Human Factors Regulations for Medical Devices

2021 ◽  
pp. 201-225
Author(s):  
Russell J. Branaghan ◽  
Joseph S. O’Brian ◽  
Emily A. Hildebrand ◽  
L. Bryant Foster
Keyword(s):  
Human Factors ◽  
Medical Devices

Human Factors Considerations in the Migration of Medical Devices from Clinical to Homecare Settings

2004 ◽  
Vol 48 (15) ◽  
pp. 1685-1689 ◽  
Author(s):  
Melanie J. Turieo ◽  
Marlene A. Devine ◽  
Rodney Hasler ◽  
Ronald Kaye ◽  
Wendy A. Rogers
Keyword(s):  
Human Factors ◽  
Medical Devices

Planning Human Factors Engineering for Development of Implantable Medical Devices

2018 ◽  
Vol 7 (1) ◽  
pp. 156-160
Author(s):  
Maria Lund Jensen ◽  
Jayme Coates
Keyword(s):  
Human Factors ◽  
Medical Devices ◽  
User Interfaces ◽  
Implantable Devices ◽  
Human Factors Engineering ◽  
Implantable Medical Devices ◽  
Life Cycle Stages ◽  
User Groups ◽  
The Right ◽  
High Level

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.

scholarly journals Using Role-Playing Simulations to Teach Quality Control in the Design of Medical Devices

2018 ◽  
Author(s):  
J. Christopher Bouwmeester ◽  
Vicki Komisar ◽  
Arushri Swarup
Keyword(s):  
Quality Control ◽  
Risk Analysis ◽  
Human Factors ◽  
Medical Devices ◽  
Regulatory Agency ◽  
Teaching Assistants ◽  
Role Playing ◽  
Team Based Learning ◽  
Individual Accountability ◽  
A Company

Abstract – A simulation is used to facilitate cooperative and team-based learning to introduce concepts of human factors, risk analysis, and quality control applied to the design of medical devices. We further use a friendly game-based approach to simulate the dynamics between a customer, a regulatory agency, and competitive manufacturers. Students are divided into manufacturing teams/companies and teaching assistants act as the customer and regulator. To promote positive interdependence and individual accountability, each student within a company is assigned roles of CEO, inspector, marketer, and designer. The goal for each company is to design and produce as many eye patch medical devices as possible, which must be approved by the regulator, within a tight deadline. Products are evaluated by the customer, who decides what price to pay for each unit, at the end of production. The most successful company is determined by the greatest amount of money earned after two rounds of production and sales.

scholarly journals Medical device safety: Investigating contributions of human factors

2016 ◽  
Author(s):  
Kathrin Lange
Keyword(s):  
Adverse Events ◽  
Human Factors ◽  
Medical Device ◽  
Medical Devices ◽  
Human Error ◽  
Long Term Memory ◽  
Serious Adverse Events ◽  
True Value ◽  
Federal Institute ◽  
Medical Device Safety

The core tasks of the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte [BfArM]) with respect to medical device safety include evaluating risks arising from the use or application of medical devices (based on incident reports), assessing and coordinating the counter-measures to be taken (i.e. corrective actions), and authorizing clinical trials of medical devices and evaluating the corresponding serious adverse events. Additionally, the BfArM also conducts research on medical device safety, specifically on the possibilities and challenges of data-driven approaches to detect and evaluate risk and on the contribution of human factors to device safety – i.e. factors that may have an impact on how users interact with a device. The present talk focuses on this latter issue. The significance of addressing human factors relating to the use of medical devices results from the contribution of human error to adverse events. For instance, an involvement of human error could be identified in a good 10% of the reports of suspected device-related incidents evaluated by the BfArM between 2005 and 2014. For several reasons, it may be assumed that the true value of device-related incidents involving human error is even larger and that the potential for human error is likely to increase in the future. To effectively reduce the risk for human error – or block its negative outcome - it is imperative to not only identify human error as a significant cause of adverse events, but rather understand the causation of the error, including the conditions under which errors are likely to occur. This requires the analysis of the perceptual, cognitive (e.g. attention, working memory, long term memory), motor or motivational processes involved and the identification of relevant factors at the various levels of the socio-technical system. In our research, we currently pursue two selected human factors issues, selected based on the incident-data collected at the BfArM and on the current literature: Insufficient device knowledge and the multi-faceted issue of device alarms, the latter including both the users’ interactions with alarming devices and their perceptual, cognitive, or motor responses to the devices’ alarms.

Incorporating Human Factors Into the Design of Medical Devices

JAMA ◽  
1998 ◽  
Vol 280 (17) ◽  
pp. 1484-a-1484 ◽  
Author(s):  
M. B. Weinger
Keyword(s):  
Human Factors ◽  
Medical Devices

scholarly journals Medical Device Human Factors Standards: Finding Them and What They Contain

2019 ◽  
Vol 63 (1) ◽  
pp. 592-596
Author(s):  
Molly Follette Story
Keyword(s):  
Human Factors ◽  
Medical Device ◽  
Medical Devices ◽  
Task Force ◽  
Technical Information ◽  
Engineering Practice ◽  
Human Factors Engineering ◽  
Development Organizations ◽  
Working Groups ◽  
Technical Specifications

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.

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