Department of Surgery. "The companies need to
know today if a stapler failed. So, if one fails
tomorrow, they can start putting the pieces
together."
The FDA says it will issue a draft guidance
for public comment later this year, which will
describe the proposed recommendations to
manufacturers of surgical staplers and staples
for internal use about information to include
on their product labeling. Dr. Schwaitzberg
sees the need for a better system of reporting
device failures.
"It's not that staplers are falling apart left and
right every day. We just have to have a will and
a commitment to a culture of safety," he says.
"And the healthcare community needs to com-
mit to having a workable, straightforward,
transparent reporting process so that we can
clearly understand whether there are devices
that need to be improved."
OSM
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