Perspective on ISO Standards and FDA Assessment of Wheelchairs

Program ID Number: CRS000681
CEU Course ID: P269.14
Webinar Length of Time: 1.0 hour

Link to view the lecture presentation:

https://pittrstce.adobeconnect.com/p5i77027r78/

Handouts:

Presenters

Rory A. Cooper, PhD

Rory A. Cooper, PhD is FISA & PVA Chair and Distinguished Professor of Rehabilitation Science & Technology at the University of Pittsburgh. He is Founding Director and VA Senior Research Career Scientist of the Human Engineering Research Laboratories. Dr. Cooper has helped author 300 peer-reviewed journal publications and 15 patents. Dr. Cooper is a former President of RESNA and currently serves as on Honorary Board of Advisors for SVA, NSF Advisory Committee for Education and Human Resources, Board of Directors of Easter Seals, Command Council, Staff Sergeant Donnie D. Dixon Center for Military and Veterans Community Services, and Board of PVA Research Foundation.

Note: Faculty for this activity have been required to disclose all relationships with any proprietary entity producing health care goods or services, with the exemption of nonprofit or government organizations and non-healthcare related companies.

Description

Wheelchairs are regulated as medical devices by the U.S. Food and Drug Administration (FDA). Under the authority of the FDA, wheelchair manufacturers must submit an application for notification to sell/distribute or for pre-market approval prior to sale/distribution of wheelchairs. The FDA may rely on a variety of data sources in order to make a decision. One important source of information is the performance of wheelchairs is the International Standards Organization (ISO) standards. There are a range of ISO standards to test key aspect of wheelchair function and performance to help ensure safety and effectiveness.

Learning Objectives

Upon attending this lecture/seminar, participants will be able to:

List three methods or reports available to determine if a wheelchair is appropriate for sale or distribution under FDA regulations.
List three test requirements for wheelchairs under the ISO standards.
List three types of information manufacturers are required to make available to the public to comply with FDA regulations.

CEU Registration and Cost

0.10 Continuing Education Units (CEUs) will be awarded to individuals for viewing 1.0 hours of instruction.

The cost for the webinar is $59.00

Before viewing the program

To pay for the webinar and receive CEUs please select the Sign Into RSTCE Database link
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You will receive a payment confirmation via e-mail. (Please allow 30 minutes for the database to process your payment and send the confirmation e-mail). You may view the webinar for free but to access the post test and evaluation to receive CEU's you must paid for the course.

After viewing the program

If you have paid for the course please follow the steps below, if you have not paid and want to receive CEU's please see the information above in the (Before viewing the program) section.

Select the Sign Into RSTCE Database
Log-in as Registered User
(this is your user information and password that you created prior to the viewing).
Select Post Tests and Evaluations
Select and complete the course post test and evaluation
Select Submit

You will receive your CEU Certificate via e-mailed as a pdf file (Please allow 30 minutes for the database to process your certificate and send it to your e-mail).

The University of Pittsburgh, School of Health and Rehabilitation Sciences awards Continuing Education Units to individuals who enroll in certain educational activities. The CEU is designated to give recognition to individuals who continue their education in order to keep up-to-date in their profession. (One CEU is equivalent to 10 hours of participation in an organized continuing education activity). Each person should claim only those hours of credit that he or she actually spent in the educational activity.

The University of Pittsburgh is certifying the educational contact hours of this program and by doing so is in no way endorsing any specific content, company, or product. The information presented in this program may represent only a sample of appropriate interventions.

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Updated | 12.03.2014