Medical Devices and Patient Safety

2012 ◽  
Vol 32 (4) ◽  
pp. 60-68 ◽  
Author(s):  
Elizabeth Mattox
Keyword(s):  
Health Care ◽  
Patient Safety ◽  
Intensive Care ◽  
Human Factors ◽  
Medical Devices ◽  
Human Factors Engineering ◽  
Reduce Risk ◽  
Device Use

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.

scholarly journals Error Producing Conditions in the Intensive Care Unit

2007 ◽  
Vol 51 (11) ◽  
pp. 702-706 ◽  
Author(s):  
F. A. Drews ◽  
A. Musters ◽  
B. Markham ◽  
M. H. Samore
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Human Factors ◽  
Medical Devices ◽  
Human Error ◽  
Human Factors Engineering ◽  
Patient Harm ◽  
Safety Work ◽  
The Impact ◽  
Future Patient

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.

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.

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