Instructions for use for reusable medical devices

EU guidance and harmonised standards on processing reusable devices

The Compliance and Enforcement Group (COEN) provides exchange of information between Competent Authorities (CA) responsible for market surveillance (MS) of medical devices (MD) and coordinates their enforcement activities.  COEN created a working group to address nonconformities under the Medical Devices Directive related to the instructions for use (IFU)   for resterilizable devices. This group produced a checklist intended for all individuals and organizations involved but more specifically targeted to manufacturers, end users and procurement officers. This checklist, produced in 2014, was added to the European Commission website in 2020.

The checklist was based on EN ISO 17664:2004 - Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices. The COEN working group only included checkpoints in the list deemed most relevant for a quick assessment. However, a revised edition of EN ISO 17664  was published in 2017, after the COEN checklist was developed. This second edition of EN ISO 17664 cancels and replaces the first edition from 2004. The second edition includes technical revisions to the standard. In particular, the scope in the second edition has been increased from resterilizable devices to include medical devices requiring disinfection and/or sterilization prior to use. The title of the 2017 edition has been adjusted accordingly to Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.

The changes incorporated in the revision to EN ISO 17664 include updates related to:

• inclusion of a normative reference to EN ISO 14971 - Medical devices — Application of risk management to medical devices – together with an expanded list of points to be included in the risk analysis from a reprocessing perspective;
• addition of a requirement for objective evidence that validation of the processing procedures has been undertaken to confirm that the specific medical device will be clean, disinfected and/or sterilized when processed as directed;
• incorporation of additional requirements on both automated and manual cleaning and disinfection methods for the device, with an increased emphasis on the preference for automated methods;
• encouragement of the use of cleaning, disinfection and sterilization processes that have published equipment and validation standards. 

The focus on the IFU  for reusable devices has been increased in the Medical Devices Regulation (MDR).  The conformity assessment procedure in Article 52, clause 7(c), of the MDR indicates that the involvement of a notified body is required for class I reusable surgical instruments for aspects related to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related IFU. 

Manufacturers of reusable surgical instruments who are looking to CE mark their devices under the MDR should be aware of the COEN checklist but also take into account the content of the second edition of EN ISO 17664 in developing and validating their instructions for use.

Manufacturers should also be aware that work is in hand to redesignate EN ISO 17664:2017 as EN ISO 17664-1, with the incorporation of an Annex Z showing the relationship of the standard with the requirements of the MDR. This renumbering is to facilitate the publication of a new Part 2 to the standard, EN ISO 17664-2 - Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices,which has recently been completed and is awaiting publication.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development