stryker_osteosynthesis_devices_cleaning__sterilizat.pdf
Page 1
Instructions
for Cleaning, Sterilization,
Inspection and Maintenance
of Osteosynthesis Medical Devices
Page 2
Contents
1.
Introduction
Warnings and Precautions
2.
Processing Instructions
3.
Cleaning
Inspection
Packaging
4.
Sterilization
5.
Storage before Use
6.
References
7.
Manufacturers of Stryker Osteosynthesis Medical Devices
2
Page
3
3
4
5
8
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9
11
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Appendix 1
Cleaning agents and disinfectants used during validation
of the processing instructions
12
Appendix 2
Generic product groups defined for the cleaning validation
13
13
Appendix 3
Guidelines to check proper functionality of the medical devices
16
16
12
Page 3
1. Introduction
This document is intended to give
general guidance on how medical
devices supplied by one of the Stryker
Osteosynthesis manufacturing locations (see manufacturer addresses in
section 7) may be processed to prepare
them for use. It also gives instructions
for inspection to determine when an
instrument has reached the end of its
serviceable life and must be replaced.
This document is provided in conjunction with the assembly and disassembly
instructions for multi-component
instruments which must be disassembled prior to cleaning, and the instructions for use, which come with the
products. Stryker Osteosynthesis has
demonstrated the processes described
in these instructions to be effective.
Equipment, operators, cleaning agents
and procedures all have a contribution
to the efficacy of the processing and the
healthcare facility should ensure that
the combination actually in use results
in a medical device which is safe and
effective for use. Alternative methods
of processing may be equally suitable.
In the event of conflicting national
cleaning and sterilization requirements,
these shall prevail over Stryker Osteosynthesis' recommendations. This
applies particularly to the different
procedures for inactivation of prions.
Warnings and Precautions
•
•
•
Devices labeled “for single use
must not be reprocessed
only”
for re-use. When single use devices
are supplied non-sterile and require
sterilization before use, the appropriate sections of these instructions
may be applied unless other specific
instructions are provided in the
package insert.
Single use devices must not be
reused, as they are not designed
to perform as intended after the
first usage. Changes in mechanical,
physical or chemical characteristics
introduced under conditions of
repeated use, cleaning and re-sterilization may compromise the integrity of the design and/or material
leading to diminished safety, performance and/or compliance with
relevant specifications. Please refer
to the device label to identify single
or multiple use and/or cleaning and
re-sterilization release.
Stryker Osteosynthesis medical
devices are not normally used in
surgical procedures where they
contact low or high risk TSE
(Transmissible Spongiform Encephalophaties) infective tissue as
defined by World Health Organization (WHO), Robert Koch Institute
(RKI) etc.. Therefore decontamination procedures with highly aggressive agents [i.e. sodium hydroxide
(NaOH), sodium hypochloride
(NaOCl)] are not necessary and, for
normal processing, are not recommended because material degradation may occur. The sterilization
parameters recommended in this
document are not intended and not
suitable for inactivation of prions.
3
Page 4
2. Processing Instructions
The sequence of steps required to
prepare medical devices for re-use or to
prepare new devices for initial use are
summarized in the chart below.
Point of Use
•
•
•
Remove gross soil
Rinse in running water
Place in aldehyde-free disinfectan bath
Transport to
Processing Area
•
•
Avoid mechanical damage
Minimize time before cleaning
Preparation for
Cleaning
•
Disassemble where possible
Pre-Cleaning
•
•
•
•
•
Remove gross soil
Soak in cleaning solution
Brush, operate moving parts
Rinse in running water
Inspect, place on absorbent paper
More detailed instructions for each step
are given on the following pages.
Automatic
(recommended)
Manual
•
•
Manual Cleaning and
Disinfection
•
•
•
•
•
Soak in ultrasonic bath
Clean with brushes or cleaning
wires
Rinse with syringe/running water
Soak in disinfectant solution
Clean with brushes
Rinse with syringe/running water
Dry (compressed air/wipes/oven)
Automated Cleaning
and Disinfection in
Washer-Disinfector
•
•
•
Soak in ultrasonic bath
Load into washer-disinfector
Connect cannulations
to rinsing ports, arrange
products
Operate washer-disinfector
cycle
Inspect, dry
•
•
Visual inspection
Functional check
•
•
Store devices in dedicated trays or wire
baskets
Single or double packaging
Sterilization
•
Steam autoclave
Storage
•
•
Control environment
Control shelf life
Inspection
Packaging
4
•
•
Page 5
3. Cleaning
Two methods of cleaning Stryker
Osteosynthesis medical devices are provided in these instructions, a manual
method and a method using an automated washer disinfector. Whenever
possible the automated method should
be used. The automated cleaning process is more reproducible and therefore
more reliable, and staff are less exposed
to the contaminated devices and the
cleaning agents used.
Whichever method is used, staff should
use suitable protective clothing and
equipment at all times. In particular
take note of the instructions provided
by the cleaning agent manufacturer
for correct handling and use of the
product.
The guidance concentrations and times
for device immersion in the cleaning
solutions and/or disinfectants given
by the detergent manufacturers shall
be observed. If these concentrations
and times are exceeded significantly,
discoloration or corrosion could occur
with some materials. This could also
happen if rinsing after cleaning and/or
disinfecting is insufficient.
For cleaning or disinfecting medical
devices only specifically formulated
cleaning agents and/or disinfectants
(detergents) should be used.
As not all cleaning agents and disinfectants may be available around
the globe, criteria for the selection of
appropriate detergents are provided in
Appendix 1. A list of cleaning agents
and disinfectants which Stryker Osteosynthesis used in the validation of these
processing instructions is also provided
in Appendix 1. Stryker Osteosynthesis does not recommend any specific
cleaning and/or disinfection agent. A
general description of suitable agents is
included in Appendix 1.
Preparation for cleaning
Directly after application (within a
maximum of 2 hours postoperatively)
remove gross soil using absorbent
paper wipes. Additionally, intensive
rinsing of the medical devices with
fluent water or transfer of the medical
devices into a bath with an aldehydefree disinfectant solution meeting the
criteria given in Appendix 1 is highly
recommended.
Disassemble the device where possible. See instructions provided in the
operative technique or separate information available from your Stryker
representative.
Avoid mechanical damage, e.g. do not
mix heavy devices with delicate ones.
Pay particular attention to cutting
edges, both to avoid injury and damage
to the medical device. Get the medical
devices to the point where cleaning is
to be performed as soon as practical.
If transfer to the processing area is
likely to be delayed, consider covering
the medical devices with a damp cloth
or store the medical devices in closed
boxes to avoid drying of soil.
Caution:
Stryker Osteosynthesis trays
are intended for sterilization,
transport and storage of medical
devices. They are not designed for
cleaning and disinfection in the
fully equipped state. The devices
must be removed from the tray for
adequate cleaning results.
The quality of the water used for
diluting cleaning agents and/or
Point of use
Transport to processing area
disinfectants and for rinsing medical
devices should be carefully considered.
Application of freshly prepared purified
water/highly purified water or sterile
water for rinsing purposes (according
to the pharmacopeias) with less than
10 cfu/ml and 0.25 EU/ml is highly
recommended.
Mineral residues from hard water as
well as higher contamination with
microorganisms and endotoxins can
result in staining of the device or
prevent effective cleaning and decontamination.
•
Pre-Cleaning
•
Remark:
The pre-cleaning step can be ommitted
in case of direct subsequent manual
cleaning and disinfection. In case of
highly contaminated medical devices to
be subjected to an automatic cleaning
process, pre-cleaning in an ultrasonic
bath is recommended.
Equipment required:
• Cleaning bath or vessel large
enough to allow complete immersion of the instruments.
• Freshly prepared cleaning solution
using a cleaning agent intended for
manual cleaning which meets the
5
•
•
criteria given in Appendix 1, with
concentration, temperature, and
soaking time not less than specified
in the detergent manufacturer´s
instructions (but temperature not
exceeding 50 °C)
Brushes – soft and firm, bottle brushes or cleaning wires for cannulations etc.
Personal protective equipment as
recommended by the cleaning agent
supplier (minimum overalls, gloves,
face/eye shield)
Absorbent paper
Syringes (volumes 1 to 50 ml
depending on the size of the cannulations to be rinsed)
Caution:
Never use metal brushes or steel
wool for cleaning.
Page 6
3. Cleaning
Procedure
• Remove gross soil using paper
wipes and solution of cleaning
agent.
• Immerse medical device in solution
of cleaning agent.
• Ensure that all surfaces are thoroughly wetted, using a syringe
to ensure that solution reaches all
parts of cannulations etc. Ensure
that air is not trapped within features of the device when immersing
in the solution.
• Soak at minimum for the time
recommended by the detergent
manufacturer´s instructions.
•
•
•
Using suitable brushes (only soft
brushes, never metal brushes or
steel wool) or cleaning wires clean
the medical device thoroughly
paying particular attention to rough
surfaces and features where soil may
be shielded from the brushing.
Use a firm bristle brush for cleaning
bone-cutting features such as drill
tips, reamer flutes and the teeth of
broaches.
Use a bottle brush of appropriate
diameter for cannulations. Ensure
that the brush passes the whole
length of each cannulation at least
three times.
•
•
•
•
•
Operate articulating devices and
those with moving parts.
Rinse in running water for at least
1 min until all traces of cleaning
solution are removed.
Pay particular attention to cannulations and blind holes as well as
hinges and joints between mating
parts. At least three times complete
rinsing by application of a syringe
(volume 1-50 ml) is required.
Visually inspect for any remaining
soil and repeat the steps above if
necessary.
Allow to drain on absorbent paper
or transfer immediately to cleaning
step.
Manual cleaning and disinfection
Cleaning
Equipment required:
• Ultrasonic bath large enough to
allow complete immersion of the
medical device. Frequency 25 – 50
kHz, temperature according to
detergent manufacturer`s instructions.
• Cleaning agent intended for manual
cleaning and suitable for ultrasonic
treatment which meets the criteria given in Appendix 1; concentration as specified in detergent
manufacturer’s instructions.
• Suitable brushes (only soft brushes,
never metal brushes or steel wool)
or cleaning wires (for small channels) to reach all parts of the device.
• Syringes (volumes 1 to 50 ml
depending on the size of the channels to be rinsed)
• Freshly prepared purified water/
highly purified water or sterile
water for rinsing purposes.
Procedure:
• Prepare an ultrasonic bath with a
cleaning solution at the concentration and temperature specified
in the detergent manufacturer´s
instructions.
• Immerse the device completely
and activate the bath for at least
the time specified in the detergent
manufacturer´s instructions.
• Using suitable brushes (only soft
brushes, never metal brushes or
steel wool) or cleaning wires (for
small channels) clean the device
paying particular attention to rough
surfaces and features that may be
shielded from the brushing action.
Additionally, pay particular attention to cannulations and blind holes
as well as hinges and joints between
mating parts. Rinse cannulations at
least three times with a syringe.
• Rinse for at least 1 min in running
6
•
water of the specified quality until
all traces of cleaning solution are
removed. Pay particular attention to
cannulations and blind holes as well
as hinges and joints between mating
parts. Rinse cannulations at least
three times with a syringe (volume
1-50ml).
If, after completion of the cleaning
step in the ultrasonic bath, encrusted soil remained on the device
which had to be removed with the
brush, the cleaning step must be
repeated as described above.
Equipment required:
•
Bath large enough to allow complete immersion of the medical
device, temperature according to
detergent manufacturer`s instructions.
•
Disinfectant intended for manual
disinfection and compatible
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3. Cleaning
Disinfection
•
•
•
with the applied cleaning detergent which meets the criteria
given in Appendix 1; concentration according to the detergent
manufacturer’s instructions.
Syringes (volumes 1 to 50 ml
depending on the size of the channels to be rinsed).
Freshly prepared purified water/
highly purified water or sterile
water for rinsing purposes.
Filtered medical compressed air
(if available) or clean and lint-free
single use wipes.
Procedure:
•
Prepare a bath with a disinfectant
solution at the concentration and
temperature specified in the detergent manufacturer´s instructions.
•
Immerse the device completely for
at least the time specified in the
detergent manufacturer´s instructions.
•
•
•
•
Rinse cannulations at least three
times with a syringe.
Rinse for at least 1 min in running
water of the specified quality until
all traces of disinfectant solution are removed. Pay particular
attention to cannulations and
blind holes as well as hinges and
joints between mating parts. Rinse
at least five times with a syringe
(volume 1-50ml).
Dry the medical device using
medical compressed air and clean
and lint-free single use wipes (if
required supplemented by postdrying at a clean place for up to
2 hours) or by heating in an oven
below 110°C.
Visually inspect and repeat
complete manual cleaning and
disinfection if necessary.
Automated cleaning and disinfection using washer-disinfector (recommended)
Equipment required:
• Washer-disinfector with fundamentally approved efficiency (e.g. CE
mark or FDA approval according
to ISO 15883), properly installed,
qualified and regularly subjected to
maintenance and testing
• Approved thermal disinfection
program (A0 value > 3000 or – in
case of older devices – application
of at least 5 min at 90 °C; chemical
disinfection program not recommended due to danger of remnants
of the disinfectant on the instruments) with sufficient rinsing steps
and filtered air for an active drying
program (application of rinsing
aids not recommended, danger of
remnants)
• Final rinsing/disinfection only with
freshly prepared purified water/
highly purified water
• Cleaning agent intended for
automated cleaning which meets
the criteria given in Appendix 1,
concentration as specified in the
detergent manufacturer’s instructions.
Procedure:
• Load the medical devices into the
washer-disinfector.
• Connect cannulations to the rinsing
ports of the washer-disinfector. If
no direct connection is possible,
locate the cannulations directly on
injector jets or in injector sleeves of
the injector basket.
• Avoid contact between devices
(movement during washing could
cause damage, and washing action
could be obstructed).
• Arrange medical devices so that
cannulations are not horizontal and
blind holes incline downwards (to
assist drainage).
7
•
•
•
Articulating devices should be in
the open position.
Operate the washer-disinfector
cycle.
On completion unload the washerdisinfector. Visually inspect each
device for remaining soil and
dryness. If soil remains repeat the
cleaning process including the precleaning stage. Remaining wetness
may be removed with medical grade
compressed air, clean and lintfree single use wipes (if required
supplemented by post-drying at a
clean place for up to 2 hours) or by
heating in an oven below 110°C.
Page 8
3. Cleaning
Inspection
Before preparing for sterilization, all
medical devices should be inspected.
Generally un-magnified visual inspection under good light conditions is
sufficient. All parts of the devices
should be checked for visible soil and/
or corrosion.
Particular attention should be paid to:
• Soil “traps” such as mating surfaces,
hinges, shafts of flexible reamers.
• Recessed features (holes, cannulations).
• Features where soil may be pressed
into contact with the device, e.g.
drill flutes adjacent to the cutting
tip, sides of teeth on broaches and
rasps.
• Cutting edges should be checked for
sharpness and damage.
• For devices that may be impacted
check that the device is not damaged to the extent that it malfunctions or that burrs have been
produced that could damage tissues
or surgical gloves. *
Functional checks should be performed where possible:
• Mating devices should be checked
for proper assembly.
• Medical devices with moving parts
should be operated to check correct
operation (medical grade lubricating oil suitable for steam sterilization can be applied as required).
• Rotating instruments (e.g. multiple
use drill bits, reamers) should be
checked for straightness (this can
be achieved by simply rolling the
instrument on a flat surface).
• “Flexible” instruments, e.g. IM reamers, should be checked for damage
to the spiral element.*
Note:
Stryker Osteosynthesis typically
does not specify the maximum
number of uses appropriate for
re-usable medical devices. The
useful life of these devices depends
on many factors including the
method and duration of each use,
and the handling between uses.
Careful inspection and functional test of the device before use is
the best method of determining
the end of serviceable life for
the medical device. However, for
certain instruments end of life has
been defined, verified and specified
with either a number of uses or an
expiration date. See Appendix 3 for
further details.
Packaging
Where appropriate the cleaned, disinfected, and checked medical devices
should be assembled into the dedicated
trays provided. Stryker Osteosynthesis
cases/trays should be double wrapped
according to AAMI/CSR technique.
The packaging for terminally sterilized
medical devices should fulfill the following requirements:
• EN ISO 11607
• Suitable for steam sterilization
(temperature resistance up to at
least 141 °C, sufficient steam permeability)
• Sufficient protection of the instruments as well as of the sterilization
packagings to mechanical damage
* See Appendix 3 for further inspection instructions.
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4. Sterilization
Caution:
Medical Devices containing thermolabile materials must not be
exposed to additional loads in the
autoclave.
Steam sterilization (moist heat) is
recommended.
An autoclave cycle has been validated
by Stryker as being capable of achieving
sterile medical devices; however autoclave design and performance can affect
the efficacy of the process. Healthcare
facilities should validate the process
that they use, employing the actual
equipment and operators that routinely
process the devices.
USA*
Method
Cycle
Temperature
Moist heat sterilization according to EN ISO 17665 and ANSI/
AAMI ST79
Pre-Vacuum (Pre-Vac)
270°F (132°C)
Exposure Time1
4 minutes
Pressure
2-15 PSIA
Drying Time2
30 minutes (minimum, in chamber)
Cool Time
60 minutes (minimum, at room temperature)
Outside USA*
Sterilization process
Steam autoclave (moist heat) sterilization using a pre-vacuum (forced
air removal) cycle is recommended.
Autoclaves should comply with the
requirements of, and be validated,
maintained and checked in accordance
with EN 285/EN 13060, EN ISO 17665,
and ANSI AAMI ST79.
Stryker has validated an autoclave cycle
for sterilization of complete medical
device cases/trays. Instruments shall be
sterilized in the mounting condition
as stored on the tray, i.e. if the brackets
or recessions in the tray are designed
to accommodate multi-component
instruments in their assembled state,
there is no need to disassemble these
instruments for sterilization. The process parameters shown on the right are
validated and recommended by Stryker
Osteosynthesis for sterilization:
Method
Cycle
Moist heat sterilization according to EN ISO 17665
Saturated steam with fractional forced air removal
Exposure Time1
4 minutes
Exposure time can be extended to 18 minutes to comply
with the recommendation from World Health Organization
(WHO), Robert Koch Institute (RKI) etc. Stryker Osteosynthesis medical devices are able to sustain such sterilization
cycles.
Temperature
132-137°C (270-277°F)
Drying Time2
recommended: 30 minutes (minimum, in chamber)
1
E xposure time:
Period for which the load and entire chamber is
maintained at the sterilization temperature
² D
rying time:
Period during which steam is removed from the
chamber and the chamber pressure is reduced to
permit the evaporation of condensate from the load
either by prolonged evacuation or by the injection
and extraction of hot air or other gases. The drying
time varies due to load configuration, wrapping
method and material. It is the hospital´s responsibility to validate the appropriate drying time with the
sterilization equipment used.
9
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4. Sterilization
Please note that according EN ISO
17665 the final responsibility for
validation of sterilization techniques
and equipment lies directly with the
hospital. To ensure optimal processing
all cycles and methods should be
validated for different sterilization
chambers, wrapping methods and/or
various load configurations.
* Caution:
These parameters are not applicable to the entire Stryker
Osteosynthesis portfolio. There
are exceptions for which other
validated sterilization cycles are
applicable. These are described in
the instructions for use and have
binding character. If a product is
supplied without a package insert
and if you are in doubt about the
applicable sterilization parameters
for a particular product, please
contact the manufacturer. Manufacturer addresses are provided in
section 7.
Alternative (e.g. UK, NL)*
Method
Moist heat sterilization according to EN ISO 17665
Cycle
Saturated steam with fractional forced air removal
Exposure Time1
3 minutes
Exposure time can be extended to 18 minutes to comply
with the recommendation from World Health Organization
(WHO), Robert Koch Institute (RKI) etc. Stryker Osteosynthesis medical devices are able to sustain such sterilization
cycles
Temperature
134°C-138°C (273°F-280°F)
Drying Time2
recommended: 30 minutes (minimum, in chamber)
1
E xposure time:
Period for which the load and entire chamber is
maintained at the sterilization temperature
² D
rying time:
Period during which steam is removed from the
chamber and the chamber pressure is reduced to
permit the evaporation of condensate from the load
either by prolonged evacuation or by the injection
and extraction of hot air or other gases. The drying
time varies due to load configuration, wrapping
method and material. It is the hospital´s responsibility to validate the appropriate drying time with the
sterilization equipment used.
10
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5. Storage before Use
After sterilization, please store the
medical devices in the sterilization
packagings in a dry and dust-free place.
The shelf life depends on the sterile
barrier employed, storage manner,
environmental and handling
conditions. A maximum shelf life for
sterilized medical devices before use
should be defined by each health care
facility.
6. R
eferences
(for some countries only)
1.
2.
3.
4.
EN ISO 11607 (ANSI AAMI ISO
11607): Packaging for terminally
sterilized medical devices (replaced
EN 868-1 and ISO 11607)
5.
EN ISO 17665 (ANSI AAMI ISO
17665): Sterilization of health care
products, moist heat (replaced EN
554 and ISO 11134)
ANSI/AAMI ST79: Comprehensive
guide to steam sterilization and
sterility assurance in health care
facilities
6.
World Health Organization
(WHO) and Robert Koch Institute
(RKI) recommendations regarding
exposure time:
WHO/CDS/CSR/APH/2000.3,
Annex III, section 2, 6.
RKI Communication in "Bundesgesundheitsblatt", April 2002,
45:376-394, table 11
Verbund für angewandte Hygiene
e.V. (VAH) DesinfektionsmittelListe, (VAH List of Disinfectants,
replaced the DGHM List of Disinfectants)
EN ISO 17664 (ANSI AAMI ST81):
Sterilization of medical devices Information to be provided by the
manufacturer for the processing of
resterilizable medical devices
Internal validation reports, not for
public use
7.
Stryker cleaning / decontamination
validation study; Summary report,
H. Davis, November 2001
8.
Stryker steam sterilization validation study; Summary report, H.
Davis, September 2001
9.
Stryker Trauma GmbH validation
report VAL P0011, VAL P0014
10. Stryker Orthopaedics Technical
Report T-878
11. Stryker Osteosynthesis Ti2078-09
12. Stryker Osteosynthesis Ti2381-09
7. M
anufacturers of Stryker Osteosynthesis
Medical Devices
Stryker Trauma GmbH
Stryker Trauma AG
Stryker Leibinger GmbH & Co KG
Prof.-Küntscher-Str. 1 - 5
Bohnackerweg 1
Boetzinger Str. 41
D-24232 Schönkirchen CH-2545 Selzach D-79111 Freiburg
Germany Switzerland Germany
phone: +49-4348-702 0 phone: +41-32-641 6666 phone: +49-761-4512 0
fax:
+49-4348-702 172
fax:
+41-32-641 6660
fax:
+49-761-4512 120
11
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Appendix 1
Cleaning agents and disinfectants used during validation of
the processing instructions
For cleaning and/or disinfection of
medical devices manufactured from
aluminium alloys a pH neutral agent
should be used*. Contact with strong
alkaline detergents or solutions containing iodine or chlorine should be
avoided, since the aluminium can be
chemically attacked and the instrument
may be damaged.
For automatic (washer-disinfector)
cleaning mild alkaline agents (up to pH
10.9) should be preferred, however use
only agents recommended for use in
these machines.
In all cases
• follow the indications, instructions
and warnings provided by the
supplier of the cleaning agent and/
or disinfectant,
• select only detergents intended for
cleaning and/or disinfection of
medical devices made of metals and
plastics, and
• select only disinfectants with approved efficiency (VAH/DGHM or
FDA approval or CE mark).
Ensure that the substances listed below
are not ingredients of the cleaning or
disinfection detergent chosen:
• organic, mineral, and oxidizing
acids (minimum admitted
pH-value 5.5)
• strong lye (maximum admitted pHvalue 10.9*)
• organic solvents (for example:
acetone, ether, alcohol, benzine)
• oxidizing agents (for example: peroxides, hypochloride)
• halogens (chlorine, iodine,
bromine)
• aromated, halogenated hydrocarbons.
Notes:
• The cleaning agents listed below
were used by Stryker Osteosynthesis when validating the instructions for processing provided in
this document.
• Stryker Osteosynthesis does not
recommend these products in
preference to others that are available. Other products may perform
equally in conjunction with the
equipment being used.
• The instructions provided by the
supplier of the detergents should
be followed.
• Personal protection for operators
should be provided in accordance
with the supplier´s instructions
and safety data sheets
Suitability of alternative agents
should be checked by reference to
the supplier’s information and/or
physical testing.
•
Agents for pre-cleaning and manual cleaning (used for validation)
Supplier
Designation
Comment
Johnson and Johnson Cidezyme/Enzol
Suitable for aluminium
instruments
Agents for manual disinfection (used for validation)
Supplier
Designation
Comment
Johnson and Johnson
Cidex OPA
Suitable for aluminium
instruments
Agents for automatic cleaning/disinfection in a washer
disinfector (used for validation)
Supplier
Designation
Comment
Dr. Weigert
neodisher Mediclean
forte
Not recommended for aluminium medical devices*
* In case of aluminium instruments neutral/enzymatic
detergents are recommended
(for example Neodisher Medizym)
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Appendix 2
Generic product groups defined for cleaning validation
For cleaning and sterilization validations, Stryker Osteosynthesis typically
applies a "worst case" approach, i.e. the
most challenging products are selected as representative test samples. For
the cleaning validation we defined the
following generic product groups:
Group I
One piece instruments
Group II
Instruments for bone cutting, piercing
or scraping
Group I – One piece instrument
Article number Description
Report
1806-2035
PHN Target Device
TI2078/09
62-51217
Drill Guide
TI2078/09
1806-0170
Hammer
TI2078/09
12-30180
Bi-polar Forceps, Bayonet
TI2078/09
-
PPSU Templates
TI1737/07
-
VariAx Trials
TI2347/09 and
TI2346/09
56-10X10
VariAx DR Aiming Block
TI2881/11
1806-1001
T2 Tibia Targeting Arm
171111CG2
Group III
Cannulated instruments
Group IV
Multi-component instruments
Group II – Instruments for bone cutting, piercing or scraping
Article number Description
Report
702807
Tap dia 6.5 × 180mm
TI2078/09
08-01020
Nasal Rasp, fine / very fine
TI2078/09
Group VI
1806-3026
Stepdrill
TI2078/09
Storage trays
0226-4200
Bixcut IM Reamer Head with Dovetail,
dia 20
TI2078/09
Group V
Flexible instruments
Group VII
Implants
With these product groups Stryker Osteosynthesis is covering the
division's entire portfolio and the processing instructions can be presented in
a generic form. Specific instructions for
each product would not give the health
care professional or sterilization facility
any additional benefit.
The representative products listed
below were used in the validation.
Group III – Cannulated Instruments
Article number Description
Report
12-04239
Suction Tube, extra long
TI2078/09
01-19510
Mandibular Channel Retractor,
Bremerich
TI2078/09
1806-3065
5mm, Spreading Screwdriver
TI2078/09
1320-0190
Gamma3 Stepdrill
TI2078/09
45-20001
Cannulated Screwdriver 2.0mm,
AO coupling
TI1448/07
45-20006
Cannulated Tap 2.0mm, AO coupling
TI1448/07
13
Page 14
Appendix 2
Group IV – Multi-component instruments
Article number
Description
Report
4920-1-010
Hoffmann II Rod to Rod Coupling
TI2078/09
4960-3-000
Hoffmann II Micro Lengthener Assembly
TI2078/09
702428
Elastosil Handle, small
TI2078/09, BML 08037
703566
AxSOS Tibia Targeting Arm
TI2078/09
4936-9-010
Tenxor Wire Tensioner
TI2078/09, BML 08037
0730400
Reposition Clamp
TI2078/09
62-20125
Plate Cutting Pliers
TI2078/09
5057-6-300
Pin Cutter
TI2078/09
62-20295
Screwdriver Handle, revolving, rigid
TI2078/09
702628
Elastosil T-Handle
TI2078/09
6514-7-102
Luhr-Fritzemeier
TI1728/07
0193-3600
Large Locking Forceps
BSL Bioservice 084292 + 084293
704050
Omega3 TSP Aiming Block
BML08-041
702778
AxSOS Handle
BML08-216
13-19410
Scissors straight
TI2451/10
62-00082/ 62-00081
Activation Rod (MID II)
TI2262
62-50101
Quick Drive Mini
TI2076/09
1320-5340/-50, -60
Gamma3 DTS Adjusting Device
240608CB9
69-1022074
T2 Guide Wire Pusher
SMP Report no 00810011401
SK1-913-07
One-Piece Target Sleeve
SMP Report no 04808011403
SK1-08-776
T2 Guide Wire Ruler
SMP Report no 16308012611
SK1-08-989
Gamma3 U-Blade Extractor
SMP Report no 18108012612
62-00400
Universal Check Retractor with Light Source
TI2767/11
62-00412
Universal Mandible Fracture Plate Holding Foreceps
TI2767/11
62-00400
Universal Trocar Handle
TI2925/11
56-01210
VariAx DR Aiming Block Fixation Pin
TI2881/11
56-01310
VariAx DR Aimimng Block Joystick
TI2881/11
4933-0-1XX
Hoffmann LRF Telescopic Strut
BML11-234
Group V – Flexible Instruments
Article number
Description
Report
1150-0300
Reamer Shaft
TI2078/09
0227-8510
Flexible Reamer Shaft, 8mm
TI2078/09
1806-0073
Teflon Tube
TI2078/09
1320-0233
Gamma3 Flexible Screwdriver
MDS Test Report 081727-10-A and B,
Test Report 230408CG1
14
Page 15
Appendix 2
Group VI – Storage trays
Article number
Description
Report
29-32400
Asnis Micro Tray
TI2078/09
29-13009
VariAx Hand level 4 container
TI2078/09
901585, 901587, 901584, 901588
Asnis III, 6.5 & 8.0 trays
TI2078/09
902913
AxSOS Targeting 5.0mm instrument tray
TI2078/09
-
Inlays VariAx Hand
SMP report no. 09606011411
-
Screw Racks
TI1504/07
-
Inlays VariAx Foot
TI1504/07
29-30015
Silicone Mat
TI2042/09
902855
MMT VariAx Elbow EPS
150408CG1
902845
MMT AxSOS Targeting Proximal Lateral Tibia
210307CG3
902846
MMT AxSOS Targeting 4.0mm Instruments
210307CG3
1768F955
Asnis Micro Screw Rack
TI1424/07
1320-9550/ -60
Gamma3 DTS Tray R1.5/ R2.0
240608CB7
29-13125
VariAx DR Aiming Block Tray Insert
TI2881/11
29-27005
VariAx DR Implant Module
TI3114/11 (automated)
29-27005
VariAx DR Implant Module
TI3186/11 (manual)
29-15332
Neuro 3 Instrument Inlay
TI3117/11
26-15336
Neuro 3 Screw Disc Inlay
TI3117/11
29-15954
Neuro Screw Disc
TI3117/11
Article number
Description
Report
1732-1248 (S)
S2 Femoral Nail A/R,
dia 12 × 480mm
TI2381/09
1832-3830 (S)
T2 Proximal Humerus Nail, long,
dia 8 × 300mm
TI2381/09
1859-5120 (S)
Condyle Screw, dia 5 × 120mm
TI2381/09
436008
AxSOS Distal Radius Plate 3.0
TI2381/09
SHBIP9TS
Numelock II 4.5 Distal Medial
Humerus Plate
TI2381/09
326780
Asnis III 8.0 / 180mm, St
TI2381/09
40-20230
Asnis Micro 2.0mm Cannulated Screw, length 30mm
TI2381/09
5425393
VariAx Distal Radius Universal Volar DR Plate, wide, extra
long
TI2381/09
92-15904
Screw 1.5 × 4mm, self drilling (Neuro)
TI2381/09
50-20362
MMF Screw, self drilling 2.0 × 12mm
TI2381/09
55-10580
Locking Osteotomy Plate
TI2381/09
55-28934
Full Secondary Recon Plate
TI2381/09
55-28100
Condyle Prosthesis
TI2381/09
92-00647
Pre-bent Mesh for 1.7 / 1.9mm Screws
TI2381/09
629164, 629088
VariAx Elbow Plates
BML09-424
62-00435, 62-00420
MID Distractor
TI2262
340638
Cortex Screw S.T: 4.5 × 38mm
BML08-144
Group VII – Implants
This list will be updated periodically.
15
Page 16
Appendix 3
Guidelines to check proper functionality of the
medical devices
The following guidelines should be
applied to all Stryker Osteosynthesis
instruments which are labeled for
multiple use. All functional checks and
inspections described below also cover
the interfaces with other instruments
or components.
The failure modes below may be caused
by end of life of the product, improper
use or improper maintenance.
Functional check for multiple
use Drill Bits
Stryker Osteosynthesis does not typically specify the maximum number of
uses for re-usable medical devices. The
useful life of these devices depends on
many factors including the method and
duration of each use, and the handling
between uses. Careful inspection and
functional test of the device before use
is the best method of determining the
end of serviceable life for the medical
device. However, for certain instruments end of life has been defined,
verified and specified with either a
number of uses or an expiration date.
Coupling end eroded
Description and Function:
Multiple use drill bits, cannulated drill
bits, burrs, taps, core drills
Potential Failure Modes:
• Defective coupling end (eroded)
• Blunt and dull cutting flutes
• Tips, helix coil, bent
Preventive Maintenance:
Such instruments are recommended as
single patient use.
Regular functional check and visual
inspection. In case of failure, the
instrument must be replaced and not
be used.
Blunt / dull tip
Please check at tip of drill (see mark)
Dents on cutting flutes
16
Page 17
Appendix 3
Drill Bit: Overview
Drill bit: twisted
Drill bit: blunt / dull cutting flutes
Drill bit:
helix coil - the cutting flutes change
direction
Drill bit: blunt / dull cutting flutes and
helix
17
Page 18
Appendix 3
Functional Check for Reamers
Description and Function:
Intramedullary reamer, reamer heads,
reamer shaft
Reamer shaft: deformed
Potential Failure Modes:
• Defective coupling end
• Blunt and dull cutting flutes
• Tips, helix coil of reamer shaft
deformed
Preventive Maintenance:
Regular functional check and visual
inspection. In case of failure, the instrument must be replaced and not be used.
If soil is not removed from shafts right
after use, incrustation is likely to occur
which will be baked permanently in
subsequent sterilizations.
Reamer bit: blunt / dull cutting flutes
Chunking in cutting flutes
Blunt / dull cutting flutes and tip
18
Page 19
Appendix 3
Functional Check for Screwdriver Blades
Description and Function:
Screwdrivers with drive connections of
various designs with or without selfretaining function.
Hexagon drive connection: fractured
Potential Failure Modes:
• Deformation of the blade (twisted)
• Deformation of the blade
(rounded)
• Breakage of the blade´s self-retaining mechanism without function
• Corresponding drive connection
of screw head is rounded or worn.
Hexagon drive connection: deformed
Preventive Maintenance:
Use an appropriate instrument spray
for the mechanism of the self-retaining
screwdrivers. Regular functional check
and visual inspection. Replace and do
not use in case of failure. Regular functional check of corresponding items
(screwdrivers - screws).
Hexagon drive connection: rounded
19
Page 20
Appendix 3
Hexagon drive connection: deformed
Hexagon drive connection: deformed
Gamma Lag Screwdriver: deformed/
broken off pegs
20
Page 21
Appendix 3
Connection rod of Gamma Lag Screw
Driver: damaged and squeezed thread
As above
As above
Functional Check for Torque Limiters
Description and Function:
Includes all torque limiting or indicating devices with or without a releasing
mechanism.
Potential Failure Modes:
• Malfunction due to wear
• Corrosion or contamination
Preventive Maintenance:
Use an appropriate instrument spray
for the mechanism of the self-retaining
screwdrivers. Frequent control of
torque accuracy with torque tester,
if indicated regular functional and
visual inspection. In case of failure, the
instrument must be replaced and not
be used.
21
Page 22
Appendix 3
Functional Check for Bending Instruments
Description and Function:
Instruments used for bending implants
Potential Failure Modes:
• Corrosion between adjacent surfaces
• Corrosion between pairings of
different metals
• Corrosion on frequently used
functional surfaces
• Corrosion on the laser engraving
• Bent or damaged edges imply a
risk of damaging the implant,
especially in functional area
Preventive Maintenance:
Regular functional check and visual
inspection. Use an appropriate instrument spray for the mechanism of all
moving parts and articulating surfaces.
Check and if necessary eliminate all
gaps for residuals and moisture after
usage or cleaning. In case of failure, the
instrument must be replaced and not
be used.
Bending Forceps with surface corrosion
at cutting device and in the gap between the two parts of the forceps.
22
Slight corrosion at the laser engraving
Page 23
Appendix 3
Functional Check for Scissors and Cutting Instruments
Description and Function:
All instrument which are used to cut
tissue and bone material (like scissors
or osteotomes) and also all instruments
which are used to cut implants (like
cutters)
Potential Failure Modes:
• Cutting edge is damaged, cutting
function is no longer fully given
• Spring is damaged, articulation
does not work properly
Tip of a scissors
Damaged tip of a pair of scissors - cutting function could be restricted
Preventive Maintenance:
Use an appropriate instrument spray
for the mechanism of all moving parts
and articulating surfaces.
Handle the instruments with care.
The cutting edge of the instrument
should be inspected prior to clinical
use. The cutting function could be
restricted if the cutting edge or the tip
of the instrument is damaged.
Stryker recommends the use of
silicone-free, non-mineral oil based
lubricant for the maintenance of
articulated instruments. In case
of failure, the instrument must be
replaced and not be used.
Damaged cutting edge cutting function could be restricted
In situ cutter
Damaged spring articulation function restricted
23
Page 24
Appendix 3
Functional Check for Targeting Devices
Description and Function:
Target Devices to aim at the locking
holes of implants (nails, plates)
Potential Failure Modes:
• Marks caused by hitting on the
device
• Cracks in the polymer
• Damage of threads
• Deformation of nail adapter
• Displacement of connection pin
Marks on the metal part of the device
Preventive Maintenance:
Use an appropriate instrument spray
for the mechanism of all moving parts
and articulating surfaces. Handle with
care. Do not hit on Target Devices. In
case of failure, the instrument must be
replaced and not be used.
Hit marks on functional surface
Crack
24
Crack in the polymer
Page 25
Appendix 3
Deformation of nail adapter
Damaged threads
Connection pin displaced (should be
flush with surface)
25