Citing nearly $1 billion in potential savings associated with a single medical device, researchers at the University of Michigan say the FDA needs to make use of existing administrative data to improve medical device safety.
Furthermore, requiring all medical devices to have a unique identifier would allow regulators to connect valuable claims data with each device to spot potential problems sooner.
In a viewpoint published in JAMA, two researchers with the Center for Healthcare Outcomes and Policy at the University of Michigan highlighted data points associated with a gastric band device commonly known as Lap-Band, which was approved by the FDA in 2001.
