| Ilena Rose 2005-07-20, 2:11 pm |
| http://today.reuters.com/News/newsA...-DEVICES-DC.XML
By Lisa Richwine
WASHINGTON (Reuters) - U.S. health officials need a better system for
tracking the safety of medical devices after they are approved for the
sale, especially ones used to treat children, a report released on
Monday said.
Dozens of medical devices are supposed to undergo further study after
approval but regulators do a poor job of monitoring the research, the
report by an Institute of Medicine (IOM) committee said.
The Food and Drug Administration could not say which trials had been
started or completed or otherwise confirm their progress, the IOM
report said. Nor could the agency identify which studies involved
children or focused on issues unique to them, such as how rapid growth
can affect a device's performance.
"Currently no overall compilation or summary of information on study
commitments or their status is available," the report said.
FDA officials said they had made improvements since the IOM collected
its information, including establishing an electronic system to
monitor the status of post-approval studies.
The IOM report "showed us a number of places ... we could improve. In
a number of places, we have already taken actions," said Susan
Gardner, director of the FDA's Office of Surveillance and Biometrics.
The IOM is an independent, nonprofit body that studies scientific
matters, mostly for government agencies. The IOM developed the medical
device report in response to a request from Congress.
The new report critiquing the FDA's device monitoring follows more
than a year of scrutiny of how the agency tracks the safety of
prescription drugs after approval.
More than 80,000 medical devices are sold in the United States, the
report said. They range from simple products such as plastic tubing
and hospital bedrails to complicated devices such as implanted heart
pacemakers and respirators for infants.
Most devices are intended for, and studied in, adults, leaving
questions about how the products perform in children over time.
Children's rapid growth, smaller size and active lifestyles can impact
longevity, effectiveness and safety of medical devices differently
than they do in adults.
The IOM said Congress should broaden the FDA's power to require
post-approval studies and make sure the agency sets up a reliable
system to track the studies. The FDA also should make results easily
accessible to the public, the report said.
"Better structured approaches to assure long-term monitoring of
devices in children with potential for serious problems in the
post-market environment - without overburdening an often fragile
industry - will take careful management but we feel it must be done,"
the report said.
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