Are you ready for UDI? Facts you need to know and what you should do

Do you sell or manufacture into the medical market? If so, then this article is absolutely for you. 

It may not be the best conversation starter, but Unique Device Identification (UDI) is very much a big deal right now. There's even a UDI Conference.

The history: In 2007, the Food and Drug Administration (FDA) passed legislation that all medical devices in the United States carry/be marked with a Unique Device Identification Code (I.E. UDI Code). Five years later on July 10th, 2012, FDA proposed the Unique Device Identification System Rule, leaving the comment period open until November 11th, 2012. Now that the comment period is over, FDA must issue the final UDI rules within six months. Thus, at the latest, there will be new UDI legislation implemented by May 7th, 2013.

Further, On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law; section 614 of FDASIA amends the FD&C Act in ways that require modification of the timeframe for implementation of the proposed rule's requirements as they apply to devices that are implantable, life-saving (life-supporting), or life-sustaining. I.e. Things have been bumped up.

What is a UDI? A unique device identification (UDI) is a unique numeric or alphanumeric code that must be placed/marked on each device/tool/part created by a manufacturer. The purpose of the UDI mark is to, "help reduce medical errors; allow FDA, the healthcare community, and industry to more rapidly review and organize adverse event reports; identify problems relating to a particular device (even down to a particular lot or batch, range of serial numbers, or range of manufacturing or expiration dates); and thereby allow for more rapid, effective, corrective actions that focus sharply on the specific devices that are of concern."

With all of there above, there are different time frames for placing UDI makings on Class I-III medical devices:

Class III - One year after publication of a final rule
(Examples: implantable pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators, implantables, life saving, life sustaining)
Class II - Three years after publication of a final rule
(Examples: powered wheelchairs, infusion pumps, and surgical drapes)
Class I -  Seven years after publication of a final rule
(Examples: elastic bandages, examination gloves, and hand-held surgical instruments)

There are some exemptions (Great presentation on "FDA's Unique Device Identification (UDI) System") but for the most part, if it's markable, you need to mark/label it.

Does this impact you?  If you manufacture medical products sold or implemented in medical markets, then absolutely.

Luckily, we've got you covered. Under the Gravotech umbrella, there are Gravograph and Technifor. And both have fantastic UDI marking solutions. 

Gravograph Fiber Laser Solutions:

• The Fiber100/200 - High speed; high definition; high quality. The Fiber 100/200 sits perfectly on a bench and allows for fantastic and quick annealed mark. This is a galvo laser (The laser head is stationary). 

• The LS100EX Fiber Laser - Huge marking area (610 x 305 mm), simple UI and software and perfect for a large number of items to be marked at the same time. This is a gantry laser (The laser head moves).

Technifor Fiber Laser Solutions:

• The TF410/20/30 - Incredibly fast (up to 2.5m/sec), Compact, sturdy, lightweight cast aluminum head Integrates even in the most restricted spaces, in any position and is made for intensive and heavy-duty operating. This is a galvo laser (The laser head is stationary).

• The LaserTop Work Station - Wired remote control for ease of operation, 300mm motorized Z-axis, manual U-shape door for effortless access to the marking chamber, LED light attached to chamber wall,  aiming diode Class 1 station 520mm x 580mm lab table. This is a galvo laser (The laser head is stationary).
  

Also, here's a great video of UDI marking and how it works:

So. A lot of information to digest. The take home message: If you  manufacture medical products sold or implemented in medical markets, then you need to start thinking about this. And getting your infrastructure in place.

Got more questions about fiber lasers, UDI and more? Give us a ring. We're happy to help: 800-843-7637