Feb 6, 2019

EMERGO BY UL SUMMARY OF KEY POINTS:

  • 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.

eIFU disadvantages to consider

What are some of the potential disadvantages of an eIFU, or outright obstacles to instructions assuming an electronic form? Here are a couple of important considerations:

  • (Also) Availability. Even for eIFUs that are compatible with various devices such as smartphones, tablets and laptop computers, one can envision scenarios in which a means to display the eIFU at the point of use/care is unlikely to be available. This could be the case for many devices (e.g., certain incubators, syringe pumps, sphygmomanometers) that do not have an embedded computer display suited to displaying instructions, perhaps due to a device’s small size or need to continuously display critical information that should not be displaced by instructions. Also, in emerging and developing markets, the spread of eIFUs may be inhibited by lack of access to suitable technology. And one more concern is that it might be time consuming to access an eIFU embedded in a device’s software user interface, requiring the users to navigate to the instructions via multiple steps.
  • Parallel access. In cases in which eIFU content appears on a device’s primary screen, it might become awkward or even untenable for the user to switch back and forth between instructional content and a device’s primary user interface in order to sort through a particular task requiring guidance. Moreover, warnings that might normally be continuously present when using a printed IFU would only be present intermittently, potentially reducing their effectiveness at critical junctions of device use. Of course, this problem is eliminated if an eIFU is presented on a supplemental display (i.e., a tablet computer).
  • Design quality. For some companies, it is enough of a challenge to design printed instructions that are legible, readable, clear, concise, and accurate. In fact, shortcomings in the design of IFUs are well chronicled and have led regulators to issue guidance on how to create good ones. Turning IFUs into eIFUs might fulfill many needs but also pose new challenges. Such challenges include presenting the instructional content in accordance with a simple conceptual model that people immediately “get;” partitioning instructions properly and logically among multiple screens; and enabling intuitive and swift navigation among various eIFU sections. And, some of the same challenges associated with designing printed instructions remain, including differentiating information according to its importance; displaying graphics where they can be more helpful and pleasing than text; presenting warnings in an attention-getting manner; and ensuring narrative content is clear and comprehensible by the intended users. Manufacturers need to take care not to change the instructions in a manner that changes a device’s user interface to the degree that it requires a new round of human factors validation testing and regulatory approval.

Making instructions electronic opens the door to interactive elements that can greatly improve their utility, but this requires an investment in high-quality user interface and instructional material design. Meanwhile, printed instructions are not an endangered species. There will always be a place for them in a world in which many medical devices will not be computerized themselves and a viewing screen is not nearby. Even though most users will own a handheld or tabletop device on which they could display an eIFU, some users will undoubtedly feel more comfortable and confident with a paper version in-hand; one that enables them to quickly browse a Table of Contents, highlight key points or make hand-written notes in the margin, and earmark pages--even if in a “low-tech” manner.

Labeling and user interface issues

And now, a final word about eIFUs. They are unquestionably here to stay, and will without doubt become more sophisticated, interactive and widespread. Still, keep in mind that instructions for use (including eIFUs) are part of a device’s “labeling,” which is part of a device’s user interface in the US FDA’s view. Properly performed human factors testing is important, whether the instructions are written on paper or on a smartphone.

FDA accepts patient labeling supplied in several formats, including patient brochures and leaflets, user manuals and videos.

Michael Wiklund is General Manager of Human Factors Research & Design at Emergo by UL.

Related medical device labeling and human factors information from Emergo by UL: