Medical Device eIFUs: Hurdles to Overcome

Live from the[PACK]out: Regulations, regional acceptance, and validated packaging configurations all play a role. The challenges aren’t insurmountable but will require efforts from the packaging community.

Sustainability – No Longer Just a “Nice to Have”, Speakers from Left: Lindsay Smaron, Samantha Smith, and Kevin Kane with Moderator Jamie Pero-Parker, PhD at thePACKout.
Sustainability – No Longer Just a “Nice to Have”, Speakers from Left: Lindsay Smaron, Samantha Smith, and Kevin Kane with Moderator Jamie Pero-Parker, PhD at thePACKout.

At the[PACK]out this week in Austin, TX, industry professionals participated in a sustainability panel, which included talk of eIFUs (electronic instructions for use).

When asked about the challenges around implementing paperless options, the panel—moderated by Jamie Pero-Parker, PhD, sustainability sector lead at RTI Innovation Advisors—focused on three main hurdles.

Regional acceptance: Samantha Smith, engineering director – product stewardship at Medtronic, explained that regional acceptance can be an issue. “We have a good handle on North America, in general. Once you get out into regionality—there’s a bit of a struggle to get the right folks to answer the right questions to get eIFUs in play,” she said. “Then we have SKU proliferation. We don't want to carry a SKU for a high-volume product for too many different countries. We'll want to make sure that we're reducing our inventory so we're not carrying SKUs for several different regions just 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 may be receptive, “once you get out into the smaller regions, they have a lot of regulations and getting those folks on board with understanding” is tough. She said you have to keep asking, “Why do you think you need the paper IFU?” and keep digging with a lot of “whys.” A lot of times, you find out they don't actually need it, she noted.

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

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Regulations: Of course, regulations are on everyone’s mind when considering life science packaging updates. Lindsay Smaron, senior R&D packaging engineer at Boston Scientific, noted, “On the regulation side, in Europe they allow eIFUs on products that are implantable devices. But from an EU perspective (not country-specific), they're not really keen on opening up the regulation to allow it on all the other devices. There was a survey about five or 10 years ago where we allowed it in implantables. Through MedTech Europe, we as an industry are pushing back on it and doing a survey to doctors to reevaluate that [to allow eIFUs for other devices].”

Regulators may not see paper IFUs as an issue because they're not hearing it from their customers, she explained. But their customers (on the pollical side) are different than device manufacturers’ customers (doctors). It will take effort on the part of device manufacturers to help regulators understand that it’s great that they allowed eIFUs on implantables and to press on for change for other device eIFUs.

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