Pre-disinfection Cleaning and Sterilization Instructions for Use

Table of contents Digisonic® SP screwdriver, insertion forceps, insertion fork, processor indicator, Neuro Zti magnet extractor Introduction...4 Cautions and precautions...6 The “standard” type of reprocessing cycle...6 Procedure steps... 8 1. On the site of use... 8 2. Transport to the treatment area... 8 3. Manual cleaning... 8 4. Automatic cleaning using a washer-disinfector... 13 5. Inspection... 15 6. Packaging... 16 7. Sterilisation... 17 8. Storage... 18 9. Maintenance... 19 10. Risks of transmission of NCTA (Non-Conventional Transmissible Agents)... 20

2

References... 23 Appendix: advice on the choice of cleaning products... 25 1. Pre-disinfection and manual cleaning... 25 2. Ultrasonic cleaning...26 3. Automatic cleaning (washer-disinfector)...26 4. Products used for the validation of manual and automatic cleaning...26 Neuro Zti screwdriver... 27 Introduction... 27 Basic instructions ...28 Manual cleaning and disinfection... 31 Automated cleaning and disinfection... 32 Inspection... 34 Product care... 34 Sterilisation... 34 Reusability... 36

3

Introduction This instruction for use (IFU) is applicable for pre-disinfection, cleaning, and sterilisation or resterilisation of Digisonic® SP screwdriver, insertion forceps, insertion fork, processor indicator, Neuro Zti magnet extractor surgical tools distributed by Oticon Medical. This instruction for use is designed for healthcare personnel and provides indications and recommandations to assure provide indications and recommendations to assure effective reprocessing and correct handling of reusable surgical tools. • The pre-disinfection constitutes the first treatment to be carried out on used instruments with the aim of reducing the level of contamination, facilitating further cleaning, and protecting the operator while handling the material. • The cleaning aims at eliminating soils, in particular ulterior organic matter (blood, secretions, etc.), on the equipment treated; it thus permits the simultaneous reduction of the number of microorganisms present on the instruments. Its effectiveness will depend on the combination of four factors: the physical-chemical action, the mechanical action, the temperature, and the duration of contact. The cleaning methods may include manual or automatic techniques in combination with detergents and water. • The goal of sterilisation is to make the instruments surgically sterile, meaning free of any microorganism. This sterile state is maintained through the integrity of the packaging that is used. 4

Cautions and Precautions These instructions are suited for the preparation of all the stainless steel surgical tools delivered by Oticon Medical. Other methods of cleaning may be appropriate, but they should be correctly evaluated for their effectiveness and validated in advance by the supervisor of reprocessing in order to avoid any undesirable results. The healthcare establishment should assure itself that the reprocessing is performed using appropriate equipment and material, and that the personnel in charge of cleaning the contaminated material have had the training necessary to engage in this type of handling. The operator should wear personal protection equipment that is suitable for this work in order to protect himself against any exposure to any possible pathogens or to chemical products. The internal regulations applicable in the hospitals and the recommendations from the manufacturers of cleaning products and automatic washing sterilisers must be scrupulously followed. The equipment and the procedures must be validated and monitored regularly in order to guarantee the ongoing effectiveness of the reprocessing.

5

The “standard” type of reprocessing cycle The principal stages to be followed, as part of the procedure, are briefly described in the diagram on page 7 and in more details in the next pages. Reprocessing limits The surgical instruments made of stainless steel are designed to last and be reused if they are handled and maintained correctly. Repeated treatment does not affect the useful life of the instruments. Their lifetime depends generally on wear and on damage caused by use. Thorough inspection and functional monitoring of the surgical tools before use, constitute the best way to judge the state of deterioration.

6

On the site of use

• Remove visible contaminants

Transport to the treatment area

• Reprocess as quickly as possible • Avoid having the dirt dry out

Manual cleaning

Automatic cleaning

Pre-desinfection

• Immerse in a detergent-disinfectant solution • Rinse with running water

Manual cleaning

• Immerse in a detergent-disinfectant solution • Brush the instrument • Rinse with running water

• Immerse in an ultra-sound bath with an appropriate cleaning solution Ultrasonic cleaning • Rinse with demineralised water • Dry with lint-free cloths

Pre-disinfection if necessary

Wash cycle: • Place the instruments pre-wash, cleaning, into a washer-disinfector disinfection... • Start the cleaning program

Inspection

• Visually check the state of the surface of the instruments: no residues, no corrosion, no defects

Packaging

• Single use or reusable packaging appropriate for steam sterilisation

Sterilisation

• Sterilisation in a steam autoclave : 134°C – 18min

Storage

• Store the packaged material in a cool and dry place out of the sun and free of dust.

7

Procedure steps 1. On the site of use Remove the excess of soils on the instruments using humidified absorbent paper for single use. 2. Transport to the treatment area Reprocess the instruments as soon as possible after use as close as possible to the place where they were used. Avoid dried contaminants (blood, tissue debris, organic liquids, etc.) on the instrument. If cleaning must be delayed, or if the decontamination area is far from the operating theatre, put the contaminated material in a hermetically covered container filled with cold water and an appropriate detergent solution (if possible) in order to delay the drying out of the organic material and to avoid any risk of contamination. 3. Manual cleaning 3.1. Pre-disinfection Required equipment: • Detergent-disinfectant product appropriate for surgical instruments • Bath or large soaking container with a lid 8

• Individual protection equipment: –– Single use non-sterile protective gloves –– Protective glasses –– Mask –– Hairnet –– Waterproof coat with long sleeves or a plastic apron for single use Procedure: • In advance prepare a detergent-disinfectant solution by mixing the detergent-disinfectant solution with lukewarm water (30°C ± 5°C) in a large bath with a lid according to the manufacturer’s instructions. • As soon as the surgery is completed, totally immerse the contaminated instruments in the soaking bath that contains the detergent-disinfectant solution during the period recommended by the manufacturer (or during a minimum of 15 minutes if there are no other indications). • Thoroughly rinse the instruments taken out of the pre-disinfection bath for one minute with running water (20°C ± 5°C). Recommendations: • Handle the instruments carefully in order to avoid damaging them or bending them, and to avoid any possible injuries to the operator. • Do not use any products containing protein-fixing aldehydes. • Follow the indications and the warnings for use from the manufacturer: dilution of the product and duration of soaking. 9

• Renew the detergent-disinfectant bath daily (or more often if the instruments are extremely contaminated). Clean the soaking bath every day with a proper product. 3.2. Cleaning: physical-chemical, mechanical and thermal action 3.2.1. Manual cleaning Required equipment: • Detergent-disinfectant product appropriate for surgical instruments • Bath or large soaking container with a lid • Individual protection equipment: –– Single use non-sterile protective gloves –– Protective glasses –– Mask –– Hairnet –– Waterproof coat with long sleeves or a plastic apron for single use • Soft plastic brushes and/or swabs

10

Procedure: • Prepare a new bath using the same detergent-disinfectant solution as for the pre-disinfection, and again immerse the pre-disinfected instruments for the duration recommended by the manufacturer (or during a minimum of 15 minutes if there are no other indications). • Manual cleaning : combination of a mechanical element (brushing) and a chemical element (detergent action) –– Carefully brush the item until all the remaining organic residues visible to the naked eye are removed (or during 1 minute and 30 seconds). –– Rinse with running water (20°C ± 5°C) until all traces of the cleaning solution visible to the naked eye disappear (or during 1 minute). Recommendations: • Do not use sponges or metal brushes. • Be careful to clean and disinfect the brushes before and after use. • Do not use any products containing protein-fixing aldehydes. • Follow the manufacturer’s recommendations for the dilution of the product and duration of contact of the instruments with this product. • Renew the detergent-desinfectant bath daily (or more often if the instruments are extremely contaminated). Clean the soaking bath every day with a proper product.

11

3.2.2. Ultrasonic cleaning (semi-automatic) Required equipment: • Detergent-disinfectant product compatible with ultra-sound • Ultra-sound bath with rack and lid, ultra-sound frequency 25-50 kHz • Individual protection equipment: –– Single use non-sterile protective gloves –– Protective glasses –– Mask –– Hairnet –– Waterproof coat with long sleeves or plastic apron for single use –– Absorbent, lint-free, not woven cloths for single use

12

Procedure: • Prepare a detergent or detergent-disinfectant solution by diluting it in warm water (40°C ± 2°C) according to the manufacturer’s recommendations. • Fill the ultra-sound bath with this solution. • Start the bath without the instruments, and let the solution degas for 5 minutes. • Immerse the instruments into the solution at the bottom of the rack without piling them up and activate the ultra-sound bath for 15 minutes. • During the working phase, place a lid on the ultra-sound bath. • Rinse thoroughly with demineralised water (20°C ± 5°C) until all traces of the cleaning solution visible to the naked eye disappear (or during 1 minute and 30 seconds). • After rinsing, carefully dry the instruments using absorbent dry cloths. • Visually inspect the material as indicated in ‘Inspection’.

Recommendations: • Be careful not to overload the rack and not to exceed 43°C for the ultra-sound bath temperature in order to avoid encrustations of blood and protein substances. • Renew the ultra-sound bath daily (or after each use according to the degree of contamination on the devices), and clean the bath every day with a proper product. • Regularly examine the ultra-sound cleaning equipment to verify its proper functioning (frequency and verifications described in the equipment maintenance procedure). • Follow the manufacturer’s recommendations for the dilution of the product, the contact duration of the instruments with the product, and the temperature. 4. Automatic cleaning using a washer-disinfector Required equipment: • Washing product suitable for the requirements of a washer-disinfector • Individual protection equipment: –– Single use non-sterile protective gloves –– Protective glasses –– Mask –– Hairnet –– Waterproof coat with long sleeves or plastic apron for single use • Washer-disinfector

13

Procedure: • If the cleaning area is not located close to the site of use, or when the instruments hold driedout contaminants, perform first a pretreatment of the instruments as for the manual cleaning (see Manual cleaning). • Place the instruments (immediately after use if pre-disinfection is not necessary) into the washing racks without overloading them. Then place the racks on the wash supports of the washerdisinfector. • Avoid any contact between the devices, which may cause damage during washing. • Start the washer-disinfector program. • Remove the equipment at the end of the cleaning cycle. • If this cycle does not include a drying phase, place the instruments in an oven at a temperature below 110°C. • Visually inspect the instrument as indicated in ‘Inspection’ phase.

14

Recommendations: • Follow the manufacturer’s indications for the concentration, temperature, and duration of action of the cleaning agent. • Refer to the manufacturer’s user guide for use of the washer-disinfector. • The machine cleaning should satisfy the requirements of standard EN ISO 15883-2 relative to washers-disinfectors. • The cleaning cycle should at minimum include the following stages: –– Pre-washing in cold or warm water (< 45°C) –– Cleaning with detergent and warm water (between 50 and 70°C) –– Neutralisation (if necessary) –– Intermediate rinsing in cold or warm water –– Thermal disinfection with demineralised water (between 65°C and 93°C) –– Drying (<110°) 5. Inspection All the instruments should be inspected before being packaged and sterilised. • a. Perform a careful visual inspection of the equipment to detect the possible presence of residues, soils, and/or damages. • b. in particular monitor the critical areas of the cleaned devices. • c. Also check the functioning state of the cleaned devices. • d. If this monitoring reveals the presence of residual contaminants, the instruments must be cleaned again according to the procedure described above. • e. Remove any instruments with defects (nicked, corroded, damaged, or twisted) 15

6. Packaging Required equipment: • Single use packaging (packages or sheaths made of paper and thermosealable plastic film) or reusable packaging (rigid containers) conforming to the standard EN ISO 11607-1, and appropriate for steam sterilisation. • Physical-chemical indicator conforming to standard EN ISO 11140-1. Procedure: For packages and sheaths: • Package the instruments in a double thermosealed pack (one instrument per pack). • If necessary, place a physical-chemical indicator on the package. Recommendations: • Wrap the surgical instruments quickly after drying.

16

7. Sterilisation Sterilisation in steam (moist heat in an autoclave) is the reference sterilisation procedure for reusable medical devices. The parameters recommended for the plateau of sterilisation are 134°C during 18 minutes. Required equipment: • Steam steriliser under pressure with segmented vacuum and drying, allowing recording of the cycle parameters (temperature, duration, pressure) and conforming to standards EN 285 (or EN 13060) and EN ISO 17665-1. • Physical-chemical indicators conforming to standard EN ISO 11140-1. Procedure: For packages and sheaths: • Place the packaged instruments into the cell, placing them on the edge with enough space between them to allow circulation of the condensate. • Place a physical-chemical indicator into an insulated package in the middle of the cell and start the sterilisation cycle. • At the end of the program, remove the products from the cell, and check : –– The integrity and dryness of the packages (no humidity, no damage) –– The response of the package indicators –– The indicator which enables to monitor the functionality of the equipment –– The conformity of the cycle diagram to the reference registration 17

Recommendations: • In order to assure the traceability of this procedure, a marking must appear on the packaging label and contain the following information: identification of the article, identification of the steriliser (number), cycle number, date of sterilisation, expiration date of use. • Maintenance and monitoring of the steriliser must be done regularly. 8. Storage The period for preserving the packaged devices after sterilisation depends on several factors, such as the conditions of storage, type of sterile packaging used, and the aging of the package and of the instrument. The health establishment should therefore set up a storage period for sterilised devices, while taking into account these parameters and the manufacturer’s recommendations of the sterile packaging. Since the physical parameters have an impact on the preservation of the sterile state, it is recommended that the sterilised packaging be stored in a dry place, away from humidity, dust, direct sunshine, and all types of contamination.

18

9. Maintenance Instruments loaned or addressed to the manufacturer or to the supplier for repair, revisions, or maintenance, should be subjected to all the stages of decontamination, cleaning, disinfection, inspection, and final sterilisation before being returned. Documentation relating to the decontamination measures should accompany the instruments that are returned.

19

10. Risks of transmission of NCTA (Non-Conventional Transmissible Agents) In the case of patients presenting individual risk factors of classic subacute transmissible spongiform encephalopathies (SSTE) or in the case of surgeries performed on patients whose antecedents are unknown (corpses), a « reinforced » reprocessing cycle including an inactivation of NonConventional Transmissible Agents (NCTA) should necessarily be performed. The aim is to avoid any risk of disease transmission such as Creutzfeldt-Jakob disease and of biological contamination during shipment. Required equipment: • Detergent-disinfectant product appropriate for surgical instruments • Bath or large soaking container with a lid, suitable for use with caustic soda • Individual protection equipment: –– Single use non-sterile protective gloves –– Protective glasses –– Mask –– Hairnet –– Waterproof shirt with long sleeves or a plastic apron for single use • Plastic brushes • Ultra-sound bath with rack and lid, ultra-sound frequency 25-50 KHz • 1M caustic soda solution • Absorbent, lint-free, not woven cloths for single use • Steam steriliser 20