Package Description

Instrument reprocessing is a critical component of an office’s infection control protocols. It is essential for clinicians to follow the manufacturer’s Instructions For Use Manual (IFU) of each device to minimize any risks of cross-contamination. Labeling regulations pertaining to medical devices are found in the Parts of Title 21 of the Code of Federal Regulations (CFR). The general labeling requirements for medical devices are contained in 21 CFR Part 801. These regulations specify the minimum requirements for all devices. In this session, we will discuss the General Labeling Provisions in the Code of Federal Regulation pertaining to medical devices, adequate directions for use and its exemption, and its application in medical device reprocessing Instructions for Use. We will also review the process a manufacturer follows to develop usable validated reprocessing instructions for the reuse of medical devices.

Learning Objectives:

After completing this course, learners should be able to:

• describe steps the manufacturer follows to develop validated reprocessing instructions
• apply knowledge of manufacturers IFU validation processes and the importance of following IFU's for medical devices in infection prevention training for dental office team members
• review the definition of Medical Device Labeling
• identify the General Labeling Provisions for medical devices found Parts of Title 21 of the Code of Federal Regulations (CFR), 21 CFR Part 801.
• recognize the elements of comprehensive reprocessing instructions per the FDA Guidance Document “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” issued March 17, 2015.

Price:

• Members: $15
• Non-members: $30

CE Information:

CE Credits: 1.00

Click here to view detailed CE information about this course.

Speakers:

David Kierce

Mr. Kierce is the Senior Global Product Manager for the Infection Prevention, Scaling and Diagnostic Platform for Dentsply Sirona. He is responsible for new product development in all global markets. He has been with Dentsply Sirona for 29 years holding various sales and marketing positions with increased responsibilities. Prior to joining Dentsply Sirona, he held positions at GMAC and Kraft General Foods.

Disclosures: Stock Shareholder - Dentsply Sirona

Lauren Giles, RAC

Ms. Giles is a Biomedical Engineer in the Dental and ENT Division of OHT1 serving as a lead scientific reviewer since joining the FDA in 2011. Ms. Giles received a Bachelor of Science degree in Biomedical Engineering in 2009 from Georgia Institute of Technology and received her Regulatory Affairs Certification (RAC) in 2017. As a member of the Dental Devices Branch, Ms. Giles has focused her career on the review of dental handpieces, dental operative units, and dental stereotaxic devices. Ms. Giles represents the FDA as a liaison for SubCommittee 4 Dental Instruments for both the American Dental Association Standards for Dental Products and ISO TC 106 Dentistry.

Disclosures: No relevant financial relationships to disclose.