Making sense of your medical device IFU

The instructions for use (IFU) that are delivered with every new medical device by the manufacturer are intended to enable safe use of the item. They are a mandatory component for the sale and use of the device because of the product’s impact on patient safety

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CBSPD approved through February 28, 2025

HSPA approved through February 10, 2023

Learning Objectives

  1. Identify the differences in IFU based upon a medical device’s FDA classification
  2. List the components necessary to meet FDA requirements for medical device IFU
  3. Describe two IFU challenges that exist today

About the Instructors:

Heide Ames

Product Manager, STERIS

Not Enrolled

Course Includes

  • 1 Lesson
  • 1 Test
  • Course Certificate

    The CBSPD (Certification Board for Sterile Processing and Distribution) has pre-approved this in-service for one (1) contact hour for a period of five (5) years from the date of original publication. Successful completion of the lesson and post test must be documented by facility management and those records maintained by the individual until re-certification is required.


    For additional information regarding certification contact CBSPD – 148 Main Street, Suite C-1, Lebanon, NJ 08833


    HSPA (Healthcare Sterile Processing Association) has pre-approved this in-service for 1.0 Continuing Education Credits for a period of three years.

    For more information, direct any questions to Healthcare Purchasing News (941) 259-0832.