The new report provides manufacturers with guidance on developing cleaning instructions for reusable dental instruments.
The American Dental Association (ADA) has issued a new technical report aimed at providing manufacturers of reusable dental instruments with guidance on developing and validating reprocessing instructions that follow FDA guidelines.
According to the FDA guidelines, reusable dental instruments designed and labeled for multiple uses must be reprocessed by thorough cleaning followed by sterilization or high-level disfunction between patients. If a dental instrument manufacturer does not provide validated cleaning instructions, then a device is considered “single-use.”
ADA Technical Report No. 168: Guidance on Method Development and Validation of Cleaning Processes for Dental Instruments was published by the ADA Standards Committee on Dental Products, and is available to all ADA members to download for free.
“This document combines aspects of both domestic and global requirements, resulting in a state-of-the-art guide for dental instrument manufacturers to consistently develop instrument cleaning methods that meet the safety expectations of clinicians and patients,” Mark Dammann, chairman of the working group that developed the technical report and director of global quality assurance for Hu-Friedy, told ADA News.