HF-GB-17664, Rev. D | Page 2 / 8 Status: 07/2023
Consider, that the disinfectant used in the pre-treatment step serves only for personal safety and cannot replace the disinfection step, which should be performed later. Only use soft brushes such as Art. No. 1003414000 (Schellenberger), Art. No. MED100.33, MED100.43, MED100.18, or MED100.17 (Insitumed). PROCEDURE: Completely disassemble the instruments, if applicable. Pre-soak the devices for at least 5 minutes* and make sure that all surfaces are wetted and lumens are filled with water. Brush the instruments to remove residues from the surface, paying special attention to lumens and dead ends. Also make sure that movable parts are brushed in open and closed position. Difficult to reach positions such as hinges, mating surfaces, lumens or dead ends shall be flushed at least 3 times with minimum 50 ml cold deionized water, using a syringe or a rinsing adapter.*
* These parameters are validated for Enzymax Liquid. For other cleaning agents and disinfectants, the instructions of the manufacturer must be observed.
3.2 Cleaning and Disinfection
3.2.1 Automatic Cleaning and Disinfection in a Washer-Disinfector Unit When using a Washer-Disinfector unit, make sure that… - the efficiency is fundamentally approved (e.g. EN ISO 15883, DGHM approval, CE marking), - your process is validated, including equipment, detergents, temperatures, durations and loading, and - regular maintenance and inspection/calibration is done. For the selection of detergents to be used with the Washer-Disinfector unit, consider the following items: - Fundamental suitability for cleaning of medical devices - Compatibility with the instrument materials (see 7.0 Material resistance section and 9.0 Special Procedures section) - Detergent manufacturer instructions regarding concentration and soaking time
PROCEDURE: Connect devices with lumen to flush ports in the washer-disinfector. Load the washer-disinfector as validated. Start the validated program. Remove the instruments after end of program. Let the instruments dry. Conduct post-disinfection steps (see section 4.0)
The fundamental suitability of the instruments for an effective automatic cleaning and disinfection was demonstrated by an independent accredited test laboratory under the following conditions: Washer-Disinfector Miele Professional G 7836 CD Racks Mobile injector unit (Miele) E429, Four-level rack (Miele) E 493 Cleaning Cycle • 2 minute pre-cleaning with cold tap water • Draining • 5 minute cleaning with 55 °C cleaning solution • Draining • 3 minute rinsing with cold deionized water • Draining • 2 minute rinsing with cold deionized water • Draining Cleaning Solution 0.5 % cleaning solution neodisher® Mediclean Dental (Chemische Fabrik Dr. Weigert, Hamburg) Validation Report Project Number: 00418-1 Examination of an Automated Cleaning Process using quantitative Detection of Protein and Hemoglobin and the Radionuclide Method
The responsibility for reprocessing of Hu-Friedy instruments according to parameters which are not specified in this document lies with the customer.
3.2.2 Manual and Ultrasonic Cleaning and Disinfection For the selection of detergents to be used for manual cleaning and disinfection, consider the following items: - Fundamental suitability for cleaning of medical devices. - Approved efficiency (e.g. VAH/DGHM, RKI approval or CE marking). - Compatibility with the instrument materials (see 7.0 Material resistance section and 9.0 Special Procedures section). - Detergent manufacturer instructions regarding concentration, temperature and soaking time
Combined cleaning/disinfection solutions should be used only in the case of extremely low contamination (no visible impurities), unless indicated explicitly otherwise by the manufacturer of the combined detergent/disinfectant.
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