Page 166 - Assurance of Sterility for Sensitive Combination Products and Materials

148 Assurance of sterility for sensitive combination products and materials

Most implantable devices are single-use sterile devices and are steril-
ized by the manufacturer. Implantable medical devices are used to replace
a biological structure, support a damaged biological structure, or enhance
an existing biological structure. Some implants, e.g., orthopedic plates and
screws, are sold as non-sterile and then are subjected to the cleaning and
sterilization process at the HCF. An infection can result if the device is not
properly cleaned and sterilized before use. Implantable devices should not
be reused.

Reusable devices
Reusable medical devices must be cleaned, decontaminated and/or disin-
fected, or sterilized between uses. It is not possible to disinfect or sterilize
a device that has not been properly cleaned first. Cleaning should begin as
soon as possible after use. Pre-cleaning should be performed at the point
of use. Surgical instrument pre-cleaning should be performed in the OR
suite after the patient has left the room or in a pre-cleaning room within
the surgical suite.
Manufacturers of reusable medical devices are required to validate at least
one cleaning process for the device. Often manufacturers will validate more
than one process. Validation is the documented evidence that demonstrates
a process will consistently yield product within predetermined specification
[12]. The manufacturer will develop cleaning instructions for the HCF staff
to follow when cleaning the device based on the cleaning validation.

Surgical site infections
According to the CDC “a SSI is an infection that occurs after surgery in the
part of the body where the surgery took place” [13]. At the time of surgery
the surgical wound is classified in accordance with an assessment of the de-
gree of contamination of the wound. Wounds are divided into four classes:
1. Clean. An uninfected operative site in which there is no inflammation
and the respiratory, alimentary, genital, or uninfected urinary tracts are
not entered.
2. Clean contaminated. Operative wounds that involve entry of the respira-
tory, alimentary, genital, or urinary tract under controlled conditions and
without unusual contamination. There should be no evidence of infec-
tion present and a major break in technique should not have occurred.
3. Contaminated. These are open, fresh, accidental wounds, and surgeries
where major breaks in sterile technique occurred. These might also in-
volve gross spillage from the gastrointestinal tract, incisions in which