ABSTRACT
This chapter provides support manufacturers in developing reprocessing/resterilizing instructions, a review of the similarities and differences between initial device sterilization performed by the manufacturer and the subsequent appropriate reprocessing performed in the healthcare facility. Manufacturers of reusable medical devices should understand the considerable difficulties often encountered by healthcare personnel who are charged with the responsibility of reprocessing and resterilizing used devices. Many significant differences exist between the sterilization performed by the device manufacturer and by the device user/reuser. Many users have experienced difficulty in obtaining adequate instructions for resterilizing older devices intended for reuse. The Center for Devices and Radiological Health of the Food and Drug Administration has discussed designating the user/reuser who performs device resterilization as a manufacturer subject to all the rights, responsibilities and privileges to which the traditional device manufacturer is subject.
