RE: pplying Human Factors and Usability Engineering to Optimize Medical Device Design
Document ID: FDA-2011-D-0469-0001Document Type: Notice
Docket ID:
FDA-2011-D-0469.
I would like to strongly discourage the use, by health care physicians, providers or related heath care workers, of electronic applications in the use of providing Health care information while interpreting to patients with Limited English Proficiency.
These devices and applications can not replace the effective use of a trained medical interpreter under any circumstances. It has been demonstrated that these devices are not accurate or provide cultural nuances, body language interpretation etc in the clinical setting.
“This application uses closed-ended questions to elicit yes or no answers or gestures from the patient asking them to point to the affected body part. This shows a complete lack of understanding for real communication.
Patients do not speak in yes or no answers. This is a very disappointing application and hopefully those who provide care to LEP patients will not rely on this when there are other resources such as phone, video or live interpreters available.”
Charles C Anderson - Comment
This is comment on Notice
Draft Guidance for Industry; Availability: Applying Human Factors and Usability Engineering to Optimize Medical Device Design
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