NEN publishes guidelines reprocessing during COVID-19

Introduction

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).