Clinical handling and surgical procedure

The next critical issue, specifically for implants or devices used clinically, is handling by surgical assistants and how the device is brought into contact with the patient's organs or tissues (e.g., insertion, connection, or implantation). This is a critical step, because even if the implant is made of the appropriate materials, which have been properly designed, fabricated, sterilized, tested, manufactured, packaged, shipped and stored, the "moment of truth" will be the moment the package is opened and the device is handled and eventually implanted in or contacted with the patient's organs or tissues. Thus handling in the clinic up until the implantation and/or the connection of the device to a patient (e.g., for insertion of a catheter or for extracorporeal blood treatment) can have a significant impact on the eventual success or failure of that implant or device. The surgical procedure is similarly critical because of the possibility of introduction of bacteria during contact with the patient, and eventual infection.

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