Unique Device Identification: Manufacturer, Hospital and Global Implications

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Welcome to
USDM Life Sciences
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Unique Device Identification –
Manufacturer, Hospital, and Global
Implications

2
Introductions
Grant Hodgkins
VP Commercial Services and Solutions, USDM Life Sciences
• Three decades of Pharmaceutical and Medical Device manufacturing experience
including Track and Trace, Medical Device UDI, GS1 standards adoption, ERP,
MES, Master Data Management, and other enterprise solutions.
• Drove UDI and Master Data Management initiatives for over 75 engagements.
• Recently, Head of Global Data Management at major Medical
Device/Pharma/Consumer firm.
• At USDM Life Sciences, focuses on providing business process, technology and
compliance solutions for the regulated life science industry.
INTRODUCTION

3
• UDI - Current State of Play
• Key Differences (Global vs. US FDA UDI)
• UDI Challenges (Implant Traceability, Convenience Kits, Direct Mark, Scanning)
• Hospital / Clinician Viewpoints on UDI
• What’s Next?
• Question and Answer
Agenda / Topics for Today
INTRODUCTION

4Presentation ID 0000
• UDI’s impact on instruments, including longevity of laser marking on reusable
instruments
• Current requirements for small implants
• EU requirements
• Types of bar codes
• Recommendations for AIDC on round surfaces and the abilities of readers to
capture the information
• How do I mark multi-component devices for top level UDI (e.g., devices
where components could be interchanged or swapped)?
• What is the guidance on UDI of an injection molded implant that will not have
unique lot information molded into the implant (only part number)?
Questions Submitted by Attendees
INTRODUCTION

6
Are you positioned to efficiently address additional UDI regulations?
• EU MDR and IVDR regulations – approved and in-force (starting 26-May-2017)
• Several additional countries in progress
• Every new regulation introduces additional complexities:
– New attributes (additional to GUDID)
– Local language translations of existing attributes (e.g., Description)
– Conversions of attributes (e.g., imperial to metric, True/False to Y/N)
– Different mechanisms to upload UDI data to government databases
• You have a business to run, and don’t want a ‘perpetual’ UDI project
The Challenge – Growing UDI Requirements…
STATE OF PLAY

7
US
UDI
EU
MDR
UK
NHS
Regulatory
Requirements
“Commercial” or
(Ministry of)
Health/Cost/Import
Control Requirements
UK NHS
Qatar (all devices)
In the US – Also IDNs
(Kaiser); GPOs
ONC/EHRs, CMS South Korea – 2019-2022
India – 2022
Saudi Arabia – ~2019
Netherlands – 1 July 2018
(implants)
Taiwan – ~2018-2020
Canada – “IMDRF”?
China – Summer 2018 (reg)
Singapore – coming…
Traceability
Implant Registries (several + VA)
The Evolving UDI Global Landscape (GHTF/IMDRF based)
UDI REGULATIONS

8
IMDRF Guidance – Goal Largely Realized
CONFIDENTIAL- Copyright USDM Life Sciences -
2018
UDI REGULATIONS

9
Various needs to meet multiple regulatory and commercial purposes.
• In the US – tying together device meta-data (e.g., brand name, device
attributes), premarket (e.g., 510k, PMA), and Registration and Listing (R&L
– listing number – used for import control)
• In the EU – similar – but more… (see next slides)
• In the UK – GDSN product/packaging data
• Other countries… where is it manufactured (country of origin – is that
product allowed in that country?), who (contract) manufactured it, parent-
child relationships (parent-accessory relationships), contents of kits,
combination products…?
Exponentially Growing Data Needs
2018
EU UDI SYSTEM

10
It will apply (date of application):
- for MDR – three years after entry into force [26 May 2020]
- for IVDR – five years after entry into force [26 May 2022]
Article 29 1-2 – Registration of devices – due the later of the date of application
or 6 months after publication of notice in Article 34(3):
Before placing a device, system or procedure pack … on the market, the
manufacturer shall … assign a Basic UDI-DI … and shall provide it to the
UDI database together with the other core data elements referred to in
Part B of Annex VI…
Implementation – UDI Database
2018
IMPLEMENTATION

11
The UDI carrier must be placed on the label of the device and on all higher
levels of packaging:
• For implantable and Class III devices/class D IVDs – 1 year after the date of
application [26 May 2021/2023]
• For Class IIa and Class IIb devices/class B and C IVDs – 3 years after the
date of application [26 May 2023/2025]
• For Class I devices/Class A IVDs – 5 years after the date of application [26
May 2025/2027].
For reusable devices that require UDI Carrier on the device itself:
• 2 years after the applicable class compliance date.
Implementation – Label and Packages
2018
IMPLEMENTATION

12
• As in the US, largely based on GHTF + IMDRF UDI guidances
• UDI assigned/marked with AIDC+HRI on device labels & packages
• Use of global Issuing Agencies (GS1, HIBCC, ICCBBA)
• UDI for accessories, systems (and configurable devices), and procedure
packs/convenience kits
• “Combination products” – if regulated as device – needs UDI
• UDI for SaS/SaMD in embedded screen and label/physical media
• Shipping containers, custom and investigational devices – exempt
• PIs (generally) not specified
• Retail/POS do not require PIs in UDI (US class I, others by request)
Implementation – US UDI Similarities (1/2)
2018
IMPLEMENTATION

13
• Technology neutral approach (no specific AIDC required)
• Reusable devices need “direct mark” (permanent) UDI on device
• UDI for implants MUST be identifiable prior to implantation.
• UDI Database – submit (static) core data attributes for each device
• Data for a new UDI-DI must be entered before the device is placed on the
market; other changes within 30 days.
• New UDI-DI is required when there is a change to the device or in certain
UDI Database fields
• Barcode verification
• Additional guidance being developed by MedTech Europe (in progress;
first draft released last week)
Implementation – US UDI Similarities (2/2)
2018
IMPLEMENTATION

14
• Responsibility: US Labeler vs EU Manufacturer
• SUD packaging exception: EU limited to class I/IIa [/class A/B] – also, less
restrictions (SUD and individually labeled and packaged)
• Procedure packs (aka “convenience kits”) and Systems: EU individual
devices must ALSO be UDI compliant – unless SUD or already exempted
• Configurable device: EU UDI on separately distributed components
• IVD Kits: EU UDI ALSO for individually distributed reagents and articles (but
not parts of kit)
• Standardized date format (YYYY-MM-DD): EU not required
Implementation – US UDI Differences (1/2)
2018
IMPLEMENTATION

15
• Software: EU label and software UDI must be identical
• Class I devices: EU needs both DI and PI
• DM UDI: EU UDI must be both AIDC and HRI (still unclear…)
• Direct Mark: EU does NOT exempt devices that are only cleaned between
different patient use and single patient use.
• “Existing inventory” exemption: EU does not have
Implementation – US UDI Differences (2/2)
2018
IMPLEMENTATION

16Medical Device | Global UDI & MDM Webinar | USDM.com
UDI Requirement US EU UK NHS
Basic UDI-DI No Yes – required for registration Likely to follow EU
Responsibility Labeler Manufacturer Likely to follow EU
SUD Packaging Exception All devices except implants Limited to Class I/IIa Likely to follow EU
Procedure Packs (kits) &
Systems
Pack/System Label only Individual devices must also be
UDI compliant – unless SUD or
already exempted
Likely to follow EU
Configurable device N/A UDI required on separately
distributed components
Likely to follow EU
Standardized date format
(YYYY-MM-DD)
Required Not required Not required
Software Label and software UDI not
required to be identical
Label and software UDI must be
identical
Likely to follow EU
GMP-exempt Class I devices UDI not required Not exempted Likely to follow EU
Class I devices DI only required DI & PI required Likely to follow EU
Direct Mark UDI AIDC and/or HRI AIDC and HRI required Not applicable – commercial
transactions
Direct Mark Exempts “Clean Only” devices Does not exempt “Clean Only”
devices between different patient
use and single patient use
Not applicable – commercial
transactions
“Existing inventory” exemption 3 year post compliance date Not exempted Not applicable – commercial
requirement
IMPLEMENTATION

17
Implementation – Database Similarities
2018
IMPLEMENTATION
US GUDID EU Eudamed
1 Primary DI number (and issuing
agency)
UDI-DI
2 Labeler company name and physical
address (as represented by labeler
DUNS)
Name and address of the manufacturer
(as on the label),
3 Brand name Name or trade name (optional)
4 Version or model Device model, reference, or catalogue
number (optional)5 Catalog number (optional)
6 Device description (optional) Additional product description
(optional)
7 Clinically relevant size (size type, size
value, and size unit of measure – or
size type text)
Clinical size – including volume,
length, gauge, diameter (optional)
8 Production identifier(s) – lot or batch
number, manufacturing date, serial
number, expiration date, and/or
donation identification number
Manner in which production of the
device is controlled (expiry date or
manufacturing date, lot number, serial
number)
9 For single-use (y/n) Labelled as a single-use device (y/n)
10 Device packaged as sterile (y/n) Device labelled sterile (y/n)
11 Requires sterilization prior to use (y/n) Need for sterilisation before use (y/n)
12 Device labeled as containing natural
rubber latex or dry natural rubber (y/n)
Containing latex (y/n)
13 Storage and handling (type, low value,
high value, and unit of measure)
Storage and/or handling conditions –
as indicated on the label or in the
instructions for use (optional)
14 Device Count (for primary DI) Quantity per package configuration
15 Package DI number
Quantity per package
Contains DI package
16 Unit of use DI number The unit of use UDI-DI
17 DI record publish date
Commercial distribution end date
Status of the device (on the market, no
longer placed on the market

18
Implementation – Database Differences
2018
IMPLEMENTATION
Unique US GUDID Attributes Unique EU Eudamed Attributes
Labeler DUNS Number (Company Name
and Company Physical Address)
The Basic UDI-DI
Secondary DI Number (and Issuing
Agency)
The Single Registration Number (SRN)
Device subject to direct marking DM), but
exempt
If applicable, name and address of the
authorised representative (as on the
label)
DM DI different from primary DI (and DM
DI number)
If applicable, additional trade names of
the device
Customer Contact – phone and email Risk class of the device
Prescription use (Rx) and/or Over the
Counter (OTC)
The medical device nomenclature code
as provided for in Article 26
Device is also a HCT/P, kit and/or
combination product
If applicable, the maximum number of
reuses
Premarket submission number (PMA,
PMA supplement number, 510k, or
device exempt)
Where applicable, information labelled in
accordance with Section 10.4.5 of Annex
I
FDA product code (auto-populates
product code name)
URL for additional information, such as
electronic instructions for use (optional)
FDA listing number If applicable, critical warnings or contra-
indications
GMDN code (auto-populates name and
definition)
Status – recalled, field safety corrective
action initiated
Device labeled as "Not made with natural
rubber latex"
MRI safety status (safe, unsafe, or
conditional – or label does not contain)
Special storage conditions
Sterilization method (specified list of
values)
Package type

19
These fields, which are common to GUDID and Eudamed, MAY need to be
translated into the 24 official languages of the EU:
1. Name or trade name
2. Additional product description
3. Clinical size – including volume, length, gauge, diameter
4. Storage and/or handling conditions – as indicated on label or IFU
5. Additional trade names of the device
6. Critical warnings or contra-indications
This adds another layer of complexity and overall effort…
Implementation – Database Translations
2018
IMPLEMENTATION

21
• Deep understanding of the specifics of the regulations and how they affect you
• Re-assess current UDI program vs. new/emerging requirements
• One Source of Truth to house and easily share your key attribute data
• Highly-flexible data models, workflows, and uploads to government databases
• Integrated solutions with fast deployment, validation, and startup
• Meet these requirements while maximizing business operations and reducing costs
• Your Destination: A UDI ‘Capability’, not a perpetual UDI project
What Is Needed to Succeed
SUCCESS FACTORS

22
• Current UDI compliance programs were (necessarily)
quickly enacted to meet aggressive FDA timelines
• We all learned a LOT from these initial projects, what
worked, areas to improve, what we should do differently
in the future
• For EU and other countries, we now have time to re-
evaluate, optimize, and convert UDI initiatives into
sustainable, operational capabilities
• This window of time for re-evaluation is quickly closing
and should not be missed (once in a career opportunity)
Why Now?
SUCCESS FACTORS

Back to Basics – Master Data

24
MDM – Digitally Representing Physical Objects
2018
MASTER DATA MGT

25
1. For US – about 60 attributes
2. For UK – about 20 additional/new attributes
3. For EU – about 100 additional/new attributes
4. Other countries/regulators…?
Needs:
• Robust, scalable master data solution to store, maintain, and submit data
attributes
• Scalable processes to efficiently gather and confirm new attributes and
relationships
• Connections to move this data to GDSN (e.g., UK) and regulators (e.g., EU)
Master Data Management Challenges
2018
MASTER DATA MGT

26
Example – Data Model Considerations
2018
• One product may have multiple entries (by packaging level)
• Name and Address may differ – based on differing requirements
• Registration numbers will differ – across jurisdictions
• Descriptions may differ – 26 approved EU languages – only 3 modeled here
• Some attributes only for US (510K), some only for EU (EU Max Re-Uses)
MASTER DATA MGT
Catalog
Number
UOM Description (EN) Description (FR) Description (ES) US 510K EU SRN EU BUDI-DI EU Max
Re-Uses
US Device
Class
EU Risk
Class
US Name &
Address
EU Name &
Address
1006 EA Cannula 15mm Canule 15mm Aguja 15mm K10000 19054-934 0123456000009 25 II Iib MedDev Partners
2000 Main Street
Anytown, MM 99001
MedDev Group Inc.
1402 Production Way
Smalltown, YY 00089
1006 BX Cannula 15mm Canule 15mm Aguja 15mm K10000 19054-934 0123456000009 25 II Iib MedDev Partners
2000 Main Street
Anytown, MM 99001
MedDev Group Inc.
1402 Production Way
Smalltown, YY 00089
1006 CA Cannula 15mm Canule 15mm Aguja 15mm K10000 19054-934 0123456000009 25 II Iib MedDev Partners
2000 Main Street
Anytown, MM 99001
MedDev Group Inc.
1402 Production Way
Smalltown, YY 00089

27
2018
Global UDI
Internal
Ops
Customer
Requirements
US UDI
MASTER DATA MGT
Single Source of Truth

28
MDM, PIM, PLM, PDM…What is This?
2018
MASTER DATA MGT

29
Possible Single Source of Truth Model…
2018
MASTER DATA MGT

31Vertical ID| Foucs | USDM.com Presentation ID 0000
• UDI’s impact on instruments, including longevity of laser marking on reusable
instruments
• Current requirements for small implants
• EU requirements
• Types of bar codes
• Recommendations for AIDC on round surfaces and the abilities of readers to
capture the information
• How do I mark multi-component devices for top level UDI (e.g., devices
where components could be interchanged or swapped)?
• What is the guidance on UDI of an injection molded implant that will not have
unique lot information molded into the implant (only part number)?
Questions Submitted by Attendees
INTRODUCTION

33Vertical ID| Foucs | USDM.com Presentation ID 0000
• Grant Hodgkins – ghodgkins@usdm.com
• Jay Crowley – jcrowley@usdm.com
• Jim Macdonell – jmacdonell@usdm.com
Contact Information
INTRODUCTION

All great changes are preceded by chaos.
— DEEPAK CHOPRA
UDI Adoption

AHRMM Learning UDI Community: shared responsibility
• The AHRMM Learning UDI Community is a healthcare
collaborative effort designed to address issues
impacting the implementation and use of unique device
identifiers by developing a common understanding
and approach to UDI adoption within the healthcare
setting.
• Establishing a consistent and unbiased platform for
collaboration, communication, and education between
all healthcare stakeholders
• LUC membership and content is open to all those who
are interested in advancing UDI adoption within the
healthcare field.
• Seek. Solve. Share.

• UDI Capture Case Studies
• Unit of Use Report and Webcast series
• Clinically Relevant Size work group Report
• Catalog Number work group Report
• Low Unit of Measure Supply Chain Recommended
Practices Report
• Business Case for the Benefits of UDI Comprehensive
Report and Presentation
• Human Cellular Tissue Product Guidance Document
and Presentation
LUC Resource Center: recommended practices

• GUDID Data Quality White Paper Series
• Barcodes at the Point of Care
• Multiple Device Identifiers
• Clinically Relevant Size
• Device Categorization
• High Risk Implant List
LUC: active work groups

UDI: it’s all about the data
• Data – is as important as the product
• Data – is the foundation of the transactional supply chain
• Data – is the foundation of clinical use
• Data – is the foundation of the electronic health record
• Data – is the foundation of regulatory compliance
• Data – is the foundation of post market surveillance and
recalls
• The request is always for more data, not less

Sources of Truth
* Item
Master
Supply Chain
Orders
EHR
Inventory
OR Information
Systems
* Global
UDI
Database
And many more
Real world
evidence
Charge Master/
Patient Billing
Providers need to make sure their item master has data to feed multiple systems and processes.
* Write once, read many

• Device identification in registries:
• AJRR – American Joint Replacement Registry
• NCDR – National Cardiovascular Data Registry
• Comparative effectiveness
• Documenting medical device use in patient’s EHR/PHR, hospital
information systems, and claims data
• Sentinel Initiative and other post-market surveillance activities
• Contracting
• Physician Preference
• Clinical trials – combined with Genomics
Consumption of the UDI

GUDID Data Quality
• Consistency
– provider organizations wanting to leverage UDIs for cost,
quality, and outcomes initiatives is the inability to access
consistent data.
• Crosswalk
– Providers have stated that they cannot match legacy data in
existing ERP systems to UDI-DI records in the GUDID, and
that the data they do match may contain values that are
inconsistent or incomplete to support their supply chain or
clinical requirements.

10
GUDID Records
Submission Compliance Deadlines
Data Current as of May 1, 2018
0
200,000
400,000
600,000
800,000
1,000,000
1,200,000
1,400,000
1,600,000
1,800,000
2,000,000
Class I &
Unclassified
Class II
I/LS/LS
Class III

Barcodes at the Point of Care
• Multiple Bar codes on
the label
• Scanners unable to
read additional
segments, i.e.,
application identifiers
• Barcode only on the box
and not on the device

Multiple Device Identifiers
• Records with the same Brand Name, Version and
Model, but different Device Identifier
• LUC Workgroup is addressing through a
multidisciplinary stakeholder work group
– Issuing Agency DI rules
– Mfg. business drivers and internal processes
– Impact to Provider and patient care setting
– Recommended Practice to reduce MDIs

Multiple Device Identifiers
Hospital Item Master
Brand Name MaxStent
Manufacturer MedSup
Catalog 1245
Device ID
Brand Name MaxStent
Device ID 00999911000012
Catalog 1245
Company MedSup
Brand Name MaxStent
Device ID 00999911000013
Catalog 1245
Company MedSup

Clinically Relevant Size
There are four fields within the GUDID that capture components of
device size:
• SizeType: a constrained list, intended to be the measurement type
(length, width, height, etc.)
• Unit: a constrained subset list of the Logical Observation Identifiers
Names and Codes (LOINC) for Unified Code of Unit Measure
(UCUM), intended to be the unit of measure (e.g. inches, cm, mm,
etc.)
• Value: the numeric value of the size measurement
• SizeText: analog text, intended to capture information not
represented in the sizeType, unit and value fields

There appear to be several reasons for the CRS data quality
issues:
• GUDID field names for CRS parameters that are not
completely intuitive
• Incomplete or otherwise inadequate instructions for the
completion of the CRS data fields
• Value set selection lists that are incomplete or do not have a
term to represent a dimension of measurement
• Hesitation by manufacturers (and labelers) to use said fields

Structured, discrete, and useful
MedSup1
DI:
007331326361
05
MedSup2
DI:
0082168406210
4

Value to Multiple Stakeholders
• Less paperwork
• Less time looking for,
counting supplies
• Visibility to which products
improve quality AND cost
and for which patients
• Confidence that she
knows they can find her
if there is a recall.
• Real world evidence (RWE) to:
• Better market and design products
• Achieve faster regulatory approvals

• Learning UDI Community (LUC): http://www.ahrmm.org/LUC
• Unique Device Identification-UDI
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/
• UDI Basics
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/UDIBasics/default.htm
• AccessGUDID (for the public)
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/u
cm444831.htm
• UDI Resources
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ChangesbetweenUDIPropose
dandFinalRules/default.htm
• SMI Report: Introducing UDI Labeling Strategies into the Surgical Setting
http://www.smisupplychain.com/index.php?option=com_content&view=article&id=49:20151008_udi-labeling&catid=24:pr or
http://www.smisupplychain.com/tools
• Unique Device Identifiers (UDIs): A Roadmap for Effective Implementation. Engelberg Center for Health Care Reform at
Brookings. December 2014. https://www.brookings.edu/research/unique-device-identifiers-udis-a-roadmap-for-effective-
implementation/
• Unique Device Identifier (UDI). AdvaMed. http://advamed.org/issues/9/unique-device-identifier-udi
References

How to Use a Universal UDI Scanning and
Documentation System to Track All Implants
and Supplies…Including the Tough Ones -
Hospital-Sterilized Medical Implants
Presented at OMTEC 2018 by
Larry Donnelly
940 W. Oakland Ave., Suite A-10
Oakland, Florida 34787
LDonnelly@MatrixIT.io
www.MatrixThis.com

Compliance
Landscape
• Medical device companies must begin
providing Unique Device Identifiers (UDI) for
all medical devices, which are traced through
the product’s lifecycle.
• In the U.S., the FDA, ONC and Medicare
regulate UDI compliance.
• In the EU, the European Commission
established MDR to fulfill new UDI
requirements.
• The FDA Final Rule and MDR recommends
direct part marking as an effective means to
permanently identify hospital sterilized
implants and the use of AIDC technology to
collect UDI information.

Problem
• Hospital sterilized devices lose all UDI information
when removed from their packaging and placed into
sets with identical implants.
• The UDI must be collected at the point of care
(during surgery; at the point of implantation), and
transferred to the hospital EHR system, where that
information will be submitted to government payers.
• Typical scanners may not be used to collect direct
marked UDI information for these devices, since they
are non-sterile and cannot capture data from
“micronized” data matrix codes.
• Other UDI collection methods may be space
prohibitive, expensive, inaccurate and could increase
surgical times.

Direct Mark Using Scanners Sterile Packaging/RFID
Sterilizable Tag
Manual Callout
Cross Reference Sheet
Other UDI Options
• Device manufacturers must provide UDI
compliant products. However, the approaches
that they plan to deliver UDIs to hospitals vary
widely, including manual call out, reference
sheets and sterile packaging.
• The UDI on Operating Room products will be
conveyed in many forms, but hospitals must be
prepared to collect all UDI options by a Universal
UDI Documentation System.
• The method selected will impact case time and
data integrity, cost and staffing.
• Direct part mark sterile field scanning is the only
method that collects all UDI at the point of
implantation; and does not introduce human
error, increase hospital staffing, slow down
surgical pace, require sterile breach monitoring,
expiration data tracking or increase storage
requirements.

UDI Direct Part Mark and Sterile Scanning Benefits
• Remove potential for human error
• Ensure visibility of all devices from manufacture
to implantation to removal.
• Efficient electronic UDI capture and accuracy,
without slowing surgery or increasing staff.
• Integrate transmission of case data to the
hospital EHR and manufacturer.
• Correlate device data to the patient’s implanted
anatomical locations.
• Capture all other implant and supply
information through the handheld scanner.
• Verify, through recall databases, that no recall
exists and product is not expired

What is “Technologically Feasible?”
Aneurism Clip Marked with 30
Micron Data Matrix Code Cell
Size: Read by Tractus

Track Inventory Electronically
From Manufacture to
Implantation
• Mark and verify implants with UDI compliant data matrix
codes.
• With existing software platforms, manufacturers may scan
each device and place them in a set, matching each device
with that set, and matching each set with a tray.
• Once configured, scan the tray and assign it to a rep,
distributor or hospital. All devices inside of tray are now
visible.
• Hospital manages tray visibility and captures UDI
information during surgery. That information is instantly
sent to the manufacturer.
• After each case, replenish the tray in preparation for a new
case.

Point of Implantation UDI Capture and Documentation
Scan – Document - Report
Sterile Field ScannerHandheld Scanners/RFID
Documentation Software
0.3mm^2 Data
Matrix readability

Operating Room Implant
Documentation Process
• Surgeon calls for an implant.
• If hospital sterilized or tagged, the scrub tech selects a UDI direct
marked implant from a sterile set, and scans the data matrix code
containing the UDI with the Tractus scanner.
• If packaged, the “non-sterile nurse” opens the package and drops
the device onto the sterile table, where the scrub tech collects it
and hands it off to the surgeon.
• Device data is transmitted to the circulating nurse’s computer
software system.
• Circulator correlates the device to the implanted anatomical
location.
• Wasted and explanted devices are moved into the software’s
“Discarded Bin,” with discard reason selected.
• After completion, case data is transferred to the hospital EHR
system and manufacturer or distributor

Implant Summary Report
• Integrates with recalls database,
master inventory and EHR
systems.
• Correlates UDI and catalog
numbers
• UDI is presented in universal
language format.
• UDI is conveyed via AIDC, the
preferred data collection method.
• Interfaces with GUDID and
MAUDE.
• All components are battery
powered with wireless data
transmission capability.
• Sends inventory utilization in real
time to EHR and the manufacturer.
The AIDC System is compatible with all currently identified UDI tracking
solutions, including reference sheets, human readable manual callout,
data carrier tags, RFID, handheld scanners, smart device app., sterile
packaging and Direct Mark (DM).

Observations
• 100% accurate UDI data collection, in real time during surgery
• Integrated into existing processes, without surgical flow disruption
• Staff documentation time decreased
• Information seamlessly transferred to the hospital EHR system.
• Reduction of case times via electronic data capture
• Potential for human error eliminated
• Draping of the scanner was easy, and could be performed several ways.
• Scanned device UDIs were collected, with no negative effects to the case
flow or surgical times
• Easy scanning, software management, and anatomical device assignment

Questions?
Presented at OMTEC
2018 by
Larry Donnelly
LDonnelly@MatrixIT.io
www.MatrixThis.com

Different Direct Part Mark Results
The Right Equipment and Expertise are Critical to Success
Damaged Data Matrix Code Damaged Human Readable Mark Good Data Matrix Code

Unique Device Identification: Manufacturer, Hospital and Global Implications

Unique Device Identification: Manufacturer, Hospital and Global Implications

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