There are many considerations that need to be taken into account by medical device manufacturers when designing reprocessing validations, and it only takes one oversight to cause a failure mode. Alpa Patel, Senior Scientist at Nelson Laboratories and member of AAMI, ASTM, and AATB, will share her expertise in this presentation and discuss the key factors that determine a successful reusable medical device cleaning validation. Participants who attend the presentation will learn:

• The key factors that determine a successful cleaning validation
• The current thinking of FDA regarding cleaning validations
• The main documents relevant to cleaning validations
• The stages cleaning validations should be considered when designing a reusable medical device