Published on: Tue 16 June 2020

NEN publishes guidelines reprocessing during COVID-19

The Dutch standardisation organisation NEN, has published today a so called 'NEN-spec', or 'guidelines'. In the guidelines the NEN publishes recommendations for reuse of single use medical devices (such as surgical masks and respitory devices). 

The NEN-spec describes the steps that need to be followed to reach an informed decision.

Content
A multidisciplinary team is necessary to go through the various steps, as is good documentation of the entire process (file creation) including decision moments and considerations. The NEN-spec 3 deals with this:
necessity of reprocessing and reuse;

  • collecting information about reprocessing medical devices;
  • minimum requirements for a medical device;
  • Inventory of possible reprocessing methods;
  • selection of most appropriate reprocessing method(s);
  • performing tests on product quality and product safety;
  • risk analysis;
  • possible framework conditions for re-use;
  • decision making on carrying out reprocessing and proceeding to reuse;
  • logistical aspects and traceability;
  • provision of information on reprocessing and reuse;
  • incidents.

The guideline can be downloaded through this link free of charge (a NEN connect account is however required). 


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