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Medical ultrasonic cleaner - functionality, advantages & application

Pre-cleaning medical instruments after patient contact is a crucial step in the reprocessing process. Bandelin's ultrasonic cleaners have been specifically developed to reliably fulfil this requirement. They thoroughly remove contaminants such as blood, tissue, biofilms and secretions without affecting the material or structure of the instruments. Our devices thus create the necessary clean surface, which is a prerequisite for effective disinfection and sterilisation.

Bandelin has specialised in the manufacture of robust, durable and validatable medical ultrasonic cleaners in this highly sensitive area. Our systems are used in hospitals and surgeries as recognised technology and are tailored to the strict requirements of AEMP and CSSD structures as well as the needs of private practices. Thanks to our high level of vertical integration at our Berlin site, we ensure that every step of development and production - from the design of the transducers to the final testing of the devices - is carried out in-house, thus guaranteeing consistent product quality.

Why a medical ultrasonic cleaner is indispensable today

Cleaning medical instruments is the most important and critical step for the effectiveness of the entire reprocessing chain. Organic residues such as proteins, fats, blood or cement residues can massively impair thermal disinfection and sterilisation processes. If these residues are not completely removed, „sterile dirt“ can form. This describes the dangerous phenomenon in which an instrument has been formally sterilised but still has dirt particles adhering to it that jeopardise patient safety.

Ultrasonic cleaning completely removes these complex contaminants. In contrast to the manual method, the ultrasonic cleaner works reproducibly, regardless of the experience of the personnel and even reaches hard-to-reach areas where manual scrubbing or spraying fail. This includes narrow lumens and cavities, hinges and joints as well as microstructures and fine capillaries.

The automated process also significantly minimises the risk of infection and injury to personnel, as no direct contact with contaminated material is required. The risk of puncture or cut injuries, which exists with manual brushing, is eliminated. Validatable pre-cleaning in the ultrasonic bath with coordinated cleaning agents is therefore a mandatory and indispensable part of reprocessing in surgeries and clinics today.

Functional principle: How ultrasonic cleaners remove impurities

The effective cleaning action is based on the precisely controlled, physical effect of ultrasonic cavitation.

The principle of cavitation

The process begins with piezoelectric transducers converting electrical energy into high-frequency mechanical vibrations. In the medical field, these are typically in the range of 35 to 45 kHz. These vibrations generate an alternating pressure field in the liquid bath, which contains phases of negative and positive pressure. During the negative pressure phase, millions of tiny cavitation bubbles form. During the rapid transition to overpressure, these bubbles collapse implosively. This collapse briefly generates localised pressure peaks of several hundred bars and high-energy microflows that detach dirt particles and deposits from even the finest crevices, lumens and complex instrument geometries without contact.
As the entire process is contact-free, the surface of the instruments retains its structure and remains free from micro-damage that could occur with mechanical brushing. This is particularly important for delicate cutting edges or complex joints.

Optimisation of the cleaning effect

Optimum cleaning performance is controlled by the precise coordination of several influencing variables:

Frequency:

Determines the intensity and size of the cavitation bubbles. Frequencies in the range of 35 to 45 kHz offer a good balance between intensity and gentleness.

Temperature:

A bath temperature between 40 and 60 °C optimises both the cavitation intensity and the chemical-physical effect of the cleaning solution.

Cleaning chemistry:

The combination with precisely dosed cleaning chemicals (enzymatic or surfactant-based preparations) is essential. Surfactants and enzymes chemically break down organic contaminants such as proteins and fats, while cavitation mechanically removes them from the surface.

Other influencing variables such as the sound field distribution (which ensures a uniform effect throughout the pool) and the duration of the sonication process contribute to the complete removal of all residues.

Important device and technical features for professional use

Medical ultrasonic cleaners must fulfil the highest requirements in terms of safety, durability and reproducibility. BANDELIN systems position themselves as quality leaders thanks to their technical precision and high level of vertical integration. BANDELIN develops and manufactures every device in-house. Our engineers precisely harmonise the ultrasonic field, tank geometry and transducer output to ensure a uniform sound profile and reproducible results.

Our devices are designed for continuous operation in medical reprocessing. Users report that some Bandelin devices have been in use for 20 to 30 years and continue to deliver reliable performance.
At BANDELIN, we rely on high-quality, welded stainless steel tanks that are resistant to chemicals and designed for years of use without any loss of performance.
Special ceramic transducers ensure a stable amplitude and guarantee a homogeneous sound field distribution (SWEEP technology).

Regulatory compliance

All Bandelin systems are classified as Class I medical devices in accordance with the EU MDR and bear the CE and MD mark. Production takes place under a fully certified quality management system in accordance with ISO 9001 and ISO 13485 - the basis for legally compliant processes in regulated environments. Test intervals for the devices are based on the MPBetreibV and the manufacturer's recommendations.

Digital process control

Process documentation is essential for validatable processes. Models with digital control enable the automatic recording of key parameters (temperature, duration, frequency and programme selection). This audit-proof exportable data forms the basis for validation, audits and hygiene control and automates the verification process in AEMP and CSSD structures as well as in modern surgeries.

Application in clinic and practice: step-by-step process & integration

Ultrasonic cleaning is a firmly integrated pre-cleaning step within the instrument reprocessing process recommended by the KRINKO/RKI. It is always used at the start of reprocessing and is used immediately after patient contact to prevent soiling from drying.

The recommended procedure according to KRINKO/RKI

1. pre-cleaning in an ultrasonic bath with suitable cleaning agent.

2. thermal disinfection at around 95 °C in the washer-disinfector (WD).

3. packaging in containers or sterile supply bags.

4. steam sterilisation at 134 °C in an autoclave.

The BANDELIN devices can be integrated into existing AEMP/CSSD workflows as well as into practice reprocessing rooms. With Smart and TRISON systems, suitable interfaces are available for process documentation and digital tracking.

Fields of application and suitable instruments

Bandelin ultrasonic cleaners cover all areas in which medical instruments have to be reprocessed:

Suitable are:

Surgical instruments made of stainless steel and titanium, minimally invasive instruments (MIS), robotic instruments (e.g. Da Vinci instruments), dental instruments, implant instruments and glassware.

The following are not suitable for ultrasonic cleaning:

Optics, flexible endoscopes and electrical instruments that have to be reprocessed separately.

Selection criteria & cost-benefit analysis for ultrasonic cleaners

The choice of a suitable device depends largely on the volume of instruments and the complexity of the tools to be cleaned.

Cost-benefit factors for users

The use of professional ultrasonic cleaners offers significant economic and process-related advantages:

Time saving and predictability: Ultrasound enables several instrument trays or entire trays to be cleaned in parallel in a single step. This massively reduces the pre-cleaning time and can save a considerable amount of time compared to manual cleaning. The shorter throughput times increase the availability of instruments in the practice or operating theatre.
Instrument protection: Non-contact cavitation cleaning prevents mechanical wear, scratches and damage to sensitive cutting edges or joints. This significantly extends the service life of the often expensive instruments and reduces the need for replacement purchases.
Economy through longevity: Durable, robust appliances made in Germany reduce long-term repair and replacement costs. Reports of BANDELIN appliances that are 20 to 30 years old and still working prove their cost-effectiveness compared to cheaper but short-lived alternatives.
Efficiency with complexity: Our BANDELIN TRISON system can be cited as an example of a significant efficiency gain: The cleaning time for four highly complex robotic instruments was reduced from 15 minutes per instrument (manual) to just 15 minutes for all four instruments (automated).

Hygiene, standards and safety: what do you need to know?

The safety and effectiveness of the ultrasonic cleaning process is guaranteed by strict regulatory requirements and is designed to protect medical staff and instruments.

Standards and authorisations

All procedures are based on the KRINKO/RKI recommendations for the reprocessing of medical devices. As Class I medical devices, the ultrasonic cleaners themselves fulfil the requirements of the MDR and bear the CE and MD markings. On the manufacturer side, the ISO 9001 and ISO 13485 certifications ensure controlled processes and consistently high product quality. The test intervals and maintenance requirements are based on the MPBetreibV.

Protection of personnel and instruments

Personnel protection is primarily ensured by contactless pre-cleaning in the ultrasonic bath, which minimises the risk of puncture injuries or cross-contamination. The use of combination products with a partial disinfectant effect can also help to protect users by reducing contamination in the bath.
Instrument protection is provided by the material-friendly cavitation principle, which does not exert any mechanical stress, and by the use of customised cleaning products with proven material compatibility.

Checking the cleaning performance

Quality assurance takes place via validated processes. In AEMP/CSSD structures, the entire reprocessing process is validated. In the practice environment, digital systems such as the Smart series provide audit-proof protocols on compliance with the cleaning cycles (duration, temperature, frequency), which serve as proof in hygiene management and audits.

Typical mistakes and pitfalls in ultrasonic cleaning - and how to avoid them

Although the ultrasonic method is very reliable, application errors can impair hygiene performance.

Incorrect interpretation of the cleaning purpose

Ultrasonic cleaning is clearly assigned to cleaning or pre-cleaning and never replaces subsequent disinfection (thermal in the washer-disinfector) or sterilisation.

Use of pure water

Pure water is not sufficient for removing dried organic residues (blood, proteins). Coordinated enzymatic or surfactant-based preparations with a chemical effect should therefore be used.

Incorrect or inadequate cleaning chemicals

The cleaning solution must be precisely matched to the material and type of soiling and dosed correctly.

Sound reinforcement times too short

The time recommended in the application guide must be adhered to in order to completely remove all residues and thus ensure the effectiveness of the sterilisation.

Cleaning unsuitable instruments

Optics, flexible endoscopes and electrical instruments must not be cleaned in an ultrasonic bath.

Future trends: digitalisation, sustainability and new cleaning technologies

Instrument reprocessing is increasingly characterised by digitalisation and automation, with authorities such as the RKI increasingly recommending automated processes.

Automated cleaning of complex instruments: Specialised systems such as TRISON show the trend towards full automation, especially for highly complex robotic instruments and MIS instruments with long lumens. Cleaning, rinsing and movement of the instruments are combined.
Digital documentation: Digital control systems such as the Smart series with touch operation, programmable cycles and documentation functions reduce the manual documentation effort and facilitate the traceability of all process steps for audits.
Integrated workflows: Practices and clinics want fewer manual steps, more integrated digital workflows and a „one-stop shop“ approach with perfectly coordinated devices, preparations and accessories.
Sustainability and durability: BANDELIN focusses on robust production and repairability. The longevity of the appliances leads to lower operating costs and a better environmental footprint, which will be an increasingly important factor in the near future.

Conclusion

Ultrasonic cleaning is the basis for safe, validatable and economical instrument reprocessing in modern medicine. BANDELIN combines the physical precision of cavitation with medical experience and manufactures devices that improve process reliability, staff safety and cost-effectiveness in equal measure. The systems are certified according to MDR/ISO 13485 and offer durable, reliable technology that is established as the pre-cleaning standard in surgeries and clinics. From stand-alone devices in the practice to automated systems for robotic instruments: BANDELIN stands for reliable technology, traceable processes and long-lasting quality.

FAQ area

What does „cavitation“ mean in an ultrasonic cleaner?

Cavitation describes the formation and subsequent high-energy collapse of millions of tiny gas bubbles in the cleaning fluid, triggered by ultrasonic waves. The resulting micro-currents remove dirt particles from the instrument surface thoroughly and without contact.

Which instruments can be cleaned with an ultrasonic cleaner?

Ultrasonic cleaning is suitable for almost all surgical instruments made of stainless steel and titanium, including MIS and robotic instruments, dental instruments, implant instruments and glassware. Optics, flexible endoscopes and live or electrical devices are not suitable.

How often does an ultrasonic cleaner have to be tested or validated?

The inspection intervals are based on legal requirements, in particular the MPBetreibV. BANDELIN devices are designed as medical devices (Class I) with a long service life and low maintenance requirements. The effectiveness of the processes is verified in AEMP/ZSVA structures via validations and digitally documented (e.g. by the Smart series).

Can an ultrasonic cleaner replace sterilisation?

No. The ultrasonic cleaner is clearly used for pre-cleaning and is a mandatory prerequisite for the effectiveness of disinfection and sterilisation. In the medical field, instrument reprocessing must include the steps of thermal disinfection (washer-disinfector) and steam sterilisation (autoclave).

Which cleaning chemicals are ideal for ultrasonic baths in medical applications?

Enzymatic or surfactant-based preparations (e.g. STAMMOPUR), which are precisely matched to the ultrasonic frequency and the type of soiling, are ideal for reliably dissolving organic and inorganic residues and enabling reproducible results.

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Bandelin Electronic

Quality since 1955

We - a Berlin-based family business in its third generation - specialise in the development, manufacture and distribution of ultrasonic devices, corresponding accessories and application-specific cleaning and disinfection preparations. The high vertical range of manufacture, a modern production facility and motivated employees distinguish us and are guarantors for constantly new quality products.