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 Without published data, doctors and patients may not be able to make
informed decisions about whether to use the products, the authors
warn.
The FDA defines a medical device as any instrument, machine, implant
or other device used to diagnose, prevent or treat a disease or
condition. Devices include everything from heart rate monitors to
hip replacements, intrauterine devices or new surgical tools.
Lead study author Hani Marcus of the Institute of Global Health
Innovation at Imperial College, London told Reuters Health there are
two main pathways to get a medical device approved for sale in the
U.S.
One, for devices that are not similar to any product already on the
market, requires stringent evaluations for safety and effectiveness
before the FDA gives clearance for marketing.
The other, called the 510(k) pathway, is for new devices that are
similar to products currently being sold. Requirements in this
pathway are “far less stringent” and allow for “more rapid
regulatory approval,” Marcus said. In fact, clinical studies of
these devices are not usually required, he and his colleagues note
in BMJ
The research team searched for studies of new medical devices
published between 2000 and 2004 and then looked at FDA databases for
information on clearance or approval of those devices.
Of the 218 devices described in the publications, 99, or 45 percent,
ultimately received regulatory clearance or approval.
In four of every five cases, those devices were approved via the
faster 510(k) pathway.
Of the 99 devices that made it to market, 43, or 43 percent, were
cleared or approved before the studies had been published.
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“If high quality studies of medical devices are not done and
published, it is hard for clinicians to make well informed decisions
on their clinical use, and to know what patients, if any, would
benefit and to know the risks of the devices,” said Rita Redberg, a
professor of medicine at the Philip R. Lee Institute for Health
Policy Studies at the University of California, San Francisco, by
email.
Redberg, who has studied the FDA’s process of approving high-risk
devices, told Reuters Health, “When we looked at high-risk
cardiovascular devices, we found that less than half (49 percent)
had publications to support their safety and effectiveness.”
The FDA defines a high-risk device as one that “supports or sustains
human life, is of substantial importance in preventing impairment of
human health, or presents a potential, unreasonable risk of illness
or injury.”
Even for the high-risk devices that were included in the current
study, the research often consisted of low quality, small studies,
noted Redberg, who was not involved in the new paper.
Marcus noted that while it is important to make sure new devices are
safe and effective, it the approval process becomes too difficult,
people might be deprived of important new medical developments.
“A careful balance needs to be struck,” he said.
SOURCE: bit.ly/1O6N6g9 BMJ, online May 20, 2016.
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