Medtronic ML-0714 Instructions for Use

CONTROLLED

Type:

Training Document

Title:

Reprocessing Instructions for Titan Devices

Document No. 70-0015

Revision No. 16

DCR No. 5520

Proprietary and confidential property of Medtronic

Page 1 of 12

Manufacturer: Titan Spine a division of
Medtronic

Method: Manual and Automated Cleaning with Steam Sterilization
Devices: All Titan devices provided non-sterile.

This document contains instructions for cleaning, disinfection, and sterilization of Titan product provided non-sterile,
including implants, instruments, caddies and trays. Reusable instruments may enter normally sterile parts of the human
body and are considered critical items. The cleaning and sterilization methods described below have been validated for
use at an accredited laboratory per standards ANSI/AAMI TIR12, ANSI/AAMI TIR30, and ISO 17665-1. Cleaning and
sterilization validations are summarized in the Additional Information section of this document. Any deviation from the
suggested reprocessing methods should be evaluated for effectiveness using an approved method or standard and
must be validated by the end user. Hospital approved methods should be followed when handling implants or
instruments contaminated with blood, tissue, and/or bodily fluid. Proper personal protection equipment (PPE) per
hospital procedures must be donned when handling product. Only trained personnel shall conduct reprocessing tasks.
Any Titan product that appears to be damaged or corroded should not be used and a Medtronic representative should
be notified immediately in order that product may be returned; damaged product should be reprocessed prior to
shipment. Aesculap® SterilContainersTM should be reprocessed according to the manufacturer’s specifications.

WARNINGS

• The World Health Organization (WHO) recommends special CJD (Creutzfeldt - Jakob disease)
inactivation processing procedures. Consult a WHO representative for further information, if you
have reason to believe a device has been contaminated.

• Instrument surfaces can be damaged by improper handling; handle with care.

• Take care while handling sharp instruments to avoid injury.

• Abrasive cleaners or cleaning tools, such as steel wool, are to be avoided.

• Improper concentrations of cleaning agents can damage stainless steel, titanium and aluminum

device’s protective surface leading to corrosion, discoloration, unrecognizable markings and other
surface conditions. When using such products, be sure to follow manufacture recommended
concentration, exposure time, temperature and material compatibility. Detergents with a pH
between 7 and 9.5 are recommended. Certain plastics may become brittle or discolored due to
excessive reprocessing. Follow manufacture recommended instructions when using disinfection
units, cleaning agents and all other mechanical cleaning devices.

• Do not exceed 137°C (279°F) during reprocessing steps.

• Note: The cleaning and disinfecting equipment should comply with the requirements of ISO 15883.

Follow special instructions of the manufacturer for the automated washing device. Devices must
be sterilized in a properly functioning, calibrated steam sterilizer.

Limitations on
Reprocessing

Repeated reprocessing of medical devices has minimal effect on the devices. The end of life of Titan
devices will be determined through inspection processes of each implant, instrument, caddy and tray
after reprocessing. All devices are to be examined for functional integrity, corrosion and damage
(proper assembly, scratches and dents, material residue, discoloration, impurities, etc.). Damaged
devices, those with unrecognizable markings, signs of corrosion or dull edges should not be used
and must be properly cleaned and sterilized before notifying a Medtronic representative and returning
the product to Medtronic.

Reprocessing Instructions

The instructions provided have been validated by the manufacturer of the medical device as being capable of preparing
a medical device for reuse. It remains the responsibility of the processor to ensure that the processing, as actually
performed using equipment, materials and personnel in the processing facility, achieves the desired result. This
requires verification and/or validation and routine monitoring of the process.

Initial
treatment at
the point of
use

Instruments should be wiped clean of gross soil and kept moist to prevent drying before transferring
instruments to the central processing department. Do not place used instruments back into the tray
before cleaning. Transport used instruments in a closed puncture-proof container to the reprocessing
area to avoid potential environmental contamination. Fragile instruments may be transported in a
separate container to avoid damaging the instruments. Clean instruments as soon as possible after
use. Adequate cleaning must be carried out prior to sterilization.

CONTROLLED

Type:

Training Document

Title:

Reprocessing Instructions for Titan Devices

Document No. 70-0015

Revision No. 16

DCR No. 5520

Proprietary and confidential property of Medtronic

Page 2 of 12

Preparation
before
cleaning

The general instructions for cleaning and decontamination described in this document shall be used
for all Titan devices provided non-sterile, except those listed below. The cleaning instructions for
products listed below will be described in sections that follow, as identified by their product
information. Note: Aesculap® SterilContainersTM should be reprocessed according to the
manufacturer’s specifications.

• Endoskeleton™ TCS Torque Limiting Handle, P/N 5210-1046

• Endoskeleton™ TCS 3/16 Square, Torque Driver, P/N 5210-1076

Every implant or instrument, regardless if it has been soiled, should be processed using the following
recommendations. Remove devices form trays and caddies for cleaning. Open instrument teeth,
locks, thread locks and hinges. Multi-component instruments should be disassembled in the
reprocessing area prior to cleaning. If disassembly is required, instructions are as indicated in product
specific instructions or as described in the Additional Information section.

Sort out sharp instruments to avoid injury and use caution during manual cleaning of sharp or pointed
instruments. Carefully clean long, narrow, blind holes and inner lumen of instruments. For heavily
soiled instruments, soak, flush, rinse with cool water and wipe with cloth to prevent soil from drying, as
needed.

Cleaning:
Manual

A neutral cleaner with pH 7 – 9.5 is recommended; cleaner with a pH greater than 11 should be used
only on compatible materials according to its respective data sheet. Follow manufacturer instructions
to achieve the correct dilution, temperature, and contact time and water quality of the detergent.
Implants, instruments and cases should be cleaned in a fresh, newly prepared solution. Avoid
overloading the ultrasonic wash basket.

Manually clean and process devices using the following parameters.

Phase

Cleaning instruction

Minimum

Duration of Time

(if applicable)

Water Type and

Temperature

(if applicable)

Pre-wash

Immerse disassembled device in cold water for 5
minutes. Do not use a fixating agent or hot water as this
can cause fixation of residue.

5 minutes

Cold water

Brush device with a soft bristled nylon brush. Continue
until all visible residues are removed. Carefully clean
long, narrow, blind holes and brush inner lumen of
instruments with a suitable bottle brush. Actuate all
movable and hinged parts and clean area with a brush.

N/A

Cold water

Ultrasonic

Place device in an ultrasonic bath with a clean, freshly
prepared solution of warm (40°C), demineralized water
(DI/PURW) and cleaning product(s)* for 5 minutes.

5 minutes

Warm DI/PURW

water (40°C)

Rinse

Rinse the device thoroughly, covering all geometry with
demineralized (DI/PURW) water for 15 seconds, using a
water jet pistol for small gaps and slits as necessary.

15 seconds

DI/PURW water

Drying

Dry device with a clean, soft, lint-free cloth and/or purified
air.

N/A

N/A

*Follow the detergent manufacturer’s recommendations for the correct dilution, temperature, contact
time and water quality for the detergent. A summary of the cleaning validation is included in the
Additional Information section.

CONTROLLED

Type:

Training Document

Title:

Reprocessing Instructions for Titan Devices

Document No. 70-0015

Revision No. 16

DCR No. 5520

Proprietary and confidential property of Medtronic

Page 3 of 12

Reprocessing Instructions for Endoskeleton™ TCS Torque Limiting Handles (P/N 5210-1046):

The recommended cleaning parameters for P/N 5210-1046 are detailed below. All torque drivers (P/N
5210-1046) are shipped in a non-sterile condition and must be cleaned and sterilized prior to use.
Torque drivers must not be disassembled for any reason. Consult the manufacturer’s specifications
for detailed instructions.

• Immediately after use, this device should be presoaked in an enzymatic detergent bath safe

for medical devices for five (5) minutes. The time and temperature of this soak should follow
the manufacturer’s instruction.

• Scrub the submerged device(s) with a soft bristle brush. Agitate the device while scrubbing.

Actuate moving parts. Use a small cytology brush to clean internal channels.

• Clean the cannulated devices using a small brush through the cannulation.

• Ultrasonically clean the instrument(s) for ten (10) minutes in a neutral pH detergent (or

acceptable alternative).

• Prepare the detergent according to the manufacturer’s recommendation.

• After presoak, the device must be rinsed in demineralized water.

Cleaning (Manual):

• Use a cleaning brush to remove any remaining soil or debris, paying special attention to small
grooves, crevices, and cannulation.

• Rinse thoroughly with warm (38-49˚ C (100-120˚F)) demineralized water. Agitate the device
for at least three (3) minutes.

• Check this device for any visible soil and repeat the cleaning process if soil is found. (A longer
presoak may be necessary.)

• Allow water to run through device. If the water leaving the device appears to be soiled, repeat
the cleaning procedure.

• Dry the exterior of the device(s) with a clean, lint-free cloth.

• DO NOT use any abrasive detergents, brushes, or cleaning pads. All brushes used should be

designed for use on medical devices.

Cleaning (Automated):

• An automatic cleaning device such as an ultrasonic cleaner is always preferred over manual
cleaning when available.

• Run the Automatic wash cycle with temperatures of 40°C and ultrasonic waves of 35 kHz for
10 minutes. These times and temperatures will vary depending on the equipment and
detergent used.

• Following cleaning, thoroughly rinse the devices with warm (38-49˚ C (100-120˚F))
demineralized water for at least one (1) minute.

• Allow water to run through device. If the water leaving the device appears to be soiled, repeat
the cleaning procedure.

• Dry the exterior of the device(s) with a clean, lint-free cloth.

• Only use an automatic cleaner that has been properly maintained and cleaned.

Steam Sterilization:
After a steam sterilization cycle the device must be allowed to cool for a minimum of 40 minutes in
(stagnant) open air or 30 minutes under forced air prior to being used. Failure to allow for proper
cooling can adversely affect torque performance.

Reprocessing Instructions for Endoskeleton™ TCS 3/16 Square, Torque Driver (P/N 5210-1076):

The recommended cleaning parameters for P/N 5210-1076 are detailed below. All torque drivers (P/N
5210-1076) are shipped in a non-sterile condition and must be cleaned and sterilized prior to use.
Torque-Limiting Drivers and Handles are not designed for disassembly before cleaning. To avoid
damage (pitting, rusting), avoid highly aggressive agents (NaOH, NaOCL), and salt solutions.
Surgical instruments should only be used and reprocessed by qualified healthcare practitioners.
Consult the manufacturer’s specifications for detailed instructions.

CONTROLLED

Type:

Training Document

Title:

Reprocessing Instructions for Titan Devices

Document No. 70-0015

Revision No. 16

DCR No. 5520

Proprietary and confidential property of Medtronic

Page 4 of 12

Point of Use:

1. Wipe instruments to remove visible soil.

2. Keep instruments moist, preferably submerged in cold water (<40°C) immediately after use.

Manual Cleaning:

1. Submerge instruments in a pH neutral enzymatic cleaning agent or detergent (pH <8.5)
solution for 10 to 15 minutes. Do not use aldehyde fixating detergents because they can
cross-link the protein residues, making it difficult to remove soiling. Follow detergent
manufacturer's instructions for mixing ratios and temperature.

2. Use a soft bristle brush if needed to remove visible soil from surfaces. Give special attention
to uneven surfaces (such as knurled handles) and drilled holes/cannulation. Use flexible bottle
brush, syringes, or aspiration for hard to reach places such as cannulation.

3. Thoroughly rinse with de-ionized or sterile, purified water, (<40°C), until it is no longer slippery
to the touch, for a minimum of 2 minutes. Use a syringe to apply rinsing solution under
pressure to hard to reach areas such as cannulations and drilled holes.

4. Visually inspect instruments for remaining debris, paying special attention to hard to reach
areas. Repeat rinsing steps if needed until no visible soiling remains.

5. Drain instruments on single-use drying paper or lint-free towel.

Ultrasonic Cleaning:

1. Submerge instrument in ultrasonic bath with pH neutral enzymatic cleaning agent or
detergent, (pH <8.5), solution. Follow detergent manufacturer's instructions for mixing ratios
and temperature.

2. Soak at 25 to 45 kHz for 10 to 15 minutes. Visually ensure complete immersion of
instruments.

3. Thoroughly rinse with de-ionized or sterile, purified water, (<40°C), until it is no longer slippery
to the touch, for a minimum of 2 minutes. Use a syringe to apply rinsing solution under
pressure to hard to reach areas such as cannulations and drilled holes.

4. Visually inspect instruments for remaining debris, paying special attention to hard to reach
areas. Repeat rinsing steps if needed until no visible soiling remains.

5. Drain instruments on single-use blotting paper.

Dry & Inspect Instruments:

1. Thoroughly dry instruments with a soft, lint-free cloth, with single-use drying paper, or with
medical grade, filtered, compressed air. Hard to reach areas such as drilled holes and
cannulations should be dried with medical compressed air.

2. Visually inspect instruments before sterilization. This is typically done under normal lighting
and without magnification.

3. Visually inspect for soiling, corrosion, cracks, and damage to components.

4. Functionally inspect adapters (if equipped) to ensure they connect onto mating shafts. Check
function of ratcheting screwdrivers in both directions, (forward and reverse).

5. Notify appropriate personnel regarding damage and malfunctioning components.

Sterilization:

1. Sterilization testing has been performed in accordance with ISO 17665-1:2006 Sterilization of
Health Care Products – Moist Heat – Part 1 a. Gravity: 250°F, 30 min exposure, 45 min dry
time.

2. After dry time allow a minimum of ten minutes for equilibration period to allow instrument to
cool to room temperature.

Cleaning:
Automated

Instruments and trays should be washed separately. A wire basket provided by the mechanical
washer manufacturer may be used to hold loose instruments and component devices. All design
features must be accessible for cleaning and positioned to assist with drainage where liquid may
settle. For example, cannulations and blind holes should be inclined downwards and hinges should be
open to assist with drainage. Avoid overloading the wire baskets and washer. Process the devices
using the following parameters.