Reprocessing of surgical instruments

Reprocessing of surgical instruments

Reprocessing of surgical instruments Reprocessing Reprocessing Content 1 2 5... Introduction 6 7... Pre-treatment Microsoft Tag Readers Thanks to the Microsoft Tag Technology, anyone owning a smart phone (Android, Blackberry or iphone) can now play videos featuring selected Komet products. The service is easy to use: All you need to do is go to your phone s Internet Browser, type in the link http://gettag.mobi and follow the directions. Once the software has been uploaded, you can scan the tags. Komet goes YouTube http://www.youtube.com/unser/kometonline - our video on instrument reprocessing can now be accessed and played on YouTube under this address. A film is worth a thousand words so subscribe now and learn more about the professional use of our instruments! 8 13 9 10 11 13 14 15 16... Cleaning and disinfection... Manual cleaning/disinfection... Mechanical cleaning/disinfection... Drying/control... Packaging 17... Sterilisation/storage 18 19... Regrinding 20 21... Troubleshooting Some of the products and designations mentioned in the text are patented or copyrighted. The absence of a special reference or the sign should not be interpreted as the absence of copyright protection. This publication is copyrighted. All rights, also with regard to translation, reprint and reproduction, also in the form of extracts, are reserved. No part of this publication may be reproduced or reprocessed using electronic systems in any form or by any means (photocopying, microfilm or other methods) without the written permission of the editor. Colours and products are subject to alterations. Printing errors excepted. As at August 2011

Manufacturer: Products: General information: Limited number of reprocessing cycles: Work station: Hygienic precautions according to the provisions valid in your country. Storage and transport: Immerse instruments in a suitable detergent/disinfectant (alkaline, aldehyde-free) immediately after use in the mouth to prevent residues from drying on the instru- ments (protein fixation). It is recommended to reprocess the instruments within T 100 one hour of use at the very latest. C 90 80 70 60 55 50 40 30 KOMET MEDICAL 20 GEBR. BRASSELER GmbH & Co. KG t Trophagener Weg 25 32657 Lemgo Fig.1 Diagram of the program sequence of Vario TD-programme Tel.: +49 (0)5261 701-400 Fax: +49 (0)5261 701-580 Manual pre-cleaning: Equipment: Plastic cleaning brush, info@kometmedical.de KOMET DC1 (KOMET MEDICAL, ref. no. 9829/alkaline, free of aldehyde, approved www.kometmedical.de by the German Association Control for and Hygiene functional and Microbiology test: (DGHM/VAH). Check the instruments visually for possible damage and wear. Blades should be even and free of nicks (the use of magnifying glasses is recommended). 1. Immerse saw blades in KOMET DC1 for at least 5 minutes. The present manufacturer s information applies to all reusable 2. saw Brush blades saw supplied blades until no more visible contamination is left. In saw blades with I by Gebr. Brasseler. structured surface Packing: (for example EZblades), not only the teeth Single but also pack: the Standardised spaces I packing material can be used. The bag must be large Disposable products (marked = on the packaging) may not be reused. on the The surface reuse of of the I blade should be brushed. enough for the instrument I to ensure that there is no pressure on the seal. these products poses a risk of infection and/or the safety of the 3. products Rinse with can cold no tap water. I In the set: Place instruments onto the tray provided or onto universal sterilisation longer be guaranteed. I trays. The instruments must be protected. Use an appropriate method to pack the tray. Instruments delivered Mechanical in non-sterile cleaning: condition have to be prepared Washer prior to disinfector first use. (co. Miele, with Vario TD-programme*) Equipment used: deconex 28 ALKA ONE (co. Borer Zuchwil/alkaline) Sterilisation: Steam sterilisation using a fractionated vacuum process at 134 C in a device that * Should the Miele washer disinfector be unavailable, Please follow the recommendations and instructions provided by the please manufacturer observe the parameters of the Vario TD-program sequence (see fig. 1) complies with the provisions of EN 285; with validated processes. of the washer disinfector and the autoclave. 1. Immediately before mechanical reprocessing, rinse instruments 1. Fractionated thoroughly pre-vacuum (4 x) under running water to prevent any residues of detergent/disinfectant 2. Sterilisation from temperature: 134 C 3. Hold time: 5 minutes (full cycle) The end of a product s service life depends on its degree of damage getting and wear. into the Do machine. I 4. Drying time: 10 minutes not exceed the permitted number of uses, if this is known. 2. Start the Vario TD-programme I (for diagram of program sequence see fig. 1) In order to prevent staining and corrosion, the steam must be free of particles. Frequent reprocessing does not affect the performance of these instruments. including thermal disinfection. The recommended limits for particle contents in feed water and condensed steam The cleaning procedure is carried out following the below pattern: are defined by standard EN 285. 4 minutes pre-wash with cold water Emptying Plasma sterilization: Sterilizer r Sterrad 100S. The procedure is carried out according 6 minutes pre-wash with deconex 28 Alka One (co. Borer to Zuchwil) a fixed at pattern. 55 C Emptying Make sure not to exceed the maximum capacity of the sterilizer when sterilizing 3 minutes neutralisation with warm tap water (>40 C) several instruments (follow the instructions of the device manufacturer). Emptying 2 minutes intermediate rinse with warm tap water (>40 C) Emptying Storage: The saw blades must be protected from dust, moisture and recontamination during Thermal disinfection takes place allowing for the A storage. 0 value and observing national provisions Universally (pren/iso valid 15883) notes: Observe the legal provisions regarding the reprocessing of medical products valid in 3. Remove any residual moisture from the instruments with filtered your compressed country (e.g. www.rki.de) Saw blades Page 1 of 3 air, which does not lead to recontamination. The manufacturer confirms that the above detailed reprocessing methods are suit- If after mechanical reprocessing there are still visible residues of able contamination for reprocessing the above named instrument group to enable their reuse. left on the instrument, repeat the cleaning and disinfecting process The until reprocessor no visible is responsible for ensuring that the applied method is carried out contamination is left. The disinfectant deconex 28 ALKA ONE with can appropriate be used for equipment and materials and by trained personnel at the reprocess- this, provided that the instructions on the label are observed. ing site and that it actually achieves the desired result. To guarantee this, validations and routine controls of the process are necessary. Any deviation from the above Saw blades Page 2 of 3 detailed method (e.g. use of different chemicals) must be carefully checked by the operator to ensure effectiveness and to avoid possible adverse consequences. Marking of modifications: Modified text passages that differ from the previous version are marked with a vertical line ( ) at the page margin. Saw blades Page 3 of 3 2 Reprocessing Reprocessing 3 Manufacturer s information on the reprocessing of re-sterilisable instruments according to DIN EN 17664 As at: 07/10 Revision: 4 Saw blades Pre-wash Cleaning Neutralisation Neutralisation Intermediate Intermediate rinse rinse Disinfection Disinfection Drying Validated reprocessing procedure Reprocessing Manufacturer s information on valid reprocessing 07/2010 GEBR. BRASSELER Germany Printed in Germany BRA/0 403242V4 Hygienic reprocessing of reusable KOMET MEDICAL products KOMET MEDICAL products are made of high-grade materials and are developed, constructed and manufactured with the greatest of care. Successful reuse and excellent work results can only be achieved by appropriate usage and gentle cleaning and disinfection of the instruments. Successful reuse means handling the instruments with the greatest of care. The objective of this guideline on the reprocessing of KOMET MEDICAL products is to protect patients, surgeons and nursing staff from infections caused by contaminated instruments. It is therefore absolutely essential to carry out each individual step of the reprocessing procedure with the utmost care. Another decisive factor is that surgical support staff and CSSD (Central Sterile Supply Department) personnel work closely together, to ensure that the instruments are reprocessed in a quick and efficient manner and are made available once again at the required time. Validated processes to ensure a reproducible result. The information provided by KOMET MEDICAL on validated reprocessing is applicable to its entire product range. This can be downloaded from our website www.kometmedical.de. A revisable result can be achieved with these validated procedures, thus providing increased protection from infection for both patients and operators. According to 4, section 2 of the German Medical Devices Operator Ordinance (see below), all operators of medical devices are obliged to use a validated method for the reprocessing of instruments. 4 (Maintenance) of the German Medical Devices Operator Ordinance (2) The reprocessing of medical devices that are to be used in a low-germ or sterile condition depending on the respective application is to be carried out using a suitable validated method in line with the manufacturer s instructions, so that the success of these methods is guaranteed and traceable and the health and safety of patients, operators and third parties are not at risk.

4 Reprocessing Reprocessing 5 storage instruments delivered in a sterile condition use T pre-treatment instruments delivered in a non-sterile condition sterilisation cleaning/ disinfection packaging T control drying Reprocessing Correct reprocessing is a decisive factor for a successful operation. All KOMET MEDICAL instruments are classed critical B, which is why they have to undergo a mechanical cleaning and thermal disinfection cycle, followed by steam sterilisation 1. The CSSD is required to treat the instruments in a quick and efficient manner and to return them on time for the next operation in a clean and sterile condition. Any delay could jeopardise the entire schedule of the operation. The use of validated methods is absolutely essential as these produce identical results every time. Any time saved by neglecting the instrument control would soon be lost due to extra time needed during the operation. Surgical support staff and CSSD have to work as a team. At the end of a surgical intervention, the instruments are handed over to the CSSD where they will be reprocessed according to a predefined cycle. The reprocessing can either be done in the hospital itself, in an attached CSSD or at an external reprocessing unit. Irrespective of where the reprocessing takes place, it is of the utmost importance that the instruments be prepared properly in the operating theatre. The instruments have to be placed into the correct sieves. Heavy instruments should not be stored on top of light, delicate instruments. Any instruments that are unfit for reuse should be transported separately, ready for immediate disposal. For successful reprocessing, the following general rules should be followed: The instruments should be handled with the greatest of care both by the surgical support staff and the CSSD Use of validated procedures Use of suitable detergents and disinfectants Critical evaluation of the instruments suitability for further use Use of a suitable reprocessing method Reprocessing Operation Reprocessing Marking on the label: = Operation Operation Reprocessing Operation Reprocessing All instruments delivered in a nonsterile condition n have to undergo the entire reprocessing cycle. After delivery, they should be forwarded to the CSSD. Instruments marked can be accepted directly by the surgical ward and placed into storage ready for immediate use (see fig. 1). All disposable products (=) have to be discarded after the operation. Any instruments that are delivered in a sterile condition and are not marked = can be conveyed to the normal reprocessing cycle after the first operation and reprocessed until they come to the end of their service life. During use and reprocessing, treat reusable instruments with due care. Careless handling might cause damage that prevents the reuse of the instruments. Instruments that are used as a lever during the operation might bend and run out-of-true. As a result, excessive amounts of tissue would be removed during the next operation. Light or sensitive instruments might lose their shape if they are stored under heavy hand pieces. Reusable instruments that are treated like disposable instruments don t last very long. 1 German magazine: Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 11-2001 Hygienic requirements during the reprocessing of medical devices: Recommendation of the commission for hospital hygiene and infection prevention of the RKI and the BfArM regarding the Hygienic requirements during the reprocessing of medical products, page 1116-1119 Fig. 1: Instrument path depending on the marking The number of reuses depends on the loads applied to the instrument during the operation and during reprocessing. After each cleaning and disinfection cycle, the instruments must be checked for mechanical damage, in which case they have to be discarded immediately. Imperfect instruments can considerably prolong the time needed for surgery, they can also considerably impair the quality of the operation. These factors cost money, which is why damaged instruments should not leave the CSSD. For more information, turn to page 20. To fully benefit from the saving potential of reusable instruments, these must be treated with the utmost care so that they can be reused as often as possible. Although each extra use incurs costs for reprocessing, the expense of purchasing another instrument and the administrative costs for ordering, delivery and storage can be saved.

6 Pre-treatment Pre-treatment 7 Pre-treatment Pre-treatment of the instrumentation should already start in the operating theatre. During use, the instruments are contaminated with blood, tissue remnants and saline solution. The chlorides in the solution attack the surface of the steel instruments. Large remnants of tissue should therefore be removed prior to transport to the CSSD. In principal, it is advantageous to forward contaminated instruments to the reprocessing site as soon as possible, to prevent drying of the contamination. There are two types of transport to the CSSD. The instruments are either collected in instrument trays after use and transported to the CSSD (dry transport) or they are immersed in a solution containing detergent/disinfectant during the transport in order to prevent the contamination on the instruments from drying (wet transport). Make sure that the instruments do not suffer any mechanical damage during storage, i.e. delicate instruments should not be stored under heavy hand pieces. Wet transport should be given preference over dry transport. We recommend that the instruments be transported to the CSSD in a wet condition, to prevent the contamination on the instruments from drying. The combined detergent/disinfectant should contain an anticorrosive agent to prevent the formation of rust. This type of transport has the added advantage that the use of detergents/disinfectants protects staff from infections and prevents the transmission of pathogens. For added safety, protective clothing as well as safety glasses and suitable gloves have to be worn to prevent infection 2. In those cases where dry transport is chosen, the instruments have to be forwarded directly to the CSSD to avoid long waiting times. Dried contamination is difficult to remove and might cause corrosion. The correct method of disposal has to be chosen for single-use instruments. After the operation, these are not conveyed to the reprocessing cycle but thrown away. In this case, the only aspect to be considered is the protection of the staff from infection. The instrument does not have to be preserved, which is why the wet transport method is to be given preference. GENIUS Shaver Blades: GENIUS Shaver Blades must be stripped down into their components during transport in the instrument tray in a wet condition. In the case of the GEXXXX.AC, just pull the inner tube out of the outer tube to separate the components, whereas with models GEXXXX.LI, GEXXXX.DY and GEXXXX.ST, the adapter has to be pulled off the inner tube as well. During dry transport, the instruments remain in an assembled condition. The unique three-part design of the KOMET MEDICAL GENIUS Shaver Blades allows the inner tubes of all Shavers to be cleaned with plastic brushes. The distinctive construction also enables a visual control of the inner tube, allowing any residual contamination to be detected prior to sterilisation, in which case the instrument has to undergo another cleaning cycle. 2 RKI recommendations: Hygienic requirements during the reprocessing of medical devices, German magazine: Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2001, 44:1115-1126, Springer Verlag 2001, Page 1121

8 Cleaning and disinfection Manual cleaning and disinfection 9 Cleaning and disinfection Manual cleaning and disinfection The combined pre-cleaning/disinfection process is followed by a cleaning cycle in the CSSD to remove bulk contamination from the instruments. The next step is another disinfection cycle in order to completely disinfect hidden areas that were previously covered by encrusted contamination. Any chemical disinfectant used must be approved for manual cleaning and disinfection and be effective as per points A and B below. A: Killing of vegetative bacteria including mycobacteria, fungi and their spores. B: Deactivation of viruses. C: Killing of bacterial spores, including the pathogens of anthrax. D: Killing of bacterial spores, including gas gangrene and tetanus (To kill these spores, make sure to use sterilisation procedures that comply with the relevant standards). 3 All KOMET MEDICAL products have to be cleaned and disinfected according to a mechanical procedure using alkaline detergents. Thermal disinfection observing the A 0 value should be given preference over chemical disinfection. We recommend pre-cleaning the blades of our instruments with the help of a plastic brush. Metal brushes can leave undesirable scratches on the surface of the instruments. The knee saw blades should undergo an extra cleaning step by brushing their entire surface. This is because due to their special structure, contamination might deposit in the gaps. For final rinsing, we recommend demineralised water. If the instruments have to be immersed in a combined cleaning/disinfecting solution prior to cleaning and disinfection, they can be placed in an alkaline-based bath (with anticorrosive protection). The cleaning performance of alkaline agents remains almost constant even in the case of varying degrees of water hardness. We recommend changing the solution every day or more frequently in the case of heavy contamination, since this might lead to a decrease in the disinfecting effect. In addition, a severely contaminated solution might cause corrosion of the instruments or lead to the displacement of impurities. The same risk exists if the concentration of the solution does not comply with the manufacturer s instructions. 3 German magazine: Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2007 50:1335 1356 DIO 10.2007/s00103-007-0341-4, Springer Medizin Verlag 2007, Page 1335

10 Manual cleaning and disinfection Mechanical cleaning and disinfection 11 Mechanical cleaning and disinfection GENIUS Shaver Blades: The GENIUS Shaver Blades must always be subjected to a manual pre-cleaning cycle, which entails the Shaver Blades being stripped down to their component parts. First of all, superficial contamination must be rinsed off thoroughly. The next step is cleaning the inner and outer tubes by means of plastic brushes with a suitable diameter and an appropriate detergent and disinfectant (e.g. Komet DC1). The final rinse should be carried out with the help of the GENIUSadapters which were specially developed by KOMET MEDICAL for this very purpose. The Luer-Lock connection at the GENIUSadapter allows the use of a water gun for subsequent rinsing of all blades or trocars with lateral bore hole. Ultrasound can be used to improve the cleaning effect. Ultrasonic treatment constitutes a mechanical treatment supplementary to manual cleaning and is recommended for particularly stubborn contamination of the instruments as well as sensitive and hardto-access instruments. For correct dosage of the detergents and length of exposure please refer to the instructions provided by the manufacturer. The following parameters must be given for a successful ultrasonic treatment: - The instruments must be fully immersed in the solution. - Change the solution according to the degree of contamination in order to minimise the risk of corrosion. - The mesh trays used must not jeopardise the ultrasonic effect. - Do not overload the mesh trays. - The instruments must not be allowed to come into contact with each other, in order to prevent damage to the blades. - Clean specially marked instruments separately. Once the treatment is completed, rinse instruments first under clear, running water and then with fully demineralised water. Failure to do so may lead to corrosion. As a basic principle, mechanical cleaning and disinfection procedures should be preferred over manual cleaning and disinfection. This is because validated processes guarantee identical results every time, whereas the quality of manual cleaning depends on human performance which can vary considerably from person to person. Detergents should be alkaline but free of aldehydes! KOMET MEDICAL products can be reprocessed with any detergent and disinfectant with proven material compatibility. The detergents should be alkaline-based and free of aldehydes, to avoid protein fixation on the material - we recommend deconex 28 ALKA ONE (made by the co. Borer Zuchwill, alkaline). All KOMET MEDICAL instruments are unsuitable for cleaning and disinfection in the chemical disinfector! We advise against the use of hydrogen peroxide for KOMET MEDICAL GENIUS Shaver blades and Tungsten Carbide instruments. We recommend using the gentle cycle (e.g. Vario TD) of a washer/disinfector. Please follow the instructions below: - Fill the washer/disinfector after validation in the CSSD - Do not overload the mesh trays - Arrange the instruments in such a way that they are accessible from all sides and no damage can occur - Do not obstruct the movement of the flexible parts of the washer/disinfector At the end of the ultrasonic treatment, the instrument can be prepared for the mechanical cleaning and disinfection in the washer/disinfector. All KOMET MEDICAL instruments are suitable for mechanical reprocessing.

12 Mechanical cleaning and disinfection Mechanical cleaning and disinfection 13 Thermal disinfection must take place under consideration of the A 0 value and in compliance with the relevant national provision (pren/iso 15883). Avoid temperatures of more than 55 C during the cleaning cycle to prevent the risk of protein fixation. To avoid pitting corrosion caused by an excessive chloride content of the water, we recommend rinsing the instruments with fully demineralised water. A validated procedure for the reprocessing of KOMET MEDICAL instruments can be downloaded from our website www.kometmedical.de at any time. The procedure illustrated on our website shows that after validated reprocessing, KOMET MEDICAL instruments are returned in a perfectly clean and sterile condition, ready for reuse. GENIUS Shaver Blades: The new GENIUSadapters allow validated cleaning of the GENIUS Shaver Blades in the cleaning/disinfecting device. The direct water connection provided by the GENIUSadapters guarantees an even and thorough flushing of the Shaver Blades, so that no traces of contamination are left after rinsing. A description of the validated method can be downloaded from our website www.kometmedical.de. To use the GENIUSadapter with three-part GENIUS Shaver Blades, the fixture of the blade must be connected to the inner tube. The GENIUS Shaver Blades are firmly fixed to the GENIUSadapters and then joined to the cleaning/disinfecting device via the Luer-Lock connections. For more detailed information, refer to the assembly instructions which are included with the new GENIUSadapters! Discolorations caused by residual detergent during the thermal phase in the washer/disinfector can be prevented by using a neutraliser.

14 Drying Control Control 15 Drying Control Drying after manual cleaning and disinfection and, if applicable, ultrasonic treatment should be effected by means of medically pure compressed air. This gentle, yet efficient method is preferable to any other drying method. At the end of each cleaning and disinfection cycle, the instruments must be subjected to a visual inspection and to a functional test in order to make sure that they are macroscopically clean. Damaged instruments must be discarded to prevent the reuse of blunt or damaged tools in the operating theatre. This visual control is absolutely essential for any instrument that affects the result of the operation. A blunt, corroded or contaminated instrument can damage or infect healthy tissue. The operation might even have to be interrupted while a spare instrument that is fit for use has to be found. The visual inspection is as important as cleaning, disinfection and sterilisation! Instruments that are not totally clean must undergo another cleaning and disinfection cycle. Damaged instruments always have to be discarded. The same applies to discoloured instruments in most cases. The following factors decide whether an instrument is fit for reuse or if it has to be recleaned or even discarded: Shape: Due to bent tubes, the instrument cannot be chucked properly into the power system and vibration-free operation cannot be guaranteed. Surface: - Nicks on blades, shanks, saw blades, inner or outer blades of GENIUS Shaver Blades etc. - Blank, non-coated areas on diamond instruments - Blunt instrument due to excessive abrasion - Residues of corrosion are to be removed in a special cleaning cycle. If the corrosion of an instrument is so far advanced (i.e. pitting corrosion) that its resistance to fracture can no longer be guaranteed, it has to be disposed of. Functional capability of Shaver Blades: The inner blade or the inner tube with the cutter must always rotate inside the outer blade with ease. If this is not the case, check if the preceding cleaning step has been successful ( subsequent cleaning) or if there is any damage to the material ( disposal). Discoloration of the material: Discoloration is not a sign of reduced quality, however it indicates - that certain procedures are not suitable for the respective instruments. - that there were contaminations present during the preceding procedures, i.e. residues of medicaments and detergents. - non-conforming treatment such as the omission of the pre-cleaning step, for example in case of new instruments, or inappropriate storage. Fading of the anodic coating of bur blocks or Shaver Blades does not constitute a reduction in quality. Exception: Black discoloration in Tungsten Carbide instruments. For detailed information on the above, please go to pages 20/21. To ensure proper control you can download our check list CSSD Shaver Blades from our website! GENIUS Shaver Blades should always be completely replaced, i.e. both inner and outer tube. Partial replacement of individual components must be avoided under any circumstances. During production, we take great care to ensure that the two tubes fit perfectly inside one another. Interchanging the tubes will lead to undesirable friction. Check list of the Sterile Services Department - GENIUS Shaver Blades* A visual control and a functional test must be carried out at the end of each cleaning and disinfecting process to ensure that the instruments are macroscopically clean and that damaged instruments are discarded before being reintegrated in the preparation cycle (see reverse of page). The characteristics listed below determine the next step, i.e. Packing An additional cleaning cycle Cleanliness Surface Form and Function Inspection Magnifying glass, 8 times magnified Visual control; Magnifying glass if necessary, 8 times magnified Functional test: The outer tube of the Shaver Blade is locked onto the inner tube and set in rotary motion with a finger Impurities Fracture or damage to inner or outer blades Check list Defects Obvious or hidden metal abrasion: the instrument is blunt Residual corrosion is to be subjected to a special cleaning cycle. Advanced corrosion (e.g. pitting corrosion), as a result of which resistance to fracture can no longer be guaranteed, inevitably leads to the disposal of the instrument. Difficult to rotate: low-vibration operation or proper chucking in the motor can no longer be guaranteed. Check whether the preceding cleaning cycle has been successful (=> additional cleaning) or if there is any bending ( => disposal). The inner tube of the GENIUS Shaver Blades should be lubricated with an oil spray (e.g. Aesculap Sterilit I) to minimise friction in the inner tube. The oil should not contain any silicones because these might have a negative effect on the result of the sterilisation. Only a tiny amount of oil should be applied to the inner tube. Surplus oil should be removed immediately with a lint-free cloth. * KOMET MEDICAL GENIUS Shaver Blades are reusable, which is why it is particularly important to treat the instruments with care during use and reprocessing. Use Shaver Blades without pressure and observe the optimal speed. Download this information from our website www.kometmedical.de! Not clean Free from defects Fracture Free from defects Metal abrasion Free from defects Corrosion Protocol Free from defects Difficult to rotate Free from defects Action Additional cleaning cycle Special cleaning Additional cleaning cycle GENIUS Shaver Blades If the verdict in all categories is free from defects, the instrument is ready for sterilisation and can be packed in sterilisation foil or boxes. To ensure low friction, apply suitable lubricating oil to the inner blade of the GENIUS Shaver Blade. only if Packing/sterilisation

16 Packaging Sterilisation Storage 17 Packaging Sterilisation Storage The packaging for sterilisation should be suitable for the sterilisation method used, to ensure that the packaging material can be penetrated by the sterilisation agent (e.g. water vapour). The packaging must protect its contents during transport and storage. The instruments are to be packed according to DIN 58 952/58 953. The packaging protects the sterilised goods from microbacterial recontamination during transport and storage. The packing units are to be kept as small as possible. They should be provided with labels indicating the contents, date of sterilisation, use-by date, batch number and sterilisation indicator. With a few exceptions, KOMET MEDICAL products are compatible with the most commonly used methods of sterilisation. The table below provides you with a detailed overview of the compatibility of KOMET MEDICAL products with the most frequently applied methods. Steam sterilisation is the most effective method for killing germs! According to the recommendation issued by the German Robert-Koch-institute, thermal sterilisation methods are most effective and should therefore be given preference over all other sterilisation methods. 4 Whatever method you are using, make sure not to overload the mesh trays and ensure that the weight in the sterilisation device is evenly distributed. GENIUS Shaver Blades GENIUS Shaver Blades should be sterilised and subsequently stored in the GENIUSbox. The GENIUSbox protects the instruments from getting bent and from other external factors. 9835M GENIUSbox (without instruments) To guarantee that instruments remain sterile right up to their use on the patient, store them in dust-free, dry rooms at room temperature without temperature fluctuations. This minimises the risk of damage caused by corrosion during storage. Recommendations for suitable sterilisation methods = suitable = unsuitable Sterilisation methods KOMET MEDICAL Instruments Autoclave Plasma Rotary steel instruments Rotary Tungsten Carbide instruments Rotary diamond instruments Saw blades GENIUS Shaver Blades Bur block GENIUSbox 4 German magazine: Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 11-2001, Hygienic requirements during the reprocessing of medical devices: Recommendation of the commission for hospital hygiene and infection prevention at the RKI and the BfArM regarding the Hygienic requirements during the reprocessing of medical devices, page 1123

18 Regrinding Regrinding 19 Original Reground The reground saw blade has no indication of the compatibility with the relevant power system. Original Reground After regrinding, the saw teeth are considerably shorter than in their original condition. The saw blades lose their required cutting performance. Making incisions will take longer, which will lead to heat generation on the bone. What s more, regrinding completely destroys the characteristic cut of the saw teeth of the EZ saw blades. The sawing properties of reground saw blades no longer correspond to those of the original saw blades. Original Reground The reground saw blade (below) no longer bears the CE mark and the lot numbers have been removed. The information allowing the medical device to be retraced has been removed. The indication = single use is also missing. The same applies to KMS knee saw blades which will also lose their required cutting performance after regrinding. Regrinding will considerably shorten the saw teeth, thus decreasing the space required for the removal of bone chips. Again, the sawing properties of reground saw blades no longer correspond to those of the original saw blades. There is no information on the saw blade indicting that it has been reground. In some cases, the saw blade merely features the date when it was reground. The indication of the regrinding date is no substitute for the lot number and the CE mark. There is no indication on who carried out the regrinding of the saw blade. Original Reground Regrinding Surgical saw blades are medical devices of class IIa. The range provided by KOMET MEDICAL includes disposable saw blades (KMS series) and reusable saw blades (EZ series). The term reusable comprises reprocessing, i.e. cleaning, disinfection and sterilisation according to a validated procedure but not a possible regrinding of the saw blades. Regrinding the toothing of the saw blades leads to mechanical changes and legal repercussions. Regrinding of or mechanical changes to the saw blades on the instructions of the user, for example the hospital, and carried out by a third party, will have the following consequences: 1. The saw blades of the EZ series will lose their required cutting performance. Making incisions will take longer, which will lead to heat generation on the bone. What s more, regrinding completely destroys the characteristic cut of the saw teeth which leaves them considerably shorter than in their original condition. The sawing properties of reground saw blades no longer correspond to those of original EZ saw blades. 2. The same applies to KMS knee saw blades which will also lose their required cutting performance after regrinding. Regrinding will considerably shorten the saw teeth. This decreases the space needed for the removal of bone chips. Again, the reground saw blade no longer corresponds to the original KMS saw blade. The regrinding of the saw blades contrary to the recommendations issued by KOMET MEDICAL also has legal repercussions: 1. Once the saw blade has been reground, all warranty claims against Gebr. Brasseler/ KOMET MEDICAL shall be excluded because the instrument made by Gebr. Brasseler/KOMET MEDICAL no longer complies with the strict quality requirements of the Medical Device Act and because the saw blade has lost its required characteristic properties. A considerable loss of quality has to be expected during use. Likewise, we do not assume product liability for reground saw blades. 2. In case of incorrect reprocessing, the user, i.e. the hospital as operator of medical devices as defined by the Medizinproduktebetreiberverordnung (MPBetreibV) (= Medical Devices Operator Ordinance) is liable for damage (to persons) caused by the use of incorrectly reprocessed saw blades. The hospital is responsible for the correct reprocessing of the medical device. In this case, all warranty claims against Gebr. Brasseler/KOMET MEDICAL shall be excluded. Likewise, Gebr. Brasseler/KOMET MEDICAL shall not assume product liability or be held liable for claims under the Medical Device Act.

20 Troubleshooting Troubleshooting 21 Troubleshooting KOMET MEDICAL Instruments The table below gives you a concrete guide on how to solve frequently occurring problems caused by use or reprocessing: In principle, the instruments can be reprocessed as often as wear and tear incurred during surgery allows. The degree of deterioration depends on the contact pressure applied during the operation, the consistency of the bone tissue and how long the instrument is used for during the operation. Defects and their prevention Defects Causes First aid Prevention Pitting corrosion Tarnished (brown-violet) surfaces Chloride content of rinsing water or saline solution during use Use of contaminated saline solution Organic residues (blood, tissue etc.) Mineral ingredients in the rinsing water or vapour condensate Sterilisation temperature too high Removal with special cleaner Use rinsing water with a low chloride content Do not allow contamination to dry after use Use fully demineralised water for final rinse Do not overload the mesh trays and make sure that all instruments are accessible from all sides Sterilisation temperature <180 C Flash rust Rust in the rinsing water Other rusty instruments in the load Do not add rusty instruments to the load Control rust content in the rinsing water Final rinse with fully demineralised water Faded colour of the Shaver Softened water might attack anodised aluminium during the thermal disinfection No further steps are necessary Use rinsing water with a low chloride content Bent instruments Incorrect insertion Excessive speed Tossing or dropping of the instruments Overloaded mesh tray Follow manufacturers instructions when exchanging instruments Observe maximum speed Organic residues (on the instruments) Unsuitable detergents /disinfectants Use of old, contaminated cleaning solutions Omission of the final rinse Encrusted contamination due to dried residues Sonic shadows Subsequent cleaning and disinfection Avoid drying of residues caused by long waiting times Renew cleaning/disinfecting solution more frequently Rinse with clear, running water. Final rinse with fully demineralised water Organic residues No manual pre-cleaning Subsequent cleaning and disinfection Brush the entire structured surface Damaged shanks Instruments can no longer be chucked; chucking marks; burrs at the engaging piece Defect or worn bur shank ends Defect chucks in the hand piece Check, clean and service surgical hand pieces and contra-angles regularly Water stains caused by lime on the surface of the instrument Black discoloration of the Tungsten Carbide instrument head The final rinse with demineralised water has been omitted Unsuitable detergents/disinfectants incorrect dosage excessive immersion times Removal with special cleaner Use fully demineralised water for final rinse Follow the instructions provided by the manufacturers of the detergents/disinfectants Do not exceed the indicated immersion time Rounded blades and metal abrasion Overcharge of the instrument Overcharge of the saw blade Careful monitoring of the blades during reprocessing Exchange during the operation if the saw blade only cuts if high contact pressure is applied and if excessive heat generation is to be expected Fracture Overcharge of the instruments Avoid blockages during use Avoid leverage Do not use for work on metal Missing diamond coating Coating has worn off during use Careful monitoring of the blades during reprocessing Exchange during the operation in case of excessive heat generation and a simultaneous decrease of the cutting performance Metal abrasion Overcharge of the Shaver Leverage during use Apply oil to the inner tube prior to sterilisation (see page 15) Replace instrument in case of blade fatigue Bent external teeth Clashes with metal during use (e.g. saw guides) Make sure that the blades do not come in contact with metal during the operation

GEBR. BRASSELER GmbH & Co. KG Trophagener Weg 25 32657 Lemgo Postfach 160 32631 Lemgo Germany Phone +49 (0) 5261 701-400 Telefax +49 (0) 5261 701-580 info@kometmedical.de www.kometmedical.de 11/2011 GEBR. BRASSELER Germany Printed in Germany 405872V0 +E226405872V00/$000000