Management of non-medical devices

Unlike medical devices within the meaning of the Medical Device Directive (MDD), there are various devices ➜ (NON-MEDICAL DEVICES) which are used for patient care and, in the interest of hygiene, must be cleaned, disinfected and in some cases sterilized before use.
Reference is made to non-medical devices in the following:
–– EN ISO 15883-6:2016-04
–– Recommendation No. 77 (flowchart)
–– Various regulations of individual German Federal States
Non-medical devices are all devices that do not meet the definition (of a medical device) as set out in the Medical Device Directive, Article 3(1). The non-medical devices often delivered to the Reprocessing Unit for Medical Devices (RUMED) include:
–– Infant feeding bottles, pacifiers, nipple shields
–– Feeding cups
–– Care/grooming items (e.g. combs, brushes, manicure sets, razors, etc.)
–– Toys
––Operating room (OR) shoes
–– Transport boxes
–– and many other devices
The RUMED must clarify a number of issues if such devices/items are to be reprocessed or have already been reprocessed. If available, the manufacturer’s instructions should be taken into account. The following ➜ ISSUES, among others, must be clarified in cooperation with the persons responsible for hygiene in the respective department:
–– Cleaning and disinfection of OR shoes:
• Lint
• Temperature
• Material compatibility
• Which washer-disinfector (WD) or cleaning process should be used.
–– Cleaning and disinfection of pacifiers/infant feeding bottles/nipple shields
• Water residues
• Patient assignment
• Which chemical products
• Material compatibility
–– Cleaning and disinfection, possibly sterilization, of soft toys or other toys (e.g. from
the oncology department)
• Material compatibility
• Lint
• Amenability to cleaning

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