Rep. Pascrell Praises Important Patient Safety Recommendation for Medical Devices
WASHINGTON, D.C. – Today, U.S. Representative Bill Pascrell, Jr. (D-NJ), a member of the House Committee on Ways and Means, applauded the standards committee ASC X-12’s recommendation to include the device identifier portion of the unique device identifier (UDI) on the health insurance claims form.
"This recommendation is a win for patients, providers, hospitals, the Food and Drug Administration, and Medicare – and it will help us continue to transform our health care system into one driven by quality, value, and most importantly, patient safety," said Rep. Pascrell. "I have been advocating for the addition of UDI to the claims form for a number of years now and this is a critical step in achieving that goal. I will now focus my attention on ensuring that this recommendation is fully implemented so we can leverage this data to improve patient outcomes and medical device safety."
Rep. Pascrell has been working with various stakeholders for years to incorporate UDIs for medical implant devices into health insurance claims. X-12 is a multi-stakeholder administrative committee that plays an important role in developing and updating the health insurance claims form.
In 2014 and 2015 alone, the FDA recalled nearly 100 medical devices. However, in many cases, the recall occurs only after the devices have been implanted in or used by hundreds or thousands of patients, resulting in extensive revision surgeries, severe pain or other medical problems, and in some cases, even death.