Improving patient safety and healthcare processes.
Fairfield are fully conversant with the requirements of the new FDA UDI regulations and we are currently working with a variety of organisations in this area. The FDA UDI regulations were brought in to the U.S. on 17 December 2013 and there are plans to harmonise the standards globally, including within the E.U.
A UDI is a unique number that relates to a medical device such as a hip replacement, pacemaker or prosthetic limb. The system enables the devices to be tracked and identified, with the information stored in a UDI database. Patient care, client safety and supply chain security all benefit greatly from the system, managing recalls more effectively and reducing error.
Fairfield makes UDI simple
Our coding solutions are specifically designed for medical device manufacturers and a variety of options are available. We have been delivering surgical instrument marking solutions for over 10 years and have an excellent reputation within Auto ID in the Healthcare industry. Whether it be labels, direct part marking using lasers, or other ways of identifying the device, we can provide a robust and reliable solution that will ensure you comply with the regulations and also be confident that your products are enhancing patient safety. We can also supply scanning equipment, verification equipment and a host of other consumables to ensure your implementation of UDI is simple and cost effective.
GS1 Standards have been developed to compliment the UDI regulations. Fairfield are GS1 certified and we are an Accredited Solution Provider. The standards are designed to increase interoperability and compatibility within an organisation, between organisations and across borders. Please contact us for more details.