Johnson & Johnson DePuy Synthes EXPEDIUM User manual

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0086
0902-90-067 Rev. E
en
EXPEDIUM® Fenestrated Screw System
Instructions for Use
IMPORTANT INFORMATION
Please Read Before Use
INDICATIONS FOR USE
The EXPEDIUM
® Fenestrated Screw System is intended to be
used with the CONFIDENCE SPINAL CEMENT SYSTEM
® or the
V-MAX™ Mixing and Delivery System and the VERTEBROPLASTIC
®
Radiopaque Resinous Material or the VERTECEM V+ Cement Kit
to provide immobilization and stabilization of spinal segments in
the treatment of acute and chronic instabilities or deformities of
the thoracic, lumbar and sacral spine in patients with diminished
bone quality (e.g., osteoporosis, osteopenia, metastatic disease).
It is intended to provide temporary internal support and fixation
while fusion mass is consolidating or fracture is healing, or for the
palliative reconstruction of the tumor patients.
CONTRAINDICATIONS
The use of EXPEDIUM Fenestrated Screw System is contraindi-
cated in patients presenting with any of the following conditions:
•Disease conditions that have been shown to be safely and
predictably managed without the use of internal fixation devices
•Acute compromise of the vertebral body or walls of the pedicles
and disruption of the posterior cortex
•Anatomical damage of the vertebra that prevents safe screw
implantation
•Active or incompletely treated infection
•Coagulation disorders or severe cardiopulmonary disease
•Haemorrhagic diasthesis
•Spinal stenosis > 20% caused by retropulsed fragments
•Vertebral body collapse to less than 1/3 (33%) original height
•Coagulopathy or inability to reverse anti-coagulant therapy
(both during and approximately 24 hours post-procedure)
•Allergic reaction to any of the components of the cement or
metal used
•Relative contraindications include obesity, certain degenerative
diseases, and foreign body sensitivity. In addition, the patient’s
occupation or activity level or mental capacity may be relative
contraindications to this surgery. Specifically, patients who
because of their occupation or lifestyle, or because of conditions
such as mental illness, alcoholism, or drug abuse, may place
undue stresses on the implant during bony healing and may be
at higher risk for implant failure.
DESCRIPTION
The EXPEDIUM Fenestrated Screw System consists of Fenestrated
Screws and Clip-on Delivery System (includes a Cement Cannula
and a Clip). The EXPEDIUM Fenestrated Screw is a cannulated
polyaxial screw with fenestrations at the distal end of the screw
that are designed for cement introduction. The EXPEDIUM
Fenestrated Screw is designed for use in open and percutaneous
approaches and comes in a variety of sizes and lengths. It is
compatible for use with EXPEDIUM Spine Systems and VIPER
®
and VIPER
®
2 Spine Systems.
The EXPEDIUM Fenestrated Screw System can be used either
with the CONFIDENCE SPINAL CEMENT SYSTEM, or the
V-MAX Mixing and Delivery Device and the VERTEBROPLASTIC
Radiopaque Resinous Material, or the VERTECEM V+ Cement Kit.
When used with the CONFIDENCE SPINAL CEMENT SYSTEM,
EXPEDIUM Fenestrated Screw Cement Cannula must be
attached to the CONFIDENCE Spinal Cement Delivery System.
When used with the V-MAX Mixing and Delivery Device with the
VERTEBROPLASTIC Radiopaque Resinous Material, or the
VERTECEM V+ Cement, a CONFIDENCE Needle Adapter
(sold separately as an accessory to CONFIDENCE Spinal Cement
System) must be used to attach the V-MAX Flexible Tubing luer
lock to the Clip-on Delivery System.
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WARNINGS AND CAUTIONS
These instructions are provided for the processing of heat-
resistant, immersible, critical medical devices, unless otherwise
noted on specific product inserts. Product specific inserts are
given priority over these instructions. This can include heat-
sensitive devices and certain power (air- or electric-driven) tool
designs that are provided with specific cleaning and sterilization
instructions. Consult the product specific instructions for
processing in these cases.
The instructions provided are given as guidance for medical
device processing and have been validated by the manufacturer.
It is the responsibility of the healthcare facility to ensure that
processing is performed using the required equipment, materials
and personnel at a defined processing area. This will include the
handling of devices during transportation, processing and storage
prior to surgical use.
Those using these instructions should be qualified personnel with
documented training and competency in accordance with local
procedures, guidelines, and standards.
Surgically used instruments can be considered biohazard and
facilities should ensure that transport and handling procedures
comply with local regulations and guidelines.
Sterile, single use implants must not be reused or reprocessed.
Sterile implants are labelled as single use and have not been
validated for reprocessing.
Non-sterile implants must be processed prior to use in accordance
with these processing instructions. They must be discarded
following patient use.
Reusable, non-sterile surgical instruments are required to be
cleaned, inspected and sterilized prior to surgical use.
Care should be taken in the handling and cleaning of
sharp devices.
All devices must be thoroughly cleaned and inspected prior
to sterilization. Long, narrow lumens, blind holes, moving
and intricate parts require particular attention during cleaning
and inspection. During cleaning, only use detergents that are
labelled for use on medical devices and in accordance with the
manufacturer’s instructions. Cleaning agents with a used dilution
pH of within 7–9 are recommended. Highly alkaline conditions
(pH>10) can damage components/devices, in particular aluminum
materials. Do not use saline, environmental disinfection (including
chlorine solutions) or surgical antiseptics (such as iodine- or
chlorhexidine-containing products). Do not use a cleaning aid
that can damage the surface of instruments such as steel wool,
abrasive cleaners or wire brushes.
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 encephalop-
athy (TSE) and related infections, it is recommended 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
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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 supplemental
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 cleaning to
ensure access of the cleaning process.
•All devices with lumens need to be manually cleaned. Lumens
should be 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.
Cleaning: Manual
1. Prepare a neutral or mild alkaline cleaning solution (pH 7 to 9)
in accordance to the detergent manufacturer’s instructions.
The temperature of the solution should be ≤40
° C (104 ° F) for
manual cleaning.
NOTE: The cleaning solution may contain enzymes.
Aluminum-safe alkaline cleaners can be used, but can vary
in material compatibility overtime based on their formulation.
Material compatibility should be confirmed with the detergent
manufacturer.
2. Immerse devices and parts in the detergent solution, and
soak for a minimum of 5 minutes.
3. While immersed, use a soft non-metallic bristle brush (plastic
bristles, like nylon) or sponge to thoroughly clean all traces
of blood and debris from all device surfaces for at least
one minute.
4. Ensure all lumens are thoroughly brushed. Push the brush
through the entire length of the lumen using a twisting motion
to remove debris from both ends for at least one minute.
5. During cleaning, actuate joints, handles and other movable
device features to expose all areas to the detergent solution,
if applicable. Ensure all lumens are flushed for at least
one minute.
6. Remove the devices and completely submerge in an ultrasonic
bath prepared with a neutral or mild alkaline pH detergent
(pH 7-9), prepared in accordance with the manufacturer’s
instructions. Use a large syringe (50ml or greater) flush all
lumens with the cleaning solution, articulating areas, and
flexible segments with the detergent solution to minimize the
formation of air pockets or bubbles.
NOTE: Ultrasonic cleaning is only effective if the surface to be
cleaned is immersed in the cleaning solution. Air pockets will
decrease the efficacy of ultrasonic cleaning.
7. Ultrasonically clean the device components for a minimum of
10 minutes.
8. Rinse all devices by immersion in ambient, < 40
° C (104 ° F),
tap water for a minimum of one minute and until visual
evidence of debris, soil, and cleaning solution are gone. Use a
large syringe (e.g., 50ml or greater) filled to capacity with tap
water to thoroughly flush lumens and channels. Actuate joints,
handles and other moveable device features in order to rinse
thoroughly.
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9. Remove the devices and repeat the rinsing using in ambient,
< 40
° C (104 ° F) critical water (high purity water generated by
processes such as RO, deionization or distillation) for at least
15 seconds.
10. Remove and dry device using a clean, soft, lint-free cloth or
clean compressed air. Ensure that all lumens and articulated
areas are dried using compressed air.
Cleaning: Automated
1. Prepare a neutral or mild alkaline cleaning solution (pH 7 to 9)
in accordance to the detergent manufacturer’s instructions.
The temperature of the solution should be ≤40
° C (104 ° F) for
manual cleaning.
NOTE: The cleaning solution may contain enzymes. Aluminum-
safe alkaline cleaners can be used, but can vary in material
compatibility overtime based on their formulation. Material com-
patibility should be confirmed with the detergent manufacturer.
2. Immerse devices and parts in the detergent solution, and soak
for a minimum of 5 minutes.
3. While immersed, use a soft non-metallic bristle brush (plastic
bristles, like nylon) or sponge to thoroughly scrub all traces of
blood and debris from all device surfaces for at least one minute.
4. Ensure all lumens are thoroughly brushed. Push the brush
through the entire length of the lumen using a twisting motion
to remove debris from both ends for at least one minute
5. During cleaning, actuate joints, handles and other movable
device features to expose all areas to the detergent solution, if
applicable. Ensure all lumens are flushed for at least one minute.
6. Load the device components in the washer-disinfector in
accordance with manufacturer’s instructions, ensuring that the
devices and lumens can drain freely.
7. Automated washing shall be conducted in a validated washer-
disinfector in compliance to ISO 15883-1 and-2, or to an
equivalent standard. Automated washing can be included as
part of a validated washing, disinfection, and/or drying cycle
in accordance to manufacturer’s instructions. An example of a
validated cycle used for cleaning validation include:
Phase Recirculation Time Water Temp Detergent/Water Type
Pre-wash 2:00 Cold Tap
Water N/A
Enzyme
wash 1:00 < 40
° C
(104
° F) Neutral, Enzymatic Cleaner
Wash 5:00 66
° C
(151
° F) Neutral pH Detergent
Phase Recirculation Time Water Temp Detergent/Water Type
Rinse 2:00 > 40
° C
(104
° F) Tap water
Rinse 0:15 Ambient Critical water (RO, deionized or
distilled water)
Step 4: Thermal Disinfection
Thermal disinfection is recommended to render devices safe for
handling prior to steam sterilization. Thermal disinfection should
be conducted in a washer-disinfector compliant to ISO 15883-1
and-2, or to an equivalent standard. Thermal disinfection in
the washer-disinfector shall be validated to provide an A0of at
least 600 (e.g., 90
° C (194 ° F) for 1 min). Higher levels of A0can
be achieved by increasing the exposure time and temperature
(e.g., A0of 3000 at >90
° C (194 ° F) for 5 min, in accordance
with local requirements). Load the device components in the
washer-disinfector in accordance with manufacturer’s instructions,
ensuring that the devices and lumens can drain freely. Lumened
devices should be placed in a vertical position. If this is not
possible due to space limitations within the washer-disinfector,
use an irrigating rack /load carrier with connections designed
to ensure an adequate flow of process fluids to the lumen or
cannulation of the device if provided.
The following automated cycles are examples of validated cycles:
Phase Recircula- tion Time Water Temp Water Type
Thermal
Disinfection 1:00 > 90
° C
(194
° F)
Critical water
(RO, deionized or
distilled water)
Thermal
Disinfection 5:00 > 90
° C
(194
° F)
Critical water
(RO, deionized or
distilled water)
Step 5: Drying
It is recommended that drying is conducted in a washer-disinfector
compliant to ISO 15883-1 and-2, or to an equivalent standard.
Drying efficiency in washer-disinfectors can range considerably
based on the automated system design and load configuration.
The following automated cycle is an example of a validated cycle:
Phase Recirculation Time Air Temp Air Type
Dry 7:00 115
° C (239 ° F) Medical grade
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Following automated drying, inspect the device for residual
moisture. Any residual moisture identified should be dried
manually (as described below).
For manual drying:
•Ensure each device is dried and inspected thoroughly.
•For external surfaces, use a clean, soft, lint-free cloth to avoid
damage to the surface.
•Open and close any applicable devices during drying. Pay
special attention to any device threads, ratchets and hinges or
areas where fluid can accumulate. Clean, compressed air (e.g.,
medical grade) may be used to facilitate surface drying.
•Dry all lumen/cannulated parts using clean compressed air
(e.g., medical grade).
Step 6: Maintenance and Inspection
Instruments should be visually inspected under ambient lighting,
to verify that the devices do not have visible soil, damage or
moisture.
Inspect devices for:
•Lack of moisture. If moisture is detected, manually drying
should be performed.
•Cleanliness. If any residual soil is discovered during inspection,
repeat the cleaning steps on those devices until all visible soil is
removed from the device.
•Damage, including but not limited to, corrosion (rust, pitting),
discoloration, excessive scratches, flaking, cracks and wear
•Proper function, including but not limited to, sharpness of
cutting tools, bending of flexible devices, movement of hinges/
joints/box locks and moveable features such as handles,
ratcheting and couplings and missing or removed part numbers
Improperly functioning devices, devices with unrecognizable
markings, missing or removed (buffed off) part numbers,
damaged and worn devices should be discarded.
Disassembled devices should be reassembled prior to sterilization
when specified.
Lubricate any moving parts with a water-soluble surgical
instrument lubricant. The lubricant should be approved for use on
medical devices and provided with data to ensure biocompatibility
and compatibility with steam sterilization.
Step 7: Packaging
Place cleaned, dry devices into the specified locations within the
cases provided, if applicable.
Only legally marketed, and locally approved sterilization barriers
(e.g. wraps, pouches or containers) should be used for packaging
terminally sterilized devices, in compliance to the manufacturer’s
instructions.
Step 8. Sterilization
Steam (moist heat) sterilization shall be performed in a locally
approved, pre-vacuum (forced air removal) cycle. The steam
sterilizer should be validated to the requirements of any local
standards and guidance such as EN 285 or AAMI/ANSI ST8. The
steam sterilizer should be installed and maintained in compliance
to manufacturer’s instructions and local requirements. Ensure
that the steam sterilizer cycle is chosen that is designed to
remove air from porous or lumened device loads in accordance
to manufacturer’s instructions and does not exceed the criteria for
sterilizer load.
The following steam sterilization cycles are examples of validated
cycles:
Condition-
ing Phase
Minimum Steril-
ization Exposure
Time (minutes)
Minimum
Sterilization
Exposure
Temperature Dry Time
*
Prevacuum 4132 ° C (270 ° F) 30 minutes
Prevacuum 3134
° C (274 ° F) 30 minutes
Extended steam exposure cycle can be used to meet local
requirements such as 134
° C (274 ° F) for 18 minutes.
The efficiency of steam sterilizer drying can range considerably
depending on the sterilizer design, loading, packaging and steam
supply during the sterilization process. The user should employ
verifiable methods (e.g. visual inspections) to confirm adequate
drying. Extended drying within the sterilizer or in an external
drying cabinet in accordance with manufacturer’s instructions may
be necessary. Do not exceed 140
° C (284 ° F) during drying.
Step 9: Storage
Sterilized products should be stored in a dry, clean environment,
protected from direct sunlight, pests, and extremes of temperature
and humidity.
Refer to sterilization wrap or rigid container manufacturer’s IFU for
limits on sterile product storage time and storage requirements for
temperature and humidity.
ADDITIONAL INFORMATION
Cleaning agent information: Examples of detergents that have
been used during cleaning validations include ProlysticaTM
2X Concentrate Enzymatic Cleaner, ProlysticaTM 2X Neutral
Detergent, EnzolTM, EndozimeTM, Neodisher MedizymTM,
Terg-A-ZymeTM, and NpH-KlenzTM.
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