[IP] Disetronic H-TRONplus V100
I know there has been alot of hoopla concerning Disetronic lately, but
I think alot of it is much about nothing. I've read the 8 pgae letter
from the FDA, as well as the various responses from Disetronic. I
think alot of this is to due w/ what the FDA considers adequate
recordkeeping and process controls (in their minds.) I pumped with my
HTron's for 4 years, and now the last 10 months with the D-TRONplus.
Both are excellent pumps with nary a drawback. In fact, over the
weekend I started up my H-TRONplus becasue I miss the smaller form
factor. When you're used to such a small pump, the D-Tronplus starts
to wear on you.
People should take a look see here:
"This action comes from problems with manufacturing documentation and
company procedure. European manufacturing emphasizes use of master
craftsmen who construct each pump from start to finish before
comprehensive testing is done to ensure the pump meets very high
standards. The FDA prefers a more piecemeal, add a part, then test,
approach to manufacturing. Roche, the parent company, plans to start a
manufacturing plant in the U.S. to address this need."
"Current Disetronic users will continue to receive full support for
their pumps. However, no new patients may be started on Disetronic
insulin pumps at this time. This situation is expected to last less
than 12 months and Distronic is expected to launch their small,
sophisticated, next generation pump in the U.S. at that time."
Personally, I can't wait to hear what the next generation of pumps will
look like from Disetronic!
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