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	Qualification and Validation
	In the laboratory technology sector, Miele offers a wide range of qualification services for Miele Professional machines. Miele's team of service engineers, specially trained as medical device advisers,		are available to assist in validating the reprocessing of medical devices in Miele's washer-disinfectors.

OXIVARIO PLUS – Setting new standards in instrument reprocessing

OXIVARIO PLUS - Der neue Maßstab in der Instrumentenaufbereitung

With the introduction of the Vario process in 1994, Miele set new standards in the performance and efficiency of machine-based thermal disinfection. Miele is now proud to present a new and patented approach to process technology.

A new aspect of the OXIVARIO process, alongside washing according to the VARIO method, is the inclusion of an additional washing phase. In this additional cycle, hydrogen peroxide in a mildly alkaline environment (approx. pH 11) is used to digest and destroy any proteins still remaining on the instruments by means of oxidation.
The use of this process, for example, on fibrin which forms an interlacing fibrous network causing coagulated blood residue to adhere to instruments, results in the disintegration of the interlaced polymer structure and improved solubilisation.

The OxiVario Plus method combined with an alkaline main wash is designed to cater for the needs of surgical instrument re-processing, i.e. re-processing critical medical products according to the guidelines issued by Germany's Robert Koch Institute. Furthermore, this process is able to chemically destroy prions and is therefore recommended as a method of preventing the iatrogenic spread of vCJD. A reduced version of OxiVario Plus, entitled simply OxiVario, is available for less demanding applications.

Further detailed information is available in brochure.

Using a test object soiled with synthetic fibrin, absolutely no traces of fibrin were detectable after reprocessing in the OXIVARIO PLUS programme. Chemical protein analysis and infrared spectroscopy also confirm the absence of proteins.
Cleaning performance is similar to the excellent levels achieved using detergents containing active chlorine, the difference being that alkalinity levels are much lower and no chlorides are released, making this approach even suitable for cleaning minimally invasive instruments including fibre optics. Exception: This method is not suitable for use on anodised aluminium instruments.

	Practice makes perfect, perfection ensures safety
	For over 30 years Miele has been at the forefront of developments in the field of washer-disinfectors for hospitals and surgeries. As innovation leader in the industry, Miele has made significant contributions through publications on matters of research and through its involvement on national and international comittees.		Developments patented by Miele enable processing of: Patient systems Rigid endoscopes Surgical drive and transmission systems

Miele washer-disinfectors

Profitronic controls monitor validated processes and instrument reprocessing with great precision. All process data can be documented.

It is also possible to interlink several appliances. Flexible installations result in economic operation. The single compartment system offered by Miele washer disinfectors, in which each machine cleans, disinfects and dries in one and the same cabinet, has proved to be particularly flexible and economical.

To reduce manpower levels, automatic loading and unloading conveyor systems can be used to ensure that reprocessing can continue through breaks and after regular working hours. In this case, automatic basket recognition is also of great benefit.

According to the 93/42/EWG guideline, washer-disinfectors are active medical products classified according to the relevant rules as Class 2a products.

Miele has provided the certification required from an approved authority. The machines are certified as medical devices and bear the CE mark of approval (Index 0366 from approved authority).

Comprehensive instrument reprocessing

Besides this, Miele has also developed practical system solutions for processing the instruments used in minimally invasive surgery, such as trocars and forceps.

The objective of these innovations is to reprocess all operating theatre instruments in one batch using validated processes. Validated processes must be reproducible and documented.

This requires particular attention to the following:

Control and monitoring of temperatures and times
Monitoring of circulation pump pressure
Control and monitoring of water quantities
Monitoring and control of detergent dispenser system

Fulfilment of standards and guidelines:

DIN EN ISO 9001 Quality Management
DIN EN ISO 14001 Environmental Management
(EWG) 1836/93 EG directive on environmental auditing
EN 46001 and Directive 93/42 on quality management for medical devices
Health Technical Memorandum 2030 washer disinfector design considerations

Miele Professional provides solutions to problems in instrument processing such as discolouration or corrosion using modern physical and chemical analysis methods.
The results are used to develop customised solutions to meet individual requirements.