Electronic IFU
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Dr Oliver Findl on why printed IFU makes no sense for eye surgical supplies
Ophthalmic Societies Push for Move to Electronic Instructions for Use
Three major ophthalmic societies jointly released a position paper in 2023 that urges surgical manufacturers to move to electronic instructions for use wherever possible. The paper was subsequently published in the JCRS in 2024. Every surgical supply, including IOLs, IOL cartridges, and viscoelastic syringes, is packaged with a paper instruction for use (also known as IFUs) . These pamphlets are printed in multiple languages and, in the case of an IOL, significantly increase the size and weight of the box.
“When you consider that no one reads these pamphlets and yet they accompany products used for every case, this generates an enormous amount of needless waste,” said Emily Schehlein, MD, co-chair of the EyeSustain Task Force that developed the paper.
To eliminate this unnecessary source of waste, the position paper calls for moving to QR codes that link to online electronic instructions for use as a common sense alternative. In addition to reducing paper waste and manufacturing costs, electronic instructions can be updated more easily and could be accessed by surgeons in the clinic, which is where IOL models and powers are selected.
“Although this option is permitted by the U.S. Food and Drug Administration and the EU Medical Device Regulation, we learned from manufacturers that a major problem is that many countries require a printed instructions,” said John Hovanesian, MD, the other task force co-chair.
The task force collaborated with the Medical Device Manufacturers Association to survey American instrument and supply manufactures across multiple specialties about electronic instructions. Although 95% thought they were an acceptable alternative to printed instructions, only 30% were using electronic instructions for most of their products. Inconsistent instructions for use requirements between different countries was unanimously listed as a barrier.
However, lack of customer demand and lower company prioritization were also cited as factors, according to David F. Chang, MD, chair of the EyeSustain Advisory Board. “To my knowledge, we are the first specialty to issue a multisociety position statement on electronic instructions for use for surgical products,” he said. “We hope this elevates the issue in manufacturers’ agendas and spurs collaborative efforts to align regulatory standards that encourage electronic instructions across all surgical specialties worldwide.”