"Rationale for a Unique Device Identifier“ Brad Sokol, CEO

"We make technology easy to live with"
"Rationale for a Unique Device Identifier“
Brad Sokol, CEO
Fast Track Technologies, Ltd.
[email protected]
Technical Contributor
Bill Newcum: AST Consulting
[email protected]
"We make technology easy to live with"
The Trademark’s and Logo’s are property of Fast Track Technologies “Medical Device and Instrumentation Pedigree" © is Brad
Sokol's terminology for this area of RF-medical study. "A Roadmap for Medical Device and Instrumentation Pedigree" © is the title
By using affordable commercial
technology solutions combined
with regulatory initiatives, we
improve health provider’s
processes, increase patient safety
and quality of care.
“Improving the quality of life for those who are touched
by healthcare tools”
of Brad Sokol's book scheduled for release. Please attribute any mention of "Medical Device and Instrumentation Pedigree" © to
Brad Sokol. This presentation is not to be duplicated or distributed without the express permission of Brad Sokol.
October 25, 2006
Copyright 2006, Bradley H. Sokol
A Road Map to
Medical Device and Instrumentation Pedigree
"We make technology easy to live with"
Agenda
Why we need a UDI
–
Preventing 13,000-26,000 mortalities in the US a year, from direct
and indirect medical device procedure/ process infections
–
Saving $3.1 Billion a year from direct and indirect medical device
procedure/ process infections
–
Develop a comprehensive interoperability healthcare model to
include medical non-electrical instruments and supplies
Factors to Consider for a UDI System
UDI’s Drivers
The Impact of a Universal Device Identifier
Concluding Remarks
October 25, 2006
Copyright 2006, Bradley H. Sokol
A Road Map to Medical Device and
Instrumentation Pedigree
"We make technology easy to live with"
–
–
Factors to Consider for a UDI System
Ability to incorporate the UDI system into the
Interoperability healthcare model
Address unique life cycle events experienced by a
medical device:
Reprocessing of medical devices and the
associated regulations (FDC 502.u, SUD’s)
Distributor re-labeling
Rentals
Loaners
Sterilization cycles
Maintenance cycles
FDA MDR/MHR and reporting
Adverse Event Reporting
State HAI Reporting
October 25, 2006
Copyright 2006, Bradley H. Sokol
A Road Map to Medical Device and
Instrumentation Pedigree
"We make technology easy to live with"
Factors to Consider for a UDI System
–
Creating a De- Referenced Database environment
where all authorized queries have Confidentiality,
Integrity, Authentication and Anonymity”
–
Patient privacy is controlled by the Patient so that
they personally distribute and allow limited
informational access by the inquiring party to their
Patient health record.
–
Focus on infection control: Designed a model to
increase our abilities to better detect the chain of
transmission infections, by integrating the UDI,
procedure and patient record systems.
–
Getting past the vested economic and political bias of
the current players.
October 25, 2006
Copyright 2006, Bradley H. Sokol
A Road Map to Medical Device and
Instrumentation Pedigree
"We make technology easy to live with"
UDI’s Drivers
Device maintenance and increase regulatory
compliance reporting, – in cases where
infections have been passed from patient to
patient due to improper device maintenance
(Chain of Transmission )
Reduce theft and counterfeiting of medical
devices, Adverse Events warnings/notification
Enable a process to track the reprocessing,
recalls, rentals, loaning of medical devices and
Reduce Counterfeit Instruments
October 25, 2006
Copyright 2006, Bradley H. Sokol
A Road Map to Medical Device and
Instrumentation Pedigree
"We make technology easy to live with"
UDI’s Drivers
Increase supply chain asset visibility resulting
in, increased productivity, administrative
efficiencies, billing accuracy and reduction in
Liabilities
Matching patient data records to diagnosis,
treatment and device to patient
schedule/procedure and infection cause.
Reduction of hospital associated infections and
length of stay, reducing mortalities through
ensuring sterilization and proper device usage
on the correct patient.
October 25, 2006
Copyright 2006, Bradley H. Sokol
A Road Map to Medical Device and
Instrumentation Pedigree
"We make technology easy to live with"
The Impact of a Universal Device Identifier
Issue
Solution
Result
Lack of informatic tools and
interoperability standards
to connect nomenclature to
procedure, Patient records,
Infection Control.
What patients were treated
with which devices?
Track process order events
“The 7 Device L’s”:
1.
last manufacturer
2.
last maintenance
3.
last sterilization
4.
last location
5.
last user
6.
last procedure
7.
last patient.
13,000-26,000 mortalities
could be prevent in the US a
year by developing a UDI
pedigree model for medical
tools in the healthcare Micro
and Macro supply chain:
Saving $5 Billion a year
11 competing nomenclature
systems for the naming of
medical devices
A “Universal Translator”
(Nomenclature Sequencer
Code)
Integrated global semantics
into a unified interoperable
relational standard
Lack of System
"Confidentiality, Integrity
and Authentication.“
Privacy Preserving Index
(PPI):
Erroneous Data Generator
and Filter
A secure relational database
(NSS) that directs queries and
information through the PPI
creating a de–registered
database environment for
both Patient and Manufacturer
October 25, 2006
Copyright 2006, Bradley H. Sokol
A Road Map to Medical Device and
Instrumentation Pedigree
"We make technology easy to live with"
The Impact of a Universal Device Identifier
Issue
Solution
How to account for
maintenance, sterilization
verification, reprocessing,
loaning and rentals of
Medical tools.
Placing additional data
fields on an Auto-ID label
Patient "Confidentiality,
Integrity and
Authentication.“
Patient Controls release of
personal information
Patient Record Confirmation
Certificate
Several security check points
culminating in the patient
issuing a one time access
code to the inquiring party
Inconsistent reporting of
Adverse events
A rules based
semi-automated mandatory
reporting system of adverse
medical device related
events
Combined reach and techniques of
MedSun and MAUDE with the
robust event reporting features of
ECRI Alerts Tracker. i.e. CDCNational Healthcare Safety
Network
There are no plans to
include Medical Instruments
or Supplies In today’s
Global Healthcare
Interoperability Models
UDI
A Complete Healthcare
Interoperability model and all
the gains realized: financial,
efficiency, safety and quality
October 25, 2006
Result
Third Party Liability Shift
Labeling compliance
Increased financial and
compliance reporting
efficiencies
Copyright 2006, Bradley H. Sokol
A Road Map to Medical Device and
Instrumentation Pedigree
"We make technology easy to live with"
Concluding Remarks
• Failure to incorporate the comparative relationships
(Medical Device- Universal Nomenclature- error reportingpatient record/ procedure- EHR) will yield an unstable
interoperability healthcare model and will limit our ability to
identify, analyze and eventually reduce medical errors and
mortalities.
• If we wait until UDI/Infection Control yields an
immediate ROI or until we reach a global
political compromise it may be too late.
• Don’t wait for a catastrophic disease outbreak
"We
technology easy to live
with"
tomake
implement
UDI.
The Trademark’s and Logo’s are property of Fast Track Technologies “Medical Device and Instrumentation Pedigree" © is Brad
Sokol's terminology for this area of RF-medical study. "A Roadmap for Medical Device and Instrumentation Pedigree" © is the title
of Brad Sokol's book scheduled for release. Please attribute any mention of "Medical Device and Instrumentation Pedigree" © to
Brad Sokol. This presentation is not to be duplicated or distributed without the express permission of Brad Sokol.
October 25, 2006
Copyright 2006, Bradley H. Sokol
A Road Map to
Medical Device and Instrumentation Pedigree
"We make technology easy to live with"
"Rationale for a Unique Device Identifier“
Brad Sokol, CEO
Fast Track Technologies, Ltd.
"We make technology easy to live with"
Thank You!
“Improving the quality of life for those who are touched
by healthcare tools”
The Trademark’s and Logo’s are property of Fast Track Technologies “Medical Device and Instrumentation Pedigree" © is Brad
Sokol's terminology for this area of RF-medical study. "A Roadmap for Medical Device and Instrumentation Pedigree" © is the title
of Brad Sokol's book scheduled for release. Please attribute any mention of "Medical Device and Instrumentation Pedigree" © to
Brad Sokol. This presentation is not to be duplicated or distributed without the express permission of Brad Sokol.
October 25, 2006
Copyright 2006, Bradley H. Sokol
A Road Map to
Medical Device and Instrumentation Pedigree
"We Supply
make technology
easy to live with"
Chain Members
Miss Attribute-20
Opt. Serial # 128
Mfg./Supplier/
Distributor
Accountability:
Equipment,
Parts, Materials
Adverse Reporting, Infection Control and Medical Device Pedigree
NS Code
Supply
Chain
Mgf.
Ordering
Delivery
Goods Receipts
Consignment
Stock management
Asset management
Recalls
3
2
PPI
NSS
Infection
Control Library
Can-ISMP
UK-NPSA
Aus.-ALSQHC
PPI
Federal Gov Reporting
FDA-MAUDEA Central
PHINMDR/CDC/NNIS BioSense
Clearinghouse
ECRI
Registry
for all
MedSun
Government
Databases
PPI
PHR at HC
P RC C
Facility
P RC C
Quality
Programs
MD. & Hosp.
State
HAI
Registry
Shared DeDeReferenced
Database
Environment
PPI
NS Code
Reports to- from
Mgf.
MDR/ Sentinel
Event
3
Reports to- from
FDA/CDC/DHS
DHHS/ State gov..
Infection
Control Library
De-Referenced
Environment
“PPI”
Patient-Procedure
-Instrument
Report goes direct
to-from hosp PHR.
database
De--Referenced Reports
PPI
Recalls
Sterilization
Infection
Adverse Events
Registry
OR-SSI- HAI
Opt.Serial # 128
4
De Referenced Reports Generation
Protocol:
a. Query
b. Message
c. Routing
d. Authentication
Private
Public
Protected
e. Rules for dist.
f. Report Confirm
5
NS Code
Common Key
Full Cost
Accounting
Closed Loop MicroMicro- Environment
2
PPI
NSS
NS Code
How the system works:
1. Authenticated Query is made
2. NSC Data requested by NSS
3. Data is sent to Infection Lib.
4. Encrypted Report Generated
5. Report sent through NSC/NSS
6. Recipient verified- Get Report
7. Sending Updates repeat rev.
PHR
Registry
Resides at
HC Facility
Patient issues a one
time use approval code
Public
Event Message
Form
Form
3500
3500
3500A
3500A
6
Cause of Device
Related Event (ECRI)
a. Device
b. External Environment.
c. Support Systems
d. Tampering
e. User Error
f. Queries
Feedback & Analysis
Query Results
Adverse Reporting
Customized Report
Environment
October
25, 2006
Copyright 2006, Bradley H. Sokol
Patient Record
Patient Record
Confirmation
Confirmation
Certificate
Certificate
Request For Patient Info.
Request For Patient Info.
ERP- CMS,CPT-CRM-PHR
Query.
Asset
Instrument Miss Attribute-20
Loaner Instrument
Registry
Sets
Repair SUD’s
Opt. Serial # 128
PPI
Report
1
Hosp.
PHR
at HC
Facility
Procedure
At
Hospital
Automated
Instrument
Reporting to
Incidences
Mfg.&
A Road Map to Medical Device and
Copyright 2006, Bradley H. Sokol
Sterilize.
InstrumentationSSIPedigree
HAI
"We make technology easy to live with"
Nomenclature Sequence Server Concept
Context Databases
10
Nomenclature
Orgs.
NS Code
Parent
Child
Clin Term
Updates
NS Code
NS Code
PPI
Tag Context Association
Nomenclature Sequence Serer
New
GS1-HUG/EPC-HLS-BAG= NS Code
All databases must be mapped into
NS Code- along with vendor APIs and
legacy data
Supply
Chain
Mgf.
Rules of
Registry
“PPI”
Legacy
Federal Gov
Reporting
SNOMED
Procedure
Registry
NS Code
FDA Quality
Programs
PhysicianHosp.
NS Code
5
NSS
Registry
NS Code
Infection
Control*
1
PHR at HC
Facility
P RC C
P RC C
2
NS Code
6
Document
Document
Web
Services
Web Services
Description
Description
Language--XML
Language--XML
3
4
Client
Web
Service
NS Code
Recalls
NS Code
Common Key
Sterilization
Infection
Adverse Events
Registry
OR-SSI- HAI
Opt.Serial # 128
PHR
Registry
Resides at
HC Facility
Hospital
NS Code
Common Key Asset Registry
Opt. Serial # 128
Hospitals
XML Extended
Micro Mode
Opt. Serial # 128
Closed Loop
MicroMicroEnvironment
Request For Patient Info.
ERP- CMS,CPT-CRM-PHR
Query.
Miss Attribute-20
Instrument
Repair
October 25, 2006
Patient issues a one
time use approval code
Full Cost
Accounting
Miss Attribute 20
Instrument
Loaner
Sets
SUD’s
Copyright 2006, Bradley H. Sokol
Request For Patient Info.
Miss Attribute-20
Opt. Serial # 128
Mfg./Supplier/
Distributor
Accountability:
Equipment,
Parts, Materials
How it Works
Shared DeDe-Referenced
Anonymity
Database Environment
PPI
Tag Context Association
Nomenclature Sequence Serer
Supply Chain Members
Ordering
Delivery
Goods Receipts
Consignment
Stock management
Asset management
Recalls
PHINBioSense
Infection
Registry
NS Code
Keys & Rules
NS Code
FDA/CDC/ECRI
DHHS/MedSun
Adverse Event
Registries
Patient
Patient
Record
Record
Confirmation
Confirmation
Certificate
Certificate
A Road Map to Medical Device and
Instrumentation Pedigree
"We make technology easy to live with"
Shared
-Referenced
SharedDe
De-Referenced
Database
Database
Environment
Environment
Detection
Algorithms
PPI
Data
Reporting
Content
Delivery and
Knowledge
Management
Detection
Algorithms for
each Database
PPI
Unified Person
(Patient)
Registry Pointer
Shared De-Referenced
Anonymity Databases
Logical
Data Model
(Derivative of
HL7 RIM)
Directory of
Authorized
Users
Adverse Event
Data
Repositories
Supply Chain
Data
Reporting
and Analysis
Nomenclature Sequence Server
Communications and
Alerting
Regulatory
Event
Repositories
HL7…
Data
Exchange
Messages
NSS
PPI
Nomenclature
Sequence Server
holds NDS Code Key
Detection
Algorithms
PPI
PPI= Privacy-Preserving Indexing
Strong Security
NS Code
Web
Services
Public Key Infrastructure PKI
Patient
Patient
Record
Record
Confirmation
Confirmation
Certificate
Certificate
PHR at
Hospital
Two way queries
from outside data
servers through the
NSCode
or VPN
October 25, 2006
Copyright 2006, Bradley H. Sokol
A Road Map to Medical Device and
Instrumentation Pedigree
"We make technology easy to live with"
Nomenclature
NCS ID
Sequence
Server
Nom 1
Nom 2
Nom 3
.....
Nom 11
Universal Translator =“Nomenclature Sequence Code”=
Nomenclature Sequence Code: NSC
Map-to-NSC Approach
Nomenclature
Universal
Sequence
Translator
Server
Name
Nomenclature
Sequence
Server
A rules based metadata naming system; master code (universal translator) that
combines similar data concepts in different language formats.
When the language formats’ data element’s have been mapped to the NSC, A
unique data element can be assigned to the NSC
The NSCs’ data element can than point to multiple historical events within the
community of database language
formats.
October 25, 2006
Copyright 2006, Bradley H. Sokol
A Road Map to Medical Device and
Instrumentation Pedigree
"We make technology easy to live with"
How it Works
5
Nomenclature Sequence Server (NSS)
Document
Document
Web
WebServices
Services
Description
Description
Language—XML
Language—XML
Nom. Server
Registry
2
PPI
NS Code
NS Code
1
6
Client
3
4
PPI
Web
Service
A Secured De-Referenced Registry Database that receives and sends queries as
prompted by the NSC.
This server is the gateway clearinghouse conduit to several other highly
classified and secure databases.
It operates in a secured virtual black-box server environment using Privacy-
Preserving Indexing (PPI)
http://www.almaden.ibm.com/software/quest/Publications/papers/vldb03_ppi.pdf
Assures Confidentiality, Integrity, Authentication and Publisher Anonymity
October 25, 2006
Copyright 2006, Bradley H. Sokol
A Road Map to Medical Device and
Instrumentation Pedigree
"We make technology easy to live with"
Nomenclature Sequence Code: NSC
Object
Type
3 bits
Partition
3 bits
Version
8 bits
96-bit EPC Serialized GTIN Serialized Global Trade Item Number
Company Prefix
40-20 bit range
Item Reference
4-24 bit range
Serial Number
38 bits
CRC
16 Bits
44 bits
96 bits total
Misc. Attributes
“Variable Field”
20 bits
Nomenclature Sequence Code
50 bits
128-bit User Memory
Optional Serial Number
Ordinal Expiration Date
10 bits
CRC
16 bits
32 bits
96 bits total
128 bits total
Copyright 2006, Bradley H. Sokol and Bill Newcum:
October 25, 2006
Copyright 2006, Bradley H. Sokol
A Road Map to Medical Device and
Instrumentation Pedigree
128K -256K Bits of USER MEMORY
"We make technology easy to live with"
User Memory
User Memory
Optional 32-128 Bits
96 Bits
Closed-Loop Applications
CRC
Variable
Misc. Attributes
Nomenclature Sequencer
Code
Expiration Date
Serial Number
16
20
50
10
32 avg. (8- 160)
64K
65,535-64K
2 to the 50st
1K
2 to the 280th
Copyright 2006, Bradley H. Sokol and Bill Newcum:
Universal Item Data
Reference Element
Nomenclature
Sequencer
5 layers of 3 digits
Item Reference
Shelf Life
Tag Tested: PHILPS- UCODE EPC G2 128 user Memory
October 25, 2006
Copyright 2006, Bradley H. Sokol
Cost of Data Ownership
Regulatory Compliance Verification
Use Case: 256 EPC Compliant DOD Data Construct
proposed Passive RFID Architecture & Data
Structures May 13, 2004: Nicholas Tsougas: DOD AIT
Office www.dodait.com/conf/ipt/0504/Day2/02EPC%20Data-DOD%20AIT%20IPT%20Brief%20May%2004%20v1.pdf
Variable fields, up to 3
separate, event entriesdenoted by Y/N Flags or
numeric flags for Adverse,
FDA approval, Sterilization
Cycle # , Clinical attributes
Recall, Rented, Loans
Reprocessing. Points to other
tag fields
Ordinal
Date
85 yrs
For individual item
tracking
Allows for 2 alpha
numeric characters
32k numeric.
1st 3 digits for
Sterilization Cycle
Verification Repross.
serial#
Loan/rent/ customer
#
A Road Map to Medical Device and
Instrumentation Pedigree
"We make technology easy to live with"
Reprocessing, Rental, Recall and Loaner
User Memory 128 Bits
Optional 32-128 Bits
Steps for 3 R’s and a L
Hospital
Closed-Loop Applications
Serial Number
20
32 avg. (32- 160)
5 event entries
2 to the 128th
Variable fields, up to 5
separate, event entriesdenoted by Y/N Flags or
numeric flags for Adverse
events, Maintenance Cycle #
Rented, Loans
Reprocessing.
Hospital
October 25, 2006
Copyright 2006, Bradley H. Sokol
Cost of Data Ownership
Regulatory Compliance Verification
1. Original product Mfg. serial # stays the same
2. Misc. Attribute field is activated for respective event.
a. Y/N or Numeric entry up to 3 numbers
3. Serial # assigned from Distributor Database
a. Nom. Seq. Code is updated to point to respective data
base
i. Optional User memory field could include new
serial # or code
4. Write to tag
5. Product received and Public (Regulatory) and Private
databases updated
Variable
Misc. Attributes
For individual item
tracking
Allows for 4 alpha
or 7 numeric
characters.
1st 3 digits for
Sterilization Cycle
Verification
Repross. serial#
Loan/rent/
customer#
A Road Map to Medical Device and
Instrumentation Pedigree
"We make technology easy to live with"
USER MEMORY for Sterilization in a Closed Loop
User Memory
Closed-Loop
Clinical Event
Variable
Misc. Attributes
Serial Number
20
32 avg. (32- 128)
5 event entries
2 to the 128th
Cost of Data Ownership
Regulatory Compliance Verification
Sterilization Event
Variable fields, up to 5
separate, event
entries- denoted by
Y/N Flags or numeric
flags for Sterilization
Cycle # , maintenance
Rented, Loans
Reprocessing.
Tracking of
each
Sterilization
Cycle uses
the 1st 3
digits to
count each
cycle
Copyright 2004, Bradley H. Sokol and Patni Corporation:
“The Future Adaptation of RFID to the Healthcare Industry”
October 25, 2006
CopyrightCopyright
2006, Bradley
2006, H.Bradley
Sokol H. Sokol
A Road Map to Medical Device and
Instrumentation Pedigree