Integra LifeSciences Care and Handling of Surgical and Dental Instruments - Manual

INDICATIONS FOR USE
Surgical and dental instruments are designed to perform specific functions such as cutting, grasping, clamping, dissecting,
probing, retracting, draining, aspirating, suturing, or ligating. Surgical instruments may also be used to facilitate the insertion
of surgical implants.
CONTRAINDICATION
Instruments should not be used for anything other than their intended use.
WARNING
If any device is/was used in a patient with, or suspected of having Creutzfeld Jakob Disease (CJD), the device cannot be reused
and must be destroyed after exposure as the instruments have not been validated to withstand the chemical and thermal
exposure recommended to eradicate prions.
Consult individual national infection control/prevention protocols for specific guidance regarding processing medical devices
with suspected exposure to CJD.
PRECAUTIONS
• Integra Miltex instruments are supplied non-sterile, unless otherwise noted and must be cleaned, lubricated and
sterilized prior to use according to hospital protocol and procedures outlined in this document.
• Inappropriate use of instruments may result in patient injury, damaged or broken instruments.
• Proper cleaning, handling, sterilization and standard routine maintenance (such as sharpening, if applicable)
will ensure that the instruments perform as intended and will extend their useful life.
• Delicate surgical/dental instruments require special handling to prevent damaging the tips. Use caution
during cleaning and sterilization.
• Do not use dry heat sterilization or expose to phenols or iodophors.
• Do not apply excessive stress or strain at joints; misuse will result in misalignment or cracks at the box locks
or jaws.
• Rongeurs and bone cutting forceps should only be used to cut bone, never wire or pin. Do not twist or apply
excessive stress during use.
• Wear appropriate protective gloves, eyewear and clothing when handling biologically contaminated
instruments.
• Instruments manufactured from different metals or with special coating, should be processed separately to
avoid electrolytic action between the different metals.
• Before use, inspect the instruments for possible damage, wear or non-functioning parts. Carefully inspect
the critical, inaccessible areas, joints and all movable parts.
• Damaged or defective instruments should not be used or processed.
• Suture needles are designed for single-use and should not be reprocessed. Follow sharps safety guidelines for point of use disposable.
DECONTAMINATION AND STERILIZATION PROCEDURES
Personnel should follow accepted guidelines as recommended in ANSI/AAMI ST79 - Comprehensive guide to steam sterilization
and sterility assurance in health care facilities and ISO 17664. For Ethylene Oxide sterilization, follow the ANSI/AAMI ST41 Ethyl-
ene Oxide sterilization in health care facilities: safety and effectiveness, 4th edition. Sterilization of medical devices information
to be provided by the manufacturer for the processing of resterilizable medical devices. Instruction for reprocessing reusable
surgical instruments is provided according to ISO 17664. The decontamination procedure does not sterilize the instruments.
Refer to and process the instruments as outlined in the STERILIZATION section.
CARE AND HANDLING
1. PRECLEANING:
• Keep instruments moist and do not allow blood and/or bodily fluids to dry on the instruments.
• Remove gross contaminants with steady stream of lukewarm/cool water (below 110°F/43°C). Rinse each
instrument thoroughly. Do not use saline or chlorinated solutions.
• Open jaws of hinged instruments for cleaning. Give special attention to joints and serrations. Instruments
having more than one part or piece must be disassembled to expose all surfaces to the cleaning process.
Retain all parts to facilitate reassembly.
• Separate sharps and delicate surgical instruments. Avoid processing instruments of different metallic
composition together.
• Keep ebonized instruments separate from other stainless steel instruments to avoid scratches to and
removal of the ebonized coating.
2. RINSE: Rinse instruments thoroughly under warm distilled or demineralized water.
3. CLEANING:
CLEANING PRECAUTIONS:
• If appropriate, disassemble surgical instruments prior to cleaning and sterilization.
• Do not soak instruments in hot water, alcohol, disinfectants or antiseptics to avoid coagulation of mucus,
blood or other body fluids. Do not exceed two hours soaking in any solution.
• Do not use steel wool, wire brushes, pipe cleaners or abrasive detergents to remove soil as these will
damage the instrument and lead to corrosion.
• Microsurgical, plated and delicate instruments should be cleaned manually and should not be processed in
an ultrasonic cleaner. Carefully protect the tips of delicate microsurgical instruments throughout the entire
cleaning and sterilization process.
• To preserve the surface coating of ebonized instruments, keep ebonized instruments separate from other
instruments and avoid mechanical cleaning and abrasive cleaners as these processes can scratch the
surface and remove the surface coating.
• Color anodized aluminum instruments may lose their color through the use of conventional, mechanical
treatment processes.
A. MANUAL CLEANING: To prevent formation of biofilm, cleaning should occur as soon as possible after
instrumentation is used.
• Choose a cleaning solution appropriate for surgical/dental instruments and follow manufacturer’s
instructions for use.
• The use of neutral pH detergents is recommended to avoid corrosion, pitting and breakage.
• Using a small, clean hand-held brush, remove soil from all surfaces of instrument while fully immersed in
solution.
B. ULTRASONIC AND MECHANICAL CLEANING
• For ultrasonic cleaning, follow manufacturer’s specifications for water level, concentration levels of cleaning
agent and temperature.
• Use an ultrasonic cleaner to remove soil from hard to reach surfaces such as grooves, crevices and moving
parts after gross soil has been removed.
• Open or disassemble instruments as appropriate.
• When using mechanical washer, make sure all instruments stay properly in place and do not touch or overlap
each other.
• Do not allow ebonized instruments to come in contact with each other or other instruments.
• Always follow the manufacturer’s specifications for automatic washer-sterilizers and use a free-rinsing,
low-sudsing detergent with a neutral pH (6.0 - 8.5). Due to variations in water quality, the type of detergent
and its concentration may require adjustment for optimal cleaning.
4. RINSE AND DRY: Rinse all instruments thoroughly with distilled, pyrogen-free water to remove all traces of debris and cleans-
ing agents. Make sure all internal lumens and ratchets are thoroughly rinsed.
Instruments must be thoroughly dried and all residual moisture must be removed before they are stored. Use a soft, absorbent
towel/cloth to dry external surfaces. Compressed air may be used to aid the drying process.
5. LUBRICATE: The use of a water soluble instrument lubricant that is compatible with the method of
sterilization to be used is recommended before instruments are sterilized.
• After thoroughly cleaning instruments, proper application of lubricants to all joints and movable mating
surfaces will keep them moving freely and aid in protecting surface from mineral deposits.
• Proper lubrication is required for all instruments, regardless of surface coatings.
• Note that ultrasonic cleaners remove all lubrication; therefore, this maintenance procedure should be done
routinely after ultrasonic cleaning and before sterilization.
• If following the lubricating procedure, do not rinse after this step. 6. STERILIZATION:
After following decontamination recommendations, reusable instruments are ready for sterilization.
• See ANSI/AAMI ST79.
• AAMI standards recommend that sterilizer manufacturer’s written instructions for cycle parameters should
also be followed. Medical device manufacturer’s exposure times to sterilization temperature may need to be
longer than minimum indicated by sterilizer manufacturer but must never be shorter. It is the responsibility of
the user to establish whether sterilizer meets these minimum recommendations.
• Instruments may be packaged in rigid containers, or packaging cleared for use in sterilization. Packaging
should ensure sterility of instruments until opened for use at the sterile field and permit removal of contents
without contamination.
• Recommended steam sterilization parameter to achieve Sterility Assurance Level (SAL) of 10
-6 :
Independent laboratory testing, referencing FDA (21CFR Part 58) Good Laboratory Practice Regulations has validated the
following parameters.
High Vacuum Steam (Pre-vacuum)
Unwrapped in containers
Perforated stacked/unstacked
Solid unstacked 270ºF (132ºC) 4 minutes
minimum 20 minutes
Gravity Steam
Unwrapped in containers
Perforated unstacked 250ºF (121ºC) 45 minutes 20 minutes
Gravity Steam
Wrapped in cassettes 250ºF (121ºC) 30 minutes 20 minutes
Ethylene Oxide (EtO)
Unwrapped in containers
Perforated unstacked
Solid unstacked 131ºF (55ºC) 60 minutes (minimum)
Concentration: 725 mg/l
Humidity: 70%
Aeration time: 8 hours minimum
Independent laboratory testing conducted according to ISO 17664, has validated the following
sterilization parameters.
Sterilization Method Temperature Exposure Time Dry Time
High Vacuum Steam (Pre-vacuum)
Wrapped 270ºF (132ºC) 3 minutes minimum N/A
RETURNED GOODS POLICY
Products must be returned in unopened packages with manufacturer’s seals intact to be accepted for
replacement or credit unless returned due to a complaint of product defect. Determination of a product defect will be made by Integra
Miltex. Products will not be accepted for replacement if they have been in the possession of the customer for more than 90 days.
REPAIRS AND MAINTENANCE
Improper, ineffective and insufficient maintenance can reduce the life of an instrument and will invalidate the instrument’s warranty.
Should instruments require repair or maintenance, contact Integra Miltex for return authorization and address.
Instruments returned to Integra Miltex for repair must have a statement testifying that each instrument has been
thoroughly cleaned and sterilized. Failure to supply evidence of cleaning and disinfection will result in a
cleaning charge and delayed processing of your instrument repair.
PRODUCT INFORMATION DISCLOSURE
INTEGRA AND ITS SUBSIDIARIES (“INTEGRA”) AND MANUFACTURER EXCLUDE ALL WARRANTIES, EXCEPT INTEGRA’S
APPLICABLE STANDARD WARRANTY WHETHER EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. NEITHER INTEGRA NOR MANUFACTURER SHALL BE LIABLE FOR ANY
INCIDENTAL OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY
ARISING FROM USE OF THIS PRODUCT. NEITHER INTEGRA NOR MANUFACTURER ASSUME NOR AUTHORIZE ANY PERSON
TO ASSUME FOR THEM ANY OTHER OR ADDITIONAL LIABILITY OR
RESPONSIBILITY IN CONNECTION WITH THESE PRODUCTS.
SYMBOLS USED ON LABELING
Manufacturer 1
European Authorized Representative
Catalog Number
Lot Number
Caution: See Warnings and Precautions
Consult Instructions for Use
Complies with MDD 93/42/EEC
EC REP
LOT
Federal (USA) law restricts this device to sale by
or on the order of a physician or practitioner
0297
Integra
®
Miltex
®
Care and Handling of Surgical and
Dental Instruments
Directions for Use / English
Integra, the Integra logo, and Miltex are registered trademarks of Integra LifeSciences
Corporation or its subsidiaries in the United States and/or other countries.
©2012 Integra LifeSciences Corporation. All Rights Reserved.
STANDARDIFU Rev. E 06/13
1 Company responsible for a device marketed under its own name regardless of whether
“manufactured for” or “manufactured by” the company.
Complies with MDD 93/42/EEC
Integra York PA, Inc.
589 Davies Dr.
York, PA 17402 USA
866-854-8300
717-840-9335
www.integralife.com/integra-miltex
EC REP Integra LifeSciences Services (France) SAS Immeuble Sequoia 2
97 allée Alexandre Borodine
Parc Technologique de la Porte des Alpes
69800 Saint Priest–France
Telephone: 33 (0) 4 37 47 59 10
Fax: 33 (0) 4 37 47 59 29
2
Do not reuse