The second part of the recommendation “Information to be provided by the medical device manufacturer” pointed out that the accuracy of the manufacturer’s instructions should be verified already at the time of procurement of medical devices.
The healthcare system is always in the spotlight and any suspected hygiene scandal is picked up by the media. “Rusty instruments” makes for a catchy headline but the issues involved are complex.
The information provided by the manufacturer serves as THE BASIS FOR PROCESSING each and every medical device (MD) and makes stringent demands on the organizational skills of a Reprocessing Unit for Medical Devices (RUMED) [1] with regard to the practicability and implementation of such processing measures.
The information provided by the manufacturer serves as THE BASIS FOR PROCESSING each and every medical device (MD) and makes stringent demands on the organizational skills of a Reprocessing Unit for Medical Devices (RUMED) [1] with regard to the practicability and implementation of such processing measures.
The washer-disinfectors regulated by standard EN ISO 15883-3 [1] are also known colloquially as BEDPAN WASHER-DISINFECTORS. The terms automatic bedpan washers or faecal washers are also occasionally used.
Reprocessing Units for Medical Devices (RUMEDs) face continual challenges related to the risk assessment and subsequent purchase and release of new medical devices (MDs).
Part 7 of the publication on “Requirements for construction or reconstruction of a reprocessing unit for flexible endoscopes” describes a model approach to determination of the rooms needed, their allocation and the resultant routing systems.
The Quality Task Group has deemed it necessary to revise these recommendations to bring them into line with the amended version of the “Guideline compiled by DGKH, DGSV and AKI for the validation and routine monitoring of automated cleaning and thermal disinfection processes for medical devices”, 5th Edition 2017 (termed the Validation Guideline below).
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