The What and how of Medical Device Design Validation: A Human Factors Methodology

2007 ◽  
Vol 51 (11) ◽  
pp. 750-755
Author(s):  
Merrick F. Kossack ◽  
Andrew W. Gellatly
Keyword(s):  
Human Factors ◽  
Medical Device ◽  
Quality System ◽  
Testing Methods ◽  
Validation Process ◽  
Design Validation ◽  
Medical Device Design ◽  
Medical Device Manufacturers ◽  
Proper Design ◽  
Validation Testing

To meet the FDA's Quality System Regulation, medical device manufacturers must include design validation as part of their design and development activities. However, the regulation does not specify which product requirements must be validated or what methods satisfy a proper design validation process. This paper outlines an approach that device manufacturers can follow to determine which product requirements should undergo design validation testing and what types of testing methods should be used.

What Can Medical Device Human Factors Learn from Other Industries?

2017 ◽  
Vol 6 (1) ◽  
pp. 183-184 ◽  
Author(s):  
L. Bryant Foster ◽  
Russell J. Branaghan ◽  
Dean Barker ◽  
Jen Donahue ◽  
Dave Mitropoulous-Rundus
Keyword(s):  
Human Factors ◽  
Medical Device ◽  
Draft Guidance ◽  
Medical Device Industry ◽  
Medical Device Design ◽  
Human Factors And Ergonomics ◽  
Regulatory Submission ◽  
Medical Device Manufacturers ◽  
Validation Testing ◽  
Device Industry

Human factors has grown in popularity in the medical device industry since the introduction of FDA’s Draft Guidance Applying Human Factors and Usability Engineering to Optimize Medical Device Design in 2011. However, human factors and ergonomics has been practiced since the 1940’s and adopted by various industries, regulated and unregulated, to improve user safety and satisfaction. Over the last 70+ years, many manufacturers in industries like aerospace, aviation, automotive, and consumer goods have incorporated human factors into their product design controls. Nevertheless, many medical device manufacturers still treat human factors as a singular step (validation testing) in the regulatory submission process. Leveraging the diverse experience, we aimed to identify human factors practices that have proven successful in non-medical industries that are not commonly practiced in the medical device industry, possible reasons these practices are not used by medical device manufacturers, and recommend possible solutions. Our discussions revealed four human factors practices that are not commonly used in the medical device industry, reasons the medical device industry may be slow to adopt human factors, and potential solutions for each.

scholarly journals Reducing medical device alarms by an order of magnitude: A human factors approach

2021 ◽  
Vol 49 (1) ◽  
pp. 52-61
Author(s):  
Erik Koomen ◽  
Craig S Webster ◽  
David Konrad ◽  
Johannes G van der Hoeven ◽  
Thomas Best ◽  
...  
Keyword(s):  
Human Factors ◽  
Medical Device ◽  
Medical Devices ◽  
Information Overload ◽  
Noise Pollution ◽  
Commercial Aviation ◽  
Alarm Fatigue ◽  
Medical Device Design ◽  
Information Displays ◽  
Order Of Magnitude

The intensive care unit (ICU) is one of the most technically advanced environments in healthcare, using a multitude of medical devices for drug administration, mechanical ventilation and patient monitoring. However, these technologies currently come with disadvantages, namely noise pollution, information overload and alarm fatigue—all caused by too many alarms. Individual medical devices currently generate alarms independently, without any coordination or prioritisation with other devices, leading to a cacophony where important alarms can be lost amongst trivial ones, occasionally with serious or even fatal consequences for patients. We have called this approach to the design of medical devices the single-device paradigm, and believe it is obsolete in modern hospitals where patients are typically connected to several devices simultaneously. Alarm rates of one alarm every four minutes for only the physiological monitors (as recorded in the ICUs of two hospitals contributing to this paper) degrades the quality of the patient’s healing environment and threatens patient safety by constantly distracting healthcare professionals. We outline a new approach to medical device design involving the application of human factors principles which have been successful in eliminating alarm fatigue in commercial aviation. Our approach comprises the networked-device paradigm, comprehensive alarms and humaniform information displays. Instead of each medical device alarming separately at the patient’s bedside, our proposed approach will integrate, prioritise and optimise alarms across all devices attached to each patient, display information more intuitively and hence increase alarm quality while reducing the number of alarms by an order of magnitude below current levels.

There is More to Error in Healthcare than the Care Provider

2005 ◽  
Vol 49 (11) ◽  
pp. 952-954 ◽  
Author(s):  
Marilyn Sue Bogner
Keyword(s):  
User Interface ◽  
Human Factors ◽  
Medical Device ◽  
Care Provider ◽  
Interface Design ◽  
Adverse Outcome ◽  
Order Entry ◽  
Medical Device Design ◽  
Design Activities ◽  
And Behavior

Typically when an error occurs in healthcare, the care provider is considered the cause. Because that person committed the act that lead to the adverse outcome efforts to address the error are directed to that person. Indeed, human factors practitioners have developed remedial training and their medical device design activities have emphasized user interface design. This paper presents the case for expanding that focus based on the realization that the act of committing an error is a behavior and behavior reflects the interaction of the person and factors in the environment. The counterintuitive findings that more errors occur in prescribing medications with computer order entry than with handwritten script are discussed in terms of this approach.

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