FB-618/AU – rev.E – ed.2019/08
5.3. Reprocessing of EMS parts
EMS recommends the use of cleaning, disinfection, packaging for sterilization and sterilization
procedures accordingly with ISO 17664.
Always report adverse events related to device reprocessing directly to EMS.
Reusable products must be cleaned disinfected and, if applicable, sterilized prior to first use. Do
not reprocess the products over the allowed number of sterilization cycles, but replace: refer to the
“Service life” section of the “Technical Description” chapter.
Concentrations and contact times specified by the manufacturer of the cleaning and disinfection
agent must be followed.
Remember that sterilization cannot be achieved unless the elements of the assembly are
cleaned and disinfected first.
If there is anything in the following instructions that is not clear or seem to be inadequate, do not
hesitate to contact/inform EMS.
The following instructions have been validated as being capable of preparing for re-use the EMS
medical devices and parts listed in the “Intended Use and Compatibility” chapter. It remains the
responsibility of the user to ensure that the processing as actually performed using equipment,
materials and personnel in the processing facility achieve the desired result. This requires validation
and routine monitoring of the process. Likewise any deviation by the processor from the
instructions provided should be properly evaluated for effectiveness and potential adverse
consequences.
The user shall also observe any applicable legal requirements in their country as well as the hygiene
regulations of the hospital or clinic. This applies especially with regard to the additional
requirements for the inactivation of prions.
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