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PERIOP BRIEFING
IN FOCUS
New guidance for reprocessing medical devices
Paula Nania, MSN, RN, CNOR
I n March 2015, the U.S. Food and Drug Administration (FDA) released new guidelines for reprocessing reusable medical devices.1
These guidelines resulted from collaborative efforts among government regulators, industry leaders,and professional organizations to address patient exposures to contaminated devices. Exposure to multi-drug resistant organisms such as Carbapenem-resistant Enterobacteriaceae has been reported in several states, even when manufacturers instructions for cleaning and disinfection were followed.2
Perioperative professionals are tasked with providing patients with safe surgical experiences that are free from infection. Failure to clean instruments promptly can result in dried blood or the formation of biolms (i.e., a complex structure of bacteria and other microorganisms that adheres to surgical instrument surfaces) that require manual scrubbing to remove, negatively affecting the process ow and instrument turnaround time, the life of the instrument, and the efcacy of the sterilization process. The FDA outlines the essential elements that manufacturers must include in their reprocessing instructions to facilitate the cleaning and sterilization processes for health care workers.1
Criteria for reprocessing instructions
The complex designs and decreasing lumen sizeof instruments marketed for minimally invasive procedures have made reprocessing extremely challenging.3 Instructions for instrument reprocessing are often unclear, incomplete, or difcult to follow, which may lead to inadequate cleaning and increased risk of contamination. For example, one manufacturer of eye instruments hasa 14-step cleaning process; one step has ve sub-steps that must be repeated three times for each port of each instrument. The FDAs revised guidelines send a strong message to manufacturers that easeof cleaning and reprocessing should be considered during the design phase of instrument development.