20 | EYEWORLD | SPRING 2024
ASCRS NEWS
accept e-IFU via local ophthalmologist advocacy
and partnerships with global eyecare societies.
We encourage you to visit www.EyeSustain.
org to read the position paper, learn more about
EyeSustain's mission, and to ask your surgical
facility to take the surgical pledge as a symbol
of their commitment to reducing carbon emis-
sions and waste in ophthalmology.
which surveyed American instrument and
supply manufacturers across multiple surgical
specialties about e-IFU. Importantly, while 95%
of all surveyed companies thought e-IFU are an
acceptable alternative to printed instructions,
only 30% were using electronic instructions for
most of their products.
The European Union (EU), Medical De-
vice Regulation (MDR), and the United States
Food and Drug Administration (FDA) currently
allow e-IFU, although for MDR this is limited
to certain products. Therefore, a major barrier
to implementation of this transition is approval
from regulatory agencies within several coun-
tries which still require a printed IFU.
Given the extremely high volume of devices
used in ophthalmic surgery, transitioning to
e-IFU is a straightforward way for manufactur-
ers to reduce unnecessary waste and carbon
emissions. The EyeSustain Taskforce on Elec-
tronic Instructions for Use plans to advocate for
e-IFU to regulators and countries that do not
continued from page 19
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Recommendations endorsed
by AAO, ASCRS, ESCRS:
Ophthalmic companies should move
from paper instructions for use for
materials used in cataract surgery to
electronic instructions for use as soon as
possible where able.
Global governments and regulatory
agencies in countries that do not allow
e-IFU should work to facilitate these efforts.
