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Graduate Course Proposal Form Submission Detail - EIN6274

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Current Status: Approved, Permanent Archive - 2005-05-04
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Submission Type:
Course Change Information (for course changes only):
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  1. Department and Contact Information

    Tracking Number Date & Time Submitted
    1883 2005-01-20
     
    Department College Budget Account Number
    Industrial and Mangement Systems Engineering EN 2103-000-00
     
    Contact Person Phone Email
    Prof. Dolores K. Gooding 45582 gooding@eng.usf.edu

  2. Course Information

    Prefix Number Full Title
    EIN 6274 Human Factors Engineering in Medical Devices

    Is the course title variable? N
    Is a permit required for registration? N
    Are the credit hours variable? N
    Is this course repeatable?
    If repeatable, how many times? 0

    Credit Hours Section Type Grading Option
    3 C - Class Lecture (Primarily) R - Regular
     
    Abbreviated Title (30 characters maximum)
    Human Factors Engr Med Dev
     
    Course Online? Percentage Online
    -

    Prerequisites

    Overview Regulated Industries or by permission of Instructor

    Corequisites

    None

    Course Description

    The course provides students with information for the ergonomic design and operability of medical devices. These systematic designs are critical in improving the safety of medical devices by reducing the probability of user error.


  3. Justification

    A. Please briefly explain why it is necessary and/or desirable to add this course.

    This course teaches a vital component of regulatory affairs specifically in medical device manufacturing environments. Major topics related to the integration of ergonomic principles in medical device design to reduce the potential of human error during u

    B. What is the need or demand for this course? (Indicate if this course is part of a required sequence in the major.) What other programs would this course service?

    This course serves as an elective in the MS in Engineering Management program, and MS and PhD programs in Biomedical Engineering. It is also a required course in the Graduate Certificate in Regulatory Affairs.

    C. Has this course been offered as Selected Topics/Experimental Topics course? If yes, how many times?

    No. This course has not been offered previously.

    D. What qualifications for training and/or experience are necessary to teach this course? (List minimum qualifications for the instructor.)

    The instructor should possess the following qualifications at a minimum:

    A master's degree in Industrial Engineering or other technical discipline, plus experience in a relevant technical environment with a focus in regulatory affairs. An individual with an earned PhD with the above listed expertise is preferred.


  4. Other Course Information

    A. Objectives

    The course provides students with information for the ergonomic design and operability of medical devices. These systematic designs are critical in improving the safety of medical devices by reducing the probability of user error.

    B. Learning Outcomes

    At the end of the course the student will: Understand how the medical device design, the operating environment, and the user interact; Describe the safety aspects of control/display arrangements; Identify the most appropriate methods to be used for hazard analyses; Describe the development of prototypes and scenarios to perform usability testing;

    C. Major Topics

    The Interaction of Users, Design, and Operating Environment; Design Implications; The User Interface; Control/Display Arrangement and Design; Device Logic and Micro-processing; Component Installation; Alarms; Usability Testing;

    D. Textbooks

    Medical Device and Equipment Design: Usability Engineering and Ergonomics; Author: Michael E. Wiklund; Publisher: CRC Press; Reference website: http://www.fda.gov/cdrh/humanfactors/;

    E. Course Readings, Online Resources, and Other Purchases

    F. Student Expectations/Requirements and Grading Policy

    G. Assignments, Exams and Tests

    H. Attendance Policy

    I. Policy on Make-up Work

    J. Program This Course Supports


  5. Course Concurrence Information



- if you have questions about any of these fields, please contact chinescobb@grad.usf.edu or joe@grad.usf.edu.