1 / 0

UDI: Some Implementation Challenges

UDI: Some Implementation Challenges. IMDMC 2013 Annual Conference 2013-11-07 Peter Tomicki Zimmer Inc. Warsaw, IN. UDI: An Implementation Overview. Aggregation (Packaging and Kitting). Production Identification. Labeling (Barcode). Direct Part Marking (Barcode). Product Information

jubal
Download Presentation

UDI: Some Implementation Challenges

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. UDI: Some Implementation Challenges IMDMC 2013 Annual Conference 2013-11-07 Peter Tomicki Zimmer Inc. Warsaw, IN
  2. UDI: An Implementation Overview Aggregation (Packaging and Kitting) Production Identification Labeling (Barcode) Direct Part Marking (Barcode) Product Information Internal Database External Databases (Regulatory and Customer) Database Database Database US GUDID
  3. Kits Different definitions of “kit” Industry definitions User definitions Regulatory definitions Standards definitions Different “actors” or “kitters” (aka “labelers”) who perform the act of kitting Control, rules and compliance Responsibilities History or “legacy” approaches and systems Technologies IT systems Marking and labeling Kits that are sold and kits that are not sold
  4. Existing Inventory Medical devices manufactured after each compliance date must comply to UDI… what about medical devices manufactured before each compliance date? Regulatory definition and understanding of when UDI applies to medical devices in the supply chain Medical devices follow many business models between manufacture and use: Warehoused medical devices Consigned medical devices Medical devices offered for sale, but not yet sold, between warehouse and use Medical devices that reenter the supply chain at different points Medical devices with long shelf lives, either lengthy expiration dates or no expiration dates
  5. Manufacturer’s Suppliers and 3rd Party Products Determining who is responsible for UDI requirements (aka “labeler”) upstream from the manufacturer in the supply chain rather than just downstream Suppliers who supply medical devices and are responsible for the regulatory files Suppliers who supply medical devices and manufacturers are responsible for the regulatory files Suppliers who supply unfinished medical devices and manufacturers finish the medical device and are responsible for the regulatory files Determining the capabilities of suppliers to satisfy UDI requirements Impact on a manufacturer’s UDI implementation plan if they decide to assume the “labeler” role for medical devices that originate from suppliers who cannot satisfy UDI requirements Impact on medical device supplier base
  6. Thank you Peter Tomicki Director, Global Standards Zimmer Inc. peter.tomicki@zimmer.com
More Related