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CLEANING AND STERILIZATION
The VIPER Fenestrated Screw System may be provided either
sterile or non-sterile and this will be clearly identified on the
product labels.
Sterile Implants
Implants supplied sterile are sterilized using gamma sterilization.
For these devices the contents are sterile unless the package
is damaged, opened, or the expiration date on the device label
has passed. The integrity of the packaging should be checked
to ensure that the sterility of the contents is not compromised.
Remove implants from packaging, using aseptic technique, only
after the correct size has been determined.
PRECAUTION: Do not use implants if the condition of the
package and/or labeling indicates a chance that the devices may
not be sterile. Implants must not be re-sterilized.
Non-sterile Implants
Introduction
DePuy Synthes non-sterile implants and reusable instruments
are critical medical devices. These devices must be cleaned,
inspected and sterilized prior to surgical use. These instructions
are provided to assist health care personnel in the development
of effective procedures for the processing of non-sterile implants
and reprocessing of reusable devices. It is the responsibility
of the facility to ensure that processing is performed using the
equipment, materials and competent personnel at a designated
processing area.
These instructions are provided for heat-resistant, 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.
DePuy Synthes Instruments do not have an indefinite functional
life. All reusable instruments are subjected to repeated stresses
related to surgical use, routine cleaning, and sterilization
processes. 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.
DePuy Synthes provides sterile and non-sterile implants.
These instructions do not apply to single-use devices.
Sterile, single use implants must not be reused or reprocessed.
Sterile implants are labelled as single use and have not been
validated for processing. Non-sterile implants must be processed
prior to use in accordance with these processing instructions.
They must be discarded following patient use.
Manufacturer Contact
For local contact information, visit www.depuysynthes.com or
contact your local sales representative.
SYMBOLS
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
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