European Medical Device Regulation (EU MDR) will require medical device manufacturers to create electronic instructions for use (eIFUs). To meet this requirement, it’s common for manufacturers to convert their IFU to a pdf and upload it to a website. But this practice oversimplifies the eIFU and overlooks it as a rich source of data and information—not just for EU MDR, but also FDA regulatory compliance, and more.
The spirit of the eIFU language of EU MDR—set to go into effect in May 2020—is to provide transparency to all who interact with the device—from the manufacturer’s C-suite and economic operators to implanting surgeons and patients. While it’s true that converting a paper IFU booklet into a pdf and making it available on a website does comply with regulations, taking that bare minimum approach means we are missing opportunities to bridge the disconnect between the technology employed by life-saving medical devices and the technology we use to support those devices.
Static Documents Are the Status Quo
Take a common situation in cardiac catheterization labs—one of the most advanced laboratories in a hospital—for example. IFU booklets are not allowed in the operating theater. If a question about the device comes up during surgery, someone must physically leave the room, find the IFU, search the IFU for the desired information, and scrub back in. To circumvent this inefficiency, some hospitals have staff manually scan the paper IFU into their internal systems to create an electronic format. While this may work on a case-by-case basis and if the IFU is current, it’s not a scalable solution for the healthcare industry.
Attend the MedTech Intelligence EU MDR series of workshops in-person or virtuallyThe technological disconnect occurs at other places in the supply chain, too. For example, when an economic operator tries to access storage and material handling instructions. The information is in the IFU, but without standardization of labeling, the location and language are not the same across manufacturers and devices. To access that information immediately, an economic operator must either call the manufacturer or dig up and comb through the IFU. It can be—and is—done, but is there a better way to both comply with EU MDR edict for eIFU and maximize user-friendliness and transparency?
Searchability: A Better Way?
It won’t necessarily take a new process or expensive new technology. The information is already required to be in the eIFU, but we need to find ways to make the eIFU more searchable. More searchable means moving away from an uploaded pdf and toward a dynamic document whose content is traceable and viewable across many types of devices and in multiple formats (e.g., text, graphic, and video).
In general, a more searchable eIFU can translate into several benefits for all device stakeholders:
- Access from multiple devices and locations (e.g., the surgical theater)
- Access in multiple formats (e.g., troubleshooting videos for patients)
- Faster access to device information and updates
- Real-time access to recall information
- Searchability and traceability of device information across data sources within an organization
- Easier translation of eIFUs into multiple languages
- Confidence that the information contained therein is accessible and traceable by all stakeholders
Ways to Improve Searchability
Improved searchability can be achieved by a tweak as simple as using an xml format instead of pdf format. XML (extensible markup language) is code-based, which makes it inherently more flexible than hard-coded pdf. Think of xml like e-mail and pdf like a physical letter. Both will provide the reader with the information they need, but email offers more flexibility to search, read on the go, view the information on different devices, and share. Because of its inherent flexibility, xml is easier to scrape or crawl for information—making it easier and faster to search. It’s also easier to render in different formats and is responsive, meaning the layout and content responds or adapts based on the size of screen it’s presented on (mobile versus desktop), making for a better user experience.
Another approach is to tag eIFUs with metadata—data about data—to add another level of information and traceability to the eIFU contents. Using metadata tags can transform the eIFU from a static document to the go-to source of information when manufacturers need to compile information to meet or update general EU MDR (or other regulatory) requirements, to submit engineering change requests if new contraindications arise, or to more quickly trace and mitigate supply chain issues and recall events.
Manufacturers can get more mileage from their eIFUs by transforming them from a scanned pdf of the paper IFU to a dynamic and searchable source of information that can be consumed by multiple users, across multiple devices, and in multiple formats. We can take advantage of the opportunity to use supporting technology—in the form of eIFUs—to advance, not impede, healthcare and give all stakeholders more confidence and clarity in medical devices.