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  Instruments Care
 
1.. Preparation for disinfections and cleaning.

Apart from the technical and value-retention aspects involved, there is another dimension that is of particular importance when disinfected soiled/contaminated instruments: the prevention of health risks to the staff. The guidelines issued by the Robert-Koch-Institute clearly sate: “Whenever possible, instruments should be disinfected and cleaned immediately after use. Dirt residues should not be left to dry on the instruments, as this would make subsequent cleaning even harder. If necessary, instruments should be disassembled to such an extent that all surfaces can be easily reached by the disinfectant. “Unused instruments must be treated in the same way as used instruments, i-e, they must be opened or disassembled.

In principle, both moist heat (steam) and chemical disinfectants can be use for disinfecting, although moist heat is preferable, provided the instruments

tolerated this kind of treatment.

Whenever corrosive caustic agents and medicines (e.g., silver nitrate, iodine preparations, albotyl and mercury solutions) are used in operations or other medical treatments, their residues must be removed immediately.

Instruments “ejecting” can cause damage to instruments. For Example, the TC tips of scissors may come off, or small clamps may get deformed. To avoid damage, be sure to lay aside your instruments carefully and purposefully after use.

using the dry “ discharge” method, the instruments need immediate cleaning to avoid encrustation and corrosion. The term “dry” should be taken literally. Even small amounts of liquids (e.g., physiological salt solution remaining in bowls) should be avoided.

The instruments should be stored on suitable trays, e-g. Perforated sterilizing trays, and hinged/joined instruments (such as scissors, clamps, spur crushers) must be opened first for effective cleaning.
For “Wet discharge”. The instruments must be immersed in a combined disinfecting and cleaning solution. Be sure to use only non-corrosive agents in the prescribed concentrations. Water alone is insufficient.

In either case, however, instruments should never be stored dirty over an extended period of time (e.g. overnight or over the weekend), as this would greatly increase the risk of corrosion.

Handles and cables for HF surgery are to be treated in the same way as surgical instruments.

Microsurgical instruments require special preparation techniques, so they have to be stored on racks or in suitable holding devices.

Dental materials adhering to dental instruments (such as filling materials) must be removed immediately. Otherwise, the material will harden on the instrument and/or cause corrosion.

Rotating dental instruments, such as drills, cutters, burrs and grinding tools, must be stored in special containers or holding devices for separate treatment.

As Far as possible, all component parts of surgical motors must be disassembled immediately after use, following the manufacturers instructions. The surfaces of components that cannot be cleaned and sterilized in the usual way should either be wiped with a lint-free cloth saturate with a disinfecting and cleaning agent or sprayed with a disinfecting spray in order to prevent gluing and encrustation.

Simple tools can be treated for reuse in the same way as surgical instruments.

Hose/tubing sets used for cooling liquids or spray nozzles must be rinsed with water from the rinsing

bottle immediately after disconnection and must then be checked for leaks (visual check, see “Inspection”).

MIS instruments and rigid endoscopes must be disassembled in accordance with the manufacturers instructions prior to preparation. Lenses and optical systems must be stored in special containers. Single-use articles must be discarded!

Dried-on residues are a particularly critical point with respect to surgical endoscopy instruments, as they are difficult to remove from small lumens and may impair the proper functioning of joints. These instruments should be treated immediately after use. In the case of HF instruments, a 3% hydrogen peroxide solution is recommended for removing any coagulated tissue particles still adhering to the instruments after extended operations.

To avoid damage, MIS instruments should always be transported in containers or holders specially designed for this purpose.
Instruments and endoscopes that can be taken apart have the advantage that they can be easily checked for dirt residues after cleaning.

Such items should therefore always be disassembled before treating them for reuse.

I the case of flexible endoscopes, the insertion part must be wiped with a lint-free cloth immediately after use. This cloth should be saturated with an instrument disinfecting solution containing either a suitable

Detergent or a specially added cleaning booster compatible with the disinfectant in question

To avoid encrustation and clogging, the suction dust as well as other channels should be rinsed with the same solution. To rinse the air/water channel, water from the rinsing bottle can be used.

Before entering the next stage of the preparation process, a leak test must first be carried out in accordance with the manufacturers instructions. This ensures the early detection of leaks and perforations and the prevention of more serious damage like the one caused by penetrating liquids.

A defective endoscope must be returned to the manufacturer immediately, together with a description of the problem.

Endoscope cleaning and disinfections should preferably be performed on a mechanical basis, using special automatic machines.

Elastic instruments and respiration systems must always be taken apart in accordance with the manufacturers instructions before treating them for reuse. Be sure to handle cones, sealing surfaces, threaded connections and value plates carefully, protecting them against mechanical damage.

Prior to preparation, absorbers must be checked for respiration deposit (“breathing lime deposited”). Any such residues found must be completely removed.

Sensors/pickups may only be treated for reuse in accordance with the manufacturers instructions.

2. Manual disinfcetion and cleaning.

For manual preparation, the instruments must be immersed in a combined cleaning and disinfecting solution of proven disinfecting effectiveness.When using such products, the manufacturers instructions regarding concentration, temperature and exposure time must always be strictly observed. When treating non-stainless-steel instruments, be sure to check that the materials involved.Use fresh disinfecting and cleaning solutions every day, because if the same solution is used too long, the following problems may occur:

-risk of corrosion due to dirt accumulation.
-risk of corrosion due to increased concentration caused by evaporation.
-Lower disinfecting effectiveness due to dirt accumulation.

Since instruments with narrow lumens (e.g. tubing, cannulas) or cavities are generally difficult to prepare for reuse, it is essential to ensure, prior to preparation, that all their passages are unclogged and the solution has free access to all internal surfaces.

When using powders, take care to dissolve them completely in the water before the instruments are immersed in the solution. Undissolved power particles may clog narrow lumens and may also lead to stains and discoloration on the surface of the instruments.

Be sure to always rinse the instruments thoroughly under running water after chemical cleaning and disinfection. Rubber and elastic plastic materials need to be rinsed particularly carefully. Undissolved residues must be removed manually (be careful; do not use metal brushes or scouring agents!). To avoid water spots, a final rinse with demineralized water is recommended, Subsequently, the instruments must be dried immediately.

If the instruments are not sterilized but disinfected chemically following manual cleaning, then a separate disinfecting solution must be used. Subsequently, rinse the instruments thoroughly with sterile deminiralized water until all residues have been removed, then dry them immediately. If compressed air is used for drying. Pass it through a sterile filter.

Microsurgical instruments are easily damaged by mechanical impact.Such damage is often caused by:

-metal brushes.
-scouring agents.
-use of excessive force or pressure.
-dropping or pushing or careless “ejection”.

For cleaning, use a lint-free soft cloth, a plastic brush or a cleaning gun. A compressed-air gun is a particularly gentle and effective way of drying and should therefore be the preferred method.

Dental instruments can usually be treated like surgical instruments. In some cases, however, special treatment is required.Hand pieces, elbows and turbines may not be immersed in a cleaning bath. All external surfaces should either be wiped with a cloth or sprayed with a suitable disinfectant. For internal cleaning and care, be sure to use the cleaning and disinfecting methods and agents specified by the instruments manufacturer.Rotating dental instruments may only be immersed in special disinfecting and cleaning solutions, due to the material used in their construction. To avoid corrosion, these instruments must be dried immediately after a short rinse and mustThen be treated with a sterilization-suitable anticorrosive agent. In the case of ceramic or plastic-bonded grinding tools, it is essential to check whether the disinfecting and cleaning agents to be used are compatible with such instruments. Unsuitable agents may destroy the bonding materials (including those used for shaft fixation).
Instruments used for root-canal treatment are very easily damaged by mechanical impact, so treat them separately. Root-canal treatment instruments with a color-anodized handle should not to be immersed in alkaline solutions because the “ cording” color would fade away.

The external surfaces of the various components of surgical motor systems must be wiped with a lint-free cloth saturated with a cleaning and disinfecting solution. Soft brushes can be used. After applying a disinfecting spray, be sure to wipe the surfaces dry with a cloth. Never immerse such components in water or other liquids. Any liquid that may have entered must be removed immediately by turning the respective opening downwards.

Simple tools can be treated in the same way as surgical instruments.

MIS instruments and rigid endoscopes incorporate cavities and channels that are difficult to clean. Proper cleaning and preparation for reuse requires.

-removing all seals/gaskets.
-opening all cocks.
-disassembling the instrument in accordance with the manufacturer’s instructions.

MIS instruments and rigid endoscopes are easily damaged by mechanical impact. In the manual cleaning, e.g. when removing blood encrustations, there is consequently a risk of impairing the proper functioning of the instrument by incorrect handling. Damaged may, for example, be caused by:

-metal brushes.
-scouring agents.
-use of excessive force.
-dropping or pushing or “eject” the item.

To avoid damage caused by the use of unsuitable cleaning accessories, plastic brushes, cleaning guns or soft, lint-free cloths should be used for drying. Using a compressed-air gun is a particularly gentle and effective way of drying and should therefore be the preferred method.

When immersing MIS instruments or endoscopes in a cleaning and disinfecting solution, make sure that all cavities are free air bubbles (e.g. by turning or rotating the instrument or holding it aslant) so that all surfaces are freely accessible to, and completely covered by, the solution.

Note: instruments which cannot be disassembled but incorporate a rinsing connector should be rinsing thoroughly with a cleaning/disinfecting solution

Ensure that enough liquid passes through the entire instrument down to the distal end.

Dirty windows or glass surfaces should be cleaned by rubbing them gently with a swab (use wooden applications only) saturated with alcohol. If this does not work, use a neutral detergent (manual washing-up agent).

Instruments encrusted with tenacious HF coagulation that could not be removed even by intensive cleaning (e.g. with a brush or ultrasonic treatment) must be sorted out because their proper functioning is no longer guaranteed.

Regarding flexible endoscopes, all valves and caps must be removed before starting the preparation process, to make sure that all channels/dust can be thoroughly flushed and cleaned. For cleaning, immerse the endoscope in an instrument cleaning and disinfecting bath, wiping its exterior thoroughly.

The channels must first be cleaned with the brush contained in the instrument set, then rinse them with the cleaning solution. For this purpose, some manufacturers offer a hand pump. The distal end must be cleaned with special care (optical system, Albarran lever, etc.).

Immediately after this pretreatment, the instrument must be thoroughly rinsed with water both internally (channel system) and externally. Subsequently, put the flexible endoscopes into the instrument-disinfecting bath, making sure that all channels are completely filled with the solution. You may use a hand pump for this purpose. Be sure that the suction dusts are also disinfected properly. The exposure time and concentration specified by the manufacturer must be strictly observed.

After chemical disinfections, all external surfaces and channels must be thoroughly rinsed until no residues are left. To avoid water spots, use deminiralized water. Additional sterile filtration of the water prevents unwanted recontamination.

Dry all external surfaces of the flexible endoscope with a lint-free cloth. Channel drying should be always being done following the manufacturer’s instructions, using either a hand pump and a suction pump or compressed air (max. 0.5 bar). Unwanted recontamination can be prevented using filtered, sterile compressed air.

Elastic instruments with lockable cavities (such as balloons and respiratory masks) must be cleaned and disinfected in closed condition in order to keep the cavities free from liquid.

If the instruments are not sterilized but disinfected chemically after manual preparation, then a special disinfecting solution has to be used. Subsequently, the instruments must be rinsed with sterile, deminiralized water to such an extent that they are completely residue-free and then dried immediately. If compressed air is used for drying, be sure to sterilize the air by passing it through a sterile filter.

White spots can appear on elastic instruments made of plastic or rubber, simply due to water absorption. Such spots can be removed only by drying.

To avoid damaging the diaphragms and functional parts of respiration systems, no compresses air should be used for drying.

3. Machine disinfcetion and cleaning.

Cleaning and disinfecting processes can best be standardized on a mechanical basis. Always keep in mind that proper cleaning, as an integral part of the whole preparation process, is essential also for retaining the value of your instruments. Machine preparation normally requires dry discharge, since wet discharge carries the risk of proteins attaching themselves to the instruments. For this reason, a combined cleaning and disinfecting agent should always be used. When these agents lack a foam inhibitor, thoroughly rinse the instruments because any foam produced during mechanical cleaning and disinfcetion may impair results. This also applies to the special cases of heavily soiled instruments (encrusted HF instruments, filling-material residues on dental instruments, etc.), which have been pre-treated by immersion with or without ultrasound treatment.From the viewpoint of general prophylaxis, cleaning-optimized processes and procedures with separate cleaning and disinfecting stages are to be preferred.For mechanical preparation, both thermal and chemothermal processes are available for cleaning and disinfecting. In thermal processes, disinfcetion is carried out at 80 c or higher, with corresponding exposure time. Chemothermal disinfcetion processes take place at a maximum temperature of 65 C, with an added machine-type disinfectant (concentration and exposure time as specified). If the instruments to be treated allow it, thermal processes should be used.The structure of the program used depends on general hygiene requirements, the type of instruments to be treated and the quality of the water used.

Pre-rinse.
Clear cold water (no additives), for basic dirt removal of foaming substances.

Cleaning.
Cleaning takes place at temperatures of 40-60 C.

Neutral-Ph products with or without enzymes as well as alkaline products can be used as cleaning agents.

When using chemical cleaning agents, the manufacturer’s instructions regarding concentration, working temperature and exposure time must be strictly observed in order to achieve optimum cleaning results while making sure, at the same time, that the instruments are treated as gently as possible. If automatic liquid dosing systems are used, these must be controllable. Where specific regulations (epidemiological or the like) require a combined thermal cleaning and disinfcetion process, alkaline cleaners are to be preferred.If chloride concentrations are rather high, the danger of pitting corrosion exists, which can be prevented with alkaline products in the cleaning cycle and by using deminiralized water for the final rinse.

for treating heat-sensitive instruments/materials, chemothermal processes are employed, which means that after cleaning a special disinfectant suitable for use in washer-disinfectors is used. In this case, the final rinse must be carried out at a relatively low temperature. Moreover, it is important to ensure sufficient drying.

1st intermediate rinse
With warm or cold water, no additives.

Adding an acidic neutralizer facilitates the removal of alkaline detergent residues. Even if a neutral cleaning agent used, it may be advisable to add an acidic neutralizer in order to prevent coating (e.g. in cases where the water used has a high salt content).

2nd intermediate rinse
With warm or cold water, no additives.

Thermal disinfcetion / final rinse.

Thermal disinfcetion takes place at temperatures of 80-93 C and appropriate exposure times.

Using deminiralized water prevents water spots and coating on the items to be treated.

Drying if the machine lacks a separate drying program, drying should be carried out manually or by using a separate drying cabinet.When cleaning mechanically, pay special attention to the following:

-To ensure effective machine preparation, all trays, inserts, holders etc. must be loaded correctly.
-Open all hinged/jointed instruments for proper cleaning.
-Avoiding overloading perforated trays to ensure that all instruments and surfaces can be reached by the cleaning/disinfecting solutions.
-When storing large instruments on the trays, make sure that they do not “shadow” other instruments, thereby impairing cleaning results.

-Instruments with cavities or hollow spaces (such as shafts, tubing, hoses, respiration systems) need careful inside cleaning and rinsing too. For this purpose, special (instruments-specific) inserts with appropriate rinsing facilities should be used.

-The instruments must be stored/arranged in such a way that they will not be damaged by mechanical impact (overload).

Color-anodized aluminum parts may fade as a result of mechanical cleaning thereby losing their coding function. However, if neutral pH detergents are used at lower temperatures and deminiralized water is employed for the final rinse (and also during thermal disinfcetion), then color-anodized instruments can be cleaned and disinfected together with other instruments.Treated items must be removed from the machine immediately upon completion of the cleaning program. If they are left in the closed machine, corrosion may occur. If the latent heat stored by the instruments is not enough for drying, an additional drying cycle is required.

Microsurgical instruments can be prepared mechanically, provided the instruments are safely held in place (e.g. by using racks or other suitable supports) and a suitable rinsing method is used.

Dental instruments can be treated mechanically like surgical instruments. However, the following points need to be observed.

-Probes and other easily damaged instruments must be placed on racks or special holding devices for protection.

-Rotating instruments such as drills, cutters/burrs or grinding tools are only partially suited for mechanical preparation. As a rule, an ultrasonic bath treatment is to be preferred.

-Instruments for root-canal treatment may only be treated mechanically if they are correctly and individually held in place safely; otherwise, choose an ultrasonic-bath treatment.

-Hanpieces and elbows can be treated mechanically, provided a suitable preparation technique (as specified by the manufacturer) is used.

-Mouth mirrors are subject to wear. For example, silver-backed glass mirrors may become dull as a result of machine treatment, Rhodium –metallized mirrors, in contrast, are more resistant to thermal and chemical influences but are easily damaged by mechanical impact.

Components of surgical motor systems may only be treated mechanically if the manufacturer allows such a treatment in connection with special preparation techniques and holding facilities. Original tools and accessories can be treated mechanically in the same way as surgical instruments.

MIS instruments and rigid endoscopes must be disassembled for machine preparation in accordance with the manufacturer’s instructions. All seals/gaskets must be removed and all cocks opened.

Use the mechanical preparation only if the manufacturer of the respective component has approved it. To avoid damage, fix the parts securely in place. Mechanical cleaning and disinfecting is permitted only as long as a compatible and proven technique is used. Moreover, the machine and machine inserts employed must allow hollow instruments to be sufficiently and reliably rinsed internally as well.

Instruments with tenacious coagulation residues that cannot be removed even by intensive cleaning (e.g. with a brush or ultrasonic treatment) must be sorted out discarded because their proper functioning is no longer guaranteed.

Flexible endoscopes may only be treated mechanically if special automatic machines are used. Standard washer-disinfectors are not suitable for this purpose. If endoscopes are pretreated manually prior to machine preparation, all products/detergents used must be compatible with each other. This prevents poor cleaning results as well as endoscopes surfaces changes and excessive foaming inside the machine.

Prior to mechanical preparation, a leak test must be carried out in accordance with the manufacturer’s instructions. This ensures the early detection of leaks and perforations in order to avoid more serious damage (e.g. caused by penetrating liquids). Some machines carry out a leak test automatically (either before the program starts or while it is running). Defective endoscopes must be returned to the manufacturer, together with a description of the problem.

Since the alkaline cleaning agents may damage endoscope, use only special detergents and disinfectants suitable for the mechanical treatment of flexible endoscopes. The maximum temperature of 60 C may never be exceeded throughout the cleaning and disinfecting cycles. Moreover, the instructions provided by the endoscopes manufacturer must be duly observed.

During the mechanical preparation process, the endoscope must be securely kept in place inside the machine. Use appropriate equipment to ensure that all external surfaces as well as the inside of all channels/ducts are thoroughly and reliably cleaned and rinsed.

For the final rinse, deminiralized water should be used to prevent the formation of water stains. Moreover, suitable technical processes must be employed to ensure that the water used for the final rinse is of a quality that prevents the germs growth on disinfected/sterile endoscopes.

Prior to storing the endoscope for later use, dry it properly so that the growth of microorganisms is prevented. Drying can be done in an automatic cleaning and disinfecting machine or by using a suitable drying cabinet.

Elastic instruments with lockable cavities (such as balloons, respiratory masks etc.) must be cleaned and disinfected in closed state so no liquid enters the cavities.

To prevent the mask bulge from being overstretched, discharge some of the air prior to preparation (remove the plug, squeeze out some air, then replace the plug).

Elastic (e.g. PVC) instruments with a low temperature resistance may only be disinfected, cleaned and dried at temperatures not exceeding 65 C.

Be careful with rubber instruments because detergent or disinfectant residues can cause irreversible damage during subsequent drying or sterilization, due to the fact that the surface of the material may depolymerize and turn sticky as a result. Latex coatings tend to blister off.

Residues adhering to functional parts of respiration systems are particularly damaging. Moreover, all such parts must be completely dry, as even very small amounts of moisture may cause malfunction.

Elastic instruments must never be dried at temperatures above 95 C because higher temperatures greatly reduce their useful life. The recommended temperature range is 70-80 C.

Functional parts of respiration systems of anesthesia devices vary from one manufacturer to another, so their preparation must be performed according to the manufacturer’s instructions in each case.

4. Ultrasonic treatment.

Ultrasonic treatment is a very good choice for cleaning stainless-steel instruments. Instruments sensitive to mechanical impact (e.g. microsurgical instruments, dental instruments) can likewise be gently and thoroughly cleaned with the help of ultrasound. Efficient ultrasonic devices/plants are able to dissolve encrustations even in places that are difficult to access.

Ultrasonic treatment is used.

-as an effective mechanical method supporting manual cleaning processes.

-for treating tenacious encrustations before or after mechanical preparation.

-in specially designed, optionally available component parts of automatic multi-chamber clocked cleaning systems.

To achieve optimum cleaning results, observe the following:

-Fill the bath following the manufacturer’s instructions;

-add a suitable cleaning agent or a combined cleaning and disinfecting agent;

-when using disinfectants and cleaning agents, the concentration, temperature and ultrasound treatment time (I-e, exposure time) must be matched in accordance with the manufacturer’s instructions;

-We recommend using warm water for the bath because water temperatures above 40 C facilitate degassing, thus enhancing the cleaning results;

-When a suitable detergent is used according to instructions, it will prevent protein coagulation even at higher temperatures.

Apart from a properly bath, the following basic rules should be observed in order to ensure good cleaning results:

-The items to be treated must be fully immersed in the cleaning solution.

-Hinged instruments (e.g. scissors) must remain open during treatment.

-Use only those trays that do not obstruct the ultrasonic treatment process (e.g. wire trays).

-Large-surface, bulky instruments such as hands or kidney-shaped bowls must be stored in such a way that they do not create “shadow” or anechoic zones. Position such items either vertically or put them on top pf the others.

-Do not overload trays.

-Renew the ultrasonic bath daily.

As high dirt concentration in the ultrasonic bath reduces the effectiveness of the cleaning process and increase the risk of corrosion. It may be advisable renew the bath even more frequently depending on the conditions of use.

-Where efficient plants are used, ultrasonic treatment times of approx. 3 minutes at frequencies of around 35 kHz should be sufficient.

-If disinfcetion and cleaning are carried out simultaneously, be sure to use compatible products, paying due attention to concentration and exposure time requirements.

Following ultrasonic treatment, the instruments must either be thoroughly rinsed manually or treated mechanically. The manual rinse must be carried out with drinking water, taking care that all cleaning agent and disinfectant residues are completely removed in the process. To avoid water spots, it is of course also possible to use deminiralized water for the rinse.

The instruments should then be oughly dried.

Microsurgical instruments must be stored on special racks in order to prevent damage.

To keep the surfaces and soldering joints of dental instruments intact, no acid cement remover may be added t the ultrasonic bath.

Hanpieces, elbows and turbines should never be placed in an ultrasonic bath.

Due to the materials used in their construction, rotating dental instruments must be treated with special disinfecting and cleaning agents. Prior to ultrasonic treatment,

they should be placed on special racks to avoid contact damage among the instruments (e.g. by sharp cutting edges or diamond grains). After a quick rinse under running water followed by immediate drying, be sure to treat rotating dental instruments with a sterilization-suitable anticorrosive agent.

Mouth mirrors may be adversely affected by ultrasonic treatment.

With the exception of simple tools and accessories, components of motor systems should never be treated in an ultrasonic bath.

In the case of MIS instruments and rigid endoscopes, ultrasonic-bath treatment is allowed only for those parts for hich the manufacturer has given his explicit approval (optical systems, for example, are generally excluded).

If instruments have been soiled by HF coagulation residues to such an extent that they are still not 100 % clean after intensive cleaning, they must be withdrawn from use because their proper functioning can no longer be guaranteed.

Flexible endoscopes must never be treated in an ultrasonic bath. However their accessories (such as valves, caps, biting rings or pincers) can be treated in this way.

Elastic instruments are not suitable for ultrasonic waves have no effect on them.

Functional parts of respiration systems may not be prepared in an ultrasonic bath either.

5. Maintenance and care.

Instruments with a joint or lock (such as clamps, scissors, etc.) need to be treated with an autoclavable, paraffin oil-based lubricant that complies with current pharmacopeial regulations.

These lubricants prevent metal-on-metal friction, thus ensuring ease of movement and avoiding fretting corrosion. Moreover, the regular application of such an oil prevents the joints from “sticking together: due to gumming (as might be the case when the wrong oils are used).

As a rule, it is necessary to carefully lubricate all threads, joints etc. manually and with precision each time the instrument is treated for reuse. In other words, it is not sufficient just to spray the whole instrument with oil or to apply a lubricant mechanically during the final rinse cycle.

Dental instruments are to be treated like surgical instruments, with the following exceptions:

-handpieces, elbows and turbines have to be treated with special agents in accordance with the manufacturer’s instructions, due to their complicated internal structure.

-Immediately after drying, all rotating dental instruments (drills, cutters, burrs etc.) must be treated with an anticorrosive agent suitable for use with sterilizing media such as steam or hot air.

Motor systems must always be lubricated and maintained with agent recommended by the manufacturer. Non-sealed hand pieces need internal treatment with a special cleaning and lubricating spray.

In the case of compressed air motors (with the exception of maintenance-free types), put a few drops of special oil into the air intake duct. To facilitate the distribution of the oil inside, run the motor with compressed air for a few seconds. As proper lubrication and maintenance of the motor system is a vital factor for long-term value retention, the manufacturer’s instructions should be carefully followed.

Since MIS instruments and rigid endoscopes may incorporate components made of different materials (such as plastic or rubber), a general (manual or mechanical) application of care agents might damage

Optical systems, seals/gaskets and current-carrying parts and should therefore avoided.

Joints, threads, sliding surfaces and non-maintenance-free cocks of rigid endoscopes must be treated with a special oil or grease in accordance with the manufacturer’s instructions.

Flexible endoscopes are maintenance-free, but not the valves. These need to be treated with silicone oil each time before they are inserted into the valve housing. Never use spray (the propellant gases would damage the instruments).

As lubricants, use only suitable and grease-free gels in accordance with the manufacturer’s instructions. Agents containing Vaseline or paraffin cause rubber parts to swell or soften.

Never treat elastic instruments and respiration systems with lubricants or care agents before sterilizing them. The manufacturer specifies special care and maintenance measures where they are required.

Elastic instruments made of silicone rubber are not being treated with silicone oil because this leads to swelling, rendering them useless. For same reason, never use paraffin agents for rubber and latex instruments.

6. Inspection.

Each surgical instrument has been designed for a specific purpose. Therefore, functional tests must be designed in such a way that items that do not serve their intended purpose any longer are reliably detected. In case of doubt, the instrument manufacturer should be contacted for suitable inspection/testing methods.

After cleaning, the instruments must be macroscopically clean, I-e, free from visible protein residues and other dirt.

Surgical instruments with movable parts should be given time to cool down prior to functional inspection in order to prevent metal friction that could lead to corrosion. Before carrying out functional tests, hinged and threaded instruments should always be lubricated.

Instruments with atraumatic toothing need very careful inspection. If necessary, the toothing must be subjected to additional manual cleaning to ensure atraumatic application.

Worn, damaged or porous instruments must be stored out, since they are no longer in good working order. Likewise, corroded instruments must be discarded immediately to prevent contact corrosion on other surgical instruments.

Delicate, particularly easy-to-damage instruments need to be inspected with a magnifying glass. Subsequently, they must be stored in specially designed racks, or fixed in place by other means, in order to avoid damage during transportation.

Never store flawless surgical instruments with those whose surface is defective. Especially older instruments with a peeled-off chromium and/ or nickel coating may cause discoloration or corrosion on stainless-steel instruments. We therefore recommend sorting out such instruments or pack them separately.

Handles, cables in general and neutral-electrode cables used in HF surgery must be checked for proper functioning (loose contacts!). Discard defective parts!

Instruments in need of repair have first to be cleaned and disinfected (I-e, send them through the complete treatment cycle).

Stains found on instruments result from improper treatment. The reasons for such discolorations include:

-insufficient mechanical or manual cleaning.

-use of inadequate cleaning, disinfecting or care agents;

-failure to observe the dosage instructions for cleaning, disinfecting or care agents;

-residues from cleaning, disinfecting or care agents (so-called “carry-over”).

-Poor water quality (foreign ions such as iron or silicate);

-water-soluble residues (e.g. washing agent in wrapping cloths);

-residues contained in the sterilizing steam (exceeding the standard values for steam impurities as specified in EN 28, Appendix B);

-residues from medications, marketing pens or chemical indicators;

-procedural faults (e.g. failure to clean brad-new surgical instruments before sterilizing them).

These and other potential causes of stain formation on surgical instruments are indicative of the complexity and difficulty of the problems involved. To identify the causes of any such stains in practice, we recommend seeking expert advice. Apart from their practical experience, specialized companies also help with well-equipped laboratories in such matters.

To avoid permanent damage, instruments with tenacious surface residues must first be subjected to special treatment, depending on the cause of discolorations.

To avoid damage due to metal friction (and subsequent corrosion), never use metal brushes or metal sponges for removing stains. For further details on various discoloration and corrosion causes, see chapter 2.

Surgical motors and their accessories must be subjected to functional tests in accordance with the manufacturer’s instructions prior to sterilization.

On all compresses-air components, a leak test and a visual inspection must also be carried out in addition to the functional test. This particularly applies to compressed-air hoses and motors. For checking air intake ducts the compressed-air hose needs to be connected to the compressed-air supply. Leaks can then either be detected acoustically or checked visually by immersing the hose in water.

For checking the exhaust air duct, the compressed-air motor must also be connected to the compressed-air hose. After starting the motor, leaks can best be detected by immersing the hose in water.

Simple tools are to be checked in the same way as normal surgical instruments. To avoid transportation damage, the tools should be stored in special racks

Or fixed in place by means of suitable holding devices.

The leak test for cooling-liquid tubing sets can be done with a clamp and a large syringe filled with water. Proceed as follows: fill the tubing with water, close one end with the clamp, then apply the syringe to the other end of the tube and inject the water.

Conducting a thorough functional test can only ensure the proper functioning of MIS instruments and rigid endoscopes. To achieve this, first reassemble all disassembled instruments in accordance with the manufacturer’s instructions. After the functional check, it may be necessary to disassemble the instruments once again for sterilization.Worn parts and defective components must be replaced prior to sterilization. The insulation, in particular, should be carefully inspected for potential damage.

Instruments with tenacious coagulation encrustation on working parts must be given special manual treatment as described in chapter 2 or chapter 4. should this prove ineffective, discards/replace the items.

Optical systems should be carefully cleaned with a cotton swab saturated with alcohol (to avoid damage, use a wooden or plastic applicator, not a metallic one). If this is not enough to clean the lenses, return the component to the manufacturer for inspection.

Optical fibers and optical fibers cables must be checked for fiber breaks. To do this hold one end of the optical-fiber cable against a light source, then look into the cable at the other end. If you see little black spots, this indicates fiber breakage. Note that the more breaks there are, the lesser the light output will be. Therefore, sort out such optical fibers and endoscope parts with a defective surface.

Clouded optical systems of flexible endoscopes can normally be cleaned with a wooden or plastic applicator (do not use metal!) saturated with alcohol. If this is not enough to clean the lenses, return the component to the manufacturer for inspection.

Fiber breakage in optical waveguides can be detected by holding the proximal end against a light source and looking into the fiber at the distal end. If little black spots are seen, this indicates fiber breakage. Note that the large number of such breaks significantly lowers the light output. Such defective instruments must be returned to the manufacturer for inspection. This also applies to endoscopes with visible external defects (e.g. deformation of the insertion part or supply hose; overstretched rubber sleeve of adjustable part).

Flexible endoscopes should be stored in a safe place unfolded. Suspension has proved useful, as this facilitates drying. The adjusting wheels should be unlocked for storage. Note that the carrying case is not suitable means for storage.A comprehensive functional check must be carried out each time the endoscope is used for an operation. As lubricants, use only suitable fat-free gels following the manufacturer’s instructions. Never use Vaseline or lubricants containing paraffin, as these substances swell or soften the material.

Respiration systems must be checked for proper functioning and working conditions in accordance with the manufacturer’s instructions.Eastic instruments have always to be checked for proper functioning in accordance with the purpose for important inspections include:

-check balloon potential defects;

-check balloon filling systems for tightness;

-check the lumens of catheters and probes for unobstructedness;

-test connectors for safely and reliability (e.g. ISO connectors);

-check the shape of the instrument (e.g. bending radius of tracheal tubes).

Never use damage or defective elastic instruments! Frequently observed defects include.

-peelings (blister formation).

-cracks.

-sticky surfaces.

-hardening.

-porosity.

-discolorations.

To prevent premature failure, be sure to store elastic instruments in a dry place at room temperature. Do not kink or over-stretch them (use suitable connectors only).

7. Sterilization.

Always sterilize the instruments in accordance with current standards (DIN, EN, ISO). This applies to the sterilization conditions as well as to the equipment to be used. In addition, the Operating Instructions provided by the manufacturer of the sterilizer used must be observed. The sterilizing accessories and packaging materials employed must be suitable for the items to be sterilized and must also be compatible with the sterilization method used. For a defined set of instruments, special measures need to be taken in order to ensure proper sterilization. Such measures are specified by the instrument manufacturer where required.

7.1 Autoclaving (steam sterilization).

Autoclaving is usually performed with saturated steam at 134 C. for articles with a limited thermostability; a temperature of 11 C may be used, combined with longer treatment/exposure time.The sterilization procedure must comply with accepted standards and be suitable for the items to be sterilized. The packing materials for the process must also comply with pertinent quality and application standards; moreover, they must be suitable for the sterilizing procedure selected.The sterilization steam must be free from impurities and should neither impair the sterilizing process nor damage the sterilizer or the items to be sterilized. To ensure this, the limited values specified in EN 285, Table 1, relating to the quality of the water fed to the boiler and the condensate must not be exceeded.

Other wise, contaminants (such as rust particles from the piping systems) may cause corrosion or an excessive content of silicic acid may lead to instrument discoloration.Due to the heating and cooling down that takes place during sterilization, stresses occur in surgical instruments whose ratchet mechanism is fully closed. The result may be joint cracks or a deterioration of the instruments clamping force. Consequently, during sterilization always leave such instruments either fully open or close them only at the first notch/tooth.The load of instruments stored on perforated trays should not exceed 10 kg. This avoid excessive condensate formation during sterilization. The best drying results are achieved wrapping a lint-free cloth – preferably a cotton-polyester cloth – around the trays inside the container (or around the external paper packing). Coated fleece material is less preferable due to its adverse effect on the drying process; its suitability as an inner packing material has yet to be determined.If heavy loads are unavoidable, the instruments should be distributed to several trays/packaging units. In addition, special drying measures may be necessary.
Following sterilization, the instruments must be stored dry until they are needed again. It is important to ensure that both the instruments and the inner packing of the sterilizing items are completely dry after they have cooled down to room temperature.

Dental instruments can usually be autoclaved in the same way as surgical instruments. Should separate treatment be required, the following instructions apply:

-Rotating dental instruments (e.g. drills or cutters/burrs) are autoclavable.-Handpieces and elbows should be autoclaved at 134 C wherever possible, due to the short exposure time.-In the case of turbines, consult the manufacturer’s instructions to determine whether or not autoclaving is permitted.-Mouth mirrors are items, which are subject to wear and will sooner or later become dull as a result of the expansion difference seen in the different materials during preparation.

All sterile-use components of surgical motor systems can be autoclaved at 134 C. be sure to observe the manufacturer’s instructions, particularly with respect to how to store these components properly and safely during sterilization.Compressed-air hoses need to be protected against mechanical damage during sterilization.

MIS instruments and rigid endoscopes can be sterilized conventionally, using suitable packaging material. Autoclavable optical systems should be sterilized at 134 C rather than at 121 C, due to the shorter exposure time (and correspondingly lower thermal stress). To avoid mechanical damage, optical systems should always be stored securely as recommended by the manufacturer.

Flexible endoscopes are not autoclavable due to their lower heat stability, so use a gas sterilizer in uses where sterilization is required. However, all endoscopically used items (such as clamps, catheters etc.) are autoclavable.

Elastic instruments (wit and without a balloon) made of a silicone elstomer and natural rubber (or latex) can be treated by autoclave. Due to the shorter thermal stress period, it is better to sterilize at 134 C. items made of thermoplastic materials (plastics), however, may only be autoclaved if such a treatment is expressly permitted by the manufacturer for example.

When autoclaving elastic instrument, all cavities (e.g. bulge of mask, balloon) must remain open to prevent damage due to pressure variations.Cavities locked with a valve (e.g. balloon catheters) must e completely emptied (I-e, made water-and air-free) with a syringe prior to sterilization.Functional parts of respiration systems can be autoclaved at max. 134 C. Cavities must remain open so no valves are damaged.

7.2 Hot-air sterilization.

When hot air is used for sterilizing surgical instruments, it is important to ensure that the sterilizers are properly loaded and operated. For best results, the temperature should not be lower than 180 C (the special temperature) but should not exceed it by much, either, since temperature above 200 C may cause structural changes leading to irreversible damage, especially in microsurgical instruments.Instruments with rubber, plastic or textile parts are not suited to hot-air sterilization.This also applies to plastic-coated instruments, cables and electrode handles.No care agents should be applied prior to hot-air sterilization, with the exception of joints and locks of surgical instruments. For the later, carefully and precisely apply paraffin oil that complies with current pharmacopeial requiremnents.remove any excess oil because brown discoloration may originate from thermal changes brought about in the oil during sterilization.

Dental instruments can generally be sterilized with hot air in the same way as surgical instruments. Where separate treatment is required, the following instructions should be observed:

-Handpieces, elbows and turbines should not be subjected to hot-air sterilization.

-Drill and cutters/burrs should be sterilized at temperatures are closely to 180 C as possible but not higher, due to the fact that the material already beings to soften at this threshold.

-Mouth mirrors are items subject to wear, which will sooner or later become dull as a result of the expansion differences seen in the different materials during preparation.

Motor systems components are only partly suitable for hot-air sterilization, since different materials are used for different components,So refer to the manufacturer’s instructions in each case.

MIS instruments and rigid endoscopes should not be sterilized in hot-air because of the high temperatures involved.

Flexible endoscopes are not suitable for hot-air sterilization.

Elastic instruments and respiration systems are not suitable for hot-air sterilization.

7.3 Low-temperature sterilization.

Low-temperature sterilization methods include gas sterilization using ethylene oxide or formalin and gas plasma sterilization using hydrogen peroxide. What all these methods have in common is the packaging that ensures sterility until the items is used.

For environmental as well as patient-and personnel-related safely reasons, these methods should only be used for items which cannot be autoclaved (steam-sterilized).

Items treated with ethylene oxide require sufficient aeration following sterilization (and prior to reuse). Aeration times may vary considerably, depending on aeration conditions and the type of instruments treated. For reliable aeration times, always consult the instructions given by the instrument manufacturer. Following aeration, flexible endoscopes should
Always be stored in stretched/extended condition.

For motor systems components, low-temperature sterilization may only be used if expressly permitted by the manufacturer.


Non-autoclavable optical systems of rigid endoscopes may be sterilized at low-temperatures in accordance with the manufacturer’s instructions

Flexible endoscopes can be sterilized up to a max. temperature of 60 C, using of the sterilization methods permitted by the manufacturer.For sterilization, the flexible endoscopes must be packed and sealed in a transparent tubular foil in extended condition. Be sure to install the aeration cap on the supply connector, since otherwise the instrument will be irreversibly damaged.To ensure protection against mechanical damage, the sealed-in flexible endoscopes must be stored securely in one of the gas sterilizer’s perforated trays. Be sure that a bending diameter of at least 30 cm (12 inches) is maintained.After sterilization and adequate aeration (if required), always stored flexible endoscopes in extended condition.

Elastic instruments made of thermolabile (heat-sensitive) plastic are not autoclavable, so sterilize them using one of the methods indicated by the manufacturer.

Elastic instruments made of rubber, as well as functional parts of respiration systems, should not be gas-sterilized because such items are autoclavable.Elastic instruments with lockable cavities (such as balloons or respiratory masks) must be cleaned and disinfected while closed, to keep the cavities free from liquids.If the instruments are not sterilized but disinfected chemically after manual preparation, use a special disinfectant solution.Plastic or rubber instruments often show white spots after treatment. These are simply caused by water absorbed into the surface. Removal is possible only by drying.If compressed air is used for drying, sterilize it first by passing it through a suitable filter.To avoid damage to the membranes of functional parts of respiration systems, do not dry with compressed air.

8. How to treat brand-new instruments.

After removing their packaging materials for shipping, always store brand-new instruments in a dry room temperature. Otherwise, temperature fluctuations could lead to condensation within the plastic packing and subsequent corrosion.

Never store instruments together with chemicals releasing corrosive vapors!

Before using them for the first time, brand-new instruments must be sent through the complete preparation cycle: remove any protective caps and foils, then perform the various stages- cleaning, rinsing, care, inspection/testing and sterilization – in the same way as described above for used instruments. If mild or neutral cleaning agents are used, a special procedure may be required for initial treatment in order to ensure that all oils or lubricants present are completely removed.

As the passive layer of brand-new instruments is still thin, they are more likely to corrode than older, used instruments.

To avoid mechanical damage, microsurgical instruments must be stored in suitable racks or holding devices for initial preparation. As well.

Be sure to store elastic instruments in their original packing in a dry, cool and dark place. When restocking, keep in mind that elastic instruments will age even if just stored unused.

Functional parts of respiration systems frequently incorporate valves or diaphragms which tend to adhere to the instrument body during longer storage periods. Such valves or diaphragms must be specially checked and tested before using the instruments.

9. Special information.

If the instructions given in this guide are duly observed, it makes no difference whether the instruments treated have a bright or matte surface.

Remember, however, that these instructions do not apply to disposable (single use!) items.

Instruments and cables incorporating optical fibers can, as a rule, be prepared in the same way as surgical instruments, unless such a treatment has been expressly ruled out by the instrument manufacturer. This is the case with hot-air sterilization and ultrasonic-bath treatment, which are considered unsuitable for these instruments.

For cleaning dirty light-exitsurfaces, we recommend pure alcohol.

To avoid kinking, do not overbend optical-fiber cables! This also means that a sufficiently large radius should be maintained when rolling them up.

10. Water used for instrument preparation.

Instruments must have certain properties so they can fulfill their function (e.g. edge retention of scissors, clamping force of clamps, spring power of forceps). These requirements are met only by a very limited number of steels, but even an unfavorable water composition can have a detrimental effects on such steels. This is why water quality is very important when planning the sanitary installations.

While any natural water contains dissolved salts, concentrations vary depending on the origin of the water and the purification processes used. When water evaporates, these substances form salty encrustations (scales),. The most critical water constituents are chlorides, since higher concentrations of them may cause pitting on instruments.

While it must be said that the causal relationships between the water’s chloride content and pitting are not always predictable, the danger of chloride-induced pitting generally rises with:

-increasing chloride content,

-increasing temperature,

-decreasing pH-valves,

-increasing exposure time,

-surface roughness,

-insufficient drying.

Experience shows that the probability of pitting is low as long as the chloride content does not exceed a level of approx. 120 mg/1 (equivalent to 200 mg/1 NaCl=sodium chloride). With higher chloride concentrations, however, pitting seems to increase rapidly.

To prevent excessive chloride concentrations and subsequent pitting, we recommend using deminiralized water, particularly for the final rinse.

Other substance may cause brownish, bluish, gray-black or iridescent discolorations even in small quantities/silicic acids or compounds with iron, copper, manganese or magnesium dissolved in the water. As a rule, however, such discolorations have nothing to do with corrosion. Most of these stains can be easily removed by immersing the instruments in a suitable acidic solution or wiping/rubbing them with a cloth saturated with an acidic solution, carefully following the manufacturer’s instructions. Apart from the natural constituents, drinking water often contains rust, mostly as a result of corroded pipes. This rust deposited on the instruments during the preparation cycle, producing stains (extreaneous rust) and subsequent corrosion.

As a rule, it is advisable to use only deminiralized water for the final rinse. However, if an ion exchanger is used for demineralization, this may produce a silicate coating due to the special behavior of silicic acid. Since it is not possible to control this via the conductivity valve during regeneration, a specialist should be consulted in this case.

11. Materials.

When designed and manufacturing surgical, microsurgical and dental instruments, the manufacturer must match the materials to the instruments purpose, taking due account of treatment conditions. In the case of most surgical instruments, basic requirements- such as elasticity and toughness, stiffness, high cutting ability and wears resistance plus optimum corrosion resistance – can only be met by using metals, in particular stainless and hardenable (heat-treated) chromium steel with a chromium content of approx 13 %. To satisfy user demands, such steels must then be given appropriate surface treatment (the surface- should be as smooth and homogeneous as possible, with either a mat or mirror finish, and should also be hardened). It should be noted that in spite of the fact that all these instrument steels comply with national (DIN) and international (ISO) standards and are generally resistant to the chemical and thermal stresses usually encountered in daily practice (in doctors practice and hospitals), they are nevertheless very sensitive to stress corrosion cracking and chloride-including pitting.

Apart from heat-treatable stainless chromium steels, non-hardenable chromium contents, as well as rust- and acid-resistant chromium-nickel steels, are used as well. Due to their restricted mechanical properties, however, the use of the later steels is limited to certain types of instruments.

For endoscopes, a great variety of materials is used, depending on the application technique used and the particular instrument design. The most important materials are:

-rust and acid-resistant chromium nickel steels.

-non-ferrous heavy metal alloys with surface finishing (e. g. chromium nickel plated brass).

-light metals (e.g. anodized aluminum), -non-corrosion-resistant steels (e.g. for varnished assemblies and components).

-glass (for optical systems),

-ceramics,cement and other boding agents,plastics and rubber.

Combining these very different materials naturally places restrictions on the preparation processes. In other words, such items may require special treatment different from the usual preparation techniques. When in doubt in a given case, contact the manufacturer for advice if no treatment recommendations are given in the instrument-specific Instructions for use.

The design and application requirements of elastic instruments and respiration systems also make it necessary to use and combine a wide variety of materials (which are more or less identical with those used for endoscopes). Here, the most frequently used material is natural rubber (latex) and silicone elstomer or silicone rubber, a synthetic plastic.

For surgical motor systems the full range of materials described in this booklet is used as a result of the design and manufacturing requirements involved. Stainless, heat-treatable chromium steels, for example, are used for rills, cutters, burrs, saw-blades and gear components, while sterilizable plastic materials are usually used for handles, switches, gear components are cables and hoses.

Special treatment methods may be necessary for varnished casings made of unalloyed sheet steel, handpieces with varnished color marking (including gear ratios) or anodized aluminum housings (as used for handpieces and elbows). In addition to special preparation techniques, lubrication is required for heavy-duty shafts as well as bearing and gear components made of stainless steels (and in some cases, also for those made of non-stainless quenched and tempered steels or bronze materials).

If in doubt, do not hesitate to contact the manufacturer for advice on how can best prevent damage.

12. Surface changes, corrosion and aging.

All instruments and devices described in this manual can be adversely affected, either chemically and/or thermally, during use, preparation or sterilization. This can change their appearance or lead to corrosion or aging.

Surface changes are visible changes. They ca occur in all kinds of instruments and devices, irrespective of the material used. This particularly refers to removable residues (e.g. residues from operations, whether already encrusted or not, or other contamination or soiling). Such surfaces changes can usually be removed completely, using special basic cleaning agents where necessary, and leave no damage.

Yellow-brown to dark-brown spots (often arranged in groups) on sterilized metal items are frequently mistaken for rust. Such residues tend to have a high chloride content, though, which may indeed lead to chloride-induced pitting on stainless-steel parts if they are not removed immediately,. Stains of this type are usually found in places that are difficult to reach during the cleaning process.

Colorful tarnish, black discolorations or water spots are surface changes that are rather typical for metallic items and are hardly ever seen on rubber or plastic products.

Discolorations can maintain themselves either as “blended” multi-color stains (with blurred color transitions) or single-color, deep-color spots (such as back discolorations). They do not lead to permanent damage or destruction of the items affected.

The causes are complex and may be found in the quality of the water used for cleaning or autoclaving in sub optimal machine cleaning processes or in the stem supply equipment. Existing problems can therefore only be solved through close cooperation between all parties involved – the in-house sanitary technicians, the suppliers of cleaning, sterilizing and steam supply plants, and the manufacturers of the disinfectants and cleaning agents used.

Water spots are similar phenomena, but they normally show sharply defined edges and tend to be caused by an excessive concentration of minerals (e.g. silicates) or organic substances in rinsing waters or in the sterilizing steam used.

The remedy here is to use purified steam and subject the items to a final rinse using deminiralized water.

Overloading sterilizing units may cause increased condensation and lead to increase staining during sterilization.

The term “corrosion” usually refers to metals only. Corrosion is a material-specific-phenomenon that manifests itself in different ways, depending on the type of metal. Almost always, corrosion leads to permanent damage or even destruction of the affected items.

Corrosion on surgical instruments and devices can only occur if they come in contact with water, aqueous solutions or steam. The most important types of corrosion and their effects will be dealt with in the following paragraphs (according to frequency). Note, however, that no specific reference is made to the underlying chemical and physical processes. To know more about them, consult the relevant (specialized) literature.

Pitting corrosion only occurs in metals. Unfortunately, pitting an also affect stainless steels, which are not only used for most surgical instruments but also though o a lesser extent- for endoscopes, surgical drive systems and respiration systems components. Irrespective of the type of steel, pitting is mainly caused by chlorides (so called “ chloride-induced pitting”). Even short exposure times can trigger such an attack. Other halogen ions (iodides, bromides) have the same effect. While non-ferrous metals (such as copper and aluminum alloys) can also be damaged by pitting, the electrochemical causes involved are different.

Pitting corrosion shows as holes in the instrument surface. These holes are a source of rust. As corrosion progresses, they rapidly grow bigger and bigger, thereby destroying the instrument in a very short time.

Pitting can only be avoided if those instruments that have been a contact with chlorides or other halogen ions are cleaned immediately after use. Please note that organic residues also contain chlorides which, if not removed, will lead to pitting in due time.

Since pitting corrosion most easily occurs in liquids, immersing instruments in a physiological salt solution will cause irreparable corrosion damage within very short time. Attention should also be paid to the quality (i-e, chloride content) of the water used for cleaning and rinsing.

Stress corrosion cracking normally occurs only in stainless steels. It can have a considerable influence on the useful life of such instruments.

To avoid such damage, it is absolutely necessary to keep the instruments open during the entire cleaning cycle. Where instruments incorporate a rather, potential damage resulting from the stresses caused by temperature variations during sterilization (e.g. stress cracks in the joints; loss of clamping force) can best be avoided by closing these items only at the first notch/tooth when sterilizing them. Note that even small quantities of chlorides may induce stress corrosion cracking.

Fretting and crevice corrosion have almost identical causes, since both types of corrosion occur in narrow gaps and joint as a result of chemical or mechanical destruction of the natural passive layer of the stainless steel. In joint crevices, metallic abrasion may also occur as a result of insufficient lubrication, thus restricting the instruments ease of movement. In both cases, rust will start to bloom out of these joints or crevices as soon as they come in contact with humidity.

Contact corrosion can also be occasionally observed when surgical instruments are cleaned mechanically. Under unfortunable cleaning and rinsing conditions (e.g. when the tap water used contains chlorides), “rust rings” may form on instruments in place where thy come in contact with each other.

Contact corrosion may be particularly severe where stainless steel instruments come in contact with non-stainless steel items (needles, cutters etc.). Likewise, chromium-plated instruments whose surface is defective may also induce contact corrosion on other items.

In the case of general/overall corrosion the entire surface of a metal part is relatively uniformly attacked by chemical or electrochemical forces, leading to the formation of corrosion products that are easily distinguishable from the surrounding undamaged surface by their different color. In steels, this is rust. General corrosion hardly ever occurs in stainless steel instruments.

Instruments, trays and containers made of anodized aluminum always require a preparation technique suitable for, and adapted to the material in question. Acid or alkaline solutions may cause general corrosion on anodized surfaces. On color-anodized parts, in particular, this shows as a “fading”.

In non-stainless steel or non-ferrous heavy metal items protected by a galvanically applied coating, general corrosion tends to occur in places where the protective layer is defective.

In steels, any kind of corrosion leads to rust. If particles are transferred from one instrument to another during disinfcetion, cleaning or sterilization, this primary “film rust” will subsequently cause corrosion (secondary rust) on the second instrument. If corroding instruments are not sorted out and discharged, corrosion will increase and spill over to other items with every new preparation cycle.

Sterilizing steam coming out from rusty steam supply pipes may also carry rust particles into the sterilizer. This extraneous rust manifests itself as corrosion deposits on the internal walls of the sterilizing chamber as well as on the sterilizing packing and instrument surfaces. Extraneous rust also lead to subsequent instrument corrosion (secondary rust).

“Aging” is a term that mainly refers to rubber and latex (natural rubber), I-e, materials usually used for flexible instruments and components of endoscopes and respiration systems. Aging is a slow natural process that- unavoidably – also occurs during storage. The aging process is typically accelerated by the impact of dry heat at temperatures above 80 C, by stretching and overstretching/straining the material during storage, and by the impact of light (e.g. sunlight, UV radiation). In rubber, aging manifests itself as (brownish) discolorations or brittleness (cracking in the surface). Plastics can be affected by aging: the material hardens and turns yellow. Silicone rubber (also called silicone elstomer), in contrast, never ages.

“Swelling” is another phenomenon affecting rubber, latex and plastics. Swelling is caused by liquids or gases that have penetrated the surface of an instrument.

This may be a reversible process caused temporarily by the impact of volatile solvents or propellant gases of sprays. Reversibility also applies to cases where rubber or certain plastics materials came in contact with gaseous anesthetics such as Halothane. Irreversible swelling, however, is caused by contact with non-volatile oils (paraffin oil), Vaseline and unsuitable disinfectants (e.g. phenol derivatives). Silicone rubber reacts reversibly to propellant gases of sprays and gaseous anesthetics but irreversibly to silicone oils and solvents.

Typical swelling symptoms are: softened, sticky surfaces and destroyed instruments parts, particularly those with thin walls.

13. References.


EN 285.
Sterilization
Steam sterilizers for medical purposes; large sterilizers.
EN 550
Sterilization of medical devices
Validation and routine control of ethylene oxide sterilization.
EN 554
Sterilization of medical devices
Validation and routine control of sterilization by using moist heat.
EN 868
Packaging materials and systems for medical devices to be sterilized,

Part 1-
DIN 58946
Sterilization
Steam sterilizers for sterile medical devices
Big sterilizers (in part replaced by EN 285 and EN 554).
DIN 58947
Sterilization
Hot-air sterilizers.
DIN 58948
Sterilization
Gas sterilizers.
DIN 58952
Sterilization
Packing materials for goods to be sterilized.

DIN 58953
Sterilization
Sterile supply.

10. DIN 17442

Walzwerks – Schmiede –oder Gieberie-Fertigerzeunisse aus nichtrostenden Stahlen fur medizinische Instrumente [Finished rolling, forging and foundry products made of stainless steel used for medical instruments].
11. ISO 7153-1
Surgical instruments – metallic materials

Part 1: Stainless Steel.

12. DIN Taschenbuch 100 [DIN Pocket Book]

Medizinische Instrumente [Medical Instruments].

13. Council Directive 93/42/EEC of 14 June 1993 relating to medical devices Offical journal of the European CommunitiesL 169, volume 36, 12 July 1993.

4. VGB 103 Unfallverhuntungsvorschrift mit Durchfuhrungsanweisungen Berufsgenossenschaft fur esundheitsdient und Wohlfahrtpflege [Accident Prevention Regulations, with implementation instructions – Health Services and Welfare Work Trade Association].

15.DGHM Disinfectants List.

16. RKI list of tested disinfectants and disinfecting procedures.

17.European Pharmacopoeia.
18. Gray Booklet “Test Series and Statements” –AKI publications.
14. The basics at a glance. Always clean brand-new instruments prior to first sterilization. Carefully follow the instructions for use. Strictly adhere to dosage, exposure time and temperature specifications provided for disinfecting and cleaning. Treat used instruments as soon as possible. Always open hinged instruments prior to preparation. As far as possible, disassemble all instruments before treating them. Be sure to use suitable cleaning tools and accessories. Do not overload washing machines and ultrasonic cleaning devices. Prevent the formation of “shadow” and anechoic zones. Never use metal brushes or metal sponges for manual cleaning. Rinse thoroughly and carefully after cleaning. If possible, use deminiralized water.

Dry sufficiently after rinsing.·
Worn, corroded, deformed, porous or otherwise damaged instruments must be sorted out and discarded.
For hygienic reasons, instruments must be sent through the complete preparation cycle before they are submitted for repair.

Hinged/jointed instruments must be treated with a paraffin oil-based lubricant (not applicable to flexible endoscopes and accessories).

· Following assembly, subject each instrument to a functional test. Hinged instruments must be lubricated prior to carrying out the test.

· Instruments with a ratchet should only be closed at the first tooth/notch before sterilization.

· Sterilization is no substitute for cleanliness!



 
 
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