UDI Rule for Medical Devices Finally Issued
Hospital groups complain about the delay in rule-setting, the long implementation timetable for the unique device identifier rule, and a new database.
Manufacturers of the most potentially dangerous medical devices, such as pacemakers, external defibrillators, and certain implants, now have a timetable of Sept. 24, 2014 to label them for easier recall. The U.S. Food and Drug Administration's long-awaited final rule will allow adverse events to be more quickly investigated.
The label, called a unique device identifier or UDI, must be a unique number that includes the product's lot or batch number, expiration date, and manufacturing date, the rule says.
For Class II devices, such as infusion pumps, some non-invasive surgical materials, and electric wheelchairs, manufacturers have three years. The UDI deadline for Class I devices, considered the least likely to have quality issues or cause harm, such as bandages, is 2020.
The FDA also is launching the Global Unique Device Identification Database (GUDID), which the agency will administer. The database won't include specific patient identifying information, but in the rule the FDA said that it "plans to make most of the data reported under this rule available to the public."
- MU Compliance Announcement Sparks Concern, Confusion
- New G-Codes to Pay Doctors for Broad Array of Non-Face-to-Face Care
- Telehealth Improves Patient Care in ICUs
- CMS Sets 2014 Pay Rates for Hospital Outpatient and Physician Services
- States Rejecting Medicaid Expansion Forgo Billions in Federal Funds
- Douglas Hawthorne—A Chance to Do Something Big
- Hospital M&A Volume Up, Value Down in 3Q
- Scary Financial Challenges for 2014
- LifePoint Bolsters Presence in Michigan's Upper Peninsula
- Small Doesn't Mean Doomed