UDI Benefits - UDI Conference 2021€¦ · 04/04/2016  · UDI Benefits. April 19, 2016. Nancy LeMaster, BJC HealthCare. Dave Reed, Cook Medical. Slide 2. UDI vs. GS1 Standards. ...

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UDI BenefitsApril 19, 2016

Nancy LeMaster, BJC HealthCareDave Reed, Cook Medical

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UDI vs. GS1 Standards

DI + PI = UDI

GTIN + AI = UDI

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Let’s solve the problem together

Manufacturer Distributor Hospital Patient

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Improved Patient Safety• Identifies: Right product, right

patient, right time

• Is scanned at the bedside

• Helps prevent medication errors

• Combats counterfeit products

• Facilitates recalls

Image source: http://www.gs1eg.org/Sectors-Healthcare-100.htm

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Electronic Transaction sets: • No Human

Intervention• Purchase Order• PO Confirmation• Invoice• Payment

Accuracy:• Correct Product• Correct Location • Correct Quantity• Correct Price

Improved Operational Efficiency

Timeliness:• Delivered On Time• Inventory Visibility• Purchase History

Visibility

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Value creation for allSupplier

• Reduced packaging cost• Reduced shipping cost• Improved sales rep efficiencies• End-to-end visibility to inventory

deployment• Enhanced Demand Planning• Reduced consigned stock levels

Provider• Reduced acquisition cost• Proactive supply management• Reduced solid waste• Improved inventory management• Improved charge capture & revenue• Improved clinical satisfaction

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Summary

Trust Transparency Partnership

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Realizing the Value of UDI

Managing the ChangeA look at how suppliers and providers can manage

product changes in the supply chain using standards

April 19, 2016

David W Brooks, Medtronic

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Key Questions?How does a product change at a supplier?

What happens to standards when changes occur?

Do providers know to handle these changes?

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Product StructureSeveral layers of identification may exist in the hierarchy

What might be used?• Product Family• Item Number• Model or Version• Device Identifiers (DI) / Device Package• Revisions• Product Identifiers (PI)

Documents and Records• Design History File (DHF)

• Device Master Record (DMR)

• Device History Record (DHR)

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Why Might DI or GTIN Change?U

DI a

nd G

UD

ID

Issuing agencyDevice countBrandVersion or ModelKit, Combination ProductFor single useLatexMRISterility G

S1

Sta

ndar

ds

Pre-defined characteristicsSignificant changesHierarchyOrganizationalLanguage (primary)Net contentKitConfigurationCE markMajor software

Man

ufac

ture

rs Materials

Manufacturing processesNew languagesAdditional marketsPhase-in/outInventory segregationFacility transferCountry of originCountry registrations Distribution controlsAnd many more…

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Interchangeability• Differentiate between “internal vs. external” interchangeability

Item Number and/or Device Identifier (GTIN) changes signal to the provider something has changed!

• Ensure compliance with regulations and conformance to standards

• Incorporate identified product structure in company policies and SOPs

• Align system capabilities and business processes

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Standards in Supply ChainManufacturing

•Catheter•8207

Distributor

•Catheter•CL-8207

Provider

•Catheter•2082079

Patient Use

•Catheter•9001232

Prior to Standards

With Standards AdoptionManufacturing

•Catheter•1088452134547

Distributor

•Catheter•1088452134547

Provider

•Catheter•1088452134547

Patient Use

•Catheter•1088452134547

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How to Work TogetherUnderstand the rules for changes, and communicate!

What is the provider expecting, and what is the capacity for change management within provider systems?

Ensure availability of product information between supplier and provider organizations (i.e. spreadsheets, direct feeds, data pool, GDSN, GUDID)

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April 19, 2016

Chip McIntosh, BIDMC Lana Makhanik, VUEMED

Implementing UDI with UHF-RFID Technology

- BIDMC Implementation of VueTrack -

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Brief Overview of Beth Israel Deaconess Medical Center

– 672 licensed beds– 50,000 discharges, 5,000 births and 700,000

ambulatory visits per year– 3 owned community hospitals– 3 clinical affiliated community hospitals

BIDMC is an academic medical center affiliated with Harvard Medical School and located in Boston, Massachusetts

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Initiative at BIDMC : Implementing VUEMED’s Products for Supply Chain Optimization

BIDMC has implemented a standardized process for real-time tracking of medical supplies in the Cath Lab, EP Lab, GI and Hybrid OR areas. The purpose of this initiative was to:

Optimize inventory management Eliminate expired products Mitigate overstocking of the same supplies kept in multiple locations Reduce cost and increase revenue Be prepared for potential regulatory mandate of UDI

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• It has synergistic benefits when combined with LEAN methodologies • Interface capabilities with PeopleSoft and Mac/Cardio Lab• No addition of cabinetry or change in supply location• Incorporates antenna technology (hands free) for continuous tracking,

intelligent analysis and streamlined reports • Provides a virtual centralized inventory with continuous tracking• Economical and easy for manufacturers to adopt

Why Choose RF Inventory Management?

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Project Phases

VueTrackImplemented in GI

Manufacturers Initiated Tagging

Process

Installation of VueTrack-RF

Hardware

Implemented VueTrack-RF Scanning in

Procedure Rooms

GI Cardiology and Electrophysiology

Completed in December 2014 Started in January 2015 Completed in

February 2016

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Actual Benefits Reduced supply overstock and expired products Reduced product SKU number Increased revenue by decreasing waste and capturing missed charges Automated charge procedure Improved accuracy of clinical documentation Improved patient care through effective recall and expiration management

Inventory value 4%Expiring inventory < 0.6%

Case volume 15%Cost per case 17%

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Project Result Example: Before and After Look

Ceiling Mounted Antennas

Tagging Station

Shelf or wall-mounted antennas, including inside cabinetry.

More space in supply rooms!

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Project Result Example: Captured Missed Charges

MonthTotal Cost ($) of Charges

Missed Number of Cases

January, 2016 5,292.10$ 446

February, 2016 5,492.55$ 447

Annualized missed $ based on purchase price 64,706.63$ 5358

Annualized missed $ based on billing charge 129,413.27$ 5358

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Lessons Learned: Implementing an RFID Inventory Management System

Need dedicated inventory management processes and personnel in place first Placing the hardware related to the RFID solution needs thoughtful planning and resources

during the implementation phase Champions or value analysis staff to analyze the data to fully capture all the potential

benefits of the system Need our industry partners continue to label the products prior to entry in the medical

facility Take the UDI data it provides and move it into our MMIS systems

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Continuous and automatic tracking of supply movements and locations, and reporting on availability, usage and reorder needs

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UDI data is resident on the tag itselfusing GS1 EPC GEN2 UHF encoding standards

At manufacturers: UDI data is encoded onto the RFID tag but no human readable text printed

At hospital: 2D barcode and human readable information printed on the RFID tag

Device Identifier Production Identifier Data

as applicable: Lot Number Batch Number Serial Number Expiration Date Manufacture Date HCT/P ID

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VueTrack-UDI bridges system gaps and captures comprehensive and accurate data

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Manufacturers Choosing RFID Solutions

Leading device manufacturers are currently tagging items destined for BIDMC at their distribution centers

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Why Is This Important?

No more wasting time locating products and assets No more stock-outs; ensures smart ordering Find expiring and recalled products instantly Avoid safety risks to patients Eliminate errors in EHR and billing Eliminate excess and obsolete inventory (SLOBS) No more waste through expirations The reimbursement environment is changing

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Benefits Provided by VueTrack-UDI

1. UDI data (manufacturer name, batch, serial number and expiration date) are encoded onto the RFID tag; can be read by any UHF standards-compliant reader or device.

2. Medical devices are given a standards-based identity that can be accessed and used throughout its lifecycle.

3. Manufacturers and hospitals can immediately engage UDI data to track medical devices from deep within the manufacturer’s supply chain all the way to the Point of Care.

4. With the UDI data, devices can be tracked to hospitals’ clinical, billing and ERP systems, as well as to EHR.

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Thank you!

Chip McIntosh, PhD, CCRN, ACNP, BCDirector of Contracting, Purchasing and Clinical Quality Value AnalysisBeth Israel Deaconess Medical [email protected]

Lana MakhanikCOOVUEMED, Inc.(617) [email protected]

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VA Experience with UDITracker

(4/19/2016)

Presented By: Steven ZoglmanGeorge E Wahlan VA Medical Center

Introduction By: Peter CasadyChampion Healthcare Technologies

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CHAMPION - EXPERTS IN MEDICAL DEVICE MANAGEMENT

• Entrusted for device and implant tracking by hundreds of hospitals, IDNs and GPOs nationwide since 2006

• Singular focus on providing simple to use and easy to implement Medical Device Management Systems (MDMS)

• Unique Device Identification (UDI) ready solutions• Goal - free up nurses to spend more time with patients by delivering

automated and streamlined processes• Relieve nurses from compliance and inventory management burdens

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George E. Wahlen VA Medical Center

• 121 Bed Facility on 100 acers with 22 Buildings and 1 Research Facility with 2,476 employees

• Serving a population of Veterans over 55,000 that covers 125,000 square miles• Supports 11 outlining primary and specialty medical clinics• 2015 Medical Center saw over 636 thousand outpatient visits &over 4800 inpatient stays• Associated with the University of Utah Medical Center

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Into the Mouth of Madness• Pre Medical Device Management System (MDMS)

• Each department tracking only human biological implants (no tracking of non-biological implants) using Excel, Paper Log Books, Notebooks. No communication outside clinics. Recalls taking 2 to 3 weeks to complete.

• Joint Commission inspection; current tracking system is noted as ineffective.

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Coming Out of the Storm• September 2013 MDMS - UDITracker in place

• Logistics assigned to ensure hospital passes next Joint Commission on implant tracking.

• All Clinics brought under single control using MDMS and bar code scanning in each area.

• 1st Recall using MDMS took less than 20 min to complete.• 2014 MDMS well established; Bovine, Porcine being tracked for the first

time, late 2015 non-biologicals start being tracked in Invasive Radiology, Dental, Audiology (Limited).

• 2015 Automatic temperature monitoring.

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After the Flood• Current Progress

• 2016 Cardiology implants being tracked including pacemakers and warranty information.

• 2016 Passed Joint Commission

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GIP(MMIS)• Updates inventory

levels automatically from MDMS

• Sends notifications for reorder

MDMS• Takes data fields from

EHR and auto populates

• Sends Implant Usage data to MMIS to update

Creating a Veteran Centered Care System

Eliminate redundant data entry Eliminates human error factor Automated Joint Commission compliance Safety & quality oversight on rep delivered items

Cost reduction due to more informed purchasing Optimize inventory levels

Data capture &contract compliance of rep delivered items Automated reorder alerts

CPRS (EHR)

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Points for Success• Executive support

• Comes out with strong support to all Directors, Service Chiefs, and Clinical staff

• Yearly program review (Feedback from the trenches) • Departmental collaboration

• Find out what’s working and what is not, sharing ideas• Clinical and non clinical departments working together

• Training• New employees• Yearly training• Enhancements and updates

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Recommendations1. Universal Bar Code Labels

• Global Trade Item Number (GTIN) all implantable products• Consistent barcode scanning

2. Items Clearly Marked as Implant Device• Human tissue is clearly marked but Bovine or Porcine and other

implant devices are not.3. Questions?

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Shipping Container Labeling

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