Information on cleaning, disinfecting and sterilizing medical instruments and devices

General preparation

Classification of instruments and devices (hereinafter referred to as medical devices)

Before reprocessing, a risk assessment and classification of every given medical device must be carried out. It must be specified in writing whether, how often and with which procedures a given device is to be prepared.

Categories for which different reprocessing steps are recommended are distinguished and classified as follows:

• Non-critical: medical devices that only come into contact with intact skin e.g., stethoscope, ultrasound head.
• Semicritical: A and B are medical devices that come into contact with mucosae or diseased skin e.g., speculum.
• Critical: A, B and C are medical devices for the use of blood, blood products and other sterile medicinal products as well as medical devices that penetrate the skin or mucosa and come into contact with blood, internal tissues, or organs, including wounds e.g., dissecting scissors.

Choice of cleaning agents and reprocessing

When reprocessing medical devices, the manufacturer of the medical devices is obliged to provide information on suitable reprocessing procedures. Formulations such as “Reprocessing with alkaline agents containing detergent additives” are often used to avoid mentioning product names directly. The cleaning and disinfecting agents of B. Braun SE that correspond to these descriptions can be taken from the following table.

Treatment of brand-new instruments

Clean brand-new instruments prior to the first sterilization or use. Protective caps and protective films must be removed completely, e.g., chisels, raspatories or microsurgical instruments.

Cleaning-disinfection-sterilization of power systems and handpieces

AESCULAP® power systems and handpieces are low-maintenance and renowned for their reliability. Premature wear and malfunctions can be prevented by observing the general care instructions and the special care instructions in the respective instructions about the greasing of the handpieces. If repairs or functional checks are still necessary, please contact our Customer Management colleagues or your responsible Sales Partners.

Reprocessing steps

Manual cleaning / disinfection

• Place instruments in a suitable active cleaning disinfectant in such a way that all surfaces, cavities, lumina, and openings are covered. Follow the disinfectant manufacturer’s instructions. 
• Remove any dirt with a soft plastic brush. Do not use abrasive cleaning agents or metal brushes. 
• Clean lumina and channels with soft round plastic brushes. The diameters of the lumen and the brush must match.
• Cary out interim rinsing.
• Place the instrument in a suitable disinfectant again.
• Always rinse thoroughly and intensively with clear running water after chemical disinfection. Follow the disinfectant manufacturer’s instructions. 
• Carry out a final rinse with distilled or fully desalinated water. 
• Dry the instrument with an absorbent, soft and lint-free cloth.
• Dry lumina and channels with compressed air.

Machine cleaning / disinfection

• When selecting a program, take into account the material (e.g., stainless instrument steel, aluminum) of the instrument to be cleaned. Follow the manufacturer’s instructions.
• Carry out a final rinse with fully demineralized water.
• Maintain a sufficient drying phase.
• Remove the instrument from the machine immediately after completing the program.

Material compatibility

Medical devices must always be reprocessed in accordance with the manufacturer’s instructions. This is the only way to ensure that instruments are reprocessed with the appropriate active ingredients while at the same time ensuring that the full value of the work material is retained.

The following overview can be used for guidance on the material compatibility of B. Braun instrument disinfectants.

Aesculap Online Service

Aesculap offers rapid and comprehensive information on the correct ways of reprocessing its instruments on its website: Electronic Instructions for Use (eIFU).
As soon as you have accepted the terms of use, the respective instructions for reprocessing can be called up after entering the article number of the instrument.

A safe combination: Aesculap and B. Braun

All B. Braun instrument disinfectants have been tested for material compatibility with Aesculap instruments.

Biocompatibility

When using instrument and surface disinfectants in daily practice, the selection of disinfectant agents is of particular importance. In addition to the differing suitability for certain materials and the differing spectra of action, it must be ensured that the active ingredients of the products used are compatible with each other in order to prevent undesirable reactions.

Care / checking / packing

Packing

• Store instruments with fine working tips and/or microsurgical instruments in suitable storage containers. 
• Lock the instrument only up to the first notch.

Sterilization

Steam sterilization must be carried out using a validated steam sterilization process (e.g., sterilizer in accordance with EN 285 and validated in accordance with EN 554). If the fractionated vacuum procedure is used, sterilization must be carried out using the 134° C/2 bar program with a minimum holding time of 5 minutes.