MELAG offers individual system solutions for instrument reprocessing. Get all the information you need on the safe cleaning, disinfection, lubrication and sterilization of your medical devices in our Hygiene Guide 2026.
MELAcare
The new MELAcare reprocessing and care device impresses with efficient hygiene workflows: Without stress. Without compromise. Only with options for reprocessing up to 144 instruments per working day.
The revolution in dentistry - Careclave combines the entire process of instrument reprocessing: Cleaning & disinfection, lubrication, sterilization and documentation and approval in one single device.
Made for greatness: Our innovative large steam sterilizers (100 and 200 L) facilitate the
smooth running of treatments in CSSDs, hospitals and outpatient clinics.
Automatic cleaning and disinfection with MELAtherm: Increase the efficiency of your instrument decontamination process. The innovative washer-disinfector saves time and money.
On the future, get set, go! With the fastest autoclaves in their class, we are redefining the limits of speed: with Vacuclave 105 & Vacuclave 305 you can sterilize your instruments on 2 trays in a record time of 6.5 min (plus flexDRY drying).
Save money by supplying steam sterilizers and washer-disinfectors with high-quality demineralized water from our water treatment units of the MELAdem series.
The complete instrument decontamination process consists of cleaning and disinfection, inspection, packaging, sterilization as well as documentation and approval. International guidelines state that the entire process of instrument reprocessing needs to be performed by trained personnel using monitored procedures to ensure reproducibility. These requirements contribute to the health and safety of patients, users and third persons.
Process of Instrument Decontamination in Practice and Clinic
Benefit from an aligned reprocessing cycle
The use of aligned products from a single manufacturer ensures efficient and safe workflows. The decontamination process in a medical and dental practice must be defined in the hygiene plan and standard operating procedures (SOP’s). Detailed standard operating procedures (SOP’s) ensure that re-usable instruments and medical devices are successfully decontaminated by practice staff.
The points below represent prerequisites for safe instrument decontamination:
Management and monitoring system is conducted to control all steps of the decontamination cycle.
Appropriate decontamination areas are provided.
Appropriate equipment is deployed: Please be aware of the proper maintenance and operation according to the manufacturer's specifications.
Practice Staff are properly trained and supervised.
Single use medical devices and instruments are not reused.
Records and log files of instrument reprocessing are stored.
Learn more on each single step of the instrument decontamination cycle: The entire workflow of instrument decontamination comprises preparation, cleaning, disinfection, inspection, packaging, sterilization, documentation, approval and storage of the medical devices and instruments.
1. Preparing the instruments
Correct preparation of instruments comprises the collection, pre-cleaning and if necessary, the dismantling of the instruments and their quick transport from the treatment room to the decontamination area. To minimize the infection risk, the used instruments and medical devices must be placed in closed containers and transported to the decontamination area for reprocessing as soon as possible. Pre-Cleaning includes the removal of coarse soiling and water-insoluble residues on the instruments.
Our practical tips for instrument preparation:
You can collect the instruments in an instrument bath without using disinfectants or water.
Health and safety considerations require that the instruments must be transported to the decontamination area in a closed container or instrument pan. To prevent blood, body fluids, and other contaminants from drying on the surfaces, surgical instruments should be transported immediately to the decontamination area.
Pre-clean the instruments with plastic brushes to protect the instrument surfaces. Ultrasonic devices can additionally help remove soiling.
2. Cleaning and disinfection of instruments
Compared to the manual cleaning and disinfection, the instrument decontamination in a washer-disinfector is especially time and cost-effective. Automated reprocessing in a washer-disinfector subjects the instruments to alkaline cleaning and thermal disinfection.
Our practical tips for cleaning and disinfection in a washer-disinfector:
Soaking the instruments in a washing and disinfectant solution immediately before automated decontamination is not mandatory, but it is common practice. In order to prevent foam generation in the chamber of the thermal disinfector, please rinse off instruments beforehand to remove cleaning fluids and disinfectant residue.
To prevent protein coagulation, instruments should be reprocessed in the washer-disinfector within 6 hours after use.
The hollow bodies of instruments (e.g. ultrasonic scaler tips, hand pieces, turbines or endoscopes) are cleaned and disinfected by using appropriate adapters on the injector rail of the MELAG thermal disinfectors.
4. Packaging
Before instruments can be sterilized in an autoclave they must be suitably wrapped, either sealed in a transparent sterilization package using a sealing device or simply as a set in a sterilization container. Please perform this process step in a clean and low contamination area using approved products e.g. wrappers, pouches, containers.
International hygiene guidelines require routine tests such as the seal seam stability test or the Seal Check for sealing devices.
Our practical tips for instrument packaging:
The use of protective caps on pointed instruments prevents damage of the sterilization packaging.
Hinged instruments must be opened slightly for proper sterilization.
Sterilization pouches should only be filled up to 75 % capacity and should not exceed a maximum weight of 3 kg per package.
3. Inspection, maintenance and lubrication
The electronic system of the washer-disinfector ensures that all the required parameters for automated decontamination are fulfilled. After successful cleaning, disinfection and drying, trained personnel additionally need to perform a visual and functional check of the instruments. Some of the instruments require the use of care products. To do so, please follow the specific manufacturer's recommendations.
Our practical tips for inspection and maintenance:
Remove damaged instruments or instruments with altered surfaces at once.
Please use sterilizable and steam permeable oil to prepare hinged instruments and other moving parts in accordance with the manufacturer's specifications for the sterilization.
5. Sterilization
Instruments should be sterilized with saturated steam. Hence, medical and dental practices or clinics usually use steam sterilizers. The international standard DIN EN ISO 13060 divides steam sterilizers into the classes B, S and N. Class B autoclaves have the advantage that the instruments can be sterilized independently of their packaging type and the complexity of their hollow bodies. Class B represents the highest sterilization standard.
Our practical tips for steam sterilization:
Place the sealed pouches on the tray with the paper side facing downwards.
Do not place multiple pouches on top of each other on a tray or in a sterilization container.
When loading, ensure that textiles and foil packages are placed on a tray at the top of the sterilization chamber; unwrapped and heavy instruments need to be placed at the bottom of the sterilization chamber.
Ultrasonic cleaners
An ultrasonic cleaner with a capacity of 3 or 6 litres ensures effective pre-cleaning of your instruments. This is because ultrasonic waves can remove alginates, dental cements and other stubborn deposits, even from hard-to-reach areas.
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Decontamination room in practices, clinics and hospitals
Structured processes for safe instrument reprocessing
A structured reprocessing room forms the basis for perfect infection control. The reprocessing room is also referred to by hygiene specialists as the reprocessing unit for medical devices (AEMP).
When planning the reprocessing unit for medical devices, it is important to correctly maintain the prescribed spatial separation of unclean and clean areas.
6. documentation and approval
The instrument decontamination process is completed by a batch approval. This must be performed and documented by authorized personnel. Current legislation requires proof that instrument reprocessing has been performed correctly. Complete documentation ensures legal certainty and reliable traceability of the instruments to the patient.
Our practical tips for documentation and approval:
Store all instrument reprocessing documentation for a minimum of 5 years. To avoid liability risks, we recommend that records should be stored for 30 years.
In view of these long record retention periods, we recommend that you save all documentation on digital data carriers.
To ensure complete traceability, please transfer the label or batch number to the patient record after using the instrument.
7. Storage of sterile instruments
Sterile instruments must not be recontaminated during transport and storage. Therefore, the sterilized instruments are safely wrapped to prevent recontamination. The instruments must be stored at room temperature in a clean and dry location, protected from dust. Please handle the packs carefully to prevent damage and loss of sterility.
Our practical tips for instrument storage:
Given the maintenance of the prescribed conditions, we recommend that single wrapped instruments shall not stored for more than six months. Please comply with the regulations of regional authorities.
Some countries stipulate that sterilized instruments cannot be stored in the decontamination room. Acquaint yourself with the respective regional requirements.
Seals around the doors of instrument storage cupboards protect the sterilized instruments from dust and external influences.
Consumables
Combining becomes profiting: Discover our extensive range of accessories for the process steps cleaning, disinfection, care, packaging, sterilization and documentation.
The dirty zone comprises the delivery area, the washer-disinfector and a workstation for the manual preparation or decontamination.
Clean Zone
A control area for the unloading of the washer-disinfector, the performing of functional checks and sorting the instruments is located in the clean zone. The sealing device, steam sterilizer and documentation medium are located in the clean zone as well.
Frequently Asked Questions
International hygiene guidelines recommend that instruments should bereprocessed using aligned procedures. As such, a washer-disinfector must be capable of cleaning, disinfecting and drying instruments in a way that the subsequent packaging and sterilization do not cause any damage e.g. through corrosion.
One of the advantages of the innovative MELAG system solution for instrument decontamination includes the maintenance and service cost saving. Purchasing a steam sterilizer, washer-disinfector, sealing device and water treatment unit from the same manufacturer means that a practice and clinic can ensure the alignment of the various procedures. Using the services of MELAG-trained partners, the system guarantees synchronization of the maintenance cycles.
A further advantage of the system solution results from the use of the documentation and approval software MELAtrace. In contrast to the majority of other software products, you will not require additional separate licenses for each product. Reliable documentation of the complete instrument reprocessing cycle is possible with a single, affordable software without annual license costs.
Disinfection and sterilization are important aspects of the instrument reprocessing procedure: These processes perform a different degree of microorganism destruction.
Whilst disinfection reduces the number of microorganisms by a factor of 100.000, sterilization achieves a factor of 1.000.000.
Disinfection is also classified as the irreversible deactivation of all contagious pathogens (fungi, bacteria and viruses). Instrument sterilization is required to kill off the resistant dormant bodies of pathogens such as spores. Sterilization results in the destruction of all microorganisms that are capable of reproduction and leads to a complete absence of germs.
Although wash tray systems have only been taken up by large-scale medical and dental practices with a high rate of instrument usage. Small and medium-sized practices and clinics could also benefit from a wash tray system.
Collecting the instruments in a wash tray saves a number of work steps. In comparison to the time-consuming action of placing individual instruments in washer-disinfector baskets, the wash tray can be inserted in the appropriate mount and removed after cleaning, disinfection and drying in only one step.
Nevertheless, the greatest saving of time and money is achieved in the packaging process. Instrument sets in wash trays can be wrapped and quickly prepared for sterilization and storage by using a sterilization container such as MELAstore-Box. The container is marked with a barcode label after sterilization.
The decontamination of 36 instruments in three wash trays and sterilization containers saves up to 24 minutes per batch in comparison to the individual decontamination of the same quantity of instruments. See for yourself: The video “Individual Instruments vs. MELAstore” on the MELAG Multimedia Channel summarizes the advantages of using our MELAstore system.
The decontamination of standardized instrument sets results in considerable improvement in the quality management of a clinic. The wash tray system reduces the large quantity of practice waste, protects the instruments against damage and prevents injuries to the practice team.
The MELAstore system provides a combination of wash trays (MELAstore-Tray) and sterilization containers (MELAstore-Box) which offer all the above advantages. Saving money and time produces short amortization times. A special advantage of the simultaneous use of MELAtherm 10 and its insert baskets: developed for use with the MELAstore system, the insert baskets enable especially sustainable operation and excellent cleaning results.
The proper risk assessment and classification of medical devices is a fixed prerequisite for instrument reprocessing in compliance with the standards. The medical device operator is responsible for the correct classification of the instruments. Please classify each medical device in your practice and clinic into one of the following classes. If you are unsure about the classification of the instruments, the medical device should be assigned to the next higher risk level.
Pre-classification as the first step of risk assessment is based on the field of application of the instrumentation. Medical devices in medical and dental practices are classified into non-critical, semi-critical and critical instruments. The classes can be distinguished from each other as follows:
Non-critical instruments come into contact exclusively with intact skin (e.g. rubber dam perforating forceps).
Semi-critical instruments are medical devices that come into contact with mucous membrane or pathologically altered skin (e.g. mouth mirrors).
Critical instruments are medical devices that penetrate skin or mucosa. Through invasive/surgical use, the instruments come into contact with blood, organs, internal tissues and wounds (e.g. suture scissors).
In the second step, classification is based on the instrument design. Design and material details can lead to special requirements for instrument reprocessing.
Critical and semi-critical medical devices are classified into group A or group B. No special requirements need to be observed in the reprocessing process for group A medical devices. Group B instruments place increased demands on the reprocessing process, because these instruments have hollow bodies, rough surfaces or hard-to-reach areas.
Critical medical devices include a third group. Group Critical C instruments must meet very high requirements in the reprocessing process. These are thermolabile instruments that cannot be sterilized with steam. An example of this instrument class is the flexible endoscope used in medical practices.
Instrument reprocessing and the final release are associated with a great deal of responsibility in the practice. During documentation and release, care must therefore be taken to ensure that the responsible practice employees fulfill the "requirements for expertise" based on their position and qualifications.
In the announcement "Hygiene requirements for the reprocessing of medical devices" (2012) of the Robert Koch Institute, all important information on instrument reprocessing is summarized in Annex 6 "Expertise of personnel". The Robert Koch Institute specifies the following contents under the requirements - for personnel entrusted with reprocessing - which reflect expertise:
Instrument knowledge specific to the specialist group
Knowledge of hygiene/microbiology (including transmission paths)
Risk assessment and classification of medical devices according to the recommendation of the Commission for Hospital Hygiene and Infection Prevention at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM) on the "Requirements for Hygiene in the Reprocessing of Medical Devices
Process steps of instrument reprocessing
Spatial and organizational aspects of reprocessing
Preparation of process and work instructions for reprocessing
Legal knowledge (MPG, MPBetreibV, BioStoffV)
Expertise is presumed if you have completed training in a medical profession with the relevant content (anchored in the framework curriculum). If the contents listed above have not been taught in full or are not up to date, these qualifications must be supplemented by further training events.
