Assessing readability and comprehension of informed consent materials for medical device research: A survey of informed consents from FDA's Center for Devices and Radiological Health

2019 ◽  
Vol 85 ◽  
pp. 105831 ◽  
Author(s):  
Fabienne Santel ◽  
Isatu Bah ◽  
Katherine Kim ◽  
Ja-An Lin ◽  
Jack McCracken ◽  
...  
2021 ◽  
pp. medethics-2020-107031
Author(s):  
Daniel B. Kramer ◽  
Efthimios Parasidis

Many high-risk medical devices earn US marketing approval based on limited premarket clinical evaluation that leaves important questions unanswered. Rigorous postmarket surveillance includes registries that actively collect and maintain information defined by individual patient exposures to particular devices. Several prominent registries for cardiovascular devices require enrolment as a condition of reimbursement for the implant procedure, without informed consent. In this article, we focus on whether these registries, separate from their legal requirements, have an ethical obligation to obtain informed consent from enrolees, what is lost in not doing so, and the ways in which seeking and obtaining consent might strengthen postmarket surveillance in the USA.


2018 ◽  
Vol 140 (04) ◽  
pp. 32-37
Author(s):  
Jean Thilmany

This article explores the innovative ways of using advanced modeling, simulation, and analysis software in medical field. In order to meet design requirements, engineers who work for medical device makers have been putting advanced modeling, simulation, and analysis software to use in innovative ways, such as creating models of the human anatomy that can be used to virtually test potential medical technologies. They have also put new tools such as 3D printers to work building model prototypes for real-world testing. The Food and Drug Administration’s Center for Devices and Radiological Health is now creating a simulated human capable of serving as an in-silico guinea pig. The center is building a library of computer regulatory testing models and a family of ‘virtual patients’ for product design and testing. The article also describes that medical device developers can use cinematic rendering, such as an image of the blood vessels in the skull created in Syngio via Frontier, an application enabling the realistic depiction of volume datasets, to help create better treatments.


2005 ◽  
Vol 2 (1) ◽  
pp. 41-45 ◽  
Author(s):  
Justin Boyle ◽  
Anthony Maeder ◽  
John Bell ◽  
Sabu John ◽  
Robin Scott

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