October 21, 2022
For medical devices and drug-delivery combination products, the Instructions for Use (IFU) or equivalent manual is usually the primary source of guidance. At least, product developers hope that will be the case. However, the IFU is not always as highly-utilized as product developers might envision. Users might avoid or have difficulty with an IFU, for example, because it might be hundreds of pages long (for a complex medical device), or it might be a high-density, multi-panel, origami-like leaflet (for a combination product). It is tempting to “solve” these problems by adding supplemental labeling, perhaps most notably a Quick Reference Guide (QRG) or equivalent “cheat sheet,” to help users focus on (and, ideally, reduce errors on) key use steps. But, adding a QRG isn’t always as easy – or as effective – as it seems; in certain situations, a QRG can serve users well, and in other situations, such guides can actually induce, versus reduce, use errors and use difficulties.
When a QRG might – or might not – be the answer
QRGs can be valuable tools to help ensure safe and effective product use. Depending on the product’s complexity, products may have a single QRG that draws users’ attention to key use steps (typically those associated with critical tasks). Or, there might be a series of QRGs; for example, one associated with each use stage (e.g., setup, use, troubleshooting). QRGs should be readily accessible at the point of care and product use. They might take the form of “quick steps” printed on the inside of a carton lid, a few laminated cards on an in-clinic dialysis machine, or a wallet card with key use details for an insulin pump or other product used on-the-go.
However, one potential drawback of introducing a QRG is that users might overlook or intentionally disregard the IFU. Compared to IFUs, QRGs are often shorter, more colorful, better-illustrated, and less text-heavy. On the other hand, during usability testing, we frequently encounter users who prefer a “trial-and-error” approach to product use and may not reference the IFU. For these users, a QRG is a “better than nothing” tool that can convey key points. When designing and implementing QRGs, manufacturers should consider user characteristics as well as device complexity.
When a QRG might be the answer
In our experience, a QRG is particularly valuable when there are only one or two true critical tasks. (We say “true” critical tasks because we know that the FDA’s Center for Drug Evaluation and Research [CDER] broadly defines tasks as critical, but recognize that there is sometimes a shorter list of tasks truly essential to ensuring effective medication delivery.) Considering a single-use injection device, it might be most important to check the expiration date, select the correct injection site, activate the device, and hold the needle in the skin for a full 10 seconds after injecting. While there are other important use steps, the aforementioned steps are arguably most pivotal to remind users about during repeat use.
A QRG also adds value for products that are similar to currently-marketed devices except for one or two steps and/or features. A QRG could call attention to these differences more effectively than a sentence or two buried within the full IFU. This is especially important if the steps are deemed critical per the use-related risk analysis.
When a QRG might not be the answer
In contrast, consider a product that requires mixing a freeze-dried powdered drug using two vials, two syringes, and other ancillary materials. While a few steps are pivotal – perhaps ensuring that the powder is fully dissolved within the diluent and that the user draws up and injects the correct dose – there are several nuances related to interacting with the vials and syringes that are critical, such as withdrawing the right volume of fluids and eliminating air bubbles. There may not be a clear way to distill the detailed reconstitution process into a simpler handful of steps, and users should rely on the full IFU rather than a “cheat sheet” that cannot communicate all of the sub-steps effectively.
In many cases, a well-designed QRG can reduce the likelihood of users committing the most critical use error – or two or three. However, it’s not a panacea, in that the presence of a QRG could lead users to disregard the IFU and/or commit use errors on steps excluded from the QRG. The decision largely depends on your users’ characteristics, the complexity of your device, and the number of “true” critical tasks your device has.
Now that we’ve covered assessing when and if a QRG would benefit a product, what’s next? If you’ve determined a QRG would add value to your product, you design an effective guide that attracts and engages users while clearly communicating key information. In a future blog, we’ll share some best practices for QRG design.
Allison Strochlic is Research Director at Emergo by UL’s Human Factors Research & Design division.
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