TORNIER Instrumentation Instructions for Use Jan 2013.pdf
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UTBI2013.1
TORNIER INSTRUMENTATION
INSTRUCTIONS FOR USE
The manufacturer recommends that all personnel responsible for
handling and implanting the devices read and understand this
information before use. The use of surgical instrumentation
requires knowledge of anatomy, biomechanics, and reconstructive
surgery of the musculo-skeletal system. Surgical instrumentation
must be used only by a qualified surgeon operating in accordance
with current information on the state of scientific progress and the
art of surgery.
The user must ensure the adequate condition and function of
surgical instrumentation before use.
IMPORTANT: When the hospital does not own the surgical
instrumentation, it accepts invoicing and delivers payment in the
following cases:
- when the instrumentation must be destroyed according to sanitary
rules
- when the instrumentation has been damaged due to non-respect of
Tornier instructions mentioned herein.
1. DESCRIPTION
The surgical instrumentation consists of ancillary instruments,
packaging trays as well as containers. The instrumentation type is
inscribed on the metal container or, if the instrument is delivered
individually, on the packaging. The exact designation of each
instrument is given on the instrumentation list supplied or, if the
instrument is delivered individually, on the package label.
Symbols are sometimes used to identify instruments (labeling or
marking) and they have the following meanings:
XS = Extra-small;
S or SM = Small;
S+ or SM+ = Small+;
M or ME = Medium;
M+ or ME+ = Medium+;
L or LA = Large;
L+ or LA+ = Large+;
XL = Extra-large;
2XL = Extra-extra-large;
3XL = Extra-extra-extra-large;
L = Left;
R = Right;
"-" = Short neck; "0" = Medium neck; "+" = Long neck.
Tornier surgical instrumentation has been specially designed to
facilitate the implantation of Tornier implants and must be used
solely for this purpose. It is important to refer to the technical
documentation prior to the operation, or contact your Tornier
representative for a more detailed description of how to use the
instrumentation. Under no circumstance should an instrument be
implanted.
2. INTENDED USE:
The surgical instrumentation is used by surgeons for the
implantation of orthopedic implants.
Do not modify the instruments.
3. INSTRUMENT DELIVERED NON-STERILE
When surgical instrumentation is delivered non-sterile, the hospital
is responsible for its cleaning and sterilization prior to use, in
accordance
with
validated
methods.
The
following
recommendations do not substitute for the sanitary rules in force:
standards, guides, government notices, ministerial texts, etc…
Before any operation, it is necessary to remove wedging foam in
the metal containers as well as plastic bags if the instrument is
delivered individually.
Instruments made up of removable components must be dismantled
before pre-disinfection and cleaning, in accordance with
instructions provided in the inventory list. Articulated instruments
must be opened in order to allow the cleaning of all interstices.
The instructions hereafter must be followed in order to maintain
optimal efficiency and safety of instruments:
- The use of metallic brushes, scrub pads and other articles likely to
damage the instruments must be avoided.
- Chemicals such as chlorine or soda as well as organic or
ammoniated acids or solvents (e.g. acetone) which are likely to
damage the instruments must not be used.
- Chemicals including soda must not be used for metal containers.
- Phosphoric acid must not be used for the neutralization of alkaline
residues after the cycle of automated machine cleaning on
instrumentation packaging trays and on instruments made up of polymere
pieces (example : polymer handle).
Note: Orthopedic procedures are not considered at risk in relation to
NCTA (Non-Conventional Transmissible Agents). A complete cleaning
using molar sodium (1N) or sodium hypochlorite with a concentration of
2% active chlorine should only be reserved for instruments that have been
used on a patient with suspected or confirmed TSE (Transmissible
Spongiform Encephalopaties) before the invasive procedure.
3.1. STORAGE AND HANDLING: Surgical instrumentation must be
handled with care and stored in an appropriate, clean and dry location.
It is recommended to remove instruments from plastic bags before
storing them to avoid condensation. Instruments must not be stored in
contact with or near products that may have a corrosive effect.
3.2. PRE-DISINFECTION : Pre-disinfection aims to reduce the population of
micro-organisms and to make subsequent cleaning easier. It is also
intended to protect staff while handling instruments and avoid
contamination of the environment. All reusable devices must undergo
immediate pre-disinfection or be immediately treated in a washerdisinfector.
Pre-disinfection is achieved by dipping instruments, for a minimum of
15 minutes, in a neutral or alkaline decontaminant/disinfectant
bactericidal, fungicidal and possibly virucidal solution that does not
contain aldehyde nor ethanol. The use of brushes is authorized to
clean the parts from all soils that can potentially alter the action of
detergents and decontaminants. The instruments should then be
carefully rinsed in a controlled water to avoid interference between the
decontaminant/disinfectant and cleaning solutions. It is important to
refer to the instructions supplied by the manufacturer of these
products.
CAUTION : Packaging trays and baskets must not be in contact with
decontaminating solutions for a long time. Clean dirty areas and rinse
immediately.
3.3. CLEANING: The equipment is then thoroughly cleaned out of the
container (the efficiency of parts cleaned inside their loading container
is not ensured), after disassembly if necessary. A cleaning process
done out of qualification ranges can lead to sterility or toxicity issue.
Cleaning eliminates contamination of the material. It must be
performed in a washer-disinfector with a neutral or slightly alkaline
detergent used at a maximum of 60°C. The detergent shall be selected
for medical applications and present no known residual toxicity for the
patient. The use of a mechanical action through manual of ultra-sonic
means is recommended. In case the process cannot be done
automatically, a manual process shall be used by reproducing the
conditions described in the cleaning recommendations. The cleaning
cycle must include a final rinse with a controlled water. Time, water
flow and rinsing volumes shall be sufficient to produce a low level of
cleaning agent residues left on the product surface. Instruments should
be carefully dried to avoid recontamination.
A thermal decontamination at 93°C is recommended. The correct
operation of each instrument must be inspected thereafter per the
specific product documentation supplied.
The cleaning conditions validated by Tornier can be found in this
document.
In the case of patients with suspected or confirmed TSE, the cleaning
procedure for the washer-disinfector shall be done after a
decontamination process conform to the instruction DGS/RI3/2011/449
and 29CFR1910.1030.
The use of lubricants to optimize the use of the instruments is authorized.
The products used shall be selected specifically for a medical use.
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Wrapped
Immersion
Rinsing 1
Rinsing 2
Water
Drying
Solution
Time
(min)
T°C
Water
1. Pre-disinfection
/ Decontamination
(FR / UK
conditions)
MEDICLEAN
0.5%
or
ALKAZYME 0.5%
pH10-11
15
Ambient
Tap water 1’ in
ambient
temperature –
12.5l minimum
2. Manual
precleaning on
ultrasonic bath
(FR / UK
conditions)
MEDICLEAN
FORTE 2%
pH10.4-10.8
5
20-30°C
Tap water 1’ in
ambient
temperature –
12.5l minimum
3. Automatic
cleaning process
(FR / UK
conditions)
MEDICLEAN
0.6%
pH 8.5-9.5
10
93°C
Softened water in
ambient
temperature –
12.5l minimum
1. Pre-disinfection
/ Decontamination
(US conditions)
ALKAZYME 0.5%
pH10-11
15
Ambient
Tap water 1’ in
ambient
temperature –
12.5l minimum
2. Manual
precleaning on
ultrasonic bath
(US conditions)
CIDEX 28
7.5-8.1
5
20-30°C
Tap water 1’ in
ambient
temperature –
12.5l minimum
3. Automatic
cleaning process
(US condition)
Prolystica 0.7%
pH1.2
10
93°C
Softened water in
ambient
temperature –
12.5l minimum
STERILIZATION PARAMETERS RECOMMENDED IN THE UK6,7:
The heaviest containers must be placed at the bottom of the autoclave.
In order to avoid residual water in containers after sterilization we
advise that a folded paper or non woven sheet is placed on the back of
the container before sterilization, to improve vaporization during final
drying.
Tornier recommends to sterilize through this method:
Purified water 1’ in
ambient
temperature –
12.5l minimum
Y
T°C
Incertainty
Time
Drying
Wrapped
Purified water 1’ in
ambient
temperature –
12.5l minimum
After sterilization, the wrapped trays shall be handled with care
to the point of use to prevent any disrupture of the sterile
barrier.
The sterilization conditions validated by Tornier can be found in
this document.
STERILIZATION PARAMETERS RECOMMENDED IN THE USA5,7
The sterilization may be performed using the following method.
Tornier recommends to sterilize through this method :
Pre-vacuum
method
132°C (269.6°F)
+3°, -0°
4 min
20 min
yes
STERILIZATION PARAMETERS RECOMMENDED IN FRANCE1,2,3,4,7
The heaviest containers must be placed at the bottom of the
autoclave.
In order to avoid residual water in containers after sterilization
we advise that a folded paper or non woven sheet is placed on
the back of the container before sterilization, to improve
vaporization during final drying.
Tornier recommends to sterilize through this method :
T°C
Incertainty
Time
Drying
Pre-vacuum method
134°C (273.2°F)
+3°, -0°
18 min
20 min
Pre-vacuum method
134°C (273.2°F)
+3°, -0°
3 min
20 min
yes
Y
3.4. STERILIZATION: Instruments, packaging trays and baskets are
adapted for steam sterilization at a temperature not exceeding
140°C. Sterilization is mandatory for Tornier instruments,
disinfection is not sufficient. It shall be done using the containers
wrapped per the l’ANSI AAMI ST 79, Fig.6.
The instruments’ function shall be controlled before the
sterilization per the specific product check-lists supplied.
Generally speaking, the instruments must be sterilized when
assembled, but certain instruments consisting of components
that can be disassembled must be disassembled before predisinfection and cleaning if assembly/disassembly instructions
are provided with the product check-list.
T°C
Incertainty
Time
Drying
Wrapped
yes
3.5 AFTER USE:
After each use and before returning to Tornier, the instrumentation (entire
box or isolated instrument) must be pre-disinfected, cleaned and sterilized
according to the aforementioned recommendations. Instruments that
appear to be non-functional must immediately be sent to Tornier for
maintenance or exchange. The nature of dysfunction must be clearly
indicated. The instrumentation must be correctly packaged before being
returned, and the original positioning of the components in corresponding
containers should be respected.
Instrumentation must be returned with the Count Sheet filled in and duly
signed by authorized hospital personnel (with respect to position,
qualification or authority).
4. SINGLE USE INSTRUMENT DELIVERED STERILE
4.1. PRECAUTIONS OF USE:
- Never re-use an instrument designated for single-use, even if it
appears to be in perfect condition, to prevent any risks of crosscontamination or a risk of reduced performances.
- Never re-sterilize an instrument designated for single-use.
4.2. STORAGE AND HANDLING: The instrumentation must be stored in an
appropriate, dry and clean location to prevent any loss of sterility.
Instrumentations must not be exposed to direct sunlight, ionising
radiation, extreme temperatures nor particular contamination.
Instrumentations must be handled with care to preserve integrity of their
packaging.
Instruments delivered sterile must be stored in their sealed packaging of
origin.
4.3. PACKAGING AND STERILIZATION: Instruments delivered sterile are
sterilized by gamma irradiation. The expiration date for sterilization and
integrity of the packaging must be checked.
An instrument whose packaging is open or damaged or whose expiration
date has passed must not be used.
Every precaution must be taken to ensure sterility when opening the
packaging of the instrument.
NOTES
1. French rule DGS/RI3/2001/449 of December 1st, 2011 updating
recommendations to reduce the risk of transmitting non-conventional
transmissible agents during invasive procedures and French Circular
DGS/SD5C/DHOS/2005/435 of 23 September 2005 regarding
recommendations for treatment of medical devices used on patients
having received labile blood products retrospectively from donors that
suffered suffering from a variant of Creutzfeld-Jakob Disease (CJD).
2. Good Pharmaceutical Practice – 22 June 2001 French regulation.
3. FD S 98-135 : April 2005 – Guide for the sterilisation of medical
devices – Treatments applied to reusable medical devices.
4. NF EN ISO 17664 – August 2004 – Sterilization of medical devices –
Information to be provided by the manufacturer for the processing of
resterilizable medical devices.
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5. “Recommended practices for sterilization in perioperative
practice settings,” in Standards, Recommended Practices, and
Guidelines (Denver: AORN, Inc, 2007) 673 – 677.
Comprehensive guide to steam sterilization and sterility assurance
in health care facilities - ANSI/AAMI ST79-2010.
AAMI TIR12 : Designing, testing, and labelling reusable medical
devices for reprocessing in health care facilities : a guide for
medical device manufacturers.
AAMI TIR30 : A compendium of processes, materials, test
methods, and acceptance criterias for cleaning reusable devices.
6. “Health Technical Memorandum 2010” – Part 2: design
considerations – Sterilization – London: HMSO – NHS Estates
7. NF EN ISO 17665-1 - Sterilization of health care products.
Moist heat. Requirements for the development, validation and
routine control of a sterilization process for medical devices
Interpretation of terms and symbols
Do not reuse
Use by
Sterilized using irradiation
Batch code (sterilization)
Serial number (manufacturing)
Catalogue number
Caution, consult accompanying documents
Consult instructions for use
Non-sterile
Do not use if package is damaged
Do not re-sterilize
Not made with natural rubber latex
Rev. 02/2013
The French text is the reference text.
Manufacturer :
TORNIER SAS
161, rue Lavoisier
38330 MONTBONNOT SAINT MARTIN - FRANCE
Tél: +33 (0)4.76.61.35.00 – Fax: +33 (0)4.76.61.35.33
USA Business address:
TORNIER, Inc.
10801 Nesbitt Avenue South
Bloomington, MN 55437 USA
Tel +1 952 921 7100
Fax +1 952 236 4007
= Reusable instrument
0459
= Instrument depending on a
source of electrical energy /
single-use instrument
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