Presently, Instructions/Information-for-use (IFU’s) are a mandatory safety critical user document that provide key information on how to use a medical device correctly and thus, safely.
IFU’s are not required for medium to low-risk devices if they can be proved to be used safely in trials without the user having access to an IFU. However, this is often difficult to prove so IFU’s are generally found with most devices, and so the MDR stipulates that IFU’s should be provided with the device. IFU’s can come in the form of paper based booklets as seen with the NHS Covid-19 self-test, packaged with an inhaler, or on the exterior of devices such as EpiPens.
With this being said, every person discovers things in their own unique way, and there may be circumstances where the device is perfectly understandable and the steps are clear for 80% of the population, but that 20% need something extra. There are also engineering and practical constraints that may hinder what methods of discovery can be designed into a device.
So, there are a few things to bear in mind when we look at where the future of IFU’s might lead, they definitely aren’t going anywhere!
The market has recently seen regulation on when/where eIFU’s can be used, these will slowly become more common place, but the key caveat for many of these is with assessing the risk that the user will not have access to technology. eIFU’s already offer a good alternative to cater for multiple languages; MDR dictates that IFU’s must be provided in the native language of the region the device is sold, with a large number of languages an eIFU is much more streamlined.
- Connected devices: These are already entering the market, but development will continue. Allowing for feedback to both user and medical expert on efficacy of use.
- Novel packaging: Approaches that include building the IFU’s into the packaging to provide information practically or signify an action that will be useful in the device’s operation.
The IFU’s purpose will not change over time and the format it is provided in will move with the times. As new tech allows for better digestion of instructions and training, innovation will slowly happen. Our goal is to make the user understand how to use the device as elegantly and seamlessly as possible, which in turn will result in better patient outcomes. How IFU’s are presented will only follow the trend of this, ultimately tech will be utilized to make information easier to digest.
Overall, the future of medical device instructions for use is likely to be shaped by a combination of technological advances, regulatory requirements, and evolving user needs.
We hope you enjoyed our insight.