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We agree that:
1
The FDA defines an implant as a “device that is placed into a surgically or naturally formed cavity of the
human body if it is intended to remain there for a period of 30 days or more. FDA may, in order to protect
public health, determine that devices placed in subjects for shorter periods are also ‘implants.’ “ [21 CFR
812.3(d)]
Recommended practices for cleaning and care of surgical instruments and powered
equipment. In: Standards, Recommended Practices and Guidelines. Denver, CO:
AORN, Inc; 2010.
Centers for Disease Control, Guideline for Disinfection and Sterilization in Healthcare
Facilities, 2008.