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 2024.
Careclave
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.
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).
Automatic cleaning and disinfection with MELAtherm: Increase the efficiency of your instrument decontamination process. The innovative washer-disinfector saves time and money.
Save money by supplying steam sterilizers and washer-disinfectors with high-quality demineralized water from our water treatment units of the MELAdem series.
Combining becomes profiting: Discover our extensive range of accessories for the process steps cleaning, disinfection, care, packaging, sterilization and documentation.
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.
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.
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.
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.
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.
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.
Dirty Zone
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.
