EIFU: Labelling Basics
In March 2013, electronic instructions for use (EIFU) regulation came into effect, leaving MDMs to address their current labelling strategy and decide if switching to EIFUs, or at least adding them to their devices, is a wise move or not.
In a recent MD+DI article, Jayanth Katta, certification manager and device expert at BSI Healthcare, shares how to comply with the new EU regulations.
What is an EIFU?
According to Katta's article "The regulation defines EIFUs as instructions available from a Web site, supplied in portable electronic media (e.g., CD, DVD, USB drives), or displayed in electronic form on the product screen. In the latter two cases, manufacturers are also required to provide instructions on a Web site." It should be noted that EIFUs must be accompanied by a paper form "if the device design requires that a part of the instructions is intended to be provided to the patient."
Is it worth it?
Katta points out that the benefits to using EIFUs go beyond being an alternative to paper instructions. EIFUs can include videos or audio files to that demonstrate proper use and handling, as well as provide a quick and easy way to update patients for enhanced patient safety. Also, EIFUs allow MDMs to augment current instructions and provide additional information.
The new regulations are burdensome, Katta admits. "Key risks associated with EIFUs include delayed or no access to the instructions for use in healthcare settings and inadequate security provisions related to the EIFUs."
However, Katta believes the perceived burden is worth it:
The costs associated with paper and printing can be greatly reduced, along with the environmental footprint, while enhancing speed-to-market of products. Economic benefits could also come by avoiding expensive recalls associated with inaccurate information provided in paper IFUs.
How has your team addressed these new regulations? Have you seen any benefit by adding EIFUs to your device packaging? Have you experienced any failures?
Stephanie Wiseman, Community Editor, UBM