Depuy Synthes EXPEDIUM SFX Handbuch Seite 5

Instruments should be carefully inspected before each use
to ensure that they are functional. Scratches, dents or other
damage can result in instrument breakage or tissue injury.
Instruments must be cleaned separately from instrument trays
and cases. Instrument trays and cases are designed as an
organizational tool in preparation for sterilization, storage and
surgical use. Non-sterile implant sets may be processed in
their trays provided.
Automated equipment, including washer-disinfectors and
steam sterilizers must be installed, maintained and operated
in accordance with manufacturer's instructions.
Do not exceed 140°C (284°F) during reprocessing steps.
For patients with, or suspected with, Creutzfeldt-Jakob
disease (CJD), variant CJD or other transmissible spongiform
encephalopathy (TSE) and related infections, it is recom-
mended to treat the patient using single-use instruments.
Safely dispose of all devices used in accordance with local
procedures and guidelines.
Limitations on Processing
Repeated processing cycles in compliance with these
instructions for use have minimal effects on device life and
function. Instruments do not have an indefinite functional life.
End of life of devices is determined by wear and damage
due to surgical use and handling. Evidence of damage and
wear on a device may include but is not limited to corrosion
(i.e. rust, pitting), discoloration, excessive scratches, flaking,
wear and cracks. Improperly functioning devices, devices
with unrecognizable markings, missing or removed (buffed
off) part numbers, damaged and excessively worn devices
should not be used.
Non-sterile implants must be discarded following patient
use. Any implant with evidence of damage, such as due to
handling or processing must be discarded.
Step 1: Point of Use Care
Ensure that no instruments or parts are left in the surgical site
prior to closure as patient injury may result.
All single use devices and materials should be removed and
discarded in compliance to local policies.
The drying of gross soil (blood, tissue and/or debris) on
devices following surgical use should be avoided. It is
preferred that gross soil is removed from devices following
use and in preparation for transportation to a processing area.
Gross soil can be removed using sponges, cloths, or soft
brushes. Water and/or cleaning detergents (labelled for use
on medical devices) may be used.
Do not use saline, environmental disinfection (including
chlorine solutions) or surgical antiseptics (such as iodine- or
chlorhexidine-containing products. Flush all lumened devices
with water (or detergent solution) to prevent the drying of soil
and/or debris to the inside.
If gross-soil cannot be removed at the point of use, the devices
should be transported to prevent drying (e.g., covered with a
towel dampened with purified water) and cleaned as soon as
possible at a designated processing area.
Surgical cement should be removed from devices during
surgical use and prior to setting. When cement hardens it
will typically require physical methods to remove. Chemical
solvents should not be used. Hardened cement may be
removed with an approved stylus or removing tool, but these
may damage devices.
Step 2: Containment and Transportation
Surgically used devices may be considered bio-hazardous
and should be safely transported to a designated processing
area in accordance with local policies.
Step 3: Cleaning
Preparation before Cleaning
It is recommended that devices should be reprocessed as
soon as is reasonably practical following surgical use.
Instruments must be cleaned separately from instrument
trays and cases.
Non-sterile implants may be cleaned and disinfected in the
provided implant trays.
Care should be taken in the handling and cleaning of sharp
devices. These are recommended to be cleaned separately to
reduce risks of injury.
Multi-part or complex instruments may require disassembly
for cleaning. Refer to any technique guides or other supple-
mental information for specific device disassembly and/or
reassembly instructions.
Any devices with moving parts (e.g. ratchets, box locks,
hinges or actuated parts) need to be actuated during manual
cleaning to ensure access of the cleaning process.
All devices with lumens need to be manually flushed to
remove debris and brushed thoroughly using appropriately
sized soft-bristled brushes and twisting action. Brush size
should be approximately the same diameter of the lumen to
be cleaned. Using a brush that is too big or too small for the
diameter of the lumen/cannulation may not effectively clean the
lumen. Refer to any technique guides or other supplemental
information for specific device lumen diameters. After brushing,
rinse with water by flushing and blow clean compressed air
through all lumens.
NOTE: Two cleaning methods are provided, a Manual and an
Automated Method, and at least one shall be performed.
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