The 11th Annual Orthopaedic Manufacturing & Technology Exposition and Conference

UDI: Uncover and Overcome

Challenges Facing Orthopaedics

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Presentation Outline

• Introductions• Current challenges• SMI Initiative• Surgical Simulation• Q and A

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© 2014 Global Healthcare Exchange, LLC. All rights reserved. GHX proprietary information. Do not copy or distribute.

Karen Conway works internationally with standards bodies, government, analysts, academic researchers, trade associations, hospitals, healthcare systems and suppliers to optimize clinical and business performance through supply chain excellence.  Conway’s work related to UDI is focused on how manufacturers and providers can realize value beyond compliance, including real world data on product performance, increased supply chain efficiencies, and the ability to sell and source products that improve both the cost and quality of patient care. 

Karen Conway, CMRPExecutive Director, Industry Relations , GHX

IntroductionsIntroductions

SMI’s Mission: To shape the future of the healthcare supply chain

• Not for profit• All executive

level members• All tools and

resources are free at

www.smisupplychain.com

Provider Partners

Adventist Health SystemAdvocate Health CareAscension Health AllianceAvera HealthBayCare Health SystemBaylor Scott & White Health ServicesBeth Israel Deaconess Medical CenterBJC HealthCareBoston Medical Center Catholic Health InitiativesCentura HealthCHE Trinity HealthChildren's Hospital of PhiladelphiaCHRISTUS HealthCleveland ClinicCook Children's Health Care SystemDenver Health and Hospital AuthorityDuke University Health SystemEssentia Health

Provider Partners

Fairview Health ServicesFletcher Allen Health CareFMOL Health SystemGeisinger Health SystemGreenville Hospital SystemGroup Health CooperativeHCA / ParallonHospital for Special SurgeryHospital Sisters Health SystemInova Health SystemIntermountain HealthcareJohns Hopkins Health SystemKaiser PermanenteKettering Health NetworkLahey HealthLeeSarLHP Hospital GroupLifespanLoma Linda University Medical Center

Provider Partners

Mayo ClinicMercy / ROiMethodist Hospital System, TheMultiCare Health SystemNorth Shore Long Island Jewish Health SystemNorthwestern Memorial HealthCareNovant HealthNYU Langone Medical CenterOchsner Health SystemOhio State University Medical Center Orlando HealthOSF Healthcare SystemParkland Health & Hospital SystemParkview HealthPartners HealthCarePremier HealthPresbyterian Healthcare Services

Provider Partners

ProMedica Health SystemProvidence Health & ServicesRoper St. Francis HealthcareSanford HealthScottsdale HealthcareSentara HealthcareSSM HealthSt. Luke's Health SystemTexas Health ResourcesThomas Jefferson University HospitalsUAB Health SystemUnityPoint HealthUniversal Health ServicesUPMCVirginia Mason Medical CenterWheaton Franciscan HealthcareYale New Haven Health System

Industry Partners

3M Health CareAbbott LaboratoriesAcelityAesculapAmerican Contract SystemsAramarkBaxter Healthcare CorporationBecton, Dickinson and Company (BD)Boston Scientific CorporationC.R. Bard, Inc.Cardinal HealthCare Line Industries, Inc.CareFusionThe Claflin CompanyColoplast Corporation

Industry Partners

Cook Medical IncorporatedCovidienDePuy SynthesEcolabExcelsior Medical CorporationGeorgia-Pacific CorporationGlobal Healthcare Exchange (GHX)Halyard Health (prev. Kimberly-Clark)Henry Schein, Inc.Hill-Rom Company, Inc.Infor (previously Lawson)Intralign HealthJohnson & Johnson Health Care Systems, Inc.KARL STORZ Endoscopy-AmericaManagement Health Solutions

Industry Partners

McKesson Healthcare CorporationMedical Action Industries, Inc.Medline Industries, Inc.MedSpeedMolnlycke Health CareOmnicell, Inc.Owens & Minor Inc.PAR Excellence Systems, Inc.RoundTable Healthcare PartnersSage Products, Inc.Salter LabsSeneca Medical, Inc.

Industry Partners

SiemensSmith & NephewSmiths MedicalSodexoStaplesSterilMed, Inc.STERIS CorporationStryker CorporationTECSYSThermo Fisher Scientific - Fisher HealthCare DivisionVUEMEDW.L. Gore & Associates, Inc.

© 2014 Global Healthcare Exchange, LLC. All rights reserved. GHX proprietary information. Do not copy or distribute.

UDI: What?UDI: What?

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A system requiring the labels of medical devices to each bear a unique identifier [to] identify the devices through

distribution and use.

Three-Part Compliance Process1. Assign a UDI compliant code to each product at each

unit of measure, e.g. GTIN, HIBC-LIC, ISBT-1282. Label the product in human and machine readable

manner (Device Identifier + Production Identifier*, e.g., lot number, expiration date, donor ID)

3. Provide additional data attributes to FDA Global UDI Database (GUDID)- the “Good ID”

* For most products

© 2014 Global Healthcare Exchange, LLC. All rights reserved. GHX proprietary information. Do not copy or distribute.

Device Identifier (GTIN) Production Identifier

UDI Compliant Label: GTIN as a Linear Barcode

UDI:  When?Risk-based Compliance Deadlines

September 24, 2014 - Class III devices/those licensed under PHS Act

September 24, 2015 - “…devices that are implantable, life-saving, and life sustaining” (FDASIA)

September 24, 2016 – Balance of Class II devices

September 24, 2018 – non-exempt Class I devices, unclassified

Direct Marking:• Compliance dates are extended by 2 years, except for FDASIA

(year 2) devices – still at year 2.

But Wait!

How do we label these with UDI in a manner that meets the FDA requirements?

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How do we label all the pieces and parts with UDI?

Non‐Sterile Implant Extension• Nov. 2014 – FDA extends “point of use” label compliance date for many class II (FDASIA) non‐sterile implants from 2015 to 24 Sep 2016

• GUDID submissions are still required in 2015.

• AdvaMed had requested or 2 additional years (2017). 

• “Most of the devices that meet these … criteria are supplied non‐sterile by the manufacturer” and are “intended to be sterilized (or cleaned and sterilized) before use.”

© Copyright 2015 by USDM Life Sciences

More Time, Higher Bar

© Copyright 2015 by USDM Life Sciences

“FDA is initiating this extension to allow time for the development and implementation of an alternative that would provide for more accurate and precise device identification than the requirements of 21 CFR 801 subpart B.” [Labeling Requirements for Unique Device Identification – which requires the label of every medical device to bear a UDI]

Success depends on your Customer

© Copyright 2015 by USDM Life Sciences

Enter SMI

Current challenges• Orthopaedic devices present unique

challenges for UDI compliance: – Funky supply chain – hi touch/low control– No “real estate” for UDIs on products– Many products cycle through system

multiple times – Labeling systems need to enable capture

of the UDI at the point of use– Products are often removed from their

original package and placed in trays. 17

Clinical Supply Documentation at the Point of Care

Benefits include:• Adverse event reporting/recall mgt.• Better understanding of clinical efficacy• Better Data for Comparative

Effectiveness, Population Health Studies 18

Value-based healthcare demands knowing which devices contribute to the highest quality at the most

optimal cost

SMI UDI Compliance Initiative Background

• March 2014 – Advanced Medical Technology Association (AdvaMed) created a Non-Sterile Implant Working Group to address industry concerns for UDI compliance with implantables

• August 2014 – AdvaMed’s Orthopedics Working Group presents potential compliance strategies:

• Data Carrier Tags• Date Carrier Strips• Direct Marking• Individual Sterile Packaging• Inventory Sheets 19

Compliance Strategy

Data Carrier Tags• Tag is affixed to product by manufacturer

and bears UDI information in human readable and/or AIDC technology

• OR staff removes tag and captures UDI information manually or via scanner

• Scanned information can be electronically captured and downloaded into EHR system

• Product is intended to remaintagged until point of use; onceremoved it cannot typically be re-attached

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Labeling Strategies

Compliance Strategy

Data Carrier Strips• Implants from the same LOT are

attached to plastic strip where each implant has its own compartment

• Individual compartments can be snapped off strip as needed

• The plasticized paper UDI label remains with each implant on strip until point of use

• Plastic strips are loaded into trays • Staff break off and remove needed

number of implants from plastic strip and retrieve UDI information 21

Labeling Strategies

Compliance Strategy

Individual Sterile Packaging• Sterile supplied devices are common

practice for many implantable medical devices, including some spine and trauma products.

• It is not common practice for large set configurations due to: – increased packaging waste – limited space in O.R. – increased O.R. time due to removing

packaging for each implant information

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Labeling Strategies

Compliance Strategy

Direct Part Mark• Implants are etched with a

human readable and/or AIDC readable UDI

• Larger implants that have sufficient space for the UDI in human readable format will have the device identifier (DI) and production identifier (PI) marked

• Medium implants may have sufficient space for only the device identifier to be marked and will require an exemption from PI marking

• Small implants will not have sufficient space for any human readable text and will require an exemption from PI and DI marking 23

Labeling Strategies

Compliance Strategy

Inventory Sheets• Sheet is a map of the

items in the implant tray • Circulating nurse will

document implants used and quantities on the inventory sheet.

• Inventory sheet could have UDI and a bar code for scanning or keying into electronic health record 24

Labeling Strategies

SMI UDI Compliance Initiative Background

November 2014• FDA requests SMI organize next step on compliance

strategies – obtain user feedback.December – January 2015• SMI researches on potential project.February 2015 • SMI commits to lead UDI Compliance Initiative• Major AMC commits to serve as host site• AORN and IASHMM join effort• SMI organized UDI Compliance Initiative Team • Initial site visit to academic medical center 25

SMI Team CharterInitiative Objectives

• To simulate the compliance strategies in a near-real environment, focusing on: a) The operational impact of each labeling strategy on the full surgical process (pre, intra, and post op) b) Each strategy’s ability to support the accurate capture by providers of device UDI data into applicable systems, such as an electronic medical record

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Initiative Process

Host site secured, visit conductedTeam charter, education, & backgroundSimulation lab secured and scheduledSurgical teams recruitedLogistics coordinatedCurrent state documentedFocus on Inventory Sheet, DPM, and

Sterile Package labeling strategies 27

Two Primary Questions

• What are the impacts of the labeling strategies on the surgical process? (Pre-Op, Intra-Op, and Post-Op)

• Do the labeling strategies enable and support the effective electronic capture of product UDI data?

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• Clinical Documentation in Surgery: Current State

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Simulated Surgeries

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Simulated Surgery

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Simulated Surgery

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Circulator

Surgeon Scrub Nurse

Initial Observations

• Data collection process variation• Protecting the sterile field• Participant education on UDI• Maintaining surgeon’s pace• Workflow and process variation in both

SPD and OR• Scanning systems can work

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Next Steps

• Expansion of user input– More surgeons and pilots– Multiple sites

• Understanding scanning system requirements

• TBD

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THANK YOU

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