a saúde. Brasília; 2003 [cited 2009 Dec 15]. Available from: http://www.anvisa.gov.br/scriptsweb/correlato/correlato_rotulagem.htm.
Brasil. Agência Nacional de Vigilância Sanitária - ANVISA. RDC nº 185, de 13 de outubro de 2006. Diário Oficial da União, Brasília, out. 2006.
Brasil. Agência Nacional de Vigilância Sanitária - ANVISA. Stents farmacológicos e stents metálicos no tratamento da doença arterial coronariana. Boletim Brasileiro de Avaliação de Tecnologias em Saúde 2009a; IV(8).
Brasil. Agência Nacional de Vigilância Sanitária – ANVISA. Pós-comercialização pós-uso/Regulação de mercado/Publicações regulação economica. Estudo de sistematização de informações de produtos para a saúde de uso cardiovascular. Brasília; 2009b [cited 2014 Jul 15]. Available from: http://www.anvisa.gov.br.
Brasil. Banco Central do Brasil. Conversão de Moeda. Brasilia; 2014. [cited 2014 Sept 20]. Available from: http://www4.bcb.gov.br/pec/conversao/conversao.asp.
Calil SJ. Situação dos hospitais brasileiros: panorama da distribuição e dos custos de manutenção de (alguns) equipamentos médicos para diagnóstico. In: Workshop Anvisa; 2004; Rio de Janeiro, Brazil.
Chin JP, Diehk VA, Norman KL. Development of an instrument measuring user satisfaction of the human-computer interface. In: Proceedings of the SIGCHI conference on Human Factors in Computing Systems; 1988 May 15-19; Washington, USA. p. 213-8.
Cohen D, Billingsley M. Europeans are left to their own devices. British Medical Journal 2011; 342:d2748. http://dx.doi.org/10.1136/bmj.d2748. PMid:21572130.
Departamento de Informática do Sistema Único de Saúde - DATASUS. 2011 [cited 2011 Nov 21]. Available from: http://www2.datasus.gov.br/DATASUS/index.php?area=02.
Deconinck E, Sohier J, De Scheerder I, Van den Mooter G. Pharmaceutical aspects of drug eluting stents. Journal of Pharmaceutical Sciences 2008; 97(12):5047-60. http://dx.doi.org/10.1002/jps.21356. PMid:18384155.
Emergency Care Research Institute - ECRI. Cardiac Pacemaker-Implantable. Health Product Comparison System. 2005a [cited 2009 Oct 27]. Available from: https://www.ecri.org/Products/Pages/hpcs.aspx.
Emergency Care Research Institute - ECRI. Defibrillator-Pacemakers Implantable. Health Product Comparison System. 2005b [cited 2009 Oct 27]. Available from: https://www.ecri.org/Products/Pages/hpcs.aspx.
Emergency Care Research Institute - ECRI. Universal Medical Device Nomenclature System™. 2009 [cited 2009 Oct 27]. Available from: https://www.ecri.org/Products/Pages/UMDNS.aspx.
França AHG, Pereira AH. Atualização sobre endopróteses vasculares (stents): dos estudos experimentais à prática clínica. Jornal Vascular Brasileiro 2008; 7(4):351-63. http://dx.doi.org/10.1590/S1677-54492008000400010.
Global Harmonization Task Force Study Group 1 - GHTF. GHTF/SG1/N29R16: information document concerning the definition of the term “Medical Device”. The Global Harmonization Task Force; 2005.
Global Medical Device Nomenclature Agency - GMDN. The Global Medical Device Nomenclature. 2005 [cited 2009 Oct 27]. Available from: http://www.gmdn agency.org/.
Heart Rhythm Society. 2012a [cited 2012 Aug 05]. Available from: http://www.hrsonline.org/.
Heart RhythmUK. 2012b [cited 2012 Aug 05]. Available from: http://heartrhythmuk.org.uk/.
HoffmanG. 1958: primeiro implante de marca-passo. 2009 [cited 2012 Aug 05]. Available from: http://www.dw-world.de/dw/article/0,967232,00.html.
International Health Terminology Standards Development Organization – IHTSDO. Systematized Nomenclature of Medicine-Clinical Terms. 2009 [cited 2009 Sep 21]. Available from: http://www.ihtsdo.org/snomed-ct/.
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo – HCFMUSP
Orientações ao portador de cardioversor desfibrilador implantável. 2009 [cited 2009 Oct 27]. Available from: http://www.incor.usp.br/marca-passo/orientacao_cdi.html.
Kalil C, Nery PB, Bartholomay E, Albuquerque LC. Tratamento com cardioversor-desfibrilador implantável e ressincronização cardíaca: isolados ou associados? Revista Brasileira de Cirurgia Cardiovascular2006; 21(1):85-91. http://dx.doi.org/10.1590/S0102-76382006000100015.
Kingsley PA. Health care practitioners’ medical device information and labeling needs. 1995 [cited 2011 Nov 21]. Disponível em: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/HumanFactors/ucm126024.pdf.
Kramer DB, Xu S, Kesselheim AS. Regulation of medical devices in the United States and European Union. The New England Journal of Medicine 2012; 366(9):848-55. http://dx.doi.org/10.1056/NEJMhle1113918. PMid:22332952.
Martinelli MF. Terapia de ressincronização cardíaca (TRC). Jornal Diagnósticos em Cardiologia 2008; 38:1-14.
National Cancer Institute - NCI. National Cancer Institute Thesaurus. 2011 [cited 2011 Feb 18]. Available from: http://ncit.nci.nih.gov/.
Nelken N, Schneider PA. Advances in stent technology and drug-eluting stents. The Surgical Clinics of North America 2004; 84(5):1203-36, v. http://dx.doi.org/10.1016/j.suc.2004.05.003. PMid:15364552.
Noy N, McGuinness D. Ontology development 101: a guide to creating your first ontology. Palo Alto: Stanford University; 2001. Stanford Knowledge Systems Laboratory Technical Report KSL-01-05 and Stanford Medical Informatics Technical Report SMI-2001-0880.
Otto CC, Freire SM, Almeida RT. Terminologias para produtos para a saúde – revisão e análise crítica. In: Anais do XXII Congresso Brasileiro de Engenharia Biomédica; 2010 Nov; Tiradentes, Brazil. p. 21-5.
Otto CC. Sistematização de informações sobre os produtos para a saúde de uso cardiovascular utilizando o Protégé [dissertation]. Rio de Janeiro: Programa de Engenharia Biomédica, Universidade Federal do Rio de Janeiro; 2011.
Pauly MV, Burns LR. Price transparency for medical devices. Health Affairs 2008; 27(6):1544-53. http://dx.doi.org/10.1377/hlthaff.27.6.1544. PMid:18997210
Protégé. 2011 [cited 2011 Nov 21]. Available from: http://protege.stanford.edu/.
Rubin DL, Noy NF, Musen MA. Protégé: a tool for managingand using terminology in radiology applications. Journal of Digital Imaging 2007; 20(Suppl 1):34-46. http://dx.doi.org/10.1007/s10278-007-9065-0. PMid:17687607.
TsakonasG, PapatheodorouC. Exploring usefulness and usability in the electronic information services. Journal of Information Science 2006; 32(5):400-19. http://dx.doi.org/10.1177/0165551506065934.
World Health Organization - WHO. Medical devices: managing the mismatch. 2010 [cited 2011 Nov 21]. Available from: http://whqlibdoc.who.int/publications/2010/9789241564045_eng.pdf.
World Health Organization - WHO. First WHO global forum on medical devices: context outcomes and future actions. 2011 [cited 2011 Nov 21]. Available from: http://www.who.int/medical_devices/gfmd_report_final.pdf.
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