Used items

Your safety first: How to handle used or newly bought items

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Cleaning

The first and decisive step for successful reprocessing

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Disinfection

Significant reduction of the microbial contamination

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Inspection

A close look at functionality and efficiency

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Packaging

Only correctly packaged items can maintain their long-term sterility

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Sterilization

The power to reduce germs to their absolute minimum

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Storage

Prolong sterility by optimum conditions

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Used items

Definition

[juːzd] adjective
All dental items & instruments used during treatment as well as newly purchased items if not pre-sterilized by the manufacturer.

W&H Best Practice

For your own safety, pre-disinfect/pre-clean all items immediately after use.
Make sure you wear protective clothing, masks, gloves and eyewear.

If pre-cleaning in the treatment-area is not recommended by your local guidelines, place all items in a covered puncture-proof container and keep them moist to prevent any liquids from settling.

Your safety comes first

Handling used/contaminated items poses a high risk of infection, so wearing personal protective equipment is of the utmost importance.

Click here to learn how to do it right.

Contamination:

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Efficient infection prevention is a must!

Besides the current risk of Sars-CoV2 there are several other disease-causing microorganisms that can have a major impact on your health and your patient’s health. Find out about the impact of aerosols and much more here.

Ready, steady, read!

Always refer to the manufacturer’s instructions for use before starting to reprocess your used items or items you have bought new.

Each instrument is in a class of its own!

To ensure you carry out all the required steps correctly, please refer to your local guidelines based on the Spaulding Classification.

Important facts

Facts versus fiction – easy-to-read information, based on scientific evidence about the risks involved in handling contaminated items.

Important steps

Handling of used items or items that have been bought new – step by step

Important facts

Knowledge is power – when it comes to risks of infection and transmission in dental offices and clinics

In view of the ongoing pandemic it might seem strange to talk about the risks of other infectious diseases. But, in fact, cross-contamination with Hepatits B poses a particular challenge to dental medicine. And this is just one example.

A number of studies have proven that oral bacteria and body fluids such as blood and saliva can contaminate both the inside and the outside of dental handpieces, for example in gear units and spray and air channels. Learn more about this here.

Possible risks of infection also include the 'aerosols' released during dental treatment. The right protective equipment can help to keep patients and staff safe.

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Important steps

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The most important step when handling used items or new items you have purchased is to protect yourself in the best possible way.

Make sure you wear protective clothing, safety glasses, face masks and gloves (PPE) during treatment and while pre-cleaning any used instruments.

Single-use items must be disposed of immediately after use; following the relevant instructions for use and the disposal of waste.

Please check your local regulations regarding reprocessing carefully.

If your regional guidelines recommend pre-disinfection/pre-cleaning in the treatment area, please follow the step-by-step guide.

If your local guidelines do not recommend carrying out pre-disinfection/pre-cleaning in the treatment area, please go directly to the step Cleaning.

In terms of effectiveness, traceability and usability W&H recommends automated cleaning instead of manual cleaning. Automated cleaning, for example with our thermal washer disinfector W&H Teon, is the safest method for instrument cleaning.

Handling of used items

or new items: Step by step

First step:

Information

Check your local regulations regarding the reprocessing of dental instruments as well as the relevant instructions for use.

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Next step:

Pre-disinfection & pre-cleaning

Wipe the entire surface of the instrument or unit with disinfectant to remove any residue and to prevent any settling on the internal parts.
Note, that the disinfectant used during pre-treatment is only for your personal protection and cannot replace the disinfectant step after cleaning.

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Next step:

Flushing & soaking

If your local guidelines recommend carrying out pre-cleaning directly in the treatment-area:
Clean the medical device immediately after every treatment to flush out any liquid (e.g. blood, saliva) and to prevent any settling on the internal parts.

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Next step:

Transport

Put all pre-cleaned and pre-disinfected items onto a tray or into a suitable puncture-proof container for safe and prompt transport to the reprocessing room.

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Start Cleaning

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Cleaning

Definition

[ˈkliː.nɪŋ] noun [U]
Removal of visible dirt, blood, proteins, microorganisms and other debris from dental medical devices or instruments.

W&H Best Practice

For your own safety use firm-grip, heavy-duty, puncture and chemical resistant gloves for cleaning.

If brushes are used for manual cleaning they must be disinfected/sterilized daily.

Why is cleaning necessary?

Cleaning is the most challenging step in the reprocessing cycle. Residual soiling and debris left on the instrument’s internal and external surfaces will make it impossible to achieve the sterilization conditions, resulting in non-sterile products. Contamination left on those instruments will also affect their functionality and may damage the sterilizer.

Above all cleaning is essential for minimizing the personal risk of infection.

Reduction of germs: up to

0%

Legal advice

The reference standards for cleaning are EN ISO 15883-1 and EN ISO 15883-5. ‘A clean medical device can be defined as visually free of soil and quantified as below specified levels of analytes.‘ (extract)

Choose validated processes

Cleaning should ideally be carried out using a validated cleaning process, e.g. a washer or thermal washer disinfector (TWD). If this is not available, batch records should be kept indicating who was responsible for cleaning the devices.

Important facts

How clean is clean? Are there any specific guidelines? And who is Sinner? Learn about the science-based background of cleaning.

Important steps

Manually or automatically – how to achieve effective cleaning – step by step

Sinner’s Circle

Whether it is performed automatically or manually, effective cleaning needs water – and four main physical factors that affect each other:

  1. Time (exposure time of the other three factors)
  2. Chemical (usually a cleaning solution)
  3. Mechanical power (e.g. scrubbing to remove visible dirt or to establish contact with the cleaning solution)
  4. Temperature (affects, for example, the effectiveness of the cleaning solution)

It was in 1959 that Herbert Sinner, an employee of Henkel, combined these factors in a simple graphic showing the basic principles of cleaning: The Sinner’s Circle. This is a pie chart made up of 4 pieces whose proportions can be altered but at the end must make up a complete pie. Learn more about making this perfect pie by clicking: The history of Sinner’s Circle

Important steps

There are two ways for efficient cleaning. Proceed with manual cleaning or automated cleaning to go through the important steps:

Manual cleaning

In terms of effectiveness, safety and usability W&H recommends automated cleaning instead of manual cleaning. Automated cleaning using TWD’s (thermal washer disinfectors) is the safest method of instrument cleaning for staff.

If these machines are unavailable then please take particular care; the risk of contamination is high, particularly in the event of heavy contamination with blood. It is essential that appropriate protective clothing, gloves and masks are worn.

Manual cleaning step by step

Manual cleaning should be carried out in facilities, and using procedures, which:

  • ensure the safety of the operator
  • provide an effective cleaning method
  • minimize the possibility of cross contamination of devices being cleaned
  • minimize the possibility of contamination of devices with residual process chemicals
  • do not damage the devices being cleaned
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First step:

Treatment area

Immediately after use instruments must be pre-cleaned to ensure that organic material will not dry on.

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Next step:

Transport

If your local guidelines do not recommend pre-cleaning in the treatment area, instruments shall be placed in a suitable covered puncture-proof container and shall kept moist to prevent drying of any liquid (blood, saliva).

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Next step:

Reprocessing room

Rinse each instrument carefully under running water (<36°C/96,8°F to avoid protein coagulation). Make sure that all the surfaces and recesses are exposed to water by rotating the instrument/item.

  • If possible, dismantle the medical device according to the manufacturer’s instructions.
  • Clean the instrument/the parts with an appropriate cleaning agent.
  • Rinse carefully
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Important

For successful disinfection, it is absolutely essential to dry the instrument/the parts after cleaning. Air dry or hand dry using a clean, disposable, non-linting cloth. For further information about this, please click here.

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Start with Disinfection

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Automated cleaning

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Thermal washers are the best method for reliable, precise and validated cleaning of all types of dental devices.

Thermal washer disinfectors go one step further: they clean and disinfect all in one. This results in validated, efficient and safe processes. Find out more here

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Automated instrument maintenance procedures provide distinct advantages when it comes to the cleaning of spray channels and lubrication, as well as perfect function and long working life of dental transmission instruments. It is simple, safe and cost-effective. Find out more here

Automated cleaning step by step

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First step:

Treatment area

Immediately after use instruments must be pre-cleaned to ensure that organic material will not dry on.

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Next step:

Transport

If your local guidelines do not recommend pre-cleaning in the treatment area, instruments shall be placed in a suitable covered puncture-proof container and shall kept moist to prevent drying of any liquid (blood, saliva).

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Next step:

Reprocessing room

Choose between automated cleaning or cleaning with ultrasonic bath. The first two steps remain the same. Ultrasonic baths are especially recommended for small, complex and finely structured components. Please refer to the specifications for an ultrasonic cleaner.

Automated
Ultrasonic bath
  • Dismantle the instrument according to the manufacturer’s instructions.
  • Follow the user instructions for the related cleaning or reprocessing unit.
  • Load the cleaning unit or TWD accordingly to the instructions for use (after the process has finished, reload the cleaning unit or TWD).
  • Dismantle the instrument according to the manufacturer’s instructions.
  • Carry out the ultrasonic cleaning by following the manufacturer’s instructions.
  • NB: Don’t forget to change the solution regularly (at least once a day).
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Safety note!

Only place instruments that have been approved for this process, into an ultrasonic or disinfection bath.

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Start with Disinfection

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Disinfection

Definition

[ˌdɪs.ɪnˈfek.ʃən] noun [U]
Disinfection results in a reduction of the number of viable micro-organisms on a product or instrument to a level that has been specified beforehand. This level corresponds to the intended further handling or use of the product.

W&H Best Practice

W&H recommends the use of validated (automated) thermal disinfection processes wherever possible as they are safe, efficient and environmentally friendly.

Why carry out disinfection?

Disinfection provides a sufficient level of infection protection to each of your staff members responsible for inspection, assembly and functionality testing of instruments and devices.

Chemical vs. thermal disinfection

W&H recommends the use of validated automated thermal disinfection processes as they are safe, efficient and environmentally friendly.

When using chemical disinfectants, they must always be handled, stored, applied and disposed of appropriately. Make sure you always wear protective clothing, gloves and protective eye wear.

Legal advice

The reference standards for thermal disinfection are EN ISO 15883-1 and EN ISO 15883-6. ‘Disinfection results in a reduction of the number of viable micro-organisms on a product or instrument to a level that has been specified beforehand. This level corresponds to the intended further handling or use of the product.’ (extract)

Choose validated methods

Validated methods are by definition more reliable and efficient. Therefore, wherever practicable, use a thermal washer disinfector for cleaning and disinfection.

Where manual disinfection is carried out, ensure that the process is recorded (date/person in charge).

Each item is in a class of its own

The whole reprocessing process required for a single dental instrument or device is commonly specified as one of three levels – based on the Spaulding Classification : critical, semi-critical, non-critical.

W&H recommends the disinfection and sterilization of all re-usable critical and semi-critical items, whenever possible. Please refer to the relevant instructions for use.

Important facts

Find out how disinfection interrupts the chain of infection, the importance of the Spaulding Classification and the requirements that disinfectants must fulfill in order to achieve reliable, safe disinfection.

Important steps

Manual or automated – the way to achieve effective disinfection during the reprocessing process step by step.

Spaulding Classification – how to use it correctly

The Spaulding Classification, originally proposed in 1957 by Earle H. Spaulding, classifies all items used during a treatment into three levels to ensure they receive the appropriate reprocessing process. The three levels are ‘critical’, ‘semi-critical’ and ‘non-critical’, depending on the contact of, for example, skin, blood, or mucous membrane.

Please always refer to the relevant manufacturer’s instructions for use as well as your local guidelines based on this classification.

The purpose of disinfection

Interrupting the chain of infection:

The purpose of disinfection is to reduce disease-causing germs in such a way that any potential infection chain can be broken, and the germ count is kept as low as possible.

Chemical disinfection

Chemical disinfectants contain active substances that kill germs. Among other things, this effect is based on the chemical disinfectant’s ability to destroy the microbial cell wall, or to inhibit certain metabolic processes of the germs resulting in cell death. Find out more here.

Dental practices must use disinfectants that have a suitable range of action (bacteria, fungi, viruses). There are specific tests that disinfectants must meet in order to make claims of disinfectant activity against specific pathogens (EN 1276 and EN 13704 ).

To protect medical products and instruments from potential damage and to ensure that their functionality is maintained, please ensure you always observe the manufacturer’s instructions for processing. (see EN ISO 17664 )

Note that even if a product or active substance has been tested successfully for the whole spectrum of disinfectant activities, including sporicidal activity, it cannot be regarded as a sterilant.

Important steps

There are several ways to carry out disinfection in a dental practice. All the important steps for successful wipe disinfection or disinfection baths/disinfection spray can be found below.

Please note: W&H would always recommend using automated methods compared to manual ones because they save time, money and even more importantly, your personal resources and health. Besides this, automated methods are more environmentally friendly in terms of waste - management and resources.

Manual disinfection

Manual disinfection is necessary, where thermal disinfection is not possible due to the medical products being heat-intolerant or because no thermal disinfection processes are available.

Important note: Please always refer to the specific manufacturer’s information with regard to whether chemical disinfection processes are compatible with the instrument.

If disinfectants are mixed together or if a liquid disinfectant is not used as specified in the manufacturer’s instructions, the desired effects might not be achieved. Click here for more information

In addition, incompatibilities can substantially reduce the lifespan of an instrument or considerably limit its function.

In the case of wipe disinfection: Please be aware that inner recesses of instruments will not be disinfected.

Wipe disinfection

First step:

Checking

Ensure that cleaning has been carried out effectively and that the medical device is completely dry internally and externally. Any moisture can reduce the impact of the disinfectant.

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Next step:

Reading

Check the related instructions for use of both the disinfectant and the instrument/device to make sure that they are compatible.
See also: EN ISO 17664

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Next step:

Wiping

Wipe down with disinfectant. Make sure that the entire surface of the instrument/device has been covered by the disinfectant. Please observe the action time of the disinfectant.

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Start with Inspection

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Disinfection baths

Manual disinfection in a disinfection bath is recommended to reduce the number of viable microorganisms to a level previously specified as being appropriate for a defined purpose by immersing the items in disinfectant.

If you are using disinfection sprays instead, please ensure that the items are fully immersed, so that all internal and external parts become wet. Always observe the action time of the disinfectant.

Important note: Please always observe the specific manufacturer’s information with regard to whether chemical disinfection processes are compatible with the instrument: EN ISO 17664.

First step:

Check dryness

Ensure that cleaning has been carried out effectively and that the medical device is completely dry internally and externally. Any moisture can reduce the impact of the disinfectant.

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Next step:

Instructions for use

Check the related instructions for use of the disinfection bath, disinfectant and instrument/device to make sure that they are compatible. See also EN ISO 17664

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Next step:

Immersion

Follow the instructions for use to ensure the disinfection bath is carried out as specified. The instruments and/or medical products must be fully immersed in the liquid disinfectant.

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Next step:

Rinsing

Abundantly rinse with tap followed by demineralized water. The quality of water used should be appropriate to the clinical procedures to be undertaken. Water deionizing devices such as Multidem provide suitable water quality.

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Next step:

Drying

Fully remove any water residues, especially inside lumens (hinges, pipes), using filtered gentle compressed air and non-woven disposable tissues.

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Start with Inspection

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Automated disinfection

Thermal disinfection is the safest and most environmentally friendly method for disinfecting dental instruments.

Thermal washer disinfectors provide a cutting-edge, validated process to ensure a safe cleaning and disinfection status. In combining both cleaning and disinfection, TWDs are therefore the first choice in terms of efficiency and effectiveness.

Before using a thermal washer disinfector, please study the instructions for use of the instruments and the devices.

Thermal washer disinfection

Thermal washer disinfectors such as W&H Teon or Teon + combine cleaning and disinfection, which makes them the ultimate choice in terms of effectiveness and efficiency.

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First step:

Treatment area

Immediately after use instruments must be pre-cleaned to ensure that organic material will not dry on.

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Next step:

Transport

If pre-cleaning is not carried out in the treatment area, instruments shall be placed in a suitable covered puncture-proof container and shall kept moist to prevent drying of any liquid (blood, saliva).

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Next step:

Reprocessing room

Dismantle the instruments according to the manufacturer’s instructions for use.

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Next step:

Washing & disinfection

Follow the related instructions for use of the TWD as well as the instruments to ensure the procedure is carried out successfully. Please be aware that instruments might require special maintenance following the thermal washer disinfection process.

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Start with Inspection

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Inspection

Definition

[in-spek-shuh n] noun [U]
Inspection is the generic term for the inspection, maintenance and testing of all cleaned and disinfected dental items.

W&H Best Practice

For optimum overall inspection conditions, use an LED illuminated magnifying glass.

Why is inspection necessary?

Only careful inspection, maintenance and testing of all cleaned and disinfected items gives proof of their functionality and guarantees a long lifespan. This also minimizes the risk of infection for both you and your patient due to damaged items or items, that are not completely free of soil.

Maintain the maintenance!

For full functionality and an extended lifespan of your equipment and tools, they must be maintained regularly. Click here for a cost-saving and time saving solution.

Only a dried item is a good item

It is of the utmost importance that all items are dried after cleaning and disinfection. Moisture and heat promote the growth and replication of micro-organisms. So instruments for immediate use that are temporarily stored wet become contaminated again. Dryness is also a must prior to packaging and sterilization.

Thermal washer disinfectors guarantee that all steps from cleaning and disinfection to drying are done properly and are fully recorded.

Important facts

About the importance of dryness, maintenance and inspection for quality management.

Important steps

A step-by-step guide to carrying out inspection correctly.

Only a dried item is a good item

Instruments must be thoroughly rinsed and dried after both the cleaning and the disinfection steps.
The reasons for this are listed below:

Drying after cleaning
Any detergent residues and moisture could interfere with the disinfecting solution used in the next stage.

Drying after disinfection
Chemical residues and moisture left on instruments to be sterilized could lead to irreversible damages (stains or corrosion) to the instruments and the sterilizer.

Packaged and sterilized instruments that have not been dried could compromise sterilization. Wet packages are not compatible with sterile storage.

More information

Maintain the maintenance

The product lifetime and the medical device’s ability to operate correctly are mainly determined by mechanical stress during use and chemical influences due to processing.

Maintaining the products after cleaning, disinfection and drying is therefore an essential part of quality management and the reprocessing process.

Please refer to the related instructions for use to ensure adequate maintenance.

Handpieces in particular need regular lubrication.

Find out how W&H maintenance devices can help.

Inspection to prevent against infection

The cleaning, disinfection, drying and function of instruments must be checked carefully. Any deposits such as lime-scale or organic matter such as blood and proteins can impair the sterilization and cause further risks of infection.

Instruments and devices that are damaged or corroded also pose a risk of infection for both you and your patients.

For more information click here.

Inspection & maintenance

Inspection and maintenance must be carried out in the reprocessing room only.

W&H recommends the use of an LED illuminated magnifying glass for an
optimum overall inspection of the instruments.

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First step:

Inspection

Inspect all items for any visible soil such as blood or dental cements as well as for any remaining drops of liquid, which can cause corrosion. For all items that are not completely clean: go back to the start. (Yes, it is a bit like a board game).

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Next step:

Quick drying

Devices that are still damp or wet must be dried quickly using a lint free cloth. Any instruments with cavities must be dried quickly using compressed air. Timing is everything, because only quick drying helps to prevent any new contamination.

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Next step:

Reassemble

Reassemble multipart instruments to ensure all parts are complete and present. Please always check that the individual parts have matching serial numbers.

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Next step:

Maintenance

Maintain all items according to the manufacturer’s advice. For turbines, contra-angles, handpieces and couplings, now is the time to carry out a complete, quick and reliable maintenance of the inner parts, e.g. with the help of our Assistina devices.

For the maintenance of jointed instruments, such as scissors, W&H recommends using F1 Service Oil .

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Next step:

Storage or use

Check the Spaulding Classification to make sure that you are on the right track.

Sterilizable devices
Non sterilizable devices

For sterilizable devices and instruments please take a look at the next step.

Non sterilizable devices are now ready for storage and/or use.
Move on to the step Storage.

Packaging

Definition

[pækɪdʒɪŋ] noun [U]
Preparation and packaging of sterilizable items before sterilization

W&H Best Practice

When using pouches, ensure that they are not too small (tight) or too large as they could be either damaged or cut, or not dried properly. W&H recommends using pouches that are 3 fingers larger (or 30% larger) than the instruments.

Why is packaging necessary?

To guarantee long term-sterility all items that are not intended for immediate use but are to be stored, must be pouched or wrapped before sterilization.

The packaging system must consist of a microbial barrier and protective packaging and must be sealed to guarantee full sterility at the point of use.

Packaging materials

There are different kinds of wrapping material and pouches available.

Make sure the packaging material used is compatible with steam sterilization and validated to provide the required microbial barrier properties. Compliance with applicable standards should be checked prior to purchase.

Legal advice

The reference standard for packaging is EN ISO 11607.

Choose validated methods

The packaging procedure must be documented accordingly by labeling the pouches with the following details: contents of the packaging (if not visible), the name of the person, who releases the batch after sterilization, estimated expiry date and/or sterilization date and any sequential numbering for identification. Please refer also to the instructions for use of the sterilizer’s manufacturer.

Important facts

The detailed materials and methods for safe sterilization and storage.

Important steps

A step-by-step guide to packaging for vacuum benchtop sterilizers.

Paper, plastic, containers - which type is right?

The selection and type of packaging material depends on the sterilization procedure used and the nature of the item to be packaged.

Sterilization wraps
Sterilization wraps ,including bleached crepe paper and wraps combining cellulose and synthetic fibres are commonly used as packaging materials for steam, dry heat and ETO sterilization. They are permeable to steam, air and chemical vapours and provide an effective barrier if the packs are stored in clean, dry conditions.

Other materials
Re-usable receptacles, cassettes and container systems that are intended for sterilization are suitable for repeated use and optimized loading.

Sealing is important!

Only perfectly sealed pouches will preserve the sterility of their contents. Proper sealing ensures that the microbial barrier properties of the wrap or pouch material are preserved and that the pack can be opened aseptically.

Labelling ensures traceability

Labelling packages is part of the traceability procedure. It will make it possible to link instruments to their sterilization cycle and to the patient's records. Some local guidelines may additionally ask for the contents of the packages specified. The label should identify the sterilizer, the type and number of the sterilization cycle, the person in charge, the sterilization date, and, potentially, the expiry date of the load.

Important steps

There are packaging methods, depending on the type of sterilizer used and the items to be sterilized. Please study the related instructions for use before starting the packaging process.

Manual packaging & sealing

Where items are packaged manually, please pay special attention to the sealing process. Only items that are completely packaged and correctly sealed guarantee sterility after sterilization.

To guarantee full traceability use a label sticker that includes all the necessary information.

Important note: Please always observe the specific technical instructions of your packaging material .

First step:

Inspection

Ensure that inspection has been carried out effectively so that all components of the item in question are dry and free of any soil and/or damage.

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Next step:

Information

Follow the specific technical instructions of your packaging material.

When using paper-like materials, either an envelope or parcel packing procedure should be used.

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Next step:

Avoid tension

Make sure the sterilization package is large enough for the items for sterilization. The filled sterilization package must not be under tension.

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Next step:

Sealing

Seal package with a heat resistant, markable adhesive tape.

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Next step:

Labelling

Follow the instructions for use provided by the manufacturer of your sterilizer regarding labelling. If labelling is recommended before sterilization put the label sticker that have you already prepared on the package. Do not write directly on the packaging material. For full traceability W&H recommends noting the following information:

  • The product name/contents of the packaging (if not visible)
  • The name of the person who releases the batch
  • The estimated expiry and/or sterilization date
  • Any sequential numbering for identification (in the event that identification is requested)
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Next step:

Sterilization

The packaged items are now ready for the sterilization process.

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Start with Sterilization

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Packaging with automatic sealing

Packaging with automatic sealing guarantees long term sterility and automated documentation.

Therefore W&H always recommends automated sealing, for example our sealing system
Seal2 or SealVal2 (for pouches only) .

First step:

Inspection

Ensure that inspection has been carried out effectively so that all components of the item in question are dry and free of any soil and/or damage.

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Next step:

Avoid tension

Make sure you have chosen the right size pouch. Pouches should not be too small (tight) or too large as they could be either damaged or cut, or not dried properly. W&H recommends using pouches that are 3 fingers larger (or 30% larger) than the instruments.

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Next step:

Sealing

Follow the specific instructions for use of the packaging, sealing and documenting unit .

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Next step:

Sterilization

The wrapped items are now ready for the sterilization process.

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Start with Sterilization

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Sterilization

Definition

[ˌsterəlaɪˈzeɪʃn] noun [U]
Set of methods and means used to eliminate all living micro-organisms in any form including spores.

W&H Best Practice

W&H recommends using type B sterilization according to EN 13060.
All cycles have the same profile, which always includes fractioned pre-vacuum and complete pulsed vacuum drying. This includes safe sterilization of instruments including narrow lumen.

Why is sterilization necessary?

Sterilization guarantees the elimination of infection causing germs. All dental instruments must be sterilized to ensure that they are sterile at the point of use.
You can find the related classification here.

The same but different: The types of steam sterilizers

The EN 13060, standard for small steam sterilizer, specifies three types/cycles: types B, N, and S. W&H recommends using type B steam sterilizers.

Legal advice

The reference standards for steam sterilizer are EN 13060, EN 285 and ANSI/AAMI ST55.

All cycles/sterilizers must comply with and be validated according to these standards.

Full traceability for full peace of mind

A complete record of the entire reprocessing process helps to ensure that all steps have been carried out in the right order. When it comes to sterilization, documentation is mandatory. There are many concepts regarding traceability. The documentation system of the Lisa sterilizers, makes it possible, for example, to trace and record the individual instrument, the cycle, the person in charge of the sterilization process – and the patient. Automatic traceability saves time and ensures full safety.

Better safe than sorry: dryness check after sterilization

The dryness and integrity of each pouch/package must be checked prior to being released for storage and/or use. Moist packages are permeable, leading to microbial growth inside and thus non-sterile items. In those cases, discard the pouches affected and restart the reprocessing process from the beginning. See also: Packaging

Important facts

What types of sterilizers are available? How can I guarantee sterility?

Important steps

A step-by-step guide to sterilization

The power of sterilization

The purpose of continual germ reduction at each stage of the reprocessing procedure, right through to sterile reusable products, is to reduce the microbial population to the Safety Assurance Level of 10-6, i.e. a 6 log reduction. In other words, to achieve a probability of 1 non-sterile item in a million.

Find out more about it here.

The same but different: sterilizer types

Extended steam sterilization is currently the only recommended method to minimize the risk of prion transmission through surgical instruments. Due to the principle of thermal denaturation, steam sterilization is also effective against drug-resistant bacteria (e.g. Salmonella sp., Staphylococcus sp.), which are a growing risk nowadays.

The European standard (EN 13060) defines three types/cycles of small steam sterilizers:

  • Type B sterilizers, intended for the sterilization of all types of load, such as porous, solid and hollow instruments both wrapped and double-wrapped
  • Type N sterilizers, intended for the sterilization of non-wrapped solid products
  • Type S sterilizers, intended for the sterilization of products specified by the manufacturer of the sterilizer.

Requirements for porous load sterilizers are also defined in EN 13060 .

W&H offers a wide range of type B sterilizers that ensure sterilization of all types of loads.

Quality first, including where water is concerned

Steam sterilizers require the use of good quality demineralized water. This will prolong the lifespan not only of your sterilizer but also of your instruments. Poor quality water (hardness, chlorine) leads to damage, stains and corrosion to both your sterilizer and your instruments.

Find out more about the importance of water quality here.

W&H Multidem, our water treatment system, supplies top quality demineralized water for different steps of the reprocessing process such as rinsing, and for sterilization.

Important steps

W&H recommends sterilization according to the EN standards 13060 and 285 or ANSI/AAMI ST55.

Please pay special attention to the instructions for use and warnings issued by the manufacturers of steam sterilizers.

Sterilization

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First step:

Inspection

For all instruments, make sure functionality has been checked and any maintenance has been carried out correctly. Pouches should be 3 fingers (or 30%) longer and larger than the instrument(s).

Important note: In order to optimize drying, place all pouches paper side up or down according to the sterilizer manufacturer’s recommendations. All W&H sterilizers require paper side up.

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Next step:

Avoid overloading

Follow the sterilizer IFU regarding the tray/chamber loading method. Overlapping of pouches could impede drying. Do not exceed the maximum number/mass of instruments that can be processed by the selected cycle.

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Next step:

Information

Select a cycle designed and validated for the type of instruments to be processed.

Important note: B-type cycles are compatible with all load types that are single or double pouched.

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Next step:

Check dryness

Upon completion of the cycle, check the integrity and dryness of each package. The paper side must be absolutely dry. If not, instruments cannot be released as sterile. Instead they must be unpacked and returned to step 1 ‘used items’.

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Next step:

Link to patient file

W&H offers a safe and practical system for linking instruments and sterilization cycles to the patient records – the W&H Lisa Safe Label printer.

The label printer connects directly to any W&H sterilizers that allow label printing only if the sterilization cycle was completed successfully.

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Proceed to storage

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Traceability

Dental practitioners have a legal duty of care to their patients. They must ensure that effective infection prevention measures are in place. Traceability will help make it possible to provide proof.

This is not only to meet local regulations but first and foremost because it is essential to break the chain of infection.

The new generation of Lisa sterilizers, for example, offers a special traceability concept, called EliTrace. EliTrace makes it possible to trace back to the individual instrument and/or kit without any extra software or computers.

In order to ensure better traceability, the load must be labelled including the name of the person in charge of the sterilization process, the contents of the load, if not visible and the release date and time.

Storage

Definition

[ˈstɔ:rɪʤ] noun [U]
The action or method of storing and preserving sterilized packaged instruments as well as disinfected non- packaged instruments.

W&H Best Practice

Non-wrapped sterilized items are intended for immediate use only.

The journey is the priority: the transport of wrapped sterilized items.

  • Sterile devices must be transported in a manner that will not compromise their sterile status.
  • Only sterilized packaged items can be transported and stored.
  • Non-pouched/non-wrapped sterilized instruments are for immediate use only.

Dust free and dry: ideal storage conditions

Shelf life is considered to be event-related, not time-related. Optimum storage conditions include careful handling, separation from contaminated items and regular maintenance of dust-free and dry storage cabinets or/and rooms.

With regard to the expiry date please refer to the technical instructions of your packaging manufacturer and your local guidelines.

Important facts

Tips and tricks for transport and storage

Important steps

A step-by-step guide to transport and storage

Ideal conditions for safe storage of sterilized items

Sterile goods must be stored in a dry, dust-free environment. The storage area should be clean, regularly maintained and separated from non-sterilized products.

The shelf life of the sterile goods depends on the storage conditions and the packaging used.

The loss of sterility essentially depends on the external influences present during storage, handling and transportation. When it comes to determining the possible storage duration, the storage conditions themselves are crucial.

“First in – first out”: a recommendation of a storage system for sterilized wrapped items

W&H recommends rotating the stock of instruments according to the ‘first in, first out’ concept.
Freshly sterilized packaged instruments should be stored at the back of the shelves, so that packaged instruments towards the front that were sterilized at an earlier date will be used next. So, the first in will also be the first out.

Do check at regular intervals if all pouches are still free of damage and/or humidity. If labelled, also check the expiry date of the items.

Storage/transport of disinfected items and non-wrapped sterilized items

Disinfected items and non-wrapped sterilized items for immediate use must be transported aseptically.

Disinfected and non-wrapped sterilized items intended for immediate use in the treatment area:

  • Do not place them near the chair as they may become contaminated by non-sterilized items.
  • Do not place them near sinks or in other humid conditions.
  • Ensure that they are not touched by or do not come into contact with items that have already been used.

Important steps

The load must be cooled down on a clean surface after being removed from the sterilizer.

Some sterilizers, such as the W&H Lisa sterilizers, show the temperature of the load inside the chamber via EliSense. So the sterilizer indicates when the load can be removed from the sterilizer without any risk.

Once they have cooled, the pouches can be transported to the storage room.

Transport and storage

First step:

Inspection

Ensure that the packaging of the sterilized goods is dry. If there are any pouches that are wet or damp, they are not considered sterile and are not suitable for storage as wrapped sterilized items. Instead they must be unpacked and returned to step 1 ‘used items’. See also ‘Wet and moist packaging after sterilization’

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Next step:

Labelling

Items that are not already labelled must be labelled now, documenting that the sterilization process has been executed successfully. The
label must include the date of sterilization, the person in charge for releasing the load and the expiry date, if available.

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Next step:

Transport

Make sure that the sterile devices are transported in a manner that will not compromise their status. Transport should be carried out quickly.

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Next step:

Storage

Store the sterilized items according to your individual storage system.

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Regular checking

Check the status of stored items at regular intervals. As soon as there are any signs of damage the items can no longer be regarded as sterile.

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You completed the AIMS workflow

and your instruments are now ready for reuse.