Improving Patient Safety Through More Efficient Medical Device Recalls

Imagine that you have a pacemaker. Then imagine that you find out that a certain type of pacemaker is being recalled because it is fitted with a defective component and has been determined to be unsafe. How will you know whether your pacemaker is included in the recall? How will your physician know?

In 2013, the Food and Drug Administration (FDA) issued a final rule requiring the labels on medical devices to include a “unique device identifier” (UDI). UDIs are unique numeric or alphanumeric codes that identify:

  • The specific version or model of a device
  • The lot or batch number within which a device was manufactured
  • The serial number
  • The expiration date
  • The date a specific device was manufactured and/or
  • A distinct identification code for a human cell, tissue or cellular and tissue-based product regulated as a device

According to the FDA, the UDI system benefits patients and the public in many ways, by:

  • Managing recalls more effectively
  • Addressing counterfeiting
  • Moving toward a globalized system of medical device identification
  • Allowing faster, more accurate reporting of adverse events so that people using dangerous products can be notified more quickly
  • Reducing medical errors by helping health care providers identify problem devices
  • Enhancing analysis of devices on the market by providing a standard documentation system for use in electronic health records and databases

The FDA has noted that the benefits of the UDI system will only be fully realized when manufacturers, distributors, payers, providers, patients, healthcare systems and other stakeholders adopt and use UDIs. The Senate Health, Labor, Education and Pensions (HELP) Committee recently called for changes to the health insurance claims system for medical devices after serious infections caused by contaminated duodenoscopes exceeded cost estimates. In March of 2016, two U.S. Senators (Senator Elizabeth Warren and Charles E. Grassley) called for medical devices to be linked more closely to the health insurance system. The Senators wrote a letter to agency heads at the U.S. Department of Health and Human Services, Medicare & Medicaid, and the FDA, asking that UDIs be included in health insurance claim forms. In this letter, they take issue with the fact that Medicare & Medicaid are opposing adding UDIs to claim forms due to technological challenges.


New Jersey Defective Product Lawyers Get Compensation For Victims Injured by Defective Medical Devices

If you or someone you love has been injured by a defective medical device, we can help. Our lawyers have eight decades of combined experience representing injured victims in New Jersey, and we take pride in our successful track record. We represent clients throughout New Jersey, including Monmouth County, Middlesex County, and Ocean County, including Howell, Freehold, Middletown, Shrewsbury, Wall, Keansburg, Asbury Park, Long Branch, Union Beach and Neptune. For a free consultation with one of our experienced New Jersey defective product lawyers, call us at 732-532-2011 or contact us online today.