HMMC Webinar, August 9, 2016 Learn How To Get Started with UDI and Why All Channel Players Have A Market Stake
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1 HMMC Webinar, August 9, 2016 Learn How To Get Started with UDI and Why All Channel Players Have A Market Stake
2 Presenters Karen Wolfe, Mayo Clinic Ellenmary Martin, Dukal Amy Kohl, HIDA Dennis Black, BD Mark Thill, MDSI Editor Repertoire, The Journal of Healthcare Contracting, First Impressions Moderated by Kevin Neuman Vice President of Marketing and Operations Innovative Healthcare Corporation Office: Phone Cell: HMMC Webinar August 9, 2016: Learn How To Get Started And Why All Channel Players Have A Market Stake
3 HMMC Webinar August 9, 2016: Learn How To Get Started And Why All Channel Players Have A Market Stake
4 HMMC Webinar August 9, 2016: Learn How To Get Started And Why All Channel Players Have A Market Stake
5 UDI: Why is it importance for Providers Karen Wolfe Systems Analyst Supply Chain Management Mayo Clinic Office: HMMC Webinar August 9, 2016: Learn How To Get Started And Why All Channel Players Have A Market Stake; Presenter Karen Wolfe, Mayo Clinic
6 CLASS I UDI Clinical Use THE NEEDS OF THE PATIENT COME FIRST Customized care Each and every patient is unique Attributes to name a few Latex safe MRI information Sterile or not, sterilization needed prior to use Product Scanning EHR Class I, what would be needed Claims form requirement HMMC Webinar August 9, 2016: Learn How To Get Started And Why All Channel Players Have A Market Stake; Presenter Karen Wolfe, Mayo Clinic
7 CLASS I - UDI Product Labeling One standard UDI per product Scanning confusion Time wasted Frustration to the point of not scanning at all HMMC Webinar August 9, 2016: Learn How To Get Started And Why All Channel Players Have A Market Stake; Presenter Karen Wolfe, Mayo Clinic
8 CLASS I UDI Supply Chain Use Provider uom for product - M-A-555 Supplier uom for product - MA-0555 EACH (1) --- There is not level STD1234 PAIR (2) EACH (1) STD1235 BOX (20) CONTAINER (10) STD1236 CASE (50) CARTON (5) sellable STD1237 Unit of Measure communication issues can be eliminated Invoice matching can occur at the standard DI level not uom and product ID Price Catalog will match easily Standard DI applied to product MA-0555 Contract updates easily matched and loaded HMMC Webinar August 9, 2016: Learn How To Get Started And Why All Channel Players Have A Market Stake; Presenter Karen Wolfe, Mayo Clinic
9 UDI and responsibility of the Labeler Ellenmary Martin Chief Strategy Office/VP of Marketing DUKAL Corporation Office: x 121 Cell: HMMC Webinar August 9, 2016: Learn How To Get Started And Why All Channel Players Have A Market Stake; Presenter Ellenmary Martin, Dukal
10 UDI and responsibility of the Labeler FDA published a ruling requiring device labelers to include a unique device identifier (UDI) on device labels and packages. A "labeler" is any person who causes a label to be applied to a device, or who causes the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label. HMMC Webinar August 9, 2016: Learn How To Get Started And Why All Channel Players Have A Market Stake; Presenter Ellenmary Martin, Dukal
11 UDI and responsibility of the Labeler A UDI is a unique numeric or alphanumeric code that may consists of one or two parts: Device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device Production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device: lot #, serial #, expiration date, date of manufacture HMMC Webinar August 9, 2016: Learn How To Get Started And Why All Channel Players Have A Market Stake; Presenter Ellenmary Martin, Dukal
12 UDI and responsibility of the Labeler All UDIs are to be issued under a system operated by an FDAaccredited issuing agency: Unique number assigned to labeler. GS1 - GTIN: Global Trade Item Number HIBCC LIC: Labeler Identification Code HMMC Webinar August 9, 2016: Learn How To Get Started And Why All Channel Players Have A Market Stake; Presenter Ellenmary Martin, Dukal
13 UDI and responsibility of the Labeler The device labelers are required to submit information to the FDAadministered Global Unique Device Identification Database (GUDID). The GUDID contains ONLY the device identifier (DI), which serves as the primary key to obtain device information in the database. Production Identifiers (PI) are not submitted to or stored in the GUDID, but the GUDID will contain production identifier flags to indicate which PI attribute(s) are on the device label. quedeviceidentification/globaludidatabasegudid/ucm htm HMMC Webinar August 9, 2016: Learn How To Get Started And Why All Channel Players Have A Market Stake; Presenter Ellenmary Martin, Dukal
14 UDI and Distribution Implications Amy Kohl Senior Manager, Government Affairs Health Industry Distributors Association Office: x 121 HMMC Webinar August 9, 2016: Learn How To Get Started And Why All Channel Players Have A Market Stake; Presenter Amy Kohl, HIDA
15 UDI and Healthcare System Objectives of the UDI Program: Establish a system to adequately identify devices through distribution and use Facilitate the rapid and accurate identification of a device Enable access to important information concerning the device Provide a standard and clear way to document device use in HER, clinical information systems, and registries HMMC Webinar August 9, 2016: Learn How To Get Started And Why All Channel Players Have A Market Stake; Presenter Amy Kohl, HIDA
16 UDI and Healthcare Distribution A supplier must be able to: Transact using GTIN/LIC referenced on Purchase Order and Invoice doc. Suppliers will send price file using GLNs and GTINs. A supplier s operations (e.g. Customer Service, etc...) must be able to recognize a GTIN when referenced. Suppliers should have the ability to transact and maintain customer accounts through the GLN. (Healthcare Transformation Group) HMMC Webinar August 9, 2016: Learn How To Get Started And Why All Channel Players Have A Market Stake; Presenter Amy Kohl, HIDA
17 What is HIDA doing? HIDA is advocating that the FDA use enforcement discretion through September 2021 to allow distributors and manufacturers to determine how the labeling of the each will be handled and become compliant beyond the Class I grandfathered inventory deadline. HMMC Webinar August 9, 2016: Learn How To Get Started And Why All Channel Players Have A Market Stake; Presenter Amy Kohl, HIDA
18 Recent Federal Guidance July 2016 Draft guidance issued July 26, 2016; Comments due Sept. 26, 2016 Describes two forms of a UDI label Easily readable plain-text (single line or multiple lines of text displayed below or near the AIDC technology form of the UDI) Automatic Identification and Data Capture (AIDC) Clarifies the content of UDI Discusses the order of the data in a UDI and UDI carrier Impact on Distributors: TBD HMMC Webinar August 9, 2016: Learn How To Get Started And Why All Channel Players Have A Market Stake; Presenter Amy Kohl, HIDA
19 UDI and Healthcare Provider use of Data Standards and Unit of Use Dennis Black Director, e-business BD HMMC Webinar August 9, 2016: Learn How To Get Started And Why All Channel Players Have A Market Stake; Presenter Dennis Black, BD
20 UDI and Healthcare Provider use of Data Standards and Unit of Use Healthcare Provider use of Data Standards - GLN for location identification - GDSN or GUDID for Item Master Maintenance - GLNs and GTINs in EDI transactions to eliminate errors - Barcode scanning at the point of care for device tracking - Use of UDI in recalls - UDI in data analytics and comparative effectiveness research Healthcare Provider requests and FDA requirements may differ! HMMC Webinar August 9, 2016: Learn How To Get Started And Why All Channel Players Have A Market Stake; Presenter Dennis Black, BD
21 UDI and Healthcare Provider use of Data Standards and Unit of Use Identifying the Unit of Use There is some confusion in the industry on how manufacturers are identifying the "each" level Questions have been raised concerning products such as - Sutures - Implants (unmatched GTIN on product/package) - Syringe Convenience Trays - Other Products An AHRMM Learning Community is focused on this topic Review Issuing Agency resources (GS1 Healthcare GTIN Guide) UDI numbering assignments should follow Issuing Agency guidelines and use logic that is apparent for the industry. HMMC Webinar August 9, 2016: Learn How To Get Started And Why All Channel Players Have A Market Stake; Presenter Dennis Black, BD
22 HMMC Webinar, August 9, 2016 Learn How To Get Started with UDI and Why All Channel Players Have A Market Stake Tell us about future HMMC webinar topics and ideas to help you! HMMCWebinars@hmmc.com
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