3
3. Use a soft cloth or a soft plastic bristle brush to remove any visible soil from the
instruments prior to manual or automated cleaning. Use a soft plastic bristle brush
or a pipe cleaner to remove soil from any inner lumens. You can also use a syringe (if
appropriate) for hard to reach areas.
4. Enzymatic detergent should be used for manual and automated cleaning. All enzymatic
detergents should be prepared at the use dilution and temperature recommended by
the manufacturer. Softened tap water may be used to prepare the enzymatic detergents.
Use of recommended temperatures is important for optimal performance of enzymatic
detergent.
Manual Cleaning:
1. Completely submerge instruments in an enzymatic detergent and allow to soak for 20
minutes. Use a soft-bristled, nylon brush to gently scrub the device until all visible soil has
been removed. Particular attention must be given to crevices, lumens, mated surfaces,
connectors and other hard-to-clean areas. Lumens should be cleaned with a long, narrow,
soft-bristled brush (i.e. pipe cleaner brush).
2. Remove the instruments from the enzymatic detergent and rinse in tap water for a
minimum of 3 minutes. Thoroughly and aggressively flush lumens, holes and other
difficult to reach areas.
3. Place prepared cleaning solution in a sonication unit. Completely submerge device in
cleaning solution and sonicate for 10 minutes.
4. Rinse instrument in purified water for at least 3 minutes or until there is no sign of blood
or soil on the device or in the rinse stream. Thoroughly and aggressively flush lumens,
holes and other difficult to reach areas.
5. Repeat the sonication and rinse steps above.
6. Remove excess moisture from the instrument with a clean, absorbent and non-shedding
wipe.
7. Inspect the instruments for visible soil.
8. If visible soil is noted, repeat the steps listed above.
Automated Cleaning:
1. Completely submerge the instruments in an enzymatic detergent and allow to soak and
sonicate for 10 minutes each. Use a soft nylon bristled brush to gently scrub the device
until all visible soil has been removed. Particular attention must be given to crevices,
lumens, mated surfaces, connectors and other hard to clean areas. Lumens should be
cleaned with a long, narrow, soft nylon bristled brush (i.e. pipe cleaner). Use of a syringe
or water jet will improve flushing of difficult to reach areas and closely mated surfaces.
2. Remove instruments from the cleaning solution and rinse in purified water for a minimum
of 1 minute. Thoroughly and aggressively flush lumens, blind holes and other difficult to
reach areas.
3. Place instruments in a suitable washer/disinfector basket and process through a standard
instrument washer/disinfector cleaning cycle.
4. Orient instruments into the automated washer’s carriers as recommended by the washer
manufacturer.
5. The following minimum parameters are essential for thorough cleaning.
a. 2 minute prewash with cold tap water
b. 1 minute prewash with hot tap water
c. 2 minutes detergent wash with hot tap water (64-66°C/146-150°F)
d. 1 minute hot tap water rinse
e. 2 minute thermal rinse with purified water (80-93°C/176-200°F)
f. 1 minute purified water rinse (64-66°C/146-150°F)
g. 7 to 30 minute hot air dry (116°C/240°F)
6. Inspect the instruments for visible soil.
7. If visible soil is noted, repeat the above listed steps until no visible soil is noted.
Note:
Certain cleaning solutions such as those containing caustic soda, formalin,
glutaraldehyde, bleach, and/or other alkaline cleaners may damage instruments. These solutions
should not be used.
Note:
Visually inspect instruments after cleaning and prior to each use. Discard or return to
Orthofix any instruments that are broken, discolored, corroded, have cracked components, pits,
gouges, or are otherwise found defective. Do not use defective instruments.
Instrument End of Life Determination:
Do not reuse Single Use instruments. Visually inspect the reusable instruments to determine if
the instrument has reached end of life. Orthofix reusable instruments have reached End of Life
when:
1. Instruments show signs of damage such as binding, bending, breakage, overt signs of
wear and/or any other conditions which may impact the devices safe and effective use.
2. Instruments intended for cutting bone and/or tissue (e.g. tap, rasp, curette, rongeur) –
when any of the cutting surfaces show signs of wear such as nicks, abrasions or
otherwise dulled cutting surfaces.
3. Instruments that interface with other devices (e.g. implants, instruments, handles) – when
the mating feature binds, fails to attach or fails to hold the device securely. The instrument
function should be verified prior to each use.
4. Do not use instruments which reached End of Life. Discard End of Life instruments per
your hospital procedure or return to Orthofix for disposal.
Sterilization:
Sterilization in Orthofix Cases with Blue Wrap:
The Centurion POCT System implants and instruments are supplied NON-STERILE. Prior to use,
all implants and instruments should be place in the appropriate Orthofix case which will be
wrapped in a FDA cleared sterilization wrap and placed in the autoclave for sterilization by the
hospital using one of the following recommended cycles:
Method: Steam
or:
Method: Steam
Cycle: Gravity
Cycle: Pre-vacuum
Temperature: 270°F (132°C )
Preconditioning: Per manufacturer settings
Exposure time: 15 minutes
Temperature: 270°F (132°C)
Drying time: 30 minutes
Exposure time: 4 minutes
Drying time: 30 minutes
Sterilization in Rigid Sterilization Containers:
When using rigid sterilization containers, clean, inspect and prepare the rigid sterilization
container according to the manufacturer’s instructions.
Select the appropriate rigid sterilization container with either a filtered or solid bottom to
properly enclose the Orthofix case(s) or caddies (recommended 23¼” long x 11¼” wide
container). The following sterilization cycle has been validated:
Method: Steam
Cycle: Pre-vacuum
Temperature: 270°F (132°C)
Preconditioning: Per manufacturer settings
Exposure time: 4 minutes
Drying time: 30 minutes
Validation and routine monitoring should be performed as per ANSI/AAMI ST79 Comprehensive
guide to steam sterilization and sterility assurance in health care facilities. Other cycles may be
used as long as they comply with the above practices and provide a sterility assurance level of
10
-6
.
Physician Information:
Patient Selection:
Patient selection is an extremely important factor in the success of implant procedures. It is
important that the candidates be carefully screened and the optimal therapy selected.
Preoperative:
1. Only patients that meet the criteria described in the indications should be selected.
2. Patient conditions and/or predispositions such as those addressed in the aforementioned
contraindications should be avoided.
3. Correct selection of the implant is extremely important.
4. Use care in handling and storage of implant components. Cutting, bending, or scratching
the surface of metal components can significantly reduce the strength and fatigue
resistance of the implant system and should be avoided. These, in turn, may cause cracks
and/or internal stresses that are not obvious to the eye and may lead to fracture of the
components. Inspection should be made to determine if components have been damaged
during storage or previous procedures.
5. An adequate inventory of implant sizes should be available at the time of surgery.
6. Certain special surgical instruments are required to perform this surgery. Review of the
use and handling of these instruments is very important.
7. PRE-OP PLANNING – Use of cross sectional imaging (i.e., CT and/or MRI) for posterior
cervical screw placement is recommended due to the unique risks in the cervical spine.
The use of planar radiographs alone may not provide the necessary imaging to mitigate
the risk of improper screw placement. In addition, use of intraoperative imaging should
be considered to guide and/or verify device placement, as necessary.
Intraoperative:
1. Whenever possible, use pre-cut rods of the length needed. The rods should not be
repeatedly or excessively bent any more than absolutely necessary. The rods should not
be reverse bent in the same location. Use great care to insure that the implant surfaces
are not scratched or notched in any way. If the rods are cut to length, they should be cut
in such a way as to create a flat, non-sharp surface perpendicular to the midline of the
rod.
2. The use of two rods and cross connecting the rods will provide a more rigid construct.
3. The placement of screws should be checked radiographically prior to assembly of the rod
construct.
4. Care should be taken when positioning the implants to avoid neurological damage.
5. To facilitate proper fusion below and around the location of the instrumentation, a bone
graft should be used.
6. Confirm that the rods are fully seated in the bottom of the screw head. Rods that are not
fully seated may prevent the device from locking together.
7. Before closing the soft tissues, all of the set screws should be tightened firmly with a
torque wrench and set screw driver according to the operative technique. Recheck the
tightness of all screws to make sure that none loosened during the tightening of the other
set screws. Failure to do so may cause loosening of the other components.
8. Bone cement should not be used since this material will make removal of the component
difficult or impossible. The heat generated from the curing process may also cause
neurological damage and bone necrosis.
Postoperative:
1. Detailed instructions on the use and limitations of the implant should be given to the
patient. The patient must be made aware of the limitations of the implant. Physical
activity and load bearing have been implicated in premature loosening, bending, or
fracture of internal fixation devices.
2. Periodic X-rays for at least the first year postoperatively are recommended for close
comparison with postoperative conditions to detect any evidence of changes in position,
nonunion, loosening, and bending or cracking of components.
3. Surgical implants must never be reused. Any retrieved devices should never be reused in
another surgical procedure. The retrieved parts should be handled and disposed of in such
a manner as to ensure that reuse is not possible.
4. To allow the maximum potential for a successful surgical result, the patient or device
should not be exposed to mechanical vibration that may loosen the device construct.
5. These implants are temporary internal fixation devices. Internal fixation devices are
designed to assist in the stabilization of the operative site during the normal healing
process. After healing occurs, these devices serve no functional purpose and should be
removed. In most cases removal is indicated because the implants are not intended to
transfer or support forces developed during normal activities. If the device is not removed
following completion of its intended use, complication may occur as follows:
a. Corrosion, with localized tissue reaction or pain.
b. Migration of implant position resulting in injury.
c. Risk of injury from postoperative trauma.
d. Bending, loosening and/or breakage, which could make removal impractical or
difficult.
e. Pain, discomfort or abnormal sensations due to the presence of the device.
f. Possible increased risk of infection.
g. Bone loss caused by stress shielding.
Adequate postoperative management to avoid fracture, re-fracture or other complications should
follow implant removal.
