The Food and Drug Administration (FDA) is taking steps to assure that medical devices marketed in the United States are high quality, safe and effective while also facilitating innovation and assuring that patients and providers have timely and continued access to high-quality, safe and effective devices. This is a balancing act that FDA Commissioner Dr. Scott Gottlieb and FDA Director of the Center for Devices and Radiological Health, Dr. Jeff Shuren, said in a joint statement is “essential to meeting our public health mission.”

The action builds on the agency’s April 2018 Medical Device Safety Action Plan and takes into consideration public feedback it received on the plan. The plan laid out steps the agency had taken to enhance the safety and efficacy of medical devices, as well as efforts to bring novel new devices to the market.

As part of this effort, the FDA said it had another record year of novel technologies last year – 106, to be exact – far surpassing the 40-year record set the previous year of 99 novel device approvals. The FDA also granted 112 Breakthrough Device Designation requests since the program began in 2015. Nine were approved or cleared in 2018.

These novel new devices approved by the FDA include:

  • an automated insulin dosing system for people with diabetes as young as age 7;
  • the world’s smallest heart valve for newborns;
  • the first blood test to evaluate mild traumatic brain injury;
  • the first mobile medical app to treat substance abuse disorders;
  • and technologies using artificial intelligence to detect diabetic retinopathy.

“Our effort to promote innovation is eclipsed only by our commitment to make sure that these products are safe for patients. Our success in providing patients with new treatments and diagnostics, and more options for effective health care, are not coming at the expense of the robust non-clinical and clinical science on which we rely to make our regulatory decisions,” the statement said.

Despite these best efforts, there were more than two dozen Class I medical device recalls in 2018. Class 1 recalls involve situations in which there is a reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death. Among the recalls was the Monteris Medical NeuroBlate System, which uses probes during surgical procedures to remove, thicken, solidify or destroy cells in the brain. The recall was initiated because the probes could unexpectedly overheat and damage the tip, causing CO2 cooling glass to leak into the brain.

To better ensure device safety in the coming year, the FDA said it will continue “to enhance and implement the right tools and foster an environment that lets the FDA be innovative, while prioritizing patient safety.”

FDA Statement
FDA: 2018 Medical Device Recalls

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