Processing instructions for the Ligamys suture forceps

Processing instructions for the Ligamys suture forceps

Table of contents 1 Scope of application 4 2 Warnings and precautions 4 5 3 Restrictions 6 4 Processing instructions 7 4.1 Processing immediately after use 7 4.2 Preparation of the detergents 8 4.3 Instructions for manual pre-cleaning 9 10 4.4 Instructions for machine cleaning 11 12 and disinfection 4.5 Inspection and maintenance 13 4.6 Packaging of individual instruments 14 4.7 Sterilisation instructions 14 15 4.8 Storage instructions 15 5 Effectiveness of processing 16 6 Useful life / Number of processing cycles 16 7 Detection of damage and its causes 17 21 8 Customer service information / Address 22 3

1 Scope of application 2 Warnings and precautions Mathys Ltd Bettlach, as the manufacturer of surgical instruments which can be reprocessed, is obligated to provide processing instructions. These processing instructions which were created based on the requirements of ISO 17664, apply specifically to Ligamys suture forceps of Mathys Ltd Bettlach. The chemical parameters of the process as well as the equipment listed in the following processing instructions are recommendations resulting from the findings of the validation process for instrument processing of Mathys Ltd. The processor is responsible for ensuring that the processing that is actually performed with the individual equipment, process chemicals and personnel in the processing facility achieves the desired results. The same chemicals, parameters, and same technical equipment as in the validation method of Mathys Ltd do not necessarily have to be used. Equivalent or alternative products may be used with which a successful validated cleaning and sterilisation process can be proven as a result. If your hospital has a method that is already established and validated and which is proven to lead to the desired result, there is no need for your hospital to change the method. Personnel coming into contact with potentially contaminated or contaminated surgical instruments must implement the generally acknowledged precautions. Special care is required when handling instruments with pointed parts or sharp edges. Personal protection equipment (overall, mask, safety goggles, visor, gloves, shoes, shoe covers, etc.) is necessary in order to avoid contact with contaminated or potentially contaminated materials, instruments and products. Low-foaming detergents should be used for manual cleaning procedures in order to ensure visibility of the instruments. When cleaning manually with brushes, it is recommended that the instruments should be held constantly below the surface of the cleaning solution. This will ensure that no aerosols will form and avoid splashes that could spread contaminating substances. In order to avoid the accumulation of residues of detergents, all detergents must be removed completely from the product surfaces. 4

Heavy objects may not be placed on top of delicate products. Do not allow contaminated instruments to dry before reprocessing them. This is important, since all the steps described below for cleaning and sterilisation will be facilitated where blood, bodily fluids, bone and tissue residues as well as saline solution or disinfectants are not allowed to dry onto the surfaces of used instruments. time recommended by the manufacturers should be observed under all circumstances. Mathys Ltd Bettlach recommends using detergents with a ph of < 9.5. For machine cleaning, the indications provided by the machine and detergent manufacturers must be complied with. When loading the cleaning trays and baskets, it should be ensured that instruments do not damage each other and that they can be easily rinsed all around. The chloride and iodide ions contained in detergents and disinfectants cause pitting corrosion. For this reason, contact of the instruments with these ions must be kept as brief as possible. Rinse the instruments thoroughly with regular water and then distilled water in order to remove all residues. Never leave wet instruments to stand. Rather, dry them immediately. The condensation of moisture resulting from sterilisation can be avoided by extending the drying phase. Strong acid or alkaline detergents or overly high doses can attack and destroy the protective passive layer of the instruments or markings. The concentration and exposure 5

3 Restrictions Patients who, in view of prion diseases such as Transmissible Spongiform Encephalopathy (TSE) or variant Creutzfeldt-Jakob Disease (vcjd) and the associated infections, are considered to be a risk must therefore be operated on using disposable instruments whenever possible. When using instruments that can be reprocessed, it is recommended that the entire cleaning procedure be repeated at least twice. WARNING: It is of the utmost importance that alkaline detergents should be completely neutralised and rinsed thoroughly off the instruments. The suture forceps should be carefully inspected after cleaning. In doing so, the functionality of the forceps should be checked. It should be ensured that the tip of the cannula of the suture forceps is sufficiently sharp for use and that it was not damaged during cleaning. A guide wire must be used to check whether the cannula is completely free If in your opinion this is no longer the case, contact your local Mathys partner. Mathys Ltd Bettlach recommends choosing a cleaning agent with added enzymes to decompose blood, bodily fluids and tissues. Please note that some enzyme solutions are intended specifically for decomposing faecal matter or other organic contaminating substances, and are therefore not suitable for cleaning surgical instruments. There are no restrictions preventing repeated processing of Mathys Ltd Bettlach s instruments, since this has a limited impact on the useful life of the instruments. Their useful life is defined as a rule by wear and damage resulting from use. The use of hard water ( dh value > 14) should be avoided. For initial rinsing, soft tap water is suitable, followed by thoroughly rinsing with distilled water (conductivity < 5 microsiemens) in order to remove all residues. Ordinary water often contains high concentrations of minerals (e. g. chalk or silicic acid) which appear as sharply delimited stains on the instrument surface. TIP: Instruments should never be left wet but dried immediately. 6

4 Processing instructions 4.1 Processing immediately after use First of all, any remaining bodily fluids and tissues must be wiped off the instruments with a lint-free disposable cloth. Then the instruments must be placed in a bowl with distilled water or covered with damp cloths so that tissues and bodily fluids do not dry out. Saline solution, blood, bodily fluids, tissues, bone residues or other organic particles must be removed as soon as possible from instruments before cleaning. Optimum cleaning is ensured if the instruments are cleaned within 30 minutes after use, in order to minimise the risk of substances and materials drying on their surfaces. In order to prevent contamination, used instruments must be taken to the Main Procurement Department in closed or covered containers. TIP: Soaking instruments in proteolytic enzyme solutions facilitates cleaning, particularly in the case of instruments featuring complex shapes and areas difficult to access (e. g. cannulated and tubular designs, and so on). The enzyme solutions break down the substances containing proteins and thus prevent materials containing blood and proteins from drying on the instruments. WARNING: Always strictly follow the manufacturer s instructions for preparing and using the solutions. 7

4.2 Preparation of the detergents The concentration, temperature and exposure time for the cleaning agents recommended by the manufacturers must be observed under all circumstances to achieve optimal cleaning. Treatment with a neutralising agent and thorough rinsing are absolutely necessary after treatment with alkaline agents. The Ligamys suture forceps must be treated in a twostage cleaning procedure, first a manual cleaning followed by machine cleaning, in order to obtain the necessary cleaning results. When using dry detergents in powder form, it is necessary to make sure that the detergents are completely dissolved before use to avoid discolouration or corrosion of the instruments. Very dirty cleaning solutions (containing blood and / or that have become cloudy) must be replaced with freshly prepared solutions. 8

4.3 Instructions for manual pre-cleaning No. Step Equipment / Medium 1 Mechanical removal of all visible contaminations with a synthetic brush* under running water (cold) until all visible residue has disappeared. Synthetic brush Running water, cold 2 Flush the suture-guiding cannula of the suture forceps with 50 ml cleaning solution that contains enzymes. Ensure that liquid visibly flows out of the tip of the cannula (see Fig. 1). If the cannula is blocked by fragments of tissue, the roller housing must be folded up and the cannula must be flushed by directly applying a syringe (see Fig. 2). Once again, ensure that liquid visibly flows out of the tip of the cannula. If there is no flow of liquid, the suture forceps should not be used and must be replaced. Plastic syringe without Luer lock deconex TWIN PH10 and deconex TWIN ZYME (Bohrer Chemie AG), each 1 % (v / v) in distilled water 3 The pre-rinsed suture forceps are treated with ultrasound in the combined cleaning agent / enzyme solution in an ultrasonic batch (30 60 khz) for 30 minutes at approx. 37 C. It should be ensured that the forceps are completely covered with the cleaning agent. Ultrasound bath (30 60 khz) deconex TWIN PH10 and deconex TWIN ZYME (Bohrer Chemie AG), each 1 % (v / v) in distilled water 4 Rinse the suture forceps well under running water. Running water, cold 5 Flush the suture-guiding cannula of the suture forceps with 50 ml tap water. 50 ml plastic syringe without Luer lock Running water, cold 9

6 Flush the suture-guiding cannula of the suture forceps with 50 ml distilled water. 50 ml plastic syringe without Luer lock Running water, cold 7 The suture forceps should be checked visually for any residues or damage. If residues are still visible, these should be removed using a synthetic brush under running water and manual cleaning steps 3 to 7 should be repeated. * Brushes must be decontaminated and sterilised or disposed after use. Do NOT use steel brushes. Visual inspection Possibly synthetic brush Running water, cold Fig. 1: Flushing the cannula through the roller housing Fig. 2: Direct flushing of the cannula after folding up the roller housing. To fold up: Twist and pull on the knurled metal knob 10

4.4 Instructions for machine cleaning and disinfection It is recommended that cleaning be performed using professional cleaning and disinfection equipment, e. g. Miele G7836CD. The cleaning basket must have a Luer lock attachment so that the suture forceps can be inserted. No. Step Conditions / Medium 1 The suture forceps with the roller housing folded up are secured to the cleaning basket using a Luer lock adapter (see Fig. 3). Ensure that the forceps are not damaged when tilted or by the rotating parts of the washing machine. 2 Pre-rinse 1 Water quality: Duration: Temperature: 3 Cleaning process Dosage: Cleaning basket with Luer lock attachment Water quality: Duration: Temperature: 4 Intermediate rinse I Water quality: Duration: Temperature: Mains water 2 minutes Cold 0.5 % deconex TWIN PH10 at 30 C and 0.2 % deconex TWIN ZYME at 40 C (Bohrer Chemie AG) Distilled water 10 minutes 55 C Mains water 2 minutes 50 C 11

5 Intermediate rinse II Water quality: Duration: Temperature: 6 Rinsing and thermal disinfection Water quality: Duration: Temperature: 7 Drying Duration: Temperature: 8 The suture forceps should be checked visually for any residues or damage. If residues are visible, the entire manual and machine process should be repeated. Visual inspection Distilled water 2 minutes 50 C Distilled water 10 minutes > 90 C 15 minutes 115 C Fig. 3: Machine cleaning via Luer lock adapter 12

4.5 Inspection and maintenance In order to make sure that all dirt has been removed, top priority must be given to checking each suture forceps carefully. Should any dirt be discovered sticking to any instruments, the entire cleaning / disinfection process must be repeated without delay. The suture forceps should 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. Apply maintenance products specifically: The joint mechanisms identified with a blue arrow in Fig. 4 should be treated with small drops of paraffin / white mineral oil-based lubricant according to the EU Pharmacopoeia, e. g. with InstruCare from Laboratorium Dr. Deppe GmbH (without silicone, biocompatibility guaranteed, can be steamsterilised and is steam-permeable, physiologically safe according to DAB and 31 LMBG). Be aware of the expiry date indicated by the manufacturer for the stored concentrations diluted for use. Damage or signs of wear that might have a negative impact on the functioning of the instrument must be reported to your local Mathys partner. He / she is responsible for deciding whether to repair and / or replace instruments. Fig. 4: Joint mechanisms to be treated 13

4.6 Packaging of individual instruments 4.7 Sterilisation instructions The suture forceps can be sterilised using steam sterilisation. It is recommended to place the suture forceps in the instrument set holder and pack the entire basket either in a special bag or container suitable for steam sterilisation (e. g. paper bag according to DIN EN 868-5, heat- and self-sealing transparent bags, or other equivalent material). WARNING: If sterilisation fleece is used, this must be free of any residues of detergents. Mathys Ltd Bettlach advises against re-usable fleece. The hospital is responsible for the in-house procedures for implementing all the steps specified above in order to guarantee complete penetration of the sterilising steam through the instruments. The hospital must furthermore implement protective measures with regard to sharp or potentially dangerous places on instruments. Instructions given by the manufacturer of the sterilising equipment must always be followed. If several instrument sets are sterilised in one and the same sterilisation cycle, the maximum capacity of the sterilising equipment as specified by the manufacturer may not be exceeded. For optimum sterilisation the instrument sets must be properly prepared and packed tidily in the instrument trays and containers provided for this purpose. Only if this is done can the steam spread and penetrate so as to reach all the surfaces. In case of steam sterilisation, it must be ensured that the product is completely dry after sterilisation. 14

4.8 Storage instructions National recommendations / guidelines for sterilising instruments must be followed in all cases. The following steps at least must be taken (e. g. Zirbus Autoclave LSA 346): The following sterilisation steps are recommended: No. Step Conditions 1 Vacuum Pressure: < 120 mbar 2 Steam Duration: Temperature: Duration: Temperature: 3 Dry Pressure: Duration: 18 minutes 134 C 3 minutes * 134 C < 120 mbar 10 minutes 4 Cool Temperature: at room temperature The packaged and sterile instruments must be stored in a dry and cool room, protected from dust, insects, vermin and direct sunlight. The room may be accessed by authorised personnel only. The equipment for storage and transport must be designed in such a way as to avoid any muddling, overloading or falling of items. Sterile medical products may never be stored directly on the floor. The instruments will be used in order of arrival of the goods, and the sterile packaging must be checked very thoroughly to ensure that it is intact before it is opened. WARNING: Should the packaging or a sterile fleece have ecome torn, punctured, visibly damaged or damp, the instrument set must be repackaged and re-sterilised. Also, if there are signs on a sterilisation container that the lid seals or filters have been opened or damaged, the instrument set must be re-sterilised and the sterile filter replaced. In the case of reusable filters, these must undergo a thorough visual inspection. * Process for UK 15

5 Effectiveness of processing 6 Useful life Number of processing cycles The processing method recommended in the present processing instructions has been reviewed by an external laboratory. The results with regard to both limiting and guidance values for protein residues meet the requirements of the guideline by DGKH, DGSV and AKI for machine cleaning and thermal disinfection processes for medical products (5.2.3.1.4 Assessment, 3 rd edition, 2008). The useful life of the Ligamys suture forceps is defined as a rule by wear and damage resulting from use. The user is responsible for checking optimal functionality (cutting sharpness, cleanliness, corrosion) before each use. 16

7 Detection of damage and its causes Defects and their causes as well as correct trouble-shooting in the event of damage are shown in the following table. Defect Cause Examination and measure Bent or broken cannula tips Improper handling Overpacked trays Can be successfully bent back Continued use Not possible to bend back or broken Do not use instrument any longer and discard Complete opening of the jaws not possible Improper handling Overload during use Overpacked trays Do not use instrument any longer and discard Correct Incorrect 17

Defect Cause Examination and measure Complete closing of the jaws not possible Improper handling Overload during use Overpacked trays Do not use instrument any longer and discard Correct Incorrect Tube bent Improper handling Overload during use Overpacked trays Can be successfully bent back Continued use Not possible to bend back or broken Do not use instrument any longer and discard 18

Defect Cause Examination and measure Knurled knob blocked Improper handling Tissue residues in the roller housing Successful removal of tissue residues with positive functional check Continued use Functional check negative Do not use instrument any longer and discard Luer connection damaged Improper handling Overpacked trays Damage due to being dropped Connection can no longer be attached Do not use instrument any longer and discard 19

Defect Cause Examination and measure Labelling no longer legible Worn off due to use Fading due to the cleaning process, cleaning agents and sterilisation procedure Article number, lot and CE marking can still be read Continued use Article number, batch or CE marking can no longer be read Do not use instrument any longer and discard Corrosion Unsuitable cleaning agents Excessive time spent in cleaning agents and disinfectants Improper processing Do not use instrument any longer and discard 20

Defect Cause Examination and measure Organic residues Unsuitable cleaning agents and disinfectants Residues allowed to dry for too long prior to processing Insufficient brushing, rinsing during manual pre-cleaning Repeat the processing If repeat processing is not successful Do not use instrument any longer and discard Water spots (lime or silicate deposits) Poor water quality Rinsing with distilled water not performed Penetration of cleaning agents containing silicate Repeat the processing 21

8 Customer service information address Mathys Ltd Bettlach Robert Mathys Strasse 5 P. O. Box 2544 Bettlach, Switzerland Tel. +41 32 644 1 644 Fax +41 32 644 1 161 info@mathysmedical.com www.mathysmedical.com 22

Mathys Ltd Bettlach Robert Mathys Strasse 5 2544 Bettlach P. O. Box Switzerland Tel. +41 32 644 1 644 Fax +41 32 644 1 161 info@mathysmedical.com www.mathysmedical.com Item no. 336.060.006 01-0914-03 2014-09 Mathys Ltd Bettlach