MEDICAL TRACEABILITY MAKING A


MARK


Umbilical cord scissors with laser-annealed UDI code


New regulations on unique device identifiers for medical equipment and implants are being phased in by the US Food and Drug Administration, codes that are best marked with a laser, as Rachel Berkowitz finds out


F 38 LASER SYSTEMS EUROPE ISSUE 31 • SUMMER 2016


or companies that manufacture medical devices, it has always been important to offer a means of tracking precisely which devices have been distributed to a


hospital or implanted in a patient. However, it is no longer an option to simply print and attach a label to a medical device. Te US Food and Drug Administration


(FDA) is gradually phasing in new requirements for medical device manufacturers to place unique device identifiers (UDIs) on all of their components. In 2015, the first major milestone meant that all Class III implantable, life-supporting, and life-sustaining devices displayed UDIs on


parts and packaging. Fast approaching is the September 2016 deadline, by which Class III device manufacturers are required to have a permanent mark on the device itself, if intended for multiple uses. And Class II moderate risk devices, which require the UDI, have to submit information to the Global UDI database. Tey must bear the correct marking by 2018. Part of the challenge for meeting


increasingly stringent traceability requirements is the need to identify and log parts throughout the production and marking process. Tese challenges are driving forward a new wave of integrated system laser


@lasersystemsmag | www.lasersystemseurope.com


FOBA


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56