Cleaning And Reprocessing - Medela Trolley Instrucciones De Uso

6 Cleaning and Reprocessing

Cleaning and Reprocessing Instructions
Reusable devices and components from Medela are delivered non-sterile and are intended
for reuse� Prior to use clean and reprocess the product following the procedure described below�
The following cleaning and reprocessing processes have been validated according to interna-
tional standards and guidelines:
– ISO 17664:2004 (EN) Sterilization of medical devices — Information to be provided by the
manufacturer for the processing of resterilizable medical devices
– Guidance for Industry and FDA Staff: March 17, 2015 Processing/Reprocessing Medical
Devices in Health Care Settings: Validation Methods and Labeling
It is the responsibility of the user/processor to ensure that the cleaning/reprocessing procedure is
performed using equipment, materials and personnel which are suitable to ensure the effective-
ness of the process� Any deviation from the following instructions should be validated by the user/
processor to ensure effectiveness of the process�
Materials and equipment:
– Personal Protective Equipment (PPE: disposable gloves, proper protective gear)
– Lint free nonwoven wipes
Initial cleaning: Perform initial cleaning directly after the use of the device (within a maximum of
2 hours after procedure)� Wipe the surface of the device to remove all gross debris by using a lint
free nonwoven wipe moistened with water (< 40 °C, < 104 °F)�
Thorough manual cleaning: Use a lint free nonwoven wipe moistened with tap flowing water
(< 40 °C, < 104 °F)�
Note
Never use steel brushes or steel wool for cleaning�
Water temperatures higher than 45 °C (113 °F) can cause protein coagulation which may
negatively affect the efficacy of the cleaning process�
Manual disinfection: Use only disinfectant wipes with active substances such as alcohols,
quaternary ammonium compounds (Quats), hypochlorites, hydrogen peroxides, gluteraldehydes�
For effective and safe disinfection please follow the instructions of the disinfectant manufacturer�
Drying: After manual cleaning and disinfection, store the product on a clean and dry cloth and let
it dry or follow instructions for use of the disinfectant manufacturer�
Inspection: After reprocessing according to the steps described above, the device and its
components must be inspected for signs of degradation that may limit the useful life and / or
performance of the device, such as the following: visible corrosion, mechanical wear, abrasion,
damage, or deformation� Discard the device if any signs of degradation are evident�
Storage: Store the product dry and dust-free�
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Cleaning and Reprocessing