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Erschienen in:
Analysis of Surgeons’ Muscle Activity During the Use of a Handheld Robotic Instrument in Laparoendoscopic Single-Site Surgery Kapitel lesen Erstes Kapitel lesen

2017 | OriginalPaper | Buchkapitel

Framework Proposal Including HFE in Product Development Process: A Suitable Approach for the Brazilian Medical Equipment Industry

verfasst von : Ana Paula Almeida, Rodrigo Almeida, Renata Custódio, Clarissa Trzesniak, Carlos Mello

Erschienen in: Advances in Human Factors and Ergonomics in Healthcare

Verlag: Springer International Publishing

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Abstract

Brazilian Medical Industry is mostly comprised of small to medium-sized manufactures Small changes on requirements can pose a big challenge on their process. From December 2015 the IEC 60601-1-6 has become mandatory for all new medical equipment registration in Brazilian market. These two facts led to the development of this research, aimed at provide a framework to include HFE methods inside the product development process, while confirming with the standards. The framework should be simple to implement and provide practical information showing which tool to use at the right time, considering a device in development. The methods were selected based on previous Brazilian experiences and literature review. The final framework is constituted of 4 steps using 6 HFE methods, linked in such way that the information generated by one method can be used as input to the other method, minimizing work overhead, and documentation to the standard requirements.

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Vorheriges Kapitel &You: Design of a Sensor-Based Wearable Device for Use in Cognitive Behavioral Therapy
Nächstes Kapitel A Systematic Approach to Improve the Reprocessing of Surgical Instruments
Literatur
1.
Espicom Business Intelligence: Brazil Medical Devices Report. BMI Research Company, London (2015)
2.
Wheelwright, S.C., Clark, K.B.: Revolutionizing Product Development: Quantum Leaps in Speed, Efficiency, and Quality. Simon and Schuster (1992)
3.
Cooper, R.G., Edgett, S.J., Kleinschmidt, E.J.: New product portfolio management: practices and performance. J. Prod. Innov. Manage 16(4), 333–351 (1999)CrossRef
4.
Pahl, G., Beitz, W., Feldhusen, J., Grote, K.H.: Projeto na engenharia: fundamentos do desenvolvimento eficaz de produtos métodos e aplicações. Edgard Blucker (2005)
5.
Rozenfeld, H., Forcellini, F.A., Amaral, D.C., Toledo, J.C., Silva, S.L., Alliprandini, D.H., Scalice, R.K.: Gestão de Desenvolvimento de Produtos: Uma Referência para a Melhoria do Processo. Saraiva, São Paulo SP (2006)
6.
Medina, L., Kremer, G., Wysk, R.: Supporting medical device development: a standard product design process model. J. Eng. Des. 24(2), 83–119 (2013)CrossRef
7.
Santos, I.C., Gazelle, G.S., Rocha, L.A., Tavares, J.M.R.: Modeling of the medical device development process (Review). Informa Healthc. 9, 537–543 (2012)
8.
Silva, A., Almeida, R., Ferreira, J., Gibertoni, A.: Human factors engineering applied to risk management in the use of medical equipment. In: em XII Mediterranean Conference on Medical and Biological Engineering and Computing (2010)
9.
van der Peijl, J., Klein, J., Grass, C., Freudenthal, A.: Design for risk control: the role of usability engineering in the management of use-related risks. J. Biomed. Inf. 45, 795–812 (2012)
10.
Money, A.G., Barnett, J., Kuljis, J., Craven, M.P., Martin, J.L. Young, T.: The role of the user within the medical device design and development process: medical device manufacturers’ perspectives. BMC Med. Inf. Decis. Mak. 11, 1472–6947 (2011)
11.
ABNT.: NBR IEC 62366: Produtos para a saúde—Aplicação da engenharia de usabilidade a produtos para a saúde. Rio de Janeiro (2010)
12.
13.
Martin, J.L., Norris, B.J., Murphy, E., Crowe, J.A.: Medical device development: the challenge for ergonomics. Appl. Ergonom. 39, 271–283 (2008)
14.
Stanton, N., Salmon, P., Rafferty, L., Walker, G., Baber, C., Jenkins, D.: Human Factors Methods: A Practical Guide for Engineering and Design, 2 ed. Ashgate Publishing, Ltd. (2013)
15.
Shah, S.G.S., Robinson, I., AlShawi, S.: Developing medical device technologies from users’ perspectives: a theoretical framework for involving users in the development process. Int. J. Technol. Assess. Health Care 25, 514–521 (2009)
16.
Almeida, A., Turrione, J., Müller, Jr, E.: Mapeamento da aplicação de engenharia de fatores humanos no processo de desenvolvimento de equipamentos médicos. Dissertação de Mestrado Unifei, Itajubá MG (2013)
17.
AAMI.: Human Factors Engineering: Design of Medical Devices (ANSI/AAMI HE75:2009). Arlington, VA (2009)
18.
Zhang, J., Johnson, T.R., Patel, V.L., Paige, D.L., Kubose, T.: Using usability heuristics to evaluate patient safety of medical devices. J. Biomed. Inf. 36(1), 23–30 (2003)
19.
Martin, J.L., Barnett, J.: Integrating the results of user research into medical device development: insights from a case study. BMC Med. Inf. Decis. Mak. 12, 74 (2012)
20.
Dinka, D., Nyce, J.M., Timpka, T.: The need for transparency and rationale in automated systems. Interact. Comput. 18, 1070–1083 (2006)
21.
Sharples, S., Martin, J., Lang, A., Craven, M., O’Neill, S., Barnett, J.: Medical device design in context: a model of user-device interaction and consequences. Displays 33, 221–232 (2012)
22.
Grupo de Trabalho Interinstitucional sobre órteses: próteses e materiais especiais, “Relatório final do GTI-OPME”. Ministério da saúde, Brasilia (2015)
23.
24.
Agencia Brasileira de Desenvolvimento industrial: Estudo prospectivo – cadeia de equipamentos médicos, hospitalares e odontológicos. Série Cadernos da Indústria. ABDI, Brasília (2009)
25.
Cag, G.: “Perspectivas do investimento em saúde”, em Perspectivas do Investimento no Brasil, p. 217. UFRJ, Rio de Janeiro (2009)
26.
Marques, A.B., Antunes, A.M.D.S., Alves, F.C.: Equipamentos Médico-Hospitalares: Uma Análise Do Ambiente De Negócio E Da Estrutura Industrial. em XVI Simpósio de Administração da Produção, Logística e Operações Internacionais, São Paulo (2013)
27.
Centro de Gestão e Estudos Estratégicos.: Estudo Prospectivo Setorial: Equipamento Médico-Hospitalar e Odontológico. CGEE, Bras (ilia, 2007)
28.
Ministério do Planejamento: Orçamento e Gestão, “PLANO PLURIANUAL 2008–2011”. MPOG, Brazilia (2007)
29.
Cag, G.: Desenvolvimento, complexo industrial da saúde e política industrial. Revista de Saúde Pública 40, 11–23 (2006)CrossRef
30.
Caliari, T.E.A.: Uma década de medicamentos genéricos; sucesso relativo e progressiva perda de eficiência. em ENCONTRO NACIONAL DE ECONOMIA, Foz do Iguaçu (2009)
31.
Brasil.: Dispõe sobre a Vigilância Sanitária a que ficam sujeitos os Medicamentos, as Drogas, os Insumos Farmacêuticos e Correlatos, Cosméticos, Saneantes e Outros Produtos, e dá outras Providências. Diário Oficial da União (1976)
32.
Brasil.: Define o Sistema Nacional de Vigilância Sanitária, cria a Agência Nacional de Vigilância Sanitária, e dá outras providências. Diário Oficial da União (1999)
33.
ABNT.: NBR IEC 60601-1-6: Equipamento eletromédico Parte 1-6: requisitos gerais para segurança básica e desempenho essencial – norma colateral: usabilidade. Rio de Janeiro (2011)
34.
Anvisa.: Instrução Normativa No 4. Diário Oficial da União (2015)
35.
Metadaten
Titel
Framework Proposal Including HFE in Product Development Process: A Suitable Approach for the Brazilian Medical Equipment Industry
verfasst von
Ana Paula Almeida
Rodrigo Almeida
Renata Custódio
Clarissa Trzesniak
Carlos Mello
Copyright-Jahr
2017
Buch
Advances in Human Factors and Ergonomics in Healthcare

Print ISBN: 978-3-319-41651-9

Electronic ISBN: 978-3-319-41652-6

Copyright-Jahr: 2017

DOI
https://doi.org/10.1007/978-3-319-41652-6_25