scholarly journals Comparative Human Factors Evaluation of Two Nasal Naloxone Administration Devices: NARCAN® Nasal Spray and Naloxone Prefilled Syringe with Nasal Atomizer

2019 ◽  
Vol 8 (1) ◽  
pp. 89-98
Author(s):  
Kathryn G. Tippey ◽  
Mary Yovanoff ◽  
Larry S. McGrath ◽  
Peter Sneeringer
Author(s):  
Virginia A. Lang ◽  
David Nalan

Patients are frequently prescribed a medication that must be administered either by a nasal spray, an inhaler, or a self-injection device. These devices are classified as combination devices by the Food and Drug Administration (FDA) and the Medical Device Regulations (MDR). However, there has been an issue of who and how do these patients get trained. It has long been the stance of the pharmaceutical companies they will not provide training because they provide an Information for Use (IFU) and/or a demo on their website. The issues with either of these means is that neither the FDA, nor the MDR permit them as mitigation for use errors. And, in human factors testing there are considerable numbers of use errors when patients attempt to use the devices.


2018 ◽  
Vol 39 (5) ◽  
pp. 389-393
Author(s):  
Ronald B. Moss ◽  
Thomas Moll ◽  
Karen Daniels ◽  
Dennis J. Carlo

2021 ◽  
pp. pdajpst.2019.010835
Author(s):  
Chris Franzese ◽  
Katsuyuki Takeuchi ◽  
Hayley Carabello ◽  
Colby Thomas ◽  
Koji Nakamura ◽  
...  

2006 ◽  
Vol 40 (4) ◽  
pp. 46
Author(s):  
ELIZABETH MECHCATIE
Keyword(s):  

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