Transcript Implementation of FDASIA: Unique Device Identifiers (UDI)

Implementation of FDASIA:
Unique Device Identifiers (UDI)
Statements by Sarah Sorscher, J.D., M.P.H
Researcher, Public Citizen’s Health Research Group
Tuesday, October 28, 2014
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FDASIA
‘‘Not later than December 31, 2012, the
Secretary shall issue proposed [UDI
regulations]’’
“The Secretary . . . shall implement the final
regulations with respect to devices that are
implantable, life-saving, and life sustaining not
later than 2 years after the regulations are
finalized . . .”
Saturday, July 18, 2015
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“Finished Device” Loophole
(a) “The following types of devices are excepted.
..
(1) A finished device manufactured and labeled
prior to the compliance date established by
FDA.”
codified as § 801.30
Saturday, July 18, 2015
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Excessive Delay
• Congress requires UDIs under the Food and
Drug Administration Amendments Act: 2007
• Final implementation by the FDA: 2021
Total delay: 14 years
Saturday, July 18, 2015
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DIRECT MARK REQUIREMENT FOR
IMPLANTED DEVICES
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Feasibility
Blood vessel stent
pacemakers
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Usefulness
• Difficult to check once implanted, but
– Many problems require removal
• Already incorporated into health records, but
– medical institutions are slow to adapt
– doctors and nurses forget
– codes are mistranscribed
– patients move
– files are lost
Saturday, July 18, 2015
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