Going to MD&M East 2017? Drop by Booth 370 and learn about FDA UDI marking and how we can help you stay compliant!
Where: Javits Center, New York City, NY
What we will bring: H10 w/ LW1, XF500M, IS400
Medical device tracking is a critical element to improving our healthcare industry. Unfortunately, tragic events happen which spurred the onset of these rules. The maker of a surgical clip called the “Hem-o-lok” issued an urgent recall notice warning doctors to stop using the fasteners on living kidney donors. It said the clips could dislodge in their bodies, with "serious, even life-threatening consequences.” Not everyone got the message. A surgeon in Brooklyn used one of the clips to tie off Michael Kings’ renal artery when he donated a kidney to his ailing wife. Twelve hours later, the clip popped off. Mr. King bled to death internally in the hospital as his wife lay helplessly nearby. He was 29 (Credit: CBS News, see full article).
If today’s medical traceability and identification had been implemented, this error never would have happened. This system will adequately identify medical devices through their distribution and use. UDI implementation will improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.
In September 2013, the FDA released a rule which established a common, worldwide system for product identification applied to all medical devices placed on the US market.
The persons physically labeling the medical device must submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID). In collaboration with the National Library of Medicine, the FDA has created a portal, called AccessGUDID, to make device identification information in the GUDID available for everyone--including patients, caregivers, healthcare providers, hospitals, and industry. You can use AccessGUDID to search for specific medical devices or download all the GUDID data at once, and you do not need an account to use AccessGUDID. The device information on this website is the most recent submitted to the Food and Drug Administration (FDA) and is updated daily.
Here at Gravotech, we manufacture two very popular types of machines for direct part marking that comply with the UDI standards. Laser & Dot-Peen.
"Laser" is short for Light Amplification by Stimulated Emission of Radiation. That may sound a bit scary, but these lasers can be fully contained and pose no risk to the operator. A unique feature is that the laser light beam is the only part of the machine that touches the device. When the laser finishes, it leaves behind a high definition, permanent mark.
Dot-peen marking is when a stylus head rapidly impacts the surface of the device. This leaves a small, round, permanent indentation.
Stop by our booth (#370) at MD&M East and see our fast, reliable and user-friendly engraving and marking machines. We are here to make FDA UDI compliance easy!
Useful links for attendees: