India – Potential Advantages and Disadvantages of Electronic Instructions for Use (eIFUs) for Medical Devices

  • India has become the latest medical device market whereby regulators have begun accepting electronic indications for use (eIFU) for registrations.
  • Manufacturers can realize advantages of utilizing eIFU, but should consider how eIFU may impact other design, labeling and user interface issues.
  • Markets including the US and European Union already recognize eIFU for medical device premarket submissions.

Recently, the Indian Ministry of Health & Family Welfare granted that instructions for use (IFU) for medical devices and equipment can take an electronic form, thereby eliminating the need for printed instructions.

In doing so, India joined a growing list of other markets including the US and the European Union that allow instructions to take this form; a form that is widely being called an eIFU (electronic instructions for use). This action is likely to be replicated by many more regulators who recognize that an eIFU saves paper and offers some usability advantages as compared to printed instructions.

Advantages of eIFU

What are some of the potential advantages of an eIFU?

  • Availability. Paper IFUs can become separated from their associated devices, such as a dialysis machine or blood gas analyzer. The IFU could be lost or placed in a remote storage location and, therefore, effectively unavailable to the device user at the point of use/care. An eIFU stands a chance of remaining accessible to kit users if the manufacturer assembling it supplies it with integrated, electronic instructions. Presuming a means to display the eIFU at the point of use/care, the content should be persistently available.
  • Interactivity. eIFUs open the door to more advanced, interactive design. Whereas a paper IFU is a static resource, an eIFU can incorporate dynamic elements, such as animations and confirmations pertaining to pending and completed steps. An eIFU can even incorporate voice prompts and provide direct access to a help line via the Internet.
  • Durability. While printed documents might be subject to wear (e.g., tearing, fading, abrasion, staining, bio contamination), eIFUs are not.
  • Adaptability. eIFUs can be easily changed and updated. If there is a technical flaw in a printed IFU, it can become an ordeal to fix it, often requiring a new version that brings with it high production and distribution costs. An eIFU can be updated periodically via the Internet, which offers great economies, speed, and assurance that text and graphical instructions are updated as needed.
  • Local language. eIFUs can handily present content in many possible languages, leaving it to the user to choose as she might when arriving at a webpage that presents many language options…