Techniques for Usability Risk Assessment during Medical Device Design

Ravizza, Alice and Díaz Lantada, Andrés and Ballesteros Sánchez, Luis Ignacio and Sternini, Federico and Bignardi, Cristina (2019). Techniques for Usability Risk Assessment during Medical Device Design. In: "12th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2019)", 22 - 22 February 2019, Praga (Czech Republic). ISBN 978-989-758-353-7. pp. 207-214. https://doi.org/10.5220/0007483102070214.

Description

Title: Techniques for Usability Risk Assessment during Medical Device Design
Author/s:
  • Ravizza, Alice
  • Díaz Lantada, Andrés
  • Ballesteros Sánchez, Luis Ignacio
  • Sternini, Federico
  • Bignardi, Cristina
Item Type: Presentation at Congress or Conference (Article)
Event Title: 12th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2019)
Event Dates: 22 - 22 February 2019
Event Location: Praga (Czech Republic)
Title of Book: Proceedings of the 12th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2019)
Date: 2019
ISBN: 978-989-758-353-7
Subjects:
Freetext Keywords: Usability; Human Factors; Risk Management; Medical Device Design
Faculty: E.T.S.I. Industriales (UPM)
Department: Ingeniería Mecánica
Creative Commons Licenses: Recognition - No derivative works - Non commercial

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Abstract

Human errors during the use of medical devices, due to pitfalls in the design of the user interface, may lead to substantial risk to users and to patients. There are multiple techniques for the identification and for the assessment of user related risks, that may be chosen according to the step of the design (preliminary feasibility studies, minimum viable product assessment, verification and validation) and considering cognitive processes and information processing mechanisms of users, which may lead to errors. Some techniques are more adequate for a quick-and-dirty approach, during early stages of design: these include expert reviews, discussions among focus groups, standard reviews and heuristic analyses. Other techniques are adequate for a more detailed and systematic analysis of risk, in more advanced design stages, with a failure mode and effect analysis (FMEA) approach, including time-and-motion studies and task analyses. Lastly, user tests with the help of rapid prototypes, perhaps involving alternative embodiments to be studied, are very adequate for verification and validation of the interface. Usability analysis techniques should be part of the toolbox of a biomedical engineer and they should be carefully chosen. Each technique, regardless the step it is used, should allow the designers to define a precise level of risk in terms of probability, severity. Moreover, usability risk minimisation measures shall be measurable and able to be quantified, as well as the impact of risk mitigation strategies. For this reason, usability risk minimisation measures should be classified according to regulatory requirements as "safe by design"; "alarms and protections" and "information for safe use". Each class of risk minimisation measure should be then given a measurable risk reduction score, so that the risk assessment can be completed in a repeatable and regulatory compliant way.

Funding Projects

TypeCodeAcronymLeaderTitle
Horizon 2020731053UBORAUNIVERSITA DI PISAEuro-African Open Biomedical Engineering e-Platform for Innovation through Education

More information

Item ID: 64794
DC Identifier: http://oa.upm.es/64794/
OAI Identifier: oai:oa.upm.es:64794
DOI: 10.5220/0007483102070214
Official URL: http://www.biodevices.biostec.org/?y=2019
Deposited by: Memoria Investigacion
Deposited on: 10 Nov 2020 18:03
Last Modified: 10 Nov 2020 18:03
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