Human factors in the design of medical devices – Approaches to meeting international standards in the European Union and USA

Privitera, Mary Beth; Evans, Mark A.; Southee, Darren

doi:10.1016/j.apergo.2016.08.034

Cited by 43 publications

(37 citation statements)

References 19 publications

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“…Los estándares técnicos de los dispositivos médicos presentan puntos importantes para el diseño del producto y la mejora continua del mismo, por lo que son recomendaciones muy importantes y que se deben seguir rigurosamente para garantizar la calidad y seguridad del producto durante todo el ciclo de vida, esto debe ser evaluado por las autoridades sanitarias y no debe ser tratado de ocultar o evadir por el fabricante, para obtener mejoras económicas sin velar por la seguridad y salud de profesionales y pacientes 15,16 .…”

Section: Discussionunclassified

Normativa vigente en España sobre la utilización de la diatermia en medicina y ciencias del deporte

Lastra

2019

Rev And Med Dep

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Introducción: En el tratamiento de las lesiones deportivas se utilizan diferentes formas de energía electromagnética, entre ellas la diatermia, con fines terapéuticos. El uso seguro de los dispositivos de diatermia, tanto para el paciente como para el personal sanitario que los aplica, se basa en estándares profesionales, códigos de seguridad y directrices varias, que determinan los procedimientos de uso seguros. Estas recomendaciones se encuentran dispersas y no son bien conocidas por los usuarios, por lo que fue el objetivo de esta revisión el sintetizar y actualizar dichas recomendaciones. Metodología: revisión de la normativa vigente en España, sobre el uso de los equipos médicos de Diatermia. Discusión: Esta falta de claridad en algunos fabricantes hace que se cuestione la usabilidad o aplicación de los productos que se fabrican para uso sanitario. Esta situación favorece un marketing engañoso y el cliente final queda no solo a merced de una adquisición de un equipo sin la certificación médica adecuada, sino además desprotegido legalmente en su aplicación, lo que puede traer como consecuencia sanciones legales.

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Section: Discussionunclassified

Normativa vigente en España sobre la utilización de la diatermia en medicina y ciencias del deporte

Lastra

2019

Rev And Med Dep

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“…In the specific study, the regulatory and safety environment was dictated by current FDA and MHRA guidance and requirements. 32 Based on this analysis, the coded data was converted into functional and non-functional requirements. The main approach was to convert any need or desire expressed from the users into a technically described description.…”

Section: Methodsmentioning

confidence: 99%

Robot-Assisted Fracture Surgery: Surgical Requirements and System Design

et al. 2018

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The design of medical devices is a complex and crucial process to ensure patient safety. It has been shown that improperly designed devices lead to errors and associated accidents and costs. A key element for a successful design is incorporating the views of the primary and secondary stakeholders early in the development process. They provide insights into current practice and point out specific issues with the current processes and equipment in use. This work presents how information from a user-study conducted in the early stages of the RAFS (Robot Assisted Fracture Surgery) project informed the subsequent development and testing of the system. The user needs were captured using qualitative methods and converted to operational, functional, and non-functional requirements based on the methods derived from product design and development. This work presents how the requirements inform a new workflow for intra-articular joint fracture reduction using a robotic system. It is also shown how the various elements of the system are developed to explicitly address one or more of the requirements identified, and how intermediate verification tests are conducted to ensure conformity. Finally, a validation test in the form of a cadaveric trial confirms the ability of the designed system to satisfy the aims set by the original research question and the needs of the users.Electronic supplementary materialThe online version of this article (10.1007/s10439-018-2005-y) contains supplementary material, which is available to authorized users.

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“…Similarly, the International Organization for Standardization (ISO) emphasizes the need to evaluate "the extent to which a user can use a product to achieve specific goals with effectiveness, efficiency and satisfaction in a specific context" (IEC ISO 62366:2015) [37]. According to these regulatory requirements, Human-centred design (HCD) appears as a method that involves the user in the development process, in order to ensure that MD meets their needs and competences, but also to improve safety, satisfaction, effectiveness and efficiency, while reducing product recalls and modifications [38][39][40][41]. In order to achieve the international standards (ISO 13407:1999, ISO 14155:2011; ISO 14971:2012) [42][43][44], the HCD method defines four phases in the development of MDs: (i) identify the user and specify the context of use; (ii) specify the user requirements; (iii) produce design solutions; and (iv) evaluate design solutions against requirements.…”

Section: Legal Requirements For the Development Of New Mdsmentioning

confidence: 99%

Development of an innovative double-chamber syringe for intravenous therapeutics and flushing: Nurses’ involvement through a human-centred approach

et al. 2020

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Background In nursing practice, flushing the catheters pre and post-drug administration is considered an important clinical procedure to prevent complications, and requires the use of several syringes to comply with international standards of care. We envisioned an innovative doublechamber syringe that enables the filling and administration of both solutions. Following current international recommendations, the development of new medical devices should integrate Health Technology Assessment. The Human-centred design is usually used for that assessment purposes, as a method that actively include end-users in the devices development process. Method Application of the Human-Centred Design through the involvement of nurses in the initial stages of the device development in order to accomplish the initial stages of Technology Readiness Level. A multi-method approach was used, including literature/guidelines review, focus groups with end-users and expert panels. Results The involvement of nurses enabled the definition of user requirements and contexts of use, as well as the evaluation of design solutions and prototypes in order to accomplish with usability and ergonomic features of the medical device.

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Human factors in the design of medical devices – Approaches to meeting international standards in the European Union and USA

Cited by 43 publications

References 19 publications

Normativa vigente en España sobre la utilización de la diatermia en medicina y ciencias del deporte

Normativa vigente en España sobre la utilización de la diatermia en medicina y ciencias del deporte

Robot-Assisted Fracture Surgery: Surgical Requirements and System Design

Development of an innovative double-chamber syringe for intravenous therapeutics and flushing: Nurses’ involvement through a human-centred approach

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