Reprocessing of surgical instruments

1

IndexPage

Objective of reprocessing and sterilisation 2

General references

A. Instruments 3

B. Reprocessing 4

Instrument reprocessing

Pre-treatment 5

Cleaning and disinfection (manually – mechanically) 6

Drying 9

Examination 9

Packaging 10

Sterilisation 11

Storage 11

Additional information 12

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As at: 10/07

Revision: 0

Manufacturer:

Products:

General information:

Limited number of reprocessing cycles:

KOMET MEDICALGEBR. BRASSELER GmbH & Co. KGTrophagener Weg 25 · 32657 Lemgo

Tel.: +49 (0)5261 701-400Fax: +49 (0)5261 701-580info@kometmedical.dewww.kometmedical.de

The present manufacturer’s information applies to all surgical instruments supplied byGebr. Brasseler, i.e. rotary Tungsten carbide and diamond instruments as well asstainless steel instruments, with the exception of trepan burs.

Disposable products (marked on the packaging) may not be reprocessed.Instruments delivered in non-sterile condition have to be prepared prior to first use.

Please follow the recommendations and instructions provided by the manufacturer ofthe washer disinfector and the autoclave.

The end of a product’s service life depends on its degree of damage and wear.

Frequent reprocessing does not affect the performance of these instruments.

Rotary instruments – Page 1 of 3

Rotary instruments

0197

Manufacturer’s informationon the reprocessingof re-sterilisable instrumentsaccording to DIN EN 17664

Hygienic reprocessing of reusable KOMET MEDICAL products

Objective of reprocessing and sterilisation

KOMET MEDICAL products are made of high-grade material and are developed, constructed and manufactured with greatest care. Successful reuse and excel-lent work results can only be achieved by appropriate use and gentle cleaning and disinfection of the instruments.

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 utmost care.

Validated reprocessing according to information provided by the manufacturer

KOMET MEDICAL provides information on validated reprocessing appli cable to its entire product range. This can be downloaded from our website www.kometmedical.de.

The validated methods allow to obtain a revisable result, thus providing in creased protection from infection for both patients and operators. According to §4, section 2 of the Regulations for Operators of Medical Devices (MPBetreibV – see below), all operators of medical products are obliged to use a validated method for the reprocessing of instruments.

§4 (Maintenance) Regulations for the Operators of Medical Devices (MPBetreibV) “(2) The reprocessing of medical products that are to be used in 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 instruc-tions 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. …”

Important note: Damaged surfaces can lead

to corrosion of the instruments during cleaning and disinfection.

KOMET MEDICAL instruments are suitable for reuse. It is therefore essential that instruments are handled with special care during use and reprocessing.

Important note: Instrument reprocessing

3

InstrumentsThe entire product range is made of high-grade material obtained from carefully chosen suppliers. Our production is subject to constant quality controls. Our instruments are manufactured to the tightest tolerances, without nicks and burrs and with perfect concentricity. They can therefore be used in combina tion with all common power systems available on the market.

Competitive product: Coarse-grain tungsten carbide structure: The remaining porosity is an unfavourable condition for precise blades.

(Fig. 2) KOMET MEDICAL product:Fine-grain tungsten carbide structure:The redensification of the metal to prevent poro sity increases the resistance to wear and tear and improves the cutting performance.

Competitive product: Corroded tool steel shank

(Fig. 1) Stainless steel KOMET MEDICAL shank after repeated use

Competitive product: Out-of-concentric rotation of the instrument, which leads to vibrations, loss of precision and increased heat generation

(Fig. 3) KOMET MEDICAL product:Perfect concentricity, even at 100,000 rpm

Quality characteristics:

Instruments made of stainless steel (Fig. 1) offer the following advantages: - long service life/durability- repeated reprocessing without

problems- more cost efficient than disposable

products

Thanks to the use of fine-grain tungsten carbide (Fig. 2) only, the products feature:- blades without nicks- long service life/durability- better cutting performance than

steel instruments

KOMET precision grinding machines guarantee a consistently high quality of the product: - excellent concentricity (Fig. 3)- outstanding surface quality- low vibration during substance

removal

44

Reprocessing

To guarantee successful reprocessing, work thoroughly and with great care. Use suitable detergents and disinfectants and follow an appropriate method of reprocessing to remove all residues of tissue from the instruments and to ensure gentle cleaning of the material. All instruments – both new and used – have to pass through the complete cleaning cycle.

Important note:

To avoid fracture of the material, never throw or pour instruments.

New instruments must be cleaned, disinfected and sterilised prior to first use.

Packaging

Examination

Dry

ing

Ster

ilisa

tion

Stor

age

Usage

Pre-treatment

Disinfection/Cleaning

Newproducts

sterile one-way products

Disposal Subsequent cleaning

5

Pre-treatment1If instruments are to be pre-treated directly after surgery or after use, a com-bined detergent/disinfectant (e.g. KOMET DC1) has to be used to protect staff from infection prior to reprocessing and disposal of the instruments and to facilitate subsequent reprocessing.

The instruments can either be transported towards the reprocessing venue in dry condition, placed in special instrument dishes, or directly after the operation immersed in a combined detergent/disinfectant (transport in wet condition). In any case, the instruments should be transferred to reprocessing immediately after use to remove residues on the instruments as soon as possible. Dried contamination (e.g. blood, bone fragments, iodine, saline solution) can cause corrosion and are very hard to remove.

Make sure to avoid prolonged waiting times between operation and reprocessing of the instruments.

Important note: KOMET DC1

KOMET MEDICAL REF 9829, alka line,

free of aldehyde, DGHM/VAH approved.

GENIUS II Shaver Blades:GENIUS II Shaver Blades must be stripped down into their com-ponents during transport in the instrument dish in 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. Dry transport takes place in assembled condition.

The unique three-part design of the KOMET MEDICAL GENUS II 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 sterilisa tion, in which case the instrument has to undergo another cleaning cycle.

Available only with German instructions for use!

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66

Cleaning and disinfection

9829

2Important note: The use of hydrogen per -

oxide and other detergents and disinfectants containing chloride should be avoided, as this can lead to pitting and corrosion as well as black discolorations on tungsten carbide instruments.

The combined pre-cleaning/disinfection process is followed by a cleaning cycle which serves 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.

For manual cleaning and disinfection, any chemical disinfectant used must be approved (e.g. in Germany by the RKI or the DGHM/VAH, the German Asso-ciation for Hygiene and Microbiology) and be effective as per points A and B below.

A – Killing of bacteria, fungi and their sporesB – Deactivation of virusesC – Killing of bacterial spores, including anthraxD – Killing of bacterial spores, including gas gangrene and tetanus

On principle, manual cleaning and disinfection should be given preference; thermal disinfection – observing the A0 value – being preferable over chemical disinfection. Should these procedures be inappropriate (for example due to un -suitable detergents), manual cleaning and disinfection are a suitable alternative.

2.1. Manual cleaning and disinfection

The instruments have to be immersed in a combined alkaline-based cleaning/disinfecting solution (with anticorrosive protection, e.g. KOMET DC1), because the cleaning performance of alkaline agents remains almost constant even in the case of varying degrees of water hardness. Observe indications provided by the manufacturer regarding the proportions of the mixture and the immer-sion time. We recommend changing the solution every day or more frequently in the case of heavy contamination, since this entails the risk of a decrease in the disinfecting effect. In addition, a severely contaminated solu tion might cause the instruments to corrode or lead to the displacement of impurities. The same risk exists if the concentration of the detergent does not comply with the manufacturer’s instructions.

Approved by the German Association for Hygiene and Microbiology (DGHM/VAH), the detergent DC1 developed by KOMET is a highly effective universal concentrate for cleaning and disinfecting all instruments as part of manual reprocessing. The antiviral, antibacterial and fungicidal effect is given after just 60 minutes. The immersion time can be reduced in the case of a more concen-trated solution (see label of KOMET DC1).

Cleaning should be effected with the help of plastic brushes and cleaning guns. Use fully demineralised water for final rinse.

KOMET DC1 is suitable for manual

cleaning and disinfection of:

Steel instruments ✓Tungsten carbide instruments ✓Diamond instruments ✓Saw blades ✓GENIUS II Shaver Blades* ✓Bur blocks* ✓* Possible fading of the anodic coating does not constitute a reduction in quality

Available only with German instructions for use!

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GENIUS II Shaver Blades:The GENIUS II Shaver Blades must be subjected to a manual pre-cleaning cycle in any case, which entails the Shaver Blades being

stripped down to their components. 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 disin-fectant (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.

Important note: At the end of each

cleaning cycle, all auxiliary devices (e.g. brushes) have to be cleaned and disinfected.

Ultrasonic treatment

Ultrasonic treatment constitutes a mechanical treatment supplementary to manual cleaning and is recommended for particularly stubborn contamination on the instruments as well as sensitive and hard-to-access instruments. For correct dosage of the detergent 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 in contact 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 this may lead to corrosion caused by residues of detergent left on the instruments. A final disinfecting cycle is recommended to make sure that the instrument is fully disinfected.

The use of DC1 in the ultrasonic bath requires an immersion time of 5 minutes if a 2% solution is used to fully develop its antiviral, bactericidal and fungicidal effect and to guarantee constant compatibility with the material.

9853M – 145 x 75 x 35 mmBur block (without instruments)for 24 x 70 mm instruments

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Cleaning and disinfection2

GENIUS II Shaver Blades:The new GENIUSadapters allow validated cleaning of the GENIUS II Shaver Blades in the washer disinfector.

The direct water connection provided by the GENIUSadapters guarantees even and thorough flushing of the Shaver Blades, so that no traces of con-tamination are left after rinsing.

A description of the validated method can be down-loaded from our website www.kometmedical.de

To use the GENIUSadapters with three-part GENIUS II Shaver Blades, the fixture of the blade must be connected to the inner tube. The GENIUS II Shaver Blades are then firmly fixed to the GENIUSadapters and 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!

Important note: The cleaning and disinfection

of all KOMET MEDICAL instruments in the chemical disinfector is not recommended! We advise against the use of hydrogen peroxide for KOMET MEDICAL GENIUS II Shaver blades and tungsten carbide instruments.

2.2. Mechanical cleaning and disinfection

Mechanical cleaning and disinfection are carried out in the washer disinfector. Please observe the instructions provided by the manufacturer to ensure correct use!

KOMET MEDICAL products can be reprocessed with any detergent and disin-fectant with proven material compatibility, however we recommend deconex 28 ALKA ONE (made by co. Borer Zuchwill, alkaline). The washer disinfector should be equipped with a delicate cycle to avoid excessive strain on the instruments.

Correct loading is essential:• Do no 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.

Thermal disinfection must take place under consideration of the A0-value and in compliance with the national provision (prEN/ISO15883). Avoid temperatures of > 55°C during the cleaning cycle to prevent the risk of protein fixation.

Should you require a validated procedure, please refer to our website www.kometmedical.de where you will find a validated reprocessing method applicable to the entire KOMET MEDICAL product range.

Order numbers – GENIUSadapters* GE 9001.DY – compatible with DyonicsGE 9101.LI – compatible with LinvatecGE 9201.AC – compatible with AesculapGE 9301.ST – compatible with Stryker* suitable only for KOMET MEDICAL GENIUS II Shaver Blades

2

!

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Drying

Examination

3

4At the end of each cleaning and disinfecting cycle, the instruments must be subjected to a visual control and to a functional test in order to make sure that they are macroscopically clean. Damaged instruments must be discarded to prevent them from re-entering the cycle.

Instruments that are not scrupulously clean must undergo another mechanical or manual cleaning and disinfecting cycle. The following factors decide whether an instrument is fit for reuse or if it has to be re-cleaned or even discarded:

a. Shape: An instrument with bent tubes cannot be chucked properly into the power system, nor can vibration-free operation be guaranteed. ➔ Disposal

b. Surface: - Nicks on blades, shanks, saw blades, inner or outer blades of GENIUS II

Shaver Blades etc.: ➔ Disposal - Blank, non-coated areas on diamond instruments: ➔ Disposal - Blunt instrument due to excessive abrasion: ➔ Disposal - 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 in any case.

c. Functional capability of Shaver Blades: It must be possible at all times to rotate the inner blade or the cutter in 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 ).

d. 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 on tungsten carbide instruments. ➔ Disposal

Drying after mechanical and manual cleaning and disinfection and, if appli- cable, ultrasonic treatment should be effected by means of medically pure compressed air. This gentle, yet efficient method is preferable to any other drying method.

Delicate instruments should

always be checked with

magnifying glasses (8x) !

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1010

Examination

Packaging

4

5

GENIUS II Shaver Blades:To ensure proper examination you can download our check list of the Sterile Service Department for Shaver Blades from our

website! GENIUS Shaver Blades should always be completely replaced. Partial replacement of individual components must be avoided under any circumstances.The inner tube of the GENIUS II Shaver Blades should be lubricated with an oil spray (e.g. “Lubriflut” provided by co. MEDICON) to minimise friction in the inner tube. The inner tube should be sprayed from a distance of approx. 20 cm. As soon as the inner tube rotates in the trocar, an even film forms between the inner and outer tube, significantly reducing metal abrasion.

The packaging for sterilisation should be suitable for the sterilisation method used, to ensure that the packaging material can be penetrated by the sterilisa-tion agent (e.g. water vapour). The packaging also provides protection during transport and storage.

The instruments are to be packed according to DIN 58 952/58 953. The packag ing protects the sterilised goods from microbacterial recontamination during transport and storage.

The packing units are to be kept as small as possible and provided with labels indicating the contents, date of sterilisation, use-by date, batch number and sterilisation indicator.

Important note:

The check list can be downloaded from our website www.kometmedical.de.

Check list

Magnifying glass, 8 times magnified

Visual control;Magnifying glass if necessary, 8 times magnified

Functional test:The outer tube of the ShaverBlade is locked onto the innertube and set in rotary motion with a finger

� Not clean �

� Free from defects �

� Fracture �

� Free from defects �

� Metal abrasion �

� Free from defects �

� Corrosion �

� Free from defects �

� Difficult to rotate

� Free from defects �

� Additional cleaning cycle

☺

� Disposal

☺

� Disposal

☺

� Special cleaning

� Disposal

☺

� Additional cleaning cycle

� Disposal

☺

Inspection

Impurities

Fracture or damage to inner or outer blades

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 corro-sion), as a result of which resistance to fracture can no longer be guaranteed, inevitably leads to the dis-posal of the instrument.

Difficult to rotate: low-vibration operation or properchucking in the motor can no longer be guaranteed. Check whether the preceding cleaning cycle has beensuccessful (=> additional cleaning) or if there is anybending ( => disposal).

Defects

Cleanliness

Surface

Form and Function

Protocol Action

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 pro-cess to ensure that the instruments are macroscopically clean and that damaged instruments are discardedbefore being reintegrated in the preparation cycle (see reverse of page). The characteristics listed belowdetermine the next step, i.e.

� Packing � An additional cleaning cycle � Disposal

* KOMET MEDICAL GENIUS Shaver Blades are reusable, which is why it is particularly important to treatthe instruments with care during use and reprocessing. Use Shaver Blades without pressure and observethe optimal speed.

Download this information from our website www.kometmedical.de !

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

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11

Sterilisation

Storage

Recommendation of suitable sterilisation methods

9835M – GENIUSbox

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7

With a few noted exceptions, KOMET MEDICAL products are compatible with the most commonly used methods of sterilisation. The below table provides you with a detailed overview of the compatibility of KOMET MEDICAL products with the most frequently applied methods. Please observe the instructions of the manufacturer when applying your chosen method!Make sure not to overload the mesh trays and that the weights in the sterili-sation device are evenly distributed!

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.

GENIUS II Shaver Blades:

GENIUS II Shaver Blades should be sterilised and subsequently stored in the GENIUSbox.

The GENIUSbox protects the instru-ments from getting bent and from other external factors.

Important note: Make sure not to exceed

temperatures of > 180°C (for example during hot air sterilisa-tion). Sterilisation at low tempera-tures should only be carried out by certified personnel.

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Sterilisation method

= suitable = unsuitable

KOMET MEDICAL Instruments

Autoklave

Plasma

Rotary steel instruments

Rotary tungsten carbide instruments

Rotary diamond instruments

Saw blades

GENIUS II Shaver Blades

Bur blocks

GENIUSbox

1212

Defects Causes

Additional information

Additional cleaning recommendations for the individual products can be found in the instructions for use.

The below table gives you a concrete guide on how to solve frequently occurring problems caused by use or reprocessing:

Bent instruments

Damaged shanksInstruments can no longer be chucked; chucking marks; burrs at the engaging piece

Organic residues on the instruments

Water stains caused by lime on the surface of the instrument

Tarnished (brown-violet) surfaces

Black discoloration of the tungsten carbide instrument head

Pitting corrosion

Rounded blades and metal abrasion

· Incorrect insertion· Excessive speed· “throwing” or “dropping” of the instruments· Overloaded mesh tray

· Defect or worn bur shank ends· Defect chucks in the hand piece

· Unsuitable detergents/disinfectants· Use of old, contaminated cleaning solutions· Encrusted contamination due to dried residues· Ultrasonic shadows

· Final rinse not effected with demineralised water

· Mineral ingredients in the rinsing water or vapour condensate

· Sterilisation temperature too high

· Unsuitable detergents/disinfectant · Incorrect dosage · Excessive immersion times

· Chloride content of rinsing water or saline solution during use

· Organic residues (blood, tissue etc.)

· Excessive use of the saw blade

Defects and their prevention

13

First aid Prevention

Disposal

Disposal

Subsequent cleaning and disinfection

Removal with special cleaner

Removal with special cleaner

Disposal

Disposal

Disposal

· Follow manufacturers’ instructions when exchanging instruments· Observe max. speed

· Check, clean and maintain surgical hand pieces and contra-angles regularly

· 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

· Use fully demineralised water for final rinse

· Use fully demineralised water for final rinse· Do not overload the mesh trays· Make sure all instruments are accessible from all sides· Sterilisation temperature <180°C

· Follow the instructions provided by the manufacturers of the detergents/disinfectants· Do not exceed indicated immersion time

· Use rinsing water with a low chloride content· Do not allow contamination to dry after use

· Careful inspection of the blades during reprocessing· The saw blades need to be exchanged during the operation as soon as these only cut with

high contact pressure which leads to significant heat development (thermic necrosis)

Important note: On principle, the instruments

can be reprocessed as often as wear and tear incurred during surgery allows. The degree of dete-rioration depends on:

- the contact pressure applied during the operation

- the consistency of the bone tissue

- how long the instrument is used during the operation

© 11/2007 · GEBR. BRASSELER · Germany · Printed in Germany · BRA/0 · 403231V2

+ E 2 2 6 4 0 3 2 3 1 V 2 0 / $ 0 0 0 0 0 0

GEBR. BRASSELER GmbH & Co. KGTrophagener Weg 25 · 32657 LemgoPostfach 160 · 32631 Lemgo · Germany

Phone +49 (0) 5261 701-400Telefax +49 (0) 5261 701-580info@kometmedical.dewww.kometmedical.de