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Jean Sargent, FCS, CMRP, FAHRMM President, Sargent Healthcare Strategies

M ergers and Acquisitions: Before, During and After. Jean Sargent, FCS, CMRP, FAHRMM President, Sargent Healthcare Strategies. Objectives. Understand supply chain’s role in mergers and acquisitions Understand who from supply chain should be involved in the transition

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Jean Sargent, FCS, CMRP, FAHRMM President, Sargent Healthcare Strategies

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  1. Mergers and Acquisitions: Before, During and After • Jean Sargent, FCS, CMRP, FAHRMM • President, Sargent Healthcare Strategies

  2. Objectives Understand supply chain’s role in mergers and acquisitions Understand who from supply chain should be involved in the transition How do you measure success?

  3. What is Supply Chain’s Role in Mergers and Acquisitions?

  4. In the beginning….

  5. Details Who? What? Where? When?

  6. Current vs. Future Functions of Supply Chain

  7. Who are the players from Supply Chain?

  8. A Representative of Each Function

  9. How do you measure success?

  10. What is success? • Staff morale • Did the software work as planned? • Did the orders transmit? • What percentage of transactions had an issue? • How quickly was it resolved? • Did clinicians have what they needed? • Was the charge master linked correctly to the item master? • Was there an on-site support team? • Did anyone quit? • Was the plan effective? • What were the lessons learned • Key takeaways

  11. What is UDI?

  12. Background • Unique Device Identification program was Congressionally mandated in 2007 • Supported by many stakeholders, including medical device industry and American Hospital Association • Intent of the program was to create a common vocabulary for use throughout the supply chain in order to improve patient safety by facilitating: • better adverse event reporting • more efficient and effective recalls • fewer medical errors • enhanced analysis of devices on the market • a global, secure distribution chain

  13. UDI Regulation The regulation states: “gives the FDA the authority to issue regulations for the efficient enforcement of the FDA Act. By requiring a UDI to appear on the label of devices, and by establishing the GUDID, the proposed rule is designed to improve the accuracy and precision of adverse event reporting, as required by section 519(a) and (b) of the FD Act, which will enable FDA to more quickly and precisely identify device problems, such as safety and/or effectiveness concerns.”

  14. The Need for Standard IDs Only UDI compliant code on list

  15. UDI System Timeline

  16. The Unique Device Identifier (UDI) UDI = UDI-DI + UDI-PI Scanned UDI-DI links to a record in AccessGUDID 3 Issuing Agencies UDI-DI Synonyms GS1: GTIN HIBCC: UPN ICCBBA: ISBT 129 Required on the device label, packages and, in some cases, on the device itself Required Formats: Plain text and machine readable format (AIDC) SaMD - displayed in plain text in the software. www.fda.gov

  17. Scan UDI and link to UDI-DI AccessGUDID record

  18. 776,000+ Implant UDI-DIs as of 2/18/19 APIs allow IT systems to pull implant data into Electronic Health Information DEVICE_IDBRAND_NAMECOMPANY_NAMEVERSION_ MODEL_# DUNS_# MRI_SAFETY_STATLATEX GMDN_TERMS

  19. ADDING UDI-DI and UDI-PI TO EXISTING SYSTEMS = Interoperability Device Recalls LEARN Incident Reports Adverse Event Reporting DI PI DI PI Manufacturer (Labeler) DI PI UDIDs Electronic Patient Records Registries Jurisdiction Materials Management DI PI Reimbursement DI PI DI PI DI USE Healthcare System This Photo by Unknown Author is licensed under CC BY

  20. Driving UDI Adoption

  21. Office of National Coordinator for Health IT UDI part of REAL WORLD DATA collected by Health Systems Data must conform with specified vocabulary standards and code sets, as applicable.

  22. 1 Record Device Identifier Implant with UDI 2 4 2 Production Identifier 5 3 Lot Serial Expiration Date Mfr Date DIC Office of National Coordinator for Health IT 2015 Edition §170.315(a)(14) Implantable Device List Capability to Record UDI in 190+ EHR Vendors

  23. UDI Regulation and Requirements

  24. Patient Implant List – History of all recorded implant data UDI in Real World Data (EHR)

  25. Leaders win through logistics. Vision, sure. Strategy, yes. But when you go to war, you need to have both toilet paper and bullets at the right place at the right time. In other words, you must win through superior logistics. Tom Peters - Rule #3: Leadership Is Confusing As Hell, Fast Company, March 2001

  26. Thank you for attending. Please direct questions tojean@sargenthealthcarestrategies.comwww.sargenthealthcarestategies.com

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