ing of internal tissues and organs, increased risk of cancer recurrence
and even death.
"If you look at the most commonly reported problems in the adverse
event reports (in the FDA letter), opening of the staple line or malfor-
mation of staples, misfiring or difficulty in firing, most of those could
be attributed to the wrong height of the staple," says David Renton,
MD, MPH, FACS, chief of surgery at Ohio State University East
Hospital.
Dr. Renton believes the FDA recommendations will urge health-
care providers to rethink what staplers they use. For example, if a
motor-driven or electric stapler determines that the staple car-
tridge and the anvil are too far apart — meaning the tissue is too
thick for that height of staple — it will not fire. It will stop you
from doing it and give you feedback like, "tissue too thick, choose
another cartridge."
"That may be a benefit of this — it will lead to an earlier adoption of
staplers that offer feedback," says Dr. Renton. "Stapling has been
around for a long time. It's not like we're suddenly doing it wrong. A
lot of this is that we've used the same stapler since training, so that's
what we're going to use. Surgeons are nothing if not creatures of
habit. It can be difficult for us to accept new things."
The FDA's letter also states that the agency will consider reclassify-
ing surgical staplers for internal use as Class II medical devices —
which would subject them to premarket notification and let the FDA
establish mandatory special controls to help mitigate known risks of
the device.
Safe stapler strategies
The FDA offered the following recommendations:
• Read and carefully follow the stapler manufacturer's instructions
for use.
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