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 One study found many U.S. Food and Drug Administration (FDA)-cleared
medical devices meant to be implanted in the body were not backed by
publicly available evidence that they are similar to a device
already on the market.
“Let the buyer beware before getting an implant in their body,
because there may be no evidence the implant is going to benefit
them and no study done in case it might harm them,” said Diana
Zuckerman, the study’s lead author and president of the National
Center for Health Research in Washington, D.C.
The new report is not the first time researchers have criticized the
process the FDA uses to evaluate many medical devices.
In 2011, the Institute of Medicine issued a report that the medical
device evaluation process known as 510(k) is fatally flawed and
should be replaced. The FDA, which requested the report, disagreed.
(See Reuters story of July 29, 2011 here:
http://reut.rs/qAKdUv.)
The 510(k) process allows medical devices to get to market faster if
they are “substantially equivalent” to devices already being sold.
Certain information that’s submitted to the FDA about the devices
must be made publicly available as a summary, Zuckerman and her
colleagues write in JAMA Internal Medicine.
For the new study, the researchers evaluated the publicly available
information for implantable devices cleared by the FDA through the
510(k) process between 2008 and 2012. Because those devices are
supposed to be similar to another device already on the market, the
researchers also looked at the available information for those
original devices.
Overall, they were looking for information on 50 devices cleared
between 2008 and 2012 and 1,105 previously cleared devices.
They found enough evidence to support the claim that eight (or 16
percent) of the 50 new devices were substantially equivalent to
previously cleared devices. Of those previously cleared devices,
only 31 (or about 3 percent) were supported by publicly available
evidence.
“The study relied on publicly available information, and as noted by
the authors, this information is generally limited because
manufacturers are only required by law to provide either a safety
summary or a safety statement for the public,” the FDA said in a
statement to Reuters Health.
“However, the FDA reviews a significant amount of data – far more
than what is publicly available – to determine whether or not to
clear an implantable device under a 510(k). This approach has served
the American public well by balancing the need for robust evidence
to assure safety while expeditiously bringing new technologies to
the patients who need them,” the statement continued.
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Zuckerman said the companies are not providing sufficient summaries
of its evidence, which are required by law.
“I think this is a report card going forward,” she said. “Clearly
the FDA and companies are failing to provide information to doctors
and patients so they can make reasonable judgments to affect their
lives.”
In another study in the same journal, researchers led by Ian
Reynolds at The Pew Charitable Trusts in Washington, D.C. found that
barriers may decrease the usefulness of studies completed after
medical devices are approved by the FDA.
The researchers found the FDA ordered more than 223 studies for 158
medical devices between the start of 2005 and the end of 2011. Only
one of the studies led to an action by the FDA other than a change
of the devices label.
“We encourage the agency to work together with all stakeholders to
evaluate how these studies can more effectively be used to improve
the public health,” they write.
In a commentary accompanying the new study, Elisabeth Dietrich from
the University of California, San Francisco and Maryland’s Secretary
of Health and Mental Hygiene Dr. Joshua M. Sharfstein write that the
FDA has already taken steps to address many of the issues pointed
out in the new studies.
“It is important to recognize and support this progress, even as the
FDA’s performance continues to be monitored through research and
oversight,” they write.
SOURCES: http://bit.ly/1xusqo1,
http://bit.ly/1u6xFYp,
http://bit.ly/1wRBQqJ and
http://bit.ly/Zl8KFp JAMA Internal Medicine, online September
29, 2014.
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