First-of-its-Kind Study Focuses on Medical Device Safety

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.

“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 device.”

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 their patients.”

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 facilities. 

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 CenterBeverly Hospital, and Lahey Health Behavioral Services

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CONTACT: 

Daniel Marra
Lahey Health Media Relations
781-744-9796
Daniel.J.Marra@Lahey.org