Documentation Template for the Usability Engineering Process for Medical Devices

2018 ◽  
pp. 69-73 ◽  
Author(s):  
Daniel Scherer ◽  
Francisco Ferreira Gouveia Filho
Keyword(s):  
Medical Devices ◽  
Engineering Process ◽  
Usability Engineering

A field study of the Wheel—a usability engineering process model

2006 ◽  
Vol 79 (6) ◽  
pp. 841-858 ◽  
Author(s):  
James W. Helms ◽  
James D. Arthur ◽  
Deborah Hix ◽  
H. Rex Hartson
Keyword(s):  
Field Study ◽  
Process Model ◽  
Engineering Process ◽  
Usability Engineering

Usability Engineering Recommendations for Next-Gen Integrated Interoperable Medical Devices

2021 ◽  
Vol 55 (4) ◽  
pp. 132-142
Author(s):  
Paolo Masci ◽  
Sandy Weininger
Keyword(s):  
Medical Devices ◽  
Hazard Analysis ◽  
Technical Committee ◽  
Medical System ◽  
Analysis Method ◽  
Usability Engineering ◽  
Design Problems ◽  
Model Based ◽  
Key Aspects ◽  
System Prototype

Abstract This article reports on the development of usability engineering recommendations for next-generation integrated interoperable medical devices. A model-based hazard analysis method is used to reason about possible design anomalies in interoperability functions that could lead to use errors. Design recommendations are identified that can mitigate design problems. An example application of the method is presented based on an integrated medical system prototype for postoperative care. The AAMI/UL technical committee used the results of the described analysis to inform the creation of the Interoperability Usability Concepts, Annex J, which is included in the first edition of the new ANSI/AAMI/UL 2800-1:2019 standard on medical device interoperability. The presented work is valuable to experts developing future revisions of the interoperability standard, as it documents key aspects of the analysis method used to create part of the standard. The contribution is also valuable to manufacturers, as it demonstrates how to perform a model-based analysis of use-related aspects of a medical system at the early stages of development, when a concrete implementation of the system is not yet available.

scholarly journals Integrating a Usability Engineering Process into a Consisting Risk Management

2018 ◽  
Vol 4 (1) ◽  
pp. 645-647
Author(s):  
Michael Scholtes ◽  
Stephanie Buedenbender ◽  
Annemarie Behrend ◽  
Keywan Sohrabi ◽  
Volker Gross
Keyword(s):  
Risk Management ◽  
Medical Device ◽  
Engineering Process ◽  
Usability Engineering ◽  
User Interactions ◽  
Management Processes ◽  
Medical Device Manufacturers ◽  
Incident Reports ◽  
Development Step ◽  
Medical Device Regulation

AbstractThe complexity of medical devices and its user interactions increases. A growing number of incident reports are assumed to be associated primarily with user errors. This development is tackled through current modifications in standards, such as ISO 13485:2016 and legislations, such as the Medical Device Regulation. Both intensify the focus on use errors significantly. The aim of this paper was the development of a process orientated approach integrating usability engineering into a consisting risk management based on a classic V-model. An appropriate procedure was worked out. For each development step, risk and usability activities were cumulated. Thus, the present paper might help medical device manufacturers to reflect their risk management and usability management processes to find synergies. Prospectively, a step-by-step guide for the integration of risk management and usability engineering based on this approach should be developed.

Checklists — Suitable Tools for Usability Testing

2005 ◽  
Vol 49 (11) ◽  
pp. 955-959
Author(s):  
S. Koneczny ◽  
U. Matern
Keyword(s):  
Operating Room ◽  
Medical Devices ◽  
Unsolved Problem ◽  
Usability Testing ◽  
German Hospital ◽  
Engineering Process ◽  
Basic Tool ◽  
Hospital Medical ◽  
Working Posture

Ergonomics in the operating room (OR) is an unsolved problem for users and engineers. Deficiencies of the OR as a workplace cause potential hazards for the patient as well as for the OR staff. To detect those conditions a checklist for the OR was developed and as a first step evaluated in a German hospital. Medical technical devices were found to be lacking in usability due to such as unclear symbols, impracticability, hindrances and insufficient ease in handling. Also the positioning of devices in the OR shows ergonomic problems that in most cases necessitates an unavoidable awkward working posture for the employees that causes pain. The checklist can be used as a basic tool for the implementation of usability into the engineering process and design of new medical devices as well as for the usability testing of the final product.

Sign in / Sign up

Export Citation Format

Share Document