Why do we need quality management in the processing of medical devices?

Updated: Feb 2

With regard to #patientsafety and to minimize risks for users and reprocessors, the verifiability of correct #reprocessing of #medicaldevices is absolutely essential.

As part of the implementation of quality management in the #RUMED, core processes (reprocessing processes) and supporting processes (e.g. media supply, environmental conditions) are structured and documented.

The implementation of QM requires the involvement of all employees in the #RUMED and in the interface areas.


In particular, work instructions, created taking into account the manufacturer's instructions for reprocessing, describe the reprocessing steps in detail so that, after appropriate training, all employees perform the process steps in the same way. This in turn enables the #validation of the reprocessing processes, which is based on the fact that working steps are always carried out in the same way in order to obtain #reproducible results. Documentation of the processes is also essential to prove execution.


Certainly, work instructions can be created without reference to a "whole quality management system (QMS)," but there are other benefits in implementing a QMS. There are international standards and guides for implementing QM in #RUMED. These can be applied in a supportive manner and they serve as a kind of signpost and guide as to which areas are to be considered in addition to the actual reprocessing, so that the performance of the reprocessing is #verifiably quality assured.

Internationally, reprocessing is based on DIN EN ISO 13485. This standard is primarily a standard for manufacturers of #medicaldevices, but is also used in the area of reprocessing. Another advantage is the possibility (in some countries also obligatory for the reprocessing of medical devices of the category "Critical C") of external certification of the QMS.


About the author

Anke Carter was a member of AKI since 2016 and is one of the representatives of the sterilizer manufacturers' group. In the MMM Group, she was a specialist consultant responsible for the reprocessing of medical devices and the practice-oriented establishment and further development of QM systems in RUMED.

Sadly, Anke passed away far too early this year. She wrote this blog post for AKI in the past.

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