As FDA recommended in its comments to healthcare, it is imperative that providers inform their patients of all risks. However, it is incumbent upon patients to become knowledgeable consumers and ask questions about any procedure they are being exposed to, including the use of instruments that may have been reprocessed.
Will FDA accept reprocessing instructions from a predicate device? What do proposed guidelines say about the requirement of multiple markers to properly demonstrate cleaning efficacy? This week’s Ask the Engineer covers some frequently asked questions on this topic.