For You and Your Staff

sillysepiaElectronics - Devices

Nov 27, 2013 (3 years and 6 months ago)

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866
-
803
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3720 |
www.ChampionMT.com

| ©
2013
Champion Medical Technologies

Providing Peace of Mind…

For You and Your Staff

CONFIDENTIAL & PROPRIETARY

What is UDI?

UDI stands for
Unique Device Identifier



an FDA initiative legislated by the U.S. Congress to standardize
the labeling and improve the tracking of all medical devices.

UDI has 2 components:




Device Identifier
(DI) [FDA managed database]:


[static] manufacturer, product code, description




Production Identifier
(PI) [UDI
Tracker
®
]:


[dynamic] I.D., serial, lot number, expiration


CONFIDENTIAL & PROPRIETARY
©
2013
Champion Medical Technologies





UDI Update




7
-
3
-
12
FDA announces proposed UDI rule





UDI Label of the Future:


CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies




Uses
device identifier (DI) and production
identifier (PI) data to

track
implantable devices
throughout
your supply chain



Connects device information directly to your patient



Tracks all biologic and non
-
biologic implantable devices



Tracks across all Hospital Departments



Only UDI tracking software reviewed by the FDA



Only tracking company invited to present at the FDA sponsored


National UDI Conference


2010 & 2011




What is UDI
Tracker®
?

CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies



We just had a Joint Commission inspection
for tissue and as soon as they heard we had
Graft
Tracker
®
, they said they knew we were
going to be compliant (before even looking)
.
Needless to say, everything went extremely
well! Thank you for all you have done!



Rita Rivers RN, BSN, CNOR

Tissue Compliance Officer

Erie County Medical Center

CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies


Champion Medical Technologies Background


25 years
of software design
and development experience
in the healthcare industry

20 years
of experience in
Medical Device Tracking

Chicago
and
Phoenix
offices
serving
hospitals and GPO’s
nationwide…

CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies


Our

sole focus
is
tissue and
implant tracking

A Few of Our Clients

CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies


QuickReceipt


Integration with manufacturer
provides single click data entry of all
items in a shipment


no barcode
scanning or manual entry required
.


Supplier Regulatory Status

Regulatory Status of suppliers for
AATB, FDA and State is updated and
maintained in the application.


RecallConnect™

Real
-
time recall matching to actual
hospital inventory and affected patients.

Track Across All Departments

Track all implantable devices across all
hospital departments: OR, Cath Lab,
Wound Care, Burn Center, Interventional
Radiology.


Innovative Features of
UDITracker
®



CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies



UDI
Tracker
®

is easy to use, logical and
customer service is great to work with!
The shipment interface is fantastic; it
takes me
10 seconds to receive as
many as 100 items

at once!



Kim Degner

OR Manager

Doctor's Hospital of Augusta

HCA Healthcare

CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies


Implant Connect
SM

Improve patient safety with a medical
device registry service for patients
provided by MedicAlert
®

Foundation.


RFID Interoperability

Seamless integration with RFID
-
enabled
freezers, refrigerators and room
temperature cabinets.


Network Capability

Data can be accessed from a single
department or by multiple departments
within the facility.

Innovative Features of
UDITracker
®



CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies


SmartTrack
™ Barcodes

Create standardized barcode labels for all
manufacturers providing easy, consistent
scanning results throughout the hospital.


Tissue Prep Instructions

Tissue prep instructions can be
accessed through the software,
eliminating the need to keep a binder.

Tissue Implant Record

No more forms to complete! Return
tissue implant records easily by email
to supplier.

Additional Features of
UDITracker
®

Secure Website

Secured through 256
-
bit encryption.
Passes federal government internet
security standards.

Tiered Access

7 clearly defined levels of user
access help to control data security.

Free Upgrades

Upgrades driven by customer input,
technical advancements and
regulatory changes.

Expiration Date Alerts

Reduce cost through the elimination of
wasted items due to expiration.

CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies


Benefits of
UDITracker
®

No Software to Install

IT friendly system, the only
requirement is an internet
connected computer.

Save Time & Money

Decrease personnel time and costs by
immediately locating recalled devices.
Eliminate wasted items due to
expiration.

Joint Commission Compliance

Designed to meet Joint Commission and
OIG standards for hospitals and labs for
simplified compliance.


Save Lives & Reduce Liability

Fast, efficient response to device recalls
increases patient safety and decreases
liability to the organization.

Meets Federal UDI Guidelines

Be prepared for Federal UDI (unique
device identifier) legislation.


CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies


On
-
Site Implementation

2
-
day hands
-
on training with
Implementation Specialist. PLUS a
physical inventory of all tissue items.

CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies


Generate Reports in Excel

Designed to make reporting easy


export
owned implant data, vendor delivered data,
expired inventory data and more…

REPORTING

CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies


UDI
Tracker
® RFID Cabinets

A Seamless Tissue Storage and Tracking Solution





Provides a complete storage solution
for all required tissue temperature ranges
including room temperature, refrigerated
and frozen.






Available in Cabinets,
Refrigerators & Freezers.




Using secure access, each inventory
transaction is automatically captured and
processed


in real
-
time.



Swipe, Grab & Go!



SWIPE

Pre
-
authorized
users access
the cabinet with
personalized
badges.

2

1

Place internet
enabled RFID
cabinet at the
point of use.


3

GRAB & GO

Users add

or remove
RFID tagged
inventory from
the cabinet

Unlike other storage solutions that require data entry prior to

product access, our cabinets are swipe, grab & go.

This reduces retrieval time significantly and increases staff accountability!

CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies


Supply Chain

MMIS


Device Registry

AJRR, CV, SMISS

UDI
Tracker
®

Manufacturer

QuickReceipt™

EMR / EHR

OR Management

RFID Storage

Room Temp,

Refrigerator, Freezer

Powerful Interoperability

Patient Implant
Registry

Implant Connect

CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies


Proven innovation with first
-
to
-
market features:




RecallConnect™



Supplier Regulatory Status of AATB, FDA and State requirements



ImplantConnect
SM



QuickReceipt™



SmartTrack™ barcode labeling



Joint Commission and UDI Rule compliance



CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies


Market Leading Technology


CONFIDENTIAL & PROPRIETARY
©2012 Champion Medical Technologies


What’s Next?

The latest advancements in Tissue and Implant Tracking


SmartStorage
™ Integration:



RFID technology integrates directly with
Graft
Tracker
®

or UDI
Tracker
®
to provide a
seamless storage and tracking solution






Medical Device Recalls in the News

US Has No Good System to
Track Medical Implants

New
York, AP, October 9,
2009



Hem
-
o
-
lok

clips recalled
-

2006


Warned that clips could
dislodge
in patients


3 years later


the clip was used on Michael
King in a Brooklyn Hospital


Twelve
hours
after surgery,
the clip popped
off


King
bled to death
internally. He
was
29

Girl, 9, Learns of Second
Recall Connected to
Defibrillator

Chicago, February 4, 2013



St. Jude Medical issued a Class I
recall for Defibrillator and leads



Mother accidentally found recall one
year after recall was issued



FDA, Surgeon and Distributor
missed contacting the patient


CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies


“The distressing reality is that we can identify and remove tainted peanut butter and dog
food from the market before it reaches consumers, but
healthcare patients are at risk of
a recalled medical device used in their treatment because there is no way to quickly
and reliably locate a recalled device.”


-

Blair Childs,
Senior Vice President for Public Affairs of Premier Healthcare Alliance



CONFIDENTIAL & PROPRIETARY
©
2013
Champion Medical Technologies





Automatic matching of recalls to hospital inventory history



Real
-
time matching to specific affected patients and


current implant inventory



Ongoing matching for future inventory activity



Fast, efficient response to device recalls increases patient


safety and decreases liability to the organization



Real
-
time Recall Inventory Matching System

CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies


“Thank
you so much for
bringing this to my
attention.

It could have
been weeks before we
discovered this on our own.”


Sherry Spikes

Malcom Randall

VA Medical Center

Lebanon VA Medical Center



(4)
Zimmer Ceramic Femoral Head Recalls matched to cases

Miami VA Healthcare Systems



(1)
St
. Jude Medical Pacemaker


Accent
Recall matched to case

Malcolm Randall VA Medical Center
-

Gainesville



(2) Zimmer Ceramic Femoral Head Recalls matched to cases



(3) AMS
Acticon

Neosphincter

Pump
Recalls matched to cases



(14)
Synthes

T1 Matrix Locking Cap of the
Synthes

Matrix System
Recalls matched to cases


Real
-
time Recall Inventory
Matches at VA Facilities

CONFIDENTIAL & PROPRIETARY
©
2013
Champion Medical Technologies


Frankfort Regional Medical Center



(10
) St. Jude Medical Pacemaker


Accent
recall
matched to cases

OU Children’s



(
1) Integra
NeuroSciences
DuraGen

Plus matched to case

OU
Medical Center



(2)
Integra NeuroSciences DuraGen Plus
matched
to
items on shelf




(23)
Integra NeuroSciences DuraGen Plus matched to
cases




(6)
Integra NeuroSciences DuraGen Plus matched to
discarded items

Research
Medical Center



(1)
Integra NeuroSciences DuraGen Plus matched to items on shelf




(2) Integra
NeuroSciences DuraGen Plus matched to
cases

Real
-
time Recall Inventory
Matches at HCA Facilities

CONFIDENTIAL & PROPRIETARY
©
2013
Champion Medical Technologies


Analytics &
Benchmarking

Healthcare
Trends

Cost & Vendor

Analysis

ADMINISTRATION

CONFIDENTIAL & PROPRIETARY
©2013
Champion Medical Technologies


RFID Label is
printed and
affixed to
tissue package

Tissue Tracking Workflow

Receipt, Logging, and Storage of Tissue with RFID


CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies


Tissue received
from vendor

Receiving

Department
logs
receipt of shipment
into UDITracker

Tissue delivered to
storage location,
items scanned into
UDITracker

Tissue is
transferred
to storage
room

RFID reader
sends tissue
location to
UDITracker

Staff swipes
badge at
appropriate
RFID unit

Tissue is placed
into storage unit

RFID unit scans
cabinet to
identify added
tissue

Tissue delivered to storage
location and items received
via QuickReceipt into
UDITracker

RN
returns to
OR with
tissue
graft

RFID reader
sends tissue
“log out” to
UDITracker

Tissue Tracking Workflow

RN retrieves tissue from OR storage and brings to Surgical
Suite


CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies


Staff (RN)
enters tissue
storage
room

Tissue is
removed from
storage unit

RFID unit
scans
cabinet to
identify
removed
tissue

Staff (RN)
swipes
badge at
appropriate
storage unit

Tissue
Bank

RN electronically sends
tissue usage information as
required by the tissue
supplier

RN scans
tissue into
EHR patient
record.

Create reports or
provide
ImplantConnect™
Form to patient
(optional)

Tissue Tracking Workflow

Tissue is implanted in patient and UDITracker is updated


CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies


Tissue is
implanted in
patient

Non
-
clinical staff
scans Tissue into
UDITracker after
surgery

EHR

Interface

(flat file, HL7,
xml)

RN scans
Tissue into
UDITracker

O
R

RN captures
Tissue Implant
Record on
paper

O
R

Tissue is
scanned into
UDITracker as
“discarded”

N
O

RFID reader
sends tissue
location to
UDITracker

Staff (RN)
enters tissue
storage room

YE
S

Tissue out of
storage
within
appropriate
time limit?

Tissue Tracking Workflow

Tissue is not implanted in patient


CONFIDENTIAL & PROPRIETARY
©2013 Champion Medical Technologies


Tissue is not
implanted in
patient

Tissue is
returned to
storage unit

Staff (RN)
swipes
badge at
appropriate
storage unit

RFID unit
scans cabinet
to identify
added tissue

EHR

Interface

(flat file, HL7,
xml)

Tissue is
scanned into
EHR as

discarded