Unique Device Identifier (UDI)
The AHRMM LUC members submitted public comments and recommendations at the FDA's November 2020 meeting related to the need to include the UDI in the recall process. They highlighted the prototype recall database and electronic submission form, as well as survey data supporting its creation.
Building UDI into Longitudinal Data for Medical Device Evaluation (BUILD) Point of Care Capture of UDI for Implantable Devices final summary report and roadmap.
In September 2019, FDA announced its Technology Modernization Action Plan (TMAP).
The TMAP describes important near-term actions that FDA is taking to modernize use of technology—computer hardware, software, data and analytics—to advance FDA’s public health mission. The TMAP will provide a…
The Unique Device Identifier (UDI) is comprised of 2 segments:
UDI-DI (device identifier) – which identifies the make and model of the device
PI (production identifier) – which includes lot, serial number and expiration date
At a minimum, your Item Master should include:
Karen Conway, Vice President, Healthcare Value at GHX and Mike Schiller, Senior Director of Supply Chain at AHRMM discuss the value of UDI beyond regulations highlighting recall management and how manufacturers can help.
Also available as a podcast.
Hear one provider’s ongoing process of UDI implementation, from deciphering acronyms and educating interdepartmental staff, to working with vendors to redesign ERP software to meet FDA data capture and reporting regulations, all while creating procedures for others to follow.
This session explains the benefits of implementing the UDI such as immediate device status updates through collaboration with manufacturers and suppliers, increased patient care satisfaction, and how the data you collect can turn your analytics into strategic and critical business decisions. Learn…
Get the basics on what healthcare supply chain and manufacturers, together with clinical and IT departments, must do to implement the Unique Device Identifier and adverse event reporting, and the subsequent effects that will trickle-down to individual patients and the global health population.
As UDI capture and exchange becomes more prevalent across the healthcare ecosystem and as implantable device information is linked to patient outcomes there are a number of expected benefits to look at. Find out how UDI will improve patients safety and supply chain purchasing for years to come.
Hospitals need a tool to leverage the use of UDI within their health care organizations to empower the Cost, Quality, Outcomes Movement. This webinar explains the many benefits the UDI system can bring both to a hospital’s bottom line and to patients. With proper tools implemented by healthcare…