Burlington, MA (January 25, 2016) – A recently released study, for the first time, takes aim at the
safety of medical devices. This groundbreaking research looks at comparing
medical devices to determine if they are as effective as they were when the
device was first released on the market.
Frederic Resnic, MD, chairman of the department
of cardiovascular medicine at Lahey Hospital & Medical Center, along with his
Lahey research team hopes to shed light on medical device safety through a new
type of research rigorously comparing the safety of newly approved medical
devices with similar devices already in use. The FDA-backed study, which was
completed with collaborators at Vanderbilt University, was published in The New England Journal of Medicine on Jan.
24. It is the first study to use automated
clinical data computing tools to compare the safety and performance of approved
“Medical devices are frequently approved by the
FDA on the basis of small studies that cannot really assure their safety,
therefore we need to periodically review these devices to make sure they are
performing in the manner that we expect,” Dr. Resnic said. “Is the device still
doing what it’s supposed to be doing? Is it still the safest or best product on
the market? These are questions that we currently don’t often have answers to.”
For medical device safety surveillance, the FDA
currently relies on reports of adverse patient events from health care facilities,
health care professionals, patients and manufacturers, on a case-by-case basis.
According to Dr. Resnic, once a device is
approved, it is very uncommon for the FDA to look at it again unless enough
patients and doctors file a complaint. And even then, less than 0.2 percent of
medical device problems are reported to the FDA.
This first-of-its-kind study is a comparative
information study focused on safety. This
study developed and used a computerized safety surveillance system to analyze
clinical data from over 1,800 hospitals and 1.2 million heart procedures. Looking at a common device used in angioplasty
procedures that was approved more than a decade ago, and still used in 70,000
cases a year, Dr. Resnic discovered that 1.2 percent of patients had a serious
complication. Comparatively, similar devices that are used in the same heart procedure
reported that only 0.7 percent of patients had a serious complication.
The results of this one study and this one device
is evidence to Dr. Resnic that more research needs to be conducted on medical
devices in general.
“This study demonstrates that a comparative safety
study can and should be done,” Dr. Resnic said. “Doctors, patients and medical
device companies need to know what happens to these devices that are widely
used once they’re approved by the FDA.”
But Dr. Resnic wants to be clear – this or any similar
study on medical devices doesn’t mean they’re not safe, but instead, that there
are alternatives. In the device Dr. Resnic and his team inspected, patients who
were older, diabetic or were women had higher complication rates.
“We don’t want device manufacturers to stop
innovating or for doctors to stop using the devices,” Dr. Resnic said. “Instead,
device manufacturers should use this information to continuously improve their
The goal of every provider and every medical
device is patient safety, according to Dr. Resnic and that’s where this study
can prove valuable.
“This study demonstrates that carefully
monitoring real clinical data is essential for providers and regulators,” said
Dr. Resnic. “This will allow doctors to make better informed decisions for
About Lahey Health
Lahey Health is what's next in health care,
providing a full continuum of integrated health services close to where you
live or work. It is comprised of nationally recognized, award-winning
hospitals—including an academic hospital and medical center, and community
hospitals—primary care providers, specialist physicians, behavioral health
services, post-acute programs such as home health services, skilled nursing and
rehabilitation facilities, and senior care resources located throughout
northeastern Massachusetts and southern New Hampshire.
Lahey Health offers nearly 1,400 locally based physicians providing clinical
excellence and an exceptional patient experience in adult and pediatric primary
care and every medical specialty, including kidney and liver transplantation;
cancer, cardiovascular and orthopedic medical and surgical care; local
emergency and trauma care; urological surgery; chronic disease prevention and
health management; and pediatric emergency, newborn and inpatient care provided
in collaboration with Boston Children's Hospital physicians.
Lahey Health includes Lahey Hospital & Medical Center—a teaching hospital
of Tufts University School of Medicine—and Lahey Clinic physician group with
practices in Burlington, Peabody and other locations throughout northeastern
Massachusetts and southern New Hampshire; Beverly Hospital; Addison Gilbert
Hospital in Gloucester, Mass.; Winchester Hospital; Lahey Health Senior Care
and Lahey Health Behavioral Services as well as more than 30 primary care
physician practices and multiple outpatient and satellite specialty care
Together, we are making innovative, integrated healthcare more personal and
more accessible. For more information, visit LaheyHealth.org and its member websites Lahey Hospital & Medical Center, Beverly Hospital, and Lahey Health Behavioral Services.
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Lahey Health Media Relations