Before the first use and prior to all subsequent uses, the device must be cleaned, disinfected and sterilized. Effective cleaning and disinfection are essential for effective sterilization.
The reprocessing of reusable endoscopic equipment must remain under the responsibility of individuals with thorough training in reprocessing methods and be aware of the following points:
- Local hospitals’ reprocessing guidelines
- National health and safety guidelines
- The instructions in this instruction for use
- Additional national specifications related to effective inactivation of prions (i.e.: use of highly alkaline cleaning agent and prolonged sterilization time)
- That the methods used to clean, disinfect and sterilize are adequately validated for this type of instruments
- That the equipment used is regularly maintained and checked
- That the validated parameters are maintained during each reprocessing cycle
The reprocessing of the instrument must be initiated immediately after use, since dried organic residue can impact effective cleaning, disinfection and sterilization.
Reprocessing methods
A mechanical cleaning/disinfection process should be used whenever possible over manual cleaning.
Therefore, one of the following 2 options must be used for reprocessing:
- Perform the pretreatment and manual cleaning before the mechanical cleaning/disinfection followed by the sterilization (3 steps).
- In case a mechanical cleaning/disinfection is not available, the device must then be pretreated and manually cleaned followed by a sterilization (2 steps).
Material Resistance
Ensure that the cleaning and disinfection agent do not contain the following:
- Aldehydes (this will fix blood-based soiling)
- Strong organic, mineral or oxidizing acids (lowest permissible pH value 5.5)
- Strong alkalis (highest permissible pH 11, neutral / enzymatic or slightly alkaline cleaners are recommended)
- Organic solvents (e.g. ether, ketones, benzines), fluorinated alcohols
- Oxidizing agents (e.g. hydrogen peroxide)
- Halogens (chlorine, iodine, bromine)
- Aromatic / halogenated hydrocarbons
- Formamide
- Trichloroethylene / perchloroethylene
Pretreatment / Manual Cleaning
- Immersed the instrument in a cleaning solution within maximum 2 hours after use
- Remove any soiling visible on the jaws using a clean soft brush (or a clean, soft and lint-free cloth) which is used solely for this purpose. Never use metal brushes or wire wool.
- Open and close the jaws, immersed in the cleaning solution ate least 3 times
- Immediately place the instrument winded with a diameter not less than 20 cm into an ultrasound bath filled with cleaning solution for 30 minutes (time and concentration may vary according to the solution manufacturer’s specifications. The cleaning method has been validated with an ultrasound bath using 0.5% neodisher® Mediclean forte (Dr. Weigert GmbH) at 35 kHz)
- Rinse the instrument for at least 1 minute under running water (temperature < 35˚C/85˚F)
Mechanical Cleaning / Disinfection
Proceed as follows:
- Place the instrument winded with a diameter not less than 20 cm into the cleaning and disinfection equipment that fulfills the following requirements:
- Equipment is effective and suitable for the cleaning and disinfection of medical instruments (i.e: FDA approved, CE marked)
- Only sterile or low-germ (max. 10 bacteria/ml) and low-endotoxin (max. 0.25 endotoxin units /ml) water is used (e.g. purified water/highly purified water)
- The air used for drying is filtered (oil free, low-germ and low-particle)
- The device is maintained and checked regularly
- The cleaning and disinfection solutions used are compatible with the instrument (See “Material Resistance”)
- The concentration, temperatures and exposure times specified by the cleaning / disinfectant agent manufacturer are followed at all times. This includes the rinsing specifications
- Start the cleaning and disinfection program:
- The program must be suitable for the instrument
- Thermal disinfection program should be used (90˚C / 194˚F for at least 5 minutes)
- The program contains at least 3 rinsing cycles (depleting steps) after cleaning (or neutralization if applied) or conductance control recommended to effectively prevent detergent residues.
- Remove the instruments from the equipment when the program is finished
- Check the functionality of the device by opening and closing the jaws several times
- Check the device for signs of corrosion, damaged surfaces, cracks, soiling or discoloration
- Remove any damaged device from use
- Any soiled device must be cleaned and disinfected again
- Package the device into a single-use sterilization pack or a sterilization container (suitable for steam sterilization of at least 134˚C / 270 ˚F) as soon as possible after removal from the equipment.
Sterilization
- Only steam sterilization must be used.
- Flash sterilization, hot air sterilization, radiation sterilization, formaldehyde, ethylene oxide sterilization or plasma sterilization are not permitted.
The following aspects shall be taken into account:
- Fractionated vacuum method (at least 3 vacuum steps and with adequate product drying not less than 20 minutes)
- Steam sterilizer compliant with DIN EN 13060/DIN EN 285 or ANSI AAMI ST79
- Validated in accordance with DIN EN ISO 17665 (valid IQ/OQ and product-specific performance assessment (PQ))
- Maximum sterilization temperature 134°C / 273°F plus tolerance as defined in DIN EN ISO 17665
- Sterilization time (exposure time at sterilization temperature) at least 4 min at 134°C/270°F).
- For prion inactivation (depending on the local recommendation) at least 18 minutes at 134°C/273°F