FDA Requires Tracking Codes on Medical
Implants
from AP 20 Sep 2013, 12:19 PM
PDT
By MATTHEW PERRONE
AP Health Writer
WASHINGTON
AP Health Writer
WASHINGTON
Federal health regulators will begin
tracking millions of medical devices, from pacemakers to hip replacements, using
a new electronic system designed to protect patients by catching problematic
implants earlier.
The Food and Drug Administration published new
rules Friday that require most medical devices sold in the U.S. to
carry a unique code, identifying its make, manufacture date and lot number. The
codes will be stored in a publicly accessible database to help regulators,
doctors and companies monitor safety issues with
devices.
The tracking system has been promoted by
doctors and public safety advocates for years. Other industries, from food
processors to automakers, have used unique identification codes to track their
products through the supply chain for decades.
"The rule that came out today is a victory
for patients, hospitals and clinicians," said Josh Rising, director of Pew Charitable Trusts' medical device
initiative. "Up until now medical devices were among the only products on the
market that could not be uniquely identified. This is going to be a tremendous
victory for all of those interested in improving the performance of
devices."
Rising says doctors, hospitals and
insurers will be able to add the codes to patients' medical records, helping
them to quickly identify people who have received problematic implants and
devices.
The FDA tracking system follows years of
highly-publicized recalls involving defibrillators, artificial hips and drug
pumps, which have been plagued by design and manufacturing
flaws.
Recent recalls have included tens of
thousands of defibrillator wires made by St.
Jude Medical, due to risks they can crack and cause the heart-zapping
devices to malfunction. Johnson &
Johnson has recalled more than 100,000 artificial hips since 2010
after discovering they are likely break down early, causing pain and
inflammation.
The FDA will begin phasing in the new
system in the coming year, starting with high-risk devices like heart stents and
defibrillators. The requirement will then be expanded to moderate-risk devices
such as X-ray systems, surgical needles and power wheelchairs. Makers of those
devices will have three years to implement the tracking codes. Many low-risk
devices, such as bandages, will be exempt from the
requirements.
AdvaMed, the device industry's main
industry group, said in a statement that the rule is "a good step" toward
improving device tracking and design. However, the group added that the system
"will be costly and challenging endeavor, affecting all medical technology
manufacturers. It is imperative that it is implemented correctly the first
time."
AdvaMed represents most large medical device
manufacturers, including Medtronic
Inc., Boston Scientific
Corp. and Abbot
Laboratories.
St. Jude
Medical
Sidley Austin
LLP was the lobby firm for St. Jude
Medical, St. Jude Children's
Research Hospital, Johnson &
Johnson, Advanced Medical
Technology Association (AdvaMed),
and is the lobby firm for Bayer
HealthCare.
Note: Ray Romano is the
spokesperson for St. Jude Children's Research
Hospital, and a William Morris
Endeavor Entertainment client.
Ari Emanuel is the
co-CEO & director for William Morris
Endeavor Entertainment, and Rahm I.
Emanuel’s brother.
Rahm I. Emanuel is
Ari Emanuel’s brother, the
Chicago (IL) mayor, a member of
the Commercial Club of Chicago,
was the White House chief of staff for the Barack Obama administration.
Commercial Club of Chicago, Members Directory
Please note: This link for the members of
the Commercial Club of Chicago can no longer be
found.
R. Eden Martin is
counsel at Sidley Austin LLP, and
the president of the Commercial Club of
Chicago.
Michelle Obama was
a lawyer at Sidley Austin LLP.
Barack Obama was an
intern at Sidley Austin
LLP.
Richard M. Daley
was the Chicago (IL) mayor, a
member of the Commercial Club of
Chicago, and William M.
Daley’s brother.
William M. Daley
is Richard M. Daley’s brother, a
member of the Commercial Club of
Chicago, was the chief of staff for the Barack Obama administration, and a director
at Abbott
Laboratories.
Arthur J.
Higgins was the division president for Abbott Laboratories, and the chairman for
Bayer
HealthCare.
Arthur D. Collins
Jr. was a VP for Abbott
Laboratories, and the chairman for Medtronic Inc.
Sally Blount is a
director at Abbott Laboratories,
and a member of the Commercial Club of
Chicago.
Christopher B.
Begley was the SVP for Abbott
Laboratories, and is a member of the Commercial Club of
Chicago.
W. James Farrell
is a director at Abbott
Laboratories, and a member of the Commercial Club of
Chicago.
Jack M. Greenberg
was a director at Abbott
Laboratories, and is a member of the Commercial Club of
Chicago.
Edward M. Liddy is
a director at Abbott Laboratories,
and a member of the Commercial Club of
Chicago.
William A.
Osborn is a director at Abbott
Laboratories, and a member of the Commercial Club of
Chicago.
Samuel C. Scott
III is a director at Abbott
Laboratories, and a member of the Commercial Club of
Chicago.
Miles D. White is
the chairman & CEO for Abbott
Laboratories, and a member of the Commercial Club of
Chicago.
Robert L.
Parkinson Jr. was the president & COO for Abbott Laboratories, and is a member of the
Commercial Club of
Chicago.
William D.
Smithburg was a director at Abbott
Laboratories, and is a member of the Commercial Club of
Chicago.
Samuel C. Scott
III is a director at Abbott
Laboratories, and a member of the Commercial Club of
Chicago.
Glenn F. Tilton is
a director Abbott Laboratories,
and a member of the Commercial Club of
Chicago.
Cyrus F.
Freidheim Jr. is a member of the Commercial Club of Chicago, and an honorary
trustee at the Brookings Institution (think
tank).
Valerie B.
Jarrett is a member of the Commercial
Club of Chicago, the senior adviser for the Barack Obama administration, and her great
uncle is Vernon E. Jordan
Jr.
Vernon E.
Jordan Jr. is Valerie B. Jarrett’s great uncle, married
to Ann Dibble Jordan, a senior
counsel for Akin, Gump, Strauss, Hauer &
Feld, LLP, an honorary trustee at the Brookings Institution (think tank), a
director at the American Friends of Bilderberg (think tank), and a 2008
Bilderberg conference participant
(think tank).
Ann Dibble Jordan
is married to Vernon E. Jordan
Jr., an honorary trustee at the Brookings Institution (think tank), and was
a director at Johnson &
Johnson.
Charles O.
Prince III was a trustee at the Brookings
Institution (think tank), and is a director at Johnson &
Johnson.
Akin,
Gump, Strauss, Hauer & Feld, LLP was the lobby firm for Johnson & Johnson, Boston Scientific Corp., and is the lobby
firm for Medtronic
Inc.
John E. Sununu is an
adviser at Akin, Gump, Strauss, Hauer &
Feld, LLP, and a director at the Boston Scientific
Corp.
Nancy-Ann
DeParle was a director at the Boston
Scientific Corp., and the White House health czar & deputy chief
of staff for the Barack Obama
administration.
Warren B. Rudman
was a director at the Boston Scientific
Corp, and is an honorary trustee at the Brookings Institution (think
tank).
Robert C. Pozen is
a director at Medtronic Inc., and
a senior fellow at the Brookings Institution
(think tank).
Michael O.
Leavitt is a director at Medtronic
Inc., and was the president & vice chairman for Johnson &
Johnson.
Shirley Ann
Jackson is a director at Medtronic
Inc., and a trustee at the Brookings Institution (think
tank).
Foundation
to Promote Open Society was a funder for the Brookings Institution (think tank), the
Pew Charitable Trusts, and the
Carnegie Endowment for International Peace
(think tank).
George Soros is the
chairman for the Foundation to Promote Open
Society.
Mark B.
McClellan was a senior fellow at the Brookings Institution (think tank), and a
commissioner for the U.S. Food and Drug
Administration.
Carnegie
Endowment for International Peace (think
tank) was a funder for the Nuclear
Threat Initiative (think tank).
Margaret A.
Hamburg is a VP for the Nuclear Threat
Initiative (think tank), and the commissioner for the U.S. Food and Drug
Administration.
Donald Kennedy was
a trustee at the Carnegie Endowment for
International Peace (think tank), and a commissioner for the U.S. Food and Drug
Administration.
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