Medical Equipment Manufacturing Mar 25, 2014

New FDA Labeling Requirements Make Barcoding a Must for Medical Device Manufacturers

The FDA has recently issued a new rule for medical device manufacturing that requires many medical devices to include what is known as a Unique Device Identifier. The UDI is a barcoded number that helps the FDA identify product problems faster by improving the reporting found in medical device adverse event reports.
The new labeling requirements are geared at making strides to protect patients from medical equipment and devices that do not perform properly. The new medical device adverse event reports will help identify problems and improve targeting for any necessary medical product recalls. The UDI will be stored in a Global Unique Device Identifier database which will be made available to the public so that anyone can look up information about the medical devices they use.
At ALTEK, we have incorporated serial barcoding and manufacturing automation into many of our products for medical and other industries. In addition to promoting patient safety, automation during manufacturing also creates more efficient production while improving production accuracy and repeatability.
ALTEK’s custom automation can offer many benefits for medical OEMs and other high-tech industries like Aerospace and Industrial manufacturing. Click to learn more about ALTEK’s medical device manufacturing and customized automation capabilities.