European Guidance on IFU for Sterilizing Medical Devices
The enforcement unit of the Competent Authorities overseeing medical device market surveillance in the European Union has published new guidance for Instructions for Use (IFU) for reusable and resterilizable medical devices following several non-conformities reported across member states.
The Compliance & Enforcement Working Group of the European Commission (COEN), which issued the new guidance, focuses coordination of enforcement activities by Competent Authorities in the EU. Representatives of the European Commission as well as representatives of the Competent Authorities take part in this working group.
COEN discusses how to interpret legislation and how to approach companies that are not compliant, as well as compliance cases that involve multiple member states.
For several years I have represented The Netherlands in this group, and I have also been involved in a project looking into the quality of instructions for use (IFU) that are supplied with medical devices that are supplied non-sterile, but that have to be sterilised before use.
Many issues were seen with these IFU’s, for example:
- The IFU were not supplied;
- The IFU referred to methods of sterilisation that are different from those that are commonly used in Europe;
- Non-metric units were used;
- Following the instructions would not likely lead to a fully sterile device
New guidance to address shortcomings
COEN has now produced a guidance document (“Instruction For Use for reusable and re-sterilizable Medical Devices”) that explains when an IFU is required, and what information it should provide. The guidance also provides a rationale for the checklists that follow in the two Annexes.
Annex 1 is based on EN ISO 17664 and provides a comprehensive, methodical overview of the process of preparing, cleaning, disinfecting and sterilising, including inspection, maintenance, testing and packaging. Annex 2 addresses assessing the validation of the reprocessing of reusable medical devices based on EN ISO 14937. Although these annexes are based on standards, they are not supposed to replace them. Therefore it is strongly recommended to keep referring to the ISO standards to demonstrate compliance with the Essential Requirements.
This is a guidance document. That means it is not legislation. Ultimately the judge will determine the final interpretation of the legislation. But on the other hand, you can count on Competent Authorities using this checklist when they verify the compliance of your IFU.
In other words: use this checklist yourself, before an inspector does.