eIFU for medical devices: obstacles to overcome


To the[PACK]outside this week in Austin, TX, industry professionals participated in a sustainability panel, which included discussions on eIFUs (electronic user instructions).

Asked about the challenges of implementing paperless options, the panel – moderated by Jamie Pero-Parker, PhD, sustainability sector lead at RTI Innovation Advisor – focused on three main hurdles.

Regional acceptance: Samantha Smith, Director of Engineering – Product Management at Medtronic, explained that regional acceptance can be an issue. “We have a good command of North America in general. Once you get into regionality, there is a bit of a struggle to get the right people to answer the right questions for eIFUs to be in play,” she said. “Then we have the proliferation of SKUs. We don’t want to carry one SKU for a high volume product for too many different countries. to have the right IFU. So how can we come up with a hybrid model, so that we can use a limited amount of paper?”

While North America and Europe can be receptive, “once you get into the smaller regions, they have a lot of regulations and it’s hard to engage those people with understanding.” She said you have to keep asking, “Why do you think you need the paper IFU?” and keep digging with lots of “whys”. Often you find out they don’t actually need it, she noted.

Operations: Kevin Kane, director of packaging engineering at Stryker, said it was also important to consider the challenges of reverification, as some products have an IFU placed in a specific position that could affect sterilization and/or performance with packaging. Removing this IFU could pose a challenge or disrupt operations.

Regulations: Of course, everyone thinks of regulations when it comes to updating life science packaging. Lindsay Smaron, senior R&D packaging engineer at Boston Scientific, said, “On the regulatory side, in Europe they allow eIFUs on products that are implantable devices. But from an EU perspective (not country specific) they don’t really want to open up the regulation to allow it on all other devices. About five or ten years ago there was a survey where we allowed it in implants. By MedTech Europewe as an industry are pushing this back and doing a physician survey to reevaluate this [to allow eIFUs for other devices].”

Regulators may not see paper manuals as a problem because they don’t hear it from their customers, she explained. But their customers (on the political side) are different from the customers of device manufacturers (doctors). It will take effort from device manufacturers to help regulators understand that it is great that they have allowed eIFUs on implants and to push for other eIFUs to be changed.


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