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The FDA's curious call
In 2010, Olympus tweaked the design of its TJF-Q180V duodenoscope, sealing
the elevator channel in an effort to reduce risk of contamination. The compa-
ny did not secure 510(k) clearance for the modification.
Olympus says it determined the modification did not require a new 510(k)
application according to the FDA's policy on already cleared devices. The FDA
subsequently requested a 510(k) application for the modified scope, according
to Olympus, which says it has a pending application for approval and contin-
ues to cooperate with the agency.
In a statement, the FDA says it "is not taking action against Olympus regard-
ing its device during our review of the application, because, based on the infor-
mation currently available, we believe that removal of the device from the mar-
ket could lead to an insufficient number of available duodenoscopes to meet the
clinical demand in the United States of approximately 500,000 procedures per
year."
That somewhat stunning admission has one infection control expert wonder-
ing about the FDA's true motives in not pulling the Olympus duodenoscope from
the market.
"Are the devices staying on the market because the infection rate is so low, or
are they staying on the market because there isn't an ample supply to perform
these procedures?" asks Lawrence F. Muscarella, PhD, president of LFM
Healthcare Solutions in Montgomeryville, Pa. "Those are 2 entirely different
rationales.
"Based on an FDA risk assessment, the infection rate is low," adds Dr.
Muscarella. "How do they know it's so low if there's no federal law that
requires hospitals to report outbreaks?" In fact, the FDA recently confirmed
that it did not receive Medical Device Reports for some duodenoscope-associ-
ated infections.
