This document is valid only on the date printed. If unsure of the print date, please
re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com).
The onus resides with the user to ensure that the most up-to-date IFU is used.
6 of 12
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:
Conditioning
Phase
Minimum
Sterilization
Exposure Time
(minutes)
Minimum
Sterilization
Exposure
Temperature
Dry Time*
Prevacuum
4
132°C (270°F)
30 minutes
Prevacuum
3
134°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 considerable
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.
Immediate-Use steam sterilization is only intended for individual
instruments and should only be performed when approved by
local policies. DePuy Synthes does not support immediate-use
steam sterilization of instrument sets, cases or implants using
this method.
The following steam sterilization cycle is an example of a validated
cycle for individual instruments only:
•
Unwrapped instrument
•
A minimum 3 (three) pulse prevacuum cycle
•
132°C (270°F) for 4 minutes
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 manufacturers 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 Prolystica™ 2X
Concentrate Enzymatic Cleaner, Prolystica™ 2X Neutral Detergent,
Enzol™, Endozime™, Neodisher Medizym™, Terg-A-Zyme™,
and NpH-Klenz™.
These instructions for use have been validated in accordance
with ISO 17664. It remains the responsibility of the facility to
ensure that the processing is actually performed using equipment,
materials and personnel at a designated area, and achieves
the desired requirements. This includes validation and routine
monitoring of the process. Likewise, any deviation by the
processor from these recommendations should be evaluated for
effectiveness and any potential adverse consequences.
All personnel using these instructions should be qualified with
documented expertise, competency and training. Users should be
trained on healthcare facility policies and procedures along with
current applicable guidelines and standards.
ADVERSE EVENTS
1. Serious adverse events, some with fatal outcome, associated
with the use of acrylic bone cements in the spine include
myocardial infarction, cardiac arrest, cerebrovascular accident,
pulmonary embolism, and cardiac embolism. Although the
majority of these adverse events present early within the post-
operative period, there have been some reports of diagnoses
beyond a year or more after the procedure.
2. Other reported adverse events for acrylic bone cements
intended for use in the spine include: Leakage of the bone
cement beyond the site of its intended application with intro-
duction into the vascular system resulting in embolism of the
lung and/or heart or other clinical sequelae.
3. Bending or fracture of implant.
4. Loosening of the implant. Screw back out, possibly leading to
implant loosening, and/or reoperation for device removal.
5. Metal sensitivity, or allergic reaction to a foreign body.
6. Superficial or deep wound infection, early or late.
7. Nonunion, delayed union.
8. Decrease in bone density due to stress shielding.
9. Pain, discomfort, or abnormal sensations due to the presence
of the device.
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