MATHYS Ligamys Suturing Forceps Processing Instructions

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Table of contents

1.

Scope

4

2.

Processing cycle

5

3. Information to be provided by the manufacturer 3.1 Instructions for reprocessing 3.2 Limitations and restrictions of reprocessing 3.2.1 Warnings and precautions 3.2.2 Limitations 3.2.3 Transport after use to processing (CSSD) 3.3 Preparations at the place of use 3.3.1 Processing during and immediately after use 3.4 Preparation before cleaning 3.5 Cleaning and disinfection 3.5.1 Instructions for manual pre-cleaning 3.5.2 Instructions for automated cleaning and disinfection 3.6 Control and maintenance 3.7 Function testing 3.8 Packaging 3.9 Sterilisation 3.10 Storage 3.11 Efficacy of the treatment process 3.12 Number of processing cycles

6 6 6 6 9 9 10 10 11 13 14 16 18 19 23 24 25 25 25

4. 4.1

Symbols Symbols as used by Mathys Ltd Bettlach

26 26

5.

Customer information

27

6. 6.1 6.2 6.3

Appendix – quick overview Manual pre-cleaning Machine cleaning Sterilisation process with saturated steam

28 28 29 29

Processing instructions for the Ligamys suturing forceps – 3

1. Scope

The present processing instructions in accordance with the requirements of SN EN ISO 17664 apply to instruments that are to be reused and therefore need to be reprocessed, as well as to medical devices that are sold non-sterile, but to be used in sterile condition. The Ligamys suturing forceps (re-sterilisable surgical instruments) by Mathys Ltd Bettlach belongs to this group. The process chemistry parameters as well as the equipment of the following processing instructions are recommendations resulting from the findings of the validation process for instrument processing of Mathys Ltd Bettlach. The processor is responsible for ensuring that the processing actually performed achieves the desired results with the individual equipment, process chemicals and staff in the processing facility. It is not mandatory to use the same chemicals, parameters and technical equipment as in the validation process of Mathys Ltd Bettlach. Equivalent or alternative products may be used with which a successful validated cleaning and sterilisation process can be demonstrated as a result. If the user has a method that is already established and validated and which is proven to lead to the desired result, there is no need for the user to change the method.

4 – Processing instructions for the Ligamys suturing forceps

PACKAGING

MAINTENANCE / CARE & FUNCTIONAL TESTING

• RETURN TO MANUFACTURER

• SCRAPPING

STERILISATION

STORAGE

MONTAGE

PROCESSING CYCLE

USE

DISINFECTION (THERMAL)

CLEANING (MAN. / MECH.)

• LEASED TRAYS

• PURCHASE OF NEW INSTRUMENTS

DISASSEMBLY

TRANSPORT TO THE CSSD

2. Processing cycle

Processing instructions for the Ligamys suturing forceps – 5

3. Information to be provided by the manufacturer

3.1 Instructions for reprocessing These processing instructions for the Ligamys suturing forceps are based on a validated manual / automated processing procedure. A purely manual or purely automated processing method has not been validated by Mathys Ltd Bettlach and does not lead to sufficient cleaning success.

3.2 Limitations and restrictions of reprocessing 3.2.1 Warnings and precautions An alkaline-enzymatic cleaning solution is recommended (pH 10 – 11). Always follow the manufacturer’s instructions for preparing and using the solutions. Personnel who come into contact with potentially or actually contaminated surgical instruments must be trained with regard to generally accepted hygienic protective measures (protective clothing, mouth and nose protection, goggles, cut-resistant gloves, work shoes, etc.) and be able to use them. When handling instruments with sharp points or edges, special caution is advised. Personal protective equipment (gown, mask, goggles, visors, gloves, shoes, overshoes, etc.) are required in order to avoid contact with contaminated or potentially contaminated materials, instruments and products. Particular care must be taken when handling cutting instruments (reamers, drill bits, rasp, chisels), as they pose a risk of injury to the patients on the one hand and to the staff (operating theatre and CSSD personnel) on the other. It must be clarified in advance that the patients, as well as the staff (operating theatre and CSSD personnel), do not react with allergic reactions due to material intolerance (various steels and plastic materials) upon direct contact with instruments. For new instruments delivered to the hospital, Mathys Ltd Bettlach recommends triple cleaning before use in order to build up the protective oxide layer. In the manual cleaning process, low-foam detergents are to be used in order to ensure visibility of the instruments. In manual cleaning with brushes, it is recommended to keep the instruments always below the surface of the cleaning solution. This ensures that no aerosols form and splashes are avoided that might spread contaminants. To prevent accumulation of detergent residues, the detergents must be completely removed by thorough rinsing of the product surfaces. Heavy objects should not be placed on sensitive instruments, since this can impair the function of the instruments. Do not allow contaminated instruments to dry before reprocessing them. This is important because all the steps described below for cleaning and sterilisation are facilitated by preventing blood, body fluids, bones and tissue residues as well as saline or disinfectant from drying on used instruments.

6 – Processing instructions for the Ligamys suturing forceps

When loading the cleaning trays and baskets, ensure that instruments cannot damage each other, and that they can be easily rinsed all around. The chloride and iodide ions contained in detergents and disinfectants can cause corrosion. For this reason, contact of the instruments with such agents must be kept as brief as possible. Rinse the instruments thoroughly with tap water and then deionised water (demineralised water) in order to remove all residues. Never leave wet instruments to stand. Rather, dry them immediately. The condensation moisture resulting from sterilisation can be prevented by extension of the drying phase. Cleaning solutions that are too concentrated, too acidic or alkaline, or that contain aldehydes, mercury, active chlorine, chloride, bromine, bromide, iodine or iodide, may damage the instruments. Such cleaning solutions are to be avoided. Mathys advises against the use of drying or neutralising agents. Attention must be paid to the quality of the water used. The deionised water (hereafter DI water) used for rinsing should microbiologically be at least of drinking water quality. If only water (without the addition of cleaning solution) is used for cleaning, Mathys recommends a water temperature of no more than 45° C (113° F), since otherwise proteins will be fixed on the instrument, making removal difficult. The last rinse in mechanical cleaning is to be performed with DI water. For cleaning reusable instruments, Mathys Ltd Bettlach recommends a combined manual / automated cleaning process with a detergent and enzyme solution at an alkaline pH of < 11. It is extremely important to neutralise the alkaline cleaner completely and rinse it thoroughly off the instruments. In automated cleaning, the information provided by the manufacturers of the equipment and cleaning agents must be followed. Only instruments by Mathys Ltd Bettlach may be used for the placement of implants by Mathys Ltd Bettlach (see the respective surgical technique); instruments by other legal manufacturers may not. No additional lettering of any kind may be applied to the instruments. Before returning any instruments to Mathys, these instruments must undergo a full processing cycle in order to exclude a risk of infection. If contaminated instruments are sent to external treatment facilities for processing, they must be manually pre-cleaned, visually clean and drey in their specific instrument tray, and additionally stored in a sterilisation container. The sterile container must be closed, sealed and markde with a Biohazard label. Before being returned to Mathys, contaminated leased instrument trays must undergo a complete processing cycle in order to avoid danger to third parties. This also applies to the return of contaminated individual instruments, and to repairs.

Processing instructions for the Ligamys suturing forceps – 7

Instruments for single use may be used only once and never reprocessed or resterilised, not even if they are removed from the package but not contaminated or used. The single-use instruments are to be disposed of after use. This also includes single-use instruments that were packaged and delivered sterile, removed from the package and inserted into individual trays. The Mathys instrument trays may be loaded only with instruments manufactured and / or marketed by Mathys. Instrument trays and lids must be cleaned separately from the instruments. Non-sterile leased instrument trays that are delivered to the hospital must undergo a complete processing cycle. This also applies to the return of leased instrument trays or non-functional instruments, as well as to repairs. If necessary, after drying in the WD the instruments must be dried with medical compressed air before being serviced. For maintenance / care, the instruments must be completely dry. The instruments are packaged separately and delivered in non-sterile condition. The packaging materials must be disposed of in accordance with the local and countryspecific regulations. Mathys advises against the use of metal brushes or metal sponges, since these could damage the protective oxide layer. This can lead to corrosion. Use of steamers is not recommended, since the high temperature fixes proteins to the surface.

8 – Processing instructions for the Ligamys suturing forceps

3.2.2 Limitations High-risk patients with prion diseases such as Transmissible Spongiform Encephalopathy (TSE), Creutzfeldt-Jakob disease (CJD) and its variants (vCJD) must be operated on with disposable instruments whenever possible. Furthermore, the instruments may be exposed to body fluids that contain the hepatitis or HI virus («AIDS virus») or other pathogens. It is extremely important to neutralise alkaline cleaners completely and rinse them thoroughly off the instruments. The suturing forceps must be carefully inspected after cleaning. In doing so, the functionality of the forceps must be checked. It must be ensured that the cannula tip of the suturing forceps is sharp for use and has not been damaged by improper handling during cleaning. Also use a PDS II 2-0 thread or equivalent thread of thickness 2-0 to ensure the suture-guiding needle is completely patent. If this is no longer the case, contact your local Mathys partner. Mathys Ltd Bettlach recommends selecting a cleaning agent with enzymatic additives to decompose blood, body fluids and tissues. Please note that some enzyme solutions are intended specifically for decomposing faecal matter or other organic contaminants, and are therefore not suitable for cleaning surgical instruments. Use of hard water (> 14° dH) is to be avoided. The softer the water used, the better contamination can be removed and visible mineral residues avoided. For the initial rinsing, soft tap water is suitable. Rinse thoroughly with deionised water (demineralised water) to remove any residues. Tap water often contains high concentrations of minerals (e. g. lime or silica), which can be seen on the instrument surface as stains with sharply defined edges. Tip Never leave instruments wet, but dry them instantly.

3.2.3 Transport after use to processing (CSSD) After the use of the instruments, they must be transported in a specific instrument tray by Mathys in order to avoid defects due to transport. This instrument tray in turn must be transported in a closed container to the CSSD in order to protect the personnel and the environment from risks of contamination and infection.

Processing instructions for the Ligamys suturing forceps – 9

3.3 Preparations at the place of use 3.3.1 Processing during and immediately after use First, residues of body fluids and tissues must be removed using a specific nylon brush. Saline, blood, body fluids, tissue, bone residues or other organic particles on instruments must be removed before cleaning as soon as possible in order to avoid drying as well as corrosion. Tip Immersion of the used instruments into enzyme solutions or into cold deionised water (demineralised water) facilitates cleaning, particularly in the case of instruments featuring complex shapes and areas difficult to access (e. g. cannulated and tubular designs, etc.). The enzyme solutions degrade the protein-containing substances, preventing blood and protein-containing materials from drying on the instruments. Saline solutions as well as detergents and disinfectants that contain aldehydes, mercury, active chlorine, chloride, bromine, bromide, iodine or iodide are corrosive and must not be used. Always follow the manufacturer’s instructions for preparation and use of the solutions strictly. Optimal cleaning is ensured if the instruments are properly cleaned within one hour after use in the CSSD to minimise the risk of drying of substances and materials. If it is not possible to clean the instruments within the specified time, Mathys Ltd Bettlach recommends immersing the instruments into an enzyme solution or deionised water (demineralised water) of room temperature, or to wrap them for up to 6 hours into cloths wetted with enzyme solution or deionised water (demineralised water). For prevention of contamination, the used instruments must be transported in closed or covered containers to the CSSD.

10 – Processing instructions for the Ligamys suturing forceps

3.4 Preparation before cleaning Excessive concentrations of the cleaning agents, as well as strongly acidic and alkaline detergents, can damage the protective oxide layer and cause pitting. When using such agents, the concentration and exposure time recommended by the manufacturers must be strictly adhered to. Mathys Ltd Bettlach recommends use of alkaline cleaning agents with a pH < 11. The concentration, temperature and exposure time for the cleaning agents recommended by the manufacturers must be observed under all circumstances in order to achieve optimal cleaning. When using dry detergents in powder form, it must be made sure that these are completely dissolved before use to avoid discolouration or corrosion of the instruments. Strongly contaminated solutions (blood and / or clouding) should be replaced with freshly prepared cleaning solutions. If water without detergent additives is used for cleaning, Mathys Ltd Bettlach recommends a water temperature of no more than 45° C (113° F), since otherwise blood contained in contaminations would start to coagulate, leading to strong fixation of proteins on the instrument, which can then be detached only with great effort in the automated cleaning. The Ligamys suturing forceps must be treated in a two-stage cleaning process, first manually, followed by automated cleaning, in order to achieve the necessary cleaning results.

Processing instructions for the Ligamys suturing forceps – 11

Table 1: Overview of the reprocessing according to SN EN ISO 17664 Process Preparation at the place of use

Reusable surgical instruments Condition

Wet

• Recommendation Cold deionised water (demineralised water) or enzyme solution (fluid or wetted cloths) • Max. 6 hours

Dry Decontamination

Preparation

• Selection according to the cleaning and disinfection method

Cleaning

Manual

–

Automated

–

Ultrasound

+

Combined manual / automated

+

Mildly alkaline-enzymatic (pH 10 – 11)

+

Acidic

–

Neutral to slightly alkaline (pH 7 – 9.5)

–

Rinsing Disinfection 1

Drying Maintenance

Final rinse with deionised water (demineralised water) Chemically max. 60° C (140° F)

–

Thermally 90° C (194° F)

+

T max / time

115° C (239° F) / 15 min

Function check Care

Sterilisation

• Max. 1 hour

Mandatory Care products based on paraffin / white oil (biocompatible, steam-sterilisable and steam-permeable)

Mandatory

Moist heat 2

+

Ethylene oxide

–

Formaldehyde

–

Plasma

–

Legend: + validated method, – non-validated method 1 Non-automatic disinfection process according to «Guideline for Disinfection and Sterilisation in Healthcare Facilities, 2008» 2 Preferred sterilisation method according to SN EN ISO 17664

12 – Processing instructions for the Ligamys suturing forceps

3.5 Cleaning and disinfection For cleaning the instrumentation, Mathys recommends using a combined manual and mechanical cleaning process with a mildly alkaline-enzymatic cleaning solution (pH from 10 to 11) using DI water (according to SN EN 285) to achieve optimum and thorough cleaning results. In the case of manual pre-cleaning, all blind holes and boreholes, slits and crevices as well as other visible design features must be rinsed thoroughly with tap water and, if necessary, pre-cleaned with a nylon brush.

Processing instructions for the Ligamys suturing forceps – 13

3.5.1 Instructions for manual pre-cleaning According to Mathys's internal process, the Ligamys suturing forceps fall into cleaning category 3 and must be processed as follows: No.

Step

Material / Medium

1

Manual removal of all visible contaminations using a plastic brush* below the water surface until no visible residues are present any more.

• Nylon brush

Flush the suture-guiding cannula through the roller housing of the suturing forceps with 50 ml of enzyme-containing cleaning solution. Ensure that liquid visibly flows out of the tip of the cannula.

• 50 ml plastic syringe without Luer lock

2

• Tap water (cold)

• 1 % deconex® TWIN PH10 and 1 % deconex® TWIN ZYME (v / v) • Deionised water (demineralised water)

If the needle is blocked by tissue fragments, the roller housing must be folded up and the cannula flushed by direct application of a syringe. Ensure again that liquid visibly flows out of the tip of the cannula.

If upon rinsing of the suture-guiding cannula with enzymatic cleaning solution or deionised water no or only reduced liquid outflow is seen, neither through the roller housing nor with the roller housing folded up, the suturing forceps may not be used and must be replaced.

14 – Processing instructions for the Ligamys suturing forceps

Images

No.

Step

Material / Medium

3

The pre-rinsed suturing forceps are treated with ultrasound in the combined cleaning agent / enzyme solution in an ultrasonic bath (35 – 47 kHz) for 5 minutes. It is to be ensured that the forceps are completely covered with the cleaning agent.

• Ultrasonic bath

4

Rinse the suturing forceps well under running tap water.

• Tap water (cold)

5

Rinse the suture-guiding cannula of the suturing forceps with 50 ml of tap water.

• 50 ml plastic syringe without Luer lock

Images

• 1 % deconex® TWIN PH10 and 1 % deconex® TWIN ZYME (v / v) in DI water

• Tap water (cold)

6

Rinse the suture-guiding cannula of the suturing forceps with 50 ml of deionised water (demineralised water).

• 50 ml plastic syringe without Luer lock • Deionised water (demineralised water)

7

The suturing forceps must be checked visually for any residues or damage. If there are still any visible residues, these should be removed using a plastic brush under running water, and the manual cleaning steps 3 to 7 should be repeated.

• Visual control

* Decontaminate brushes after use and sterilise or dispose of them. Do not use steel brushes.

Processing instructions for the Ligamys suturing forceps – 15

3.5.2 Instructions for automated cleaning and disinfection The process was carried out at Mathys Ltd Bettlach using a washer and disinfector (WD) by Miele KG (Miele Professional G7836CD) and a combined manual / automated cleaning process with the detergent and enzyme solution deconex® TWIN PH10 and deconex® TWIN ZYME by Borer Chemie AG. The cleaning basket of the WD must be equipped with a Luer lock attachment and a quiver nozzle. For correct machine cleaning, the Ligamys suturing forceps must be positioned with the front end in the quiver nozzle of the WD to actively clean the suture-guiding cannula. Furthermore, the Ligamys suturing forceps must concomitantly be connected to the Luer lock connection of the WD for optimal cleaning of the suturing forceps (Fig. 1).

Fig. 1 Mechanical cleaning via Luer lock adapter and introduction of the front end of the Ligamys suturing forceps into a quiver nozzle

16 – Processing instructions for the Ligamys suturing forceps

No.

Step

Equipment / Medium

1

The Ligamys suturing forceps is positioned with the front end in a quiver nozzle of the WD and additionally attached, with the roller housing folded up, to the cleaning basket via Luer lock adapter (see Fig. 1). Make sure the Ligamys suturing forceps is not damaged during rotation or by the rotor.

• Cleaning basket with quiver nozzle and Luer lock attachment

2

Pre-rinse

Duration: 2 minutes

• Tap water (cold)

3

Cleaning process

Dosage / Temperature: 0.5 % deconex® TWIN PH10 at 35° C (95° F) 0.2 % deconex® TWIN ZYME at 40° C (104° F)

• Enzymatic cleaner 0.5 % deconex® TWIN PH10 2 and 0.2 % deconex® TWIN ZYME 2, (v / v) in deionised water (demineralised water) 3, 4

1

Duration / Temperature: 10 minutes at 55° C (131° F) 4

Rinse I

Duration: 2 minutes Temperature: Max. 50° C (122° F)

• Tap water (cold)

5

Rinse II

Duration: 2 minutes Temperature: Max. 40° C (104° F)

• Deionised water (demineralised water) 3, 4

6

Thermal disinfection 5

Duration: 5 minutes Temperature: 90° C (194° F)

• Deionised water (demineralised water) 3, 4

7

Drying

Duration: 15 minutes Temperature: 115° C (239° F)

• Hot air

8

The suturing forceps must be checked visually for any residues or damage. If any residues are visible, the entire manual and automated process must be repeated.

• Visual control

 echanical cleaning must be carried out in a WD in accordance with the DIN EN ISO 15883 series of standards M Recommendation for exposure time, concentration, temperature and pH according to the manufacturer’s product information sheet (Dr. Weigert GmbH) 3 Water quality according to SN EN 285 4 Limit value for chemical residues taking into account the information provided by the manufacturer of the cleaning solution (Dr. Weigert GmbH) 5 If necessary, after drying in the WD the instruments must be completely dried with medical compressed air 1 2

Processing instructions for the Ligamys suturing forceps – 17

3.6 Control and maintenance After cleaning, the instruments must be completely dry and free of visible and noticeable residues. Critical areas such as handle structures, long and / or thin boreholes or blind holes, joints and complex structures must be treated with special care. To ensure that all contamination has been removed, it is of crucial importance to inspect each instrument carefully and check it for cleanliness as well as water spots (for example, lime or silicate). If any contamination should be discovered adhering to instruments, the complete manual as well as mechanical cleaning and disinfection process must be repeated immediately. Once the instrument is visually clean, it must undergo maintenance (see arrows in figure 2). For this purpose, Mathys recommends use of a care product based on paraffin / white oil that is biocompatible, suitable for steam sterilisation, and steampermeable. Alternative products must be oil-free, free of silicone oil-containing care products, suitable for steam sterilisation and biocompatible (see the «Red Brochure» by the AKI). For maintenance, the instruments must be cooled to room temperature since otherwise there would be a risk of metal abrasion. The care product must be manually applied specifically, carefully, and drop by drop to hinged or ball bearings of a snap-fit, rotating or joint mechanism and / or sliding surfaces and then distributed evenly by moving the hinges, joints, snap-fit mechanisms, or sliding surfaces. Excess care product must be removed with a lint-free cloth (the manufacturer’s instructions must be observed). «Overspraying» the instruments or immersion baths is not recommended by Mathys. Plastic surfaces must not be treated with care products. Observe the expiry date indicated by the manufacturer of the care products.

Fig. 2 Hinge mechanisms to be treated

18 – Processing instructions for the Ligamys suturing forceps

3.7 Function testing The suturing forceps must be checked for damage. In particular, the tip of the cannula must be sharp, and the forceps must be able to be closed and opened without any resistance. Rotation of the wheel on the roller housing must work properly in both directions. Also use a PDS II 2-0 thread or equivalent thread of thickness 2-0 to ensure the suture-guiding needle is completely patent. If this is no longer the case, please contact your local Mathys partner. Damage or wear that might impair the function of the instrument must be reported to your local Mathys Partner. The same will decide on repair and / or exchange of the instruments. Defects and their causes, as well as correct troubleshooting in case of damage, are shown in the table below.

Processing instructions for the Ligamys suturing forceps – 19

Defect

Cause

Examination and measure

Bent or broken cannula tips

• Improper handling

Can be successfully bent back • Continued use

• Overpacked trays Not possible to bend back or broken • Do not use instrument any longer and discard

Complete opening of the jaws not possible

• Improper handling

• Do not use instrument any longer and discard

• Overload during use • Overpacked trays

Correct

Incorrect

Complete closing of the jaws not possible

• Improper handling

• Do not use instrument any longer and discard

• Overload during use • Overpacked trays

Correct

Incorrect

Tube bent

• Improper handling

Can be successfully bent back • Continued use

• Overload during use • Overpacked trays

Knurled knob blocked

• Improper handling • Tissue residues in the roller housing

Not possible to bend back or broken • Do not use instrument any longer and discard

Successful removal of tissue residues with positive functional check • Continued use Functional check negative • Do not use instrument any longer and discard

20 – Processing instructions for the Ligamys suturing forceps