By Mary Beth Versaci
Debris: This scanning electron microscope image shows enamel/dentin debris (center) deposited between diamond particles on a dental rotary diamond instrument that had been soiled and cleaned, demonstrating the difficulty of properly cleaning instruments. Image courtesy of ADA Science & Research Institute
Manufacturers of reusable dental instruments now have a guide to help them develop and validate reprocessing instructions that follow guidelines from the Food and Drug Administration.
American Dental Association Technical Report No. 168: Guidance on Method Development and Validation of Cleaning Processes for Dental Instruments addresses the gap in guidance needed to adequately clean dental instruments using a validated cleaning process as part of instrument reprocessing. Published by the ADA Standards Committee on Dental Products, the technical report is available to all ADA members to download for free at ADA.org/dentalstandards
"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," said Mark Dammann, chairman of the working group that developed the technical report and director of global quality assurance for Hu-Friedy.
Reusable dental instruments that are designed and labeled for multiple uses must be reprocessed by thorough cleaning followed by sterilization or high-level disinfection between patients, according to FDA guidelines
The FDA classifies
several dental instruments, including rotary bur instruments and diamond instruments, as "critical reprocessed single-use devices" that must submit validation data regarding cleaning as part of their premarket submission to the FDA to demonstrate they are safe and effective. The ADA technical report uses the cleaning process for rotary bur instruments as an example to provide recommendations for the formulation and validation of reprocessing instructions that will allow dentists to practice safe and effective instrumentation. Cleaning is an essential and difficult step in a multi-step instrument reprocessing procedure.
If a dental instrument manufacturer does not provide validated cleaning instructions, then a device is considered "single-use." When an instrument is not thoroughly cleaned, the downstream process of sterilization or high-level disinfection may be rendered ineffective, leading to potential cross-contamination or improper functioning of the instrument because of the presence of residual debris.
"We, as dentists, need to recognize that our instruments are classified as medical devices, and there are rules and regulations that must be followed when using them," said Neill Luebke, D.D.S., ADA member endodontist and chairman of the ADA Standards Committee on Dental Products Subcommittee on Dental Instruments. "Ignoring single-use indicators or failing to properly reprocess can have implications that could ultimately compromise one's license, to say nothing of repercussions that might occur with regard to a patient's treatment. This technical report is a big step forward in helping the dental profession have the guidance it needs to be able to meet those guidelines."
The ADA Science & Research Institute was instrumental in developing the technical report and is conducting research into the development of a dental test soil to validate the efficacy of cleaning methods at removing soil from dental rotary instruments.
The ADA Standards Program, which was founded in 1928, involves the work of more than 600 volunteers from the dental profession, dental industry, government and academia to establish baseline standards and technical recommendations for almost every tool used in modern dentistry. To learn more or download a copy of Technical Report No. 168, visit ADA.org/dentalstandards