Instrument Kit Cleaning and Sterilisation Instructions for Use

From a functional perspective, an inspection must be carried out prior to use to check for any burrs or debris that could damage tissue or personal protective equipment. Furthermore, the integrity of cutting tools and rotating tools must be verified. Any device deemed to be dull or non-functional in any manner should be returned to Tornier for maintenance or exchange. 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.

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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 polymer 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. While Tornier performs routine inspections on instrument sets when receiving and distributing, the lifetime of non-sterile instruments is dependent upon a number of factors including, but not limited to, method and duration of use and handling of instruments between uses. Consequently, Tornier does not claim a maximum number of uses, but recommends thorough functional inspection, as previously cited, to verify the absence of wear/damage and to be sure of their efficacy.

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. POINT-OF-USE PROCESSING Point-of-use processing aims 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 point-of-use processing or be immediately treated in a washer-disinfector. Point-of-use processing is achieved by dipping instruments, for a minimum of 15 minutes, in a neutral or alkaline solution that does not contain aldehyde nor ethanol. The use of soft-bristled brushes is authorized to clean the parts from all soils that can potentially alter the action of detergents and decontaminants. Devices that are able to be disassembled should be disassembled prior to point-of-use processing. Additionally, devices with movable components that do not facilitate disassembly should be manually articulated during the point-of-use processing step in order to evacuate additional soils. The instruments should then be carefully rinsed in a controlled water to avoid interference between the 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 assembly/disassembly instructions are provided. 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 detergent equivalent to those listed in the next table. Refer to the manufacturers’ labeling for instructions on how to use the washer-disinfector. 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 or 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. After cleaning, please inspect devices to ensure they are visually clean. If not, repeat the cleaning process until devices are visually clean. 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. For Europe only: In the case of patients with suspected or confirmed TSE, the cleaning procedure for the washerdisinfector shall be done after a decontamination process conform to the instruction DGS/RI3/2011/449.

Immersion Time (min) MEDICLEAN, MEDICLEAN 15 FORTE, or ALKAZYME 0.5%

Rinsing 1

Rinsing 2

T°C

Water

Water

Ambient

Tap water 30s to 1’ in ambient temperature

Solution

1. Pre-disinfection/ Decontamination 2. Manual precleaning on ultrasonic bath

MEDICLEAN FORTE 2%

5

2030°C

Tap water 30s to 1’ in ambient temperature

3. Automatic cleaning process

MEDICLEAN or MEDICLEAN FORTE 0.6%

10

93°C

Purified or Deionized water in ambient temperature

Purified water 30s to 1’ in ambient temperature yes

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.In the USA, a FDA cleared wrap for sterilization should be used. 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 pre-disinfection and cleaning if assembly/disassembly instructions are provided with the product check-list. 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. Instruments, packaging trays and baskets may be sterilized in their container. The heaviest containers must be placed at the bottom of the autoclave. Instrument trays must not be stacked together during sterilization. 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 one of the 3 following method: (tables 1, 2, 3). Table 1*

Pre-vacuum method

T°C

132°C (269.6°F)

Time

4 min

Drying

20 min

Wrapped

yes

*Sterilization parameters recommended in North America Table 2

Pre-vacuum method

T°C

134°C (273.2°F)

Time

18 min

Drying

20 min

Wrapped

yes

Table 3**

Pre-vacuum method

T°C

134°C (273.2°F)

Time

3 min

Drying

20 min

Wrapped

yes

**Sterilization parameters recommended in the UK GLOBAL-FORM-0153 Rev. A

Drying

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3.5 AFTER USE:

REFERENCE DOCUMENTS

After each use and before returning to Tornier, the instrumentation (entire box or isolated instrument) must be point-ofuse processed, 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). LIFETIME OF DEVICE The end of life for each device is determined when the device’s characteristics or performance indicate that the health or safety of the patient or user may be compromised. The device’s lifetime depends on many factors, including but not limited to, method and duration of use and level of reprocessing. Hence Tornier does not define the maximum number of uses. Careful inspection and functional testing should be completed. Examine the cutting edges, flutes, tip, shaft, handle, and features of the working end, as applicable, for dulling, chipping, warping, cracking, or other indications of material degradation or compromised structural integrity. If the device displays any of these signs of wear or other indications of malfunction, it is recommended to discontinue use and replace the device. Per the surgical technique, actuate moving parts and assemble mating devices to test for sticking or obstruction. If moving or mating parts display limited functionality, replace the device(s). During the surgery, devices may experience a variety of forces which cannot be fully anticipated. Even with proper reprocessing, maintenance, and inspection, devices may reach the end of their lifetime during surgery. A replacement or alternative should be available to the surgeon.

4. CLOSED CONTAINER CLEANING AND STERILIZATION INSTRUCTIONS

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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).

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Good Pharmaceutical Practice – 22 June 2001 French regulation. FD S 98-135 : April 2005 – Guide for the sterilisation of medical devices – Treatments applied to reusable medical devices.

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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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“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. “Health Technical Memorandum 2010” – Part 2: design considerations – Sterilization – London: HMSO – NHS Estates

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NF EN ISO 17665-1: November 2006: Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices

Closed container validation has been completed with Aesculap Steril Container System. Ensure that the sterilization container is in proper working order prior to sterilization. The care and handling of these containers can be found at

www.aesculapusa.comifu. NOTE: THE STERILIZATION PARAMETERS WITHIN THE AESCULAP STERIL CONTAINER INSTRUCTIONS-FORUSE DO NOT SUPERSEDE THE STERILIZATION PARAMETERS OUTLINED BELOW. Only FDA cleared Aesculap Steril Containers, excluding JK744, are to be used. (e.g. Lid JK489, Base JK444, Filter US994 or Lid JK789, Base JK742, Filter US994) Table 4*** Pre-vacuum method T°C

132°C (270°F)

Time

4 min

Drying

15 min

Wrapped

No

***Sterilization parameters recommended for Aesuclap Steril Container in U.S. Only

5. SINGLE USE INSTRUMENT DELIVERED STERILE 5.1. 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 cross-contamination or a risk of reduced performances.

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Never re-sterilize an instrument designated for single-use.

5.2. 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.

5.3. 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.

GLOBAL-FORM-0153 Rev. A

Published Feb-21

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