A discipline about Human Factors Engineering and Usability applied to Medical Devices for under graduation courses using Active Learning techniques

Author(s):  
R. A. R. Custódio ◽  
A. P. S. S. Almeida ◽  
R. M. A. Almeida ◽  
J. A. Ferreira Filho ◽  
A. C. B. Ramos
Author(s):  
Maria Lund Jensen ◽  
Jayme Coates

Development of implantable medical devices is becoming increasingly interesting for manufacturers, but identifying the right Human Factors Engineering (HFE) approach to ensure safe use and effectiveness is challenging. Most active implantable devices are highly complex; they are built on extremely advanced, compact technology, often comprise systems of several device elements and accessories, and they span various types of user interfaces which must facilitate diverse interaction performed by several different user groups throughout the lifetime of the device. Furthermore, since treatment with implantable devices is often vital and by definition involves surgical procedures, potential risks related to use error can be severe. A systematic mapping of Product System Elements and Life Cycle Stages can help early identification of Use Cases, and for example user groups and high-level use risks, to be accounted for via HFE throughout development to optimize Human Factors processes and patient outcomes. This paper presents a concrete matrix tool which can facilitate an early systematic approach to planning and frontloading of Human Factors Engineering activities in complex medical device development.


Author(s):  
Molly Follette Story

An HFES Task Force is considering if, when, which, and how HFES research publications should require the citation of relevant standards, policies, and practices. To support Task Force activities, papers are being written about how to find relevant standards produced by various development organizations (such as ISO, IEC and AAMI) and the content of those standards. This paper describes ISO’s, IEC’s, and AAMI’s standards programs and their technical committees and working groups that produce standards, recommended practices, technical specifications, technical information reports, guides and other publications for medical devices. This paper focuses on those medical device publications that are relevant to human factors engineering practice and explains where and how to find them.


Author(s):  
Daniel Hannon ◽  
Esa Rantanen ◽  
Ben Sawyer ◽  
Raymond Ptucha ◽  
Ashley Hughes ◽  
...  

The explosion of data science (DS) in all areas of technology coupled with the rapid growth of machine learning (ML) techniques in the last decade create novel applications in automation. Many working with DS techniques rely on the concept of “black boxes” to explain how ML works, noting that algorithms find patterns in the data that humans might not. While the mathematics are still being developed, the implications for the application of ML, specifically to questions of automation, also are being studied, but still remain poorly understood. The decisions made by ML practitioners with respect to data selection, model training and testing, data visualization, and model applications remain relatively unconstrained and have the potential to yield unexpected results at the systems level. Unfortunately, human factors engineers concerned with automation often have limited training and awareness of DS and ML applications and are unable to provide the meaningful guidance that is needed to ensure the future safety of these newly emerging automated systems. Moreover, undergraduate and graduate programs in human factors engineering (HFE) have not kept pace with these developments and future HFEs may continue to find themselves unable to contribute meaningfully to the development of automated systems based on algorithms derived from ML. In this paper, human factors engineers and educators explore some of the challenges to our understanding of automation posed by specific ML techniques and contrast this with an outline of some of the historical work in HFE that has contributed to our understanding of safe and effective automation. Examples are provided from more conventional applications using both supervised and unsupervised learning techniques, that are explored with respect to implications for algorithm performance, use in system automation, and the potential for unintended results. Implications for human factors engineering education are discussed.


2012 ◽  
Vol 32 (4) ◽  
pp. 60-68 ◽  
Author(s):  
Elizabeth Mattox

Errors related to health care devices are not well understood. Nurses in intensive care and progressive care environments can benefit from understanding manufacturer-related error and device-use error, the principles of human factors engineering, and the steps that can be taken to reduce risk of errors related to health care devices.


Author(s):  
F. A. Drews ◽  
A. Musters ◽  
B. Markham ◽  
M. H. Samore

Up to 98,000 patients die annually in U.S. hospitals due to human error. One of the areas where error occurs frequently is the Intensive Care Unit. Despite the impact of error, there is very little work that attempts to identify the human factors contributors to error in the ICU. The current study used the framework of error producing conditions to identify factors that are contributing to error. By modifying the method of assessing error producing conditions we were able to identify the extent to which individual conditions contribute to the prevalence of error. Also, we were able to identify the contribution certain devices have in the prevalence of error. Most importantly, the most critical devices for patient care were also identified as the ones that were rated the highest in their prevalence of error producing conditions and potential for hazard. Thus, developing medical devices that are reducing the device related potential for patient harm has to be a main goal for future patient safety work. This is a challenge sound human factors engineering should answer.


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