By Christina Mendat, PhD
Prefilled syringes seem to be taken for granted when it comes to human factors evaluations and testing. However, it has been our experience (working on multiple prefilled syringes) that these combination products have more to them than meets the eye. This is the first of a six-part series on prefilled syringes where we address some issues we’ve encountered in our multiple client engagements.
Oftentimes, the syringe label (also called the device label) is left to the last minute. Certainly, there is a lot more entailed to this small label than some realize. Branding, text size, positioning, manufacturing constraints, etc. the list goes on and on. From a Human Factors perspective, one of the last things companies should do is wait on creating the syringe label. The syringe label can have fairly marked adverse effects on usability if not thought through carefully and included in the development process early on.
Here are a few recent examples we have experienced:
- Verifying that the appropriate dose volume is present in the syringe is an essential part of interacting with any prefilled syringe. If the graduations are covered by the syringe label, patients and caregivers are unable to discern readily if the fill volume is correct. Making an assumption could ultimately affect the dose efficacy.
- Verifying the dose color is often an essential part of interacting with any prefilled syringe. It is critical to ensure that the labeling itself does not obscure direct visualization of the drug product. For instance, is there color on the label that is seen through the label which results in an “illusory” appearance of color to the drug?
- Is the information readily visible? Text size is often overlooked yet is a basic 101 of Human Factors. Most importantly, is the expiration date readily visible? This can be affected by the ultimate layout. A primary culprit of downgraded text size is due to branding and logos. While both branding and logo are undeniably important, it is equally important to ensure that the rest of the label content and format is presented in a way that users can safely and effectively use it.