Quest is not a Medical Device
Quest is an electronic asset tag that attaches to the exterior of an instrument tray and provides daily information regarding the location of instrument sets, or assets. The Quest product is not recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, is not intended to diagnose, treat, prevent, cure or mitigate any disease or condition and is not intended to affect the structure or any function of the body of man or other animals. Therefore, based on the definition of a medical device per Section 201(h) of the Food, Drug, and Cosmetic Act, the Quest product is not a medical device when used to locate or track instrument trays. Reference our Regulatory Assessment for further details.
The Quest Product is not in the scope of ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and Testing because it is not a medical device nor does it come in contact with the instruments in the trays. Reference our Regulatory Assessment for further details.
The Quest Tracking Device is attached to the end panel of a sterilization tray. The reduction in open steam hole area when Quest is attached to a sterilization tray ranges should have no impact on your sterilization validation. To confirm a test was using a worst-case sterilization tray. The results demonstrated that there was no significant difference in accumulated lethality with the Quest device attached and that attaching Quest to a sterilization tray has no impact on the original Sterilization Validation. Reference our No Sterilization Revalidation Rationale for further details.