Dental handpiece sterilization validation methods should be standardized, FDAer says.
This article was originally published in The Gray Sheet
Executive Summary
DENTAL HANDPIECE STERILIZATION VALIDATION METHODS should be standardized by manufacturers to ensure consistent results, Tim Ulatowski, a staffer with the General and Restorative Devices Division in FDA's Office of Device Evaluation, told the agency's Dental Products Advisory Panel at an Aug. 9 meeting in Bethesda, Maryland. "If there's not a cookbook procedure to validation... you can get almost any result you want to get," he said. "I think it's an area that deserves standardization and additional work by the manufacturing community."