Responsibilities Of The User; Sterilization And Cleaning Methods - Spinal Kinetics M6 Handhabungshinweise

Responsibilities of the User

General. Health care personnel bear the ultimate responsibility for ensuring that any
packaging method or material is suitable for use in sterilization processing
and sterility maintenance.
Cleaning/Decontamination. The health care facility is responsible to ensure that
conditions essential to safe handling and decontamination can be achieved. ANSI/
AAMI ST35 Safe Handling and Biological Decontamination of Reusable Medical
Devices in Health Care Facilities and in Nonclinical Settings and ISO 15883-1
Washer-disinfectors – Part 1: General requirements, terms and definitions and
tests provide relevant guidelines.
Sterility. Users should conduct testing in the health care facility to ensure that
conditions essential to sterilization can be achieved and that specific configuration
of the container contents is acceptable for the sterilization process and for the
requirements at the point of use. ANSI/AAMI ST33 Guidelines for the Selection
and Use of Reusable Rigid Container Systems for Ethylene Oxide Sterilization and
Steam Sterilization in Health Care Facilities and ISO 17665-1 Sterilization of health
care products – Moist heat – Part 1: Requirements for the development, validation
and routine control of a sterilization process for medical devices provide relevant
guidelines.

Sterilization and Cleaning Methods:

Instruments should be placed in the designated location for each instrument in
the sterilization case.
Universal instrument trays and cases without defined, preconfigured layouts or
containing undefined universal spaces or compartments should only be used under
the following conditions:
•
Any device capable of disassembly must be disassembled prior to placement
in the case.
•
All devices must be arranged to ensure steam penetration to all instrument
surfaces. Instruments should not be stacked or placed in close contact.
•
The user must ensure that the instrument case is not tipped or the contents
shifted once the devices are arranged in the case. Silicone mats may be used to
keep devices in place.
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