Validation Responsibility in Reprocessing of Dental Instruments (On-Demand)
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.
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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 27 years holding various sales and marketing positions with increased responsibilities. Prior to joining Dentsply Sirona, he held positions at GMAC and Kraft General Foods.
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 Sub- Committee 4 Dental Instruments for both the American Dental Association Standards for Dental Products and ISO TC 106 Dentistry.