The UDI 360 software is a cloud hosted application providing a 360-degree view of UDI marked implant devices highlighting lifetime performance metrics. Federal regulation requires UDI labels be present on all packaging for implantable devices by September 2015. This UDI mark provides a link to data connecting the tracking, lifecycle events, and stability of the implanted device. This link is the key to giving full spectrum visibility to the FDA, the hospital, the manufacturer and the patient.
UDI 360 provides a new level of patient interface. Implant patients can monitor their devices 24/7 for recalls or issues by part number and lot number. Patients become empowered to maintain device information, continuing the trend to provide patients with more flexibility and insight into their healthcare. All device information can be passed to providers and easily integrated into the provider’s Electronic Health Record System.UDI 360 Overview
The full power of UDI 360 is provided by the integration of data held in the UDI 360 system. The UDI 360 system can be implemented in a matter of minutes, and staff can be trained in a matter of hours. UDI 360 minimally impacts users as the interfaces were designed to offload as much as possible to right person at the right moment. This greatly simplifies the task of regulatory compliance. UDI 360 allows users to understand the performance of implanted devices and enables them to make informed decisions on which devices may perform better for specific demographics.
Tracks and manages allografts, autografts, and non-tissue devices.
Meets both chain of custody requirements and non-chain of custody requirements for all implanted devices.
All devices can be tracked from entry into the system, their point of implant into a patient, and any removal or adverse reaction.
Data retrieval regarding surgically implanted devices is available at the click of a button. From the starting point of the device, the patient, or the surgeon.
Stores UDI information for the device and allows for accurate device data retrieval
Scanning of manufacturer barcodes eliminates manual data entry errors
Closes the gap on UDI capture for devices that are not directly marked but lose their packaging during sterilization processing.
Medicare insurance claims expect the UDI to be provided when they release new versions of their claims forms. Other insurance companies are sure to follow suit. UDI 360 makes this simple
UDI helps hospitals and insurance companies get Manufacturer credits when devices are recalled or faulty. Quick identification means quicker credits.
Facilitate communications between hospitals within a system, and departments within a hospital.
Interfaces are built to assist users in identifying inventory that is expiring as well as quickly identifying where inventory is located.
Facilitates communications with manufacturer representatives to ensure devices are on site at the right time.
Developed with subject matter experts in tissue and device tracking to ensure streamlined processes and data capture
Multi-tiered interface access minimizes administrative burden by offloading tasks to individuals who can collect specific data points during their piece of the process, supporting an adaptive workflow.
Provides for smooth transitions and knowledge transfer at all levels as hospital staff move in and out of positions.
Help is built into the interfaces for quick reference
Point of use recall alert for manufacturer rep delivery as well as on hand inventory alerts.
View real-time recall status on all devices implanted in patients
View and share recall management reports