Surgical Instruments Sterilisation Reprocessing Guide

Symbols used in this guide Note Important information or advice. Caution (no harm) Special care to be taken to ensure safety and effectiveness. Could cause damage to equipment. Warning (harmful) Potential safety hazards and serious adverse reactions. Could cause harm to person.

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Contents Symbols used in this guide... 1 Introduction...3 Warnings... 5 Limitations on reprocessing... 5 Cautions...6 Instrument material compatibility...6 Reprocessing instructions... 7 Point of use... 7 Containment and transportation... 7 Preparation for cleaning...8 Cleaning and disinfecting...8 Drying...11 Maintenance...11 Inspection and function testing...11 Packaging... 13 Sterilisation... 13 Storage... 14 Symbols... 15 Appendix 1 – Validation information...18 Test items...18 Automated cleaning...18 Thermal disinfection... 21 Steam sterilisation... 21 Drying...23 Repeat reprocessing...23 Standards...23

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Introduction This guide is intended for staff involved in sterilisation reprocessing of the metal surgical instruments listed here: • Cochlear ™ Nucleus® BTE Template • Cochlear Nucleus CI24RE Series Bone Recess Template • Cochlear Nucleus CI24RE Series Array Exit Marking Template • Cochlear Nucleus CI500 Series Implant Template • Cochlear Nucleus CI24RE Series Implant Template • Cochlear Nucleus CI500 Series Recess Gauge • Cochlear Nucleus CI24RE Series Recess Gauge • Cochlear Nucleus Contour® Electrode Claw • Cochlear Nucleus Electrode Claw (Straight) • Cochlear Nucleus AOS™ Forceps for the Contour Advance® Electrode. For information on the instruments, refer to the guide for the appropriate implant. For the AOS Forceps refer to the guide Cochlear Nucleus® AOS™ Forceps for the Contour Advance® Electrode. The instruments listed above are supplied non-sterile and must be cleaned, disinfected and sterilised before use.

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Introduction

The sterilisation department or reprocessing centre at your hospital or clinic is responsible for surgical instrument sterility. They should: • use device and product-specific validated procedures for cleaning, disinfecting and sterilisation • use washer-disinfectors and sterilisers that are maintained and checked regularly • make sure validated parameters are applied for each cycle. Cochlear has validated the instructions in this guide for preparing a surgical instrument for re-use. Staff at the hospital or clinic are responsible for ensuring that reprocessing achieves the desired result-as performed using equipment, materials and staff in the reprocessing centre or sterilisation department. This requires validation and routine monitoring of the process. Any deviation from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences.

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Warnings •

Metal surgical instruments are supplied non-sterile and must be cleaned, disinfected and sterilised before use.

•

Instruments must not contact other instruments during cleaning and disinfecting.

•

Damaged instruments must not be used.

•

Do not use: –– combined cleaning-disinfection solutions –– dry heat, radiation, formaldehyde, ethylene oxide or plasma sterilisation –– instrument oils for instrument maintenance – no maintenance required.

•

Follow the legal provisions for your country and the hygiene instructions of your hospital or clinic. This particularly applies to different guidelines regarding the inactivation of prions.

Limitations on reprocessing Repeated processing has a minimal effect on these instruments. The instruments have been validated for 25 cycles of reprocessing as instructed in this guide. End-of-life is normally determined by visible manifestation of wear and damage. See Inspection and function testing on page 11.

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Cautions Do not use metal brushes or steel wool for cleaning.

Instrument material compatibility •

To avoid corrosion, do not process Cochlear metal instruments with instruments that have aluminium, brass, copper or chrome-plated parts.

•

Do not use cleaning detergents with the following ingredients: –– Organic, mineral, and oxidising acid. The minimum allowed pH-value is 5.5. –– Halogens (for example chlorine, iodine, bromine). –– Aromatic, halogenated hydrocarbons.

• Do not expose instruments to temperatures higher than 142 °C (287.6 °F).

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Reprocessing instructions The following reprocessing instructions are for instruments used with patients who in the general population represent no identified risk of Transmissible Spongiform Encephalopathies (TSEs) transmission and where: a.

the instruments have not been exposed to tissue that are known to have high-infectivity for Creutzfeldt-Jakob disease (CJD) (e.g. Dura) or

b.

where the instruments have been exposed to tissue known to have highinfectivity for CJD (e.g. Dura). Warning •

The reprocessing should be performed by suitably trained staff using well-maintained equipment in a facility that meets the requirements of ISO 17665- 1, for equipment validation and routine control.

•

For instruments used with patients who represent a definite or potential risk of TSE transmission, contaminated instruments should be placed immediately into the correct clinical waste container for disposal. Follow the legal provisions for your country and the hygiene instructions of your hospital or clinic.

Point of use

Throughout the surgical procedure, wipe blood and debris from instruments to prevent drying. Do not allow contaminated devices to dry before reprocessing. Directly after use, remove coarse impurities from the instruments by wiping the articles using lint-free cloths dampened with distilled water and soak in distilled water until they are reprocessed. Instruments should be reprocessed within one hour after use.

Containment Follow the validated containment and transportation and instructions of your hospital or clinic. transportation

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Reprocessing instructions

Preparation for cleaning

Rinse under water up to 50 °C (122 °F) while brushing for a minimum of 1 minute. Caution •

Do not disassemble instruments – no disassembly required.

•

Do not use metal brushes or steel wool.

For manual removal of impurities, use a soft brush only. For holes, use suitable interdental brushes. Cleaning and disinfecting

Warning Do not use a manual procedure, even in conjunction with an ultrasonic bath. Manual procedures could cause damage to delicate instrument parts, resulting in prolonged surgery time. Equipment: Washer-disinfector and cleaning detergent. The washer-disinfector must have these properties: • Approved efficiency (CE mark in Europe, FDA registration/ clearance for USA). • Validated for EN ISO 15883. • Approved program for thermal disinfection (A0 value > 3000). • Suitable program for the instruments with sufficient rinsing steps. The cleaning detergent must have the following properties: • Suitable for cleaning stainless steel instruments. • Compatible with the instruments (see Instrument material compatibility on page 6).

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Reprocessing instructions

Cleaning and disinfecting

Note •

Cleaning validation as shown in Appendix 1 – Validation information on page 18, was undertaken using minimum detergent concentration levels. Always follow the instructions from the detergent manufacturer regarding concentration, temperature and soaking time.

•

Apply only the parameters that were applied during process validation in the hospital or clinic’s reprocessing centre or sterilisation department. Warning For instruments in contact with patients with no identified risk of TSE transmission and where the instruments have been exposed to tissue known to have high infectivity for CJD (e.g. Dura), fully immerse the instruments in a 1% solution of neodisher® MediClean forte at 55°C (131°F) and stir for 10 minutes prior to automated cleaning/disinfecting. Automated cleaning and disinfecting procedure 1. Transfer instruments into the washer-disinfector in a small parts basket. Position instruments to allow for drainage of water. Warning Instruments must not contact other instruments during cleaning and disinfecting. 2. Start the validated program as described in Table 1 on page 10. 3. Execute the cycle release by checking that the process parameters were correctly applied. 4. Inspect instruments to ensure no residual moisture is present. 5. If required, use filtered, pressurised air to complete the drying process.

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Reprocessing instructions

Cycle

Minimum temperature

Time

Detergent/water type

Pre-cleaning 2 minutes

Cold <40 °C (<104 °F)

Tap water

Detergent wash

Heated 40 °C – 55 °C (104 °F – 131 °F)

Enzymatic detergent

2 minutes

OR Prion inactivating alkaline detergent*

Wash

5 minutes

Set point 55 °C (131 °F)

Neutral/non-enzymatic detergent

Rinse

2 minutes

Heated 50 °C – 60 °C (122 °F – 140 °F)

Hot tap water

Thermal disinfection

5 minutes

Heated 93 °C (199.4 °F)

Critical water†

Dry ‡

10 minutes

Heated 110 °C (230 °F)

Not applicable

Table 1: Automated cycle parameters

*

†

‡

Warning Use an alkaline detergent validated for prion inactivation (e.g. neodisher MediClean forte) for instruments in contact with patients with no identified risk of TSE transmission and where the instruments have been exposed to tissue known to have high-infectivity for CJD (e.g. Dura). Water extensively treated to ensure removal of the microorganisms and the inorganic and organic material. Treatment is usually a multistep process that may include a carbon bed, softening, DI, and RO or distillation (maximum 10 germs/ml, maximum 0.25 endotoxin units/ml). If instruments are not dry after automated cleaning / disinfection cycle, filtered, pressurised air is recommended to complete the drying process. Follow the instructions of your hospital or clinic.

Note For validation information, see Appendix 1 – Validation information on page 18.

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Reprocessing instructions

Drying

Inspect instruments to ensure no residual moisture is present. If required, use filtered, pressurised air to complete the drying process. Hot air drying is not recommended, except for drying that is part of the above-mentioned validated automatic washing-disinfecting cycle.

Maintenance

Warning Do not use instrument oils for instrument maintenance–no maintenance required.

Inspection and function testing

Check all instruments after cleaning-disinfecting for corrosion, damaged surfaces and impurities. Particular attention should be given to ensure: • correct parallel closure and absence of deformations on the clamping ends of forceps, and • absence of sharp edges on the instruments’ surfaces. Warning Do not use damaged or worn instruments. Instruments that remain dirty must be cleaned and disinfected again. For specific critical control points see Table 2: Critical control points for surgical instrument inspection on page 12.

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Reprocessing instructions

Cochlear Nucleus surgical instruments

Specific critical control points Give particular attention to the following:

• BTE Template

• Surface only.

• CI24RE/CI500 Series Implant Template • CI24RE Series Array Exit Marking Template

• Internal surfaces of cut-out sections.

• CI24RE Series Recess Gauge

• Internal surface of the hole on the base • High gradient area at the handle/gauge junction • Handle grip features.

• CI24RE Series Bone Recess Template

• High gradient area at the handle/gauge junction • Handle grip features.

• CI500 Series Recess Gauge

• High gradient area at the handle/gauge junction.

• Contour Electrode Claw • Electrode Claw (Straight)

• Claw groove • Handle grip features.

• AOS Forceps for the Contour Advance Electrode

• Forceps crevice • Spacer studs • Delicate, grooved tips.

Table 2: Critical control points for surgical instrument inspection

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Reprocessing instructions

Packaging

Pack the cleaned and disinfected instruments in sterilisation packaging that meets the following requirements: • Compliant with EN ISO/ANSI AAMI ISO 11607. • Sufficiently protects the instruments against physical damage. • Maintains sterility of the instruments during handling and storage prior to use. • Ensures the instruments are not in excessive contact with each other. • Allows sufficient inner volume to avoid strain on the instruments. • Sealed using a validated thermo-sealing process. For more information see Appendix 1 – Validation information on page 18.

Sterilisation Cochlear has developed and validated the sterilisation instructions in this guide for preparing a surgical instrument for re-use to comply with the requirements of ISO 17665-1. • Transfer instruments into the steriliser avoiding known ‘cold’ locations, typically over the drain. Use steam sterilisation as described: • Dynamic air removal steam sterilisation cycle (prevacuum). • Sterilisation parameters and instructions as specified by the steam steriliser manufacturer and your hospital or clinic, including those related to the quality of water supplied to the steam generator.

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Reprocessing instructions

Sterilisation • Validated parameters for temperature and time for instruments used with patients with no identified risk of TSE transmission and where the instruments have not been exposed to tissue that are known to have high-infectivity for CJD (e.g. Dura). Minimum temperature

Minimum exposure time

Minimum drying time

132 °C (269.6 °F)

4 minutes

20 minutes

134 °C (273.2 °F)

3 minutes

16 minutes

• Use the following parameters for instruments used with patients with no identified risk of TSE transmission and where the instruments have been exposed to tissue that are known to have high-infectivity for CJD (e.g. Dura). Minimum temperature

Minimum exposure time

Minimum drying time

134 °C (273.2 °F)

18 minutes*

16 minutes

Warning Do not use dry heat, radiation, formaldehyde, ethylene oxide or plasma sterilisation. Caution Maximum sterilisation temperature of 138 °C (280.4 °F). Storage

After sterilisation, store the instruments in sterilisation packaging in a dry and dust-free environment.

* The construction and design of the surgical instruments have been verified to withstand 18 minutes exposure time at 134 °C (273.2 °F).

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Symbols The following symbols may appear on packaging: Consult instructions for use Caution Date of manufacture 2002-05-30 Manufacturer

NON STERILE

Non-sterile

Rx Only Caution: US law restricts this device to sale by, or on the order of, a physician Catalogue number

Batch code

Authorised representative in the European Community



CE registration mark with notified body number

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Notes

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Notes

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Appendix 1 – Validation information Test items Samples of Cochlear’s reusable surgical instruments with the most challenging features to clean, disinfect and sterilise were used in the validation tests.

Automated cleaning Critical cleaning parameters were determined by rigorous automated cleaning methods developed using spore logarithmic reduction, total protein, haemoglobin and visual inspection criteria. For device contamination, a blood soil containing 2M calcium chloride (for coagulation purposes) and bone meal (1 g/100 mL of test soil) was inoculated with a minimum population of 104 CFU/mL of G. stearothermophilus and E. faecium. The instruments were exposed to the test soil for a minimum of 15 minutes and allowed to dry for a minimum of 1 hour before cleaning and disinfecting. Any pre-cleaning involved rinsing the instrument under water 49 °C (120.2 °F) while brushing with a Spectrum M-16 brush for a minimum of 1 minute. After cleaning, test samples were visually inspected for any sign of remaining blood soil. Bioburden extractions were used to determine the number of spores, total protein and haemoglobin remaining on test samples. Comparison of data to positive controls and test protocol requirements determined if acceptance criteria were met. Cleaning equipment Equipment Washer/Disinfector Type N/A

Steriliser Steam; SG-120; AMSCO

Manufacturer Steris

AMSCO

Serial Number 3603513001

0117594-02

Model GEN FH07-1XX

SG-120

Table 3: Cleaning equipment used for cleaning validations using enzymatic detergent

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Appendix 1 – Validation information

Automated cleaning validations Cycle

Time

Validated settings

Detergent/water type

*

Cold <40 °C (<104 °F)†

Tap water

Detergent wash*

2 minutes*

Heated 48 °C (118.4 °F)†

Valsure® Enzymatic Detergent 2mL/L

Wash

5 minutes*

Set point 55 °C (131 °F)†

Valsure Neutral 2mL/L†

Rinse

2 minutes*

Heated 50 °C – 60 °C (122 °F – 140 °F)†

Hot tap water

Dry

10 minutes*

Pre-cleaning 2 minutes

Heated Not applicable <84.2 °C (<183.56 °F)

Table 4: Validation for automated cycles using enzymatic detergent

* †

Validated exposure time required to achieve >3 log bioload reduction. Validated exposure temperature required to achieve >3 log bioload reduction.

For instruments used with patients with no identified risk of TSE transmission and where the instruments have been exposed to tissue that are known to have high-infectivity for CJD (e.g. Dura) the articles were soaked in a 0.5% (5 mL/L) neodisher Mediclean forte solution at 55°C whilst stirring for 10 minutes prior to the following automated cleaning cycle.

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