The user manuals offered by the medical device product are the ones that are detrimentally in need of being useful, efficient, and easily accessible. The instructions for use (IFU) for medical devices have traditionally been written on paper. But with the development of electronic technologies, some forward-thinking businesses noticed the possibility of digitizing IFUs for medical and in vitro diagnostic (IVD) devices, and regulatory bodies granted approval for it.
There are several advantages for both device makers and end-users. When paper-based manuals are replaced with electronic Instructions for Use (eIFU). Any user of a medical equipment will tell you that paper IFU is often unsightly, difficult to see, and not user-friendly. Because of layout and font size restrictions, which result from manufacturers striving to fit as much information as they can onto the smallest booklets, this is the case. The booklets’ pages are mostly taken up with translations of the same content into several languages, which makes readers to waste time looking through multiple pages for the pertinent sections.
Layout restrictions are no longer an issue thanks to eIFU, because manufacturers now have the room they need to enhance IFU designs. Instead of striving to squeeze material into the smallest format workable, the emphasis is placed on enhancing the user experience by making the information easier to understand and allowing end users to choose their preferred language.
Users of electronic devices can print off or access digital versions of eIFU. With a version of the IFU always available online, this resolves another issue for healthcare personnel who previously had to worry about misplacing or losing hard copy records.
One reason manufacturers might embrace eIFU is the potential cost savings on paper, ink, and printing expenses, as well as the reduced environmental effect. The removal of paper instructions from packaging could cause smaller boxes, which could cause further cost savings on packaging supplies and warehousing space.
This has further helpful effects on the packaging procedure. For instance, the chance of mistakes occurring at this stage is reduced by skipping putting the appropriate IFU in the box. These kinds of mistakes usually result in pricey product recalls and the actual replacement of the paper IFU. In-process controls can confirm the contents of the package would typically limit the likelihood of these incidents, but with eIFU, none of this is necessary.
Thus, digitizing IFU enables a quicker and more affordable packing process, where the appropriate IFU may always be connected to the device. EIFU enables manufacturers to distribute instructions updates as needed. This can also deliver observable enhancements to the user experience.
Because of fewer user errors, patient safety is subsequently preserved. After all, how effectively presented and legible the material actually is will always bear how effective and understandable the advice is.
More and more medical device manufacturers will be lured to the advantages of eIFU as the pace of digital change in healthcare settings heats. The organizations that can assist them in implementing this solution while adhering to the many operational and regulatory constraints will be crucial allies in this venture.
The e-IFU is an electronic device that allows medical device manufacturers to create, store and read IFUs. This helps them improve training, reduce product returns and increase first-time pass rates.
Electronic IFUs are easier to use than paper ones because they don’t require any special software or hardware. They also have many additional features, such as.
MQTS e-IFU | Powered by Alysidia GmbH | CHE-155.445.978 | Supported by TS Quality & Engineering ISO 13485 Medical device Consulting Service