This document discusses modernizing the orthopedic supply chain from a surgeon's perspective. It describes current issues with the supply chain that can lead to medical errors and waste, including complex compatibility rules between implant systems, small labels, and time pressure in the operating room. The author outlines a new system called OrthoSecure that uses barcodes and electronic displays to efficiently check implant compatibility and prevent errors. A study found this system prevented all errors in over 4,600 joint replacements and reduced wasted implants. The document advocates expanding this approach and using supply chain data to further increase efficiency and cost savings.

2. Modernize
the
Orthopedic
Supply
Chain:
A
Surgeon’s
View
Steven
B
Haas
MD
Chief
the
Knee
Service
John
N.
Insall
Chair
Knee
Surgery
Hospital
for
Special
Surgery
Professor
of
Clinical
Orthopedics
Weil
Cornell
Medical
College

3. How
Does
A
PracHcing
Ortho
Surgeon
Get
Involved
With
Supply
Chain

4. At
HSS
• Chief
Knee
Service
• Co-­‐Chief
Quality
Coordina6ng
Commi9ee

5. Surgical
Errors
Problem

6. Error
Prone
–
Medical
Errors
are
Common
• 2009
Survey
by
AAOS
– 53%
of
Respondents
Observed
a
Medical
Error
in
Past
6
Months
– 2.6%
of
Errors
Related
to
WRONG
IMPLANT

7. § Minnesota Hospitals
§ Never Events Increased from 305 to 316 in 2011
§ Wrong Procedure / Implant 62% ñ in 2011
§ Including 6 at Mayo Clinic
§ Orthopedic Errors in MN Included:
§ Wrong Knee Replacement Implants
§ Incorrect Ankle Implant

8. California
InternaHonal
Problem
-­‐
Box
Labels
are
English
Medical
Error
&
Waste
–
Problem
In
Ortho

9. How
ORen
are
Miss-­‐Matched
Components
Implanted
in
Pa-ents
• More
OQen
Than
We
Know
§ 1%
of
Revision
Hips
in
Recent
Bri6sh
Study
March 2014

10. • Almost
7,000
Total
Joint
Replacement
• 1-­‐2%
Cases
Had
Wrong
Part
Used
– Head/Liner
– Wrong
Tibial
Insert
• 4
Cases
Wrong
Side
Hosp Administrator!
Blinded Data from Hospitals!
( Public, Non-Profit and Private Hospitals) !
How
ORen
are
Mis-­‐Matched
Components
Implanted
in
Pa-ents

11. Wrong Implant – “Never Event”
§ Errors are Costly
§ Medico-legal
§Estimates for legal cost of wrong implant surgery –
Average $300,000 to $515,000 per surgical case**
§ Regulatory & Administrative
§$???
§ Damage to Hospital & Surgeon Reputation
§$???
!
State & Fed!
**1. Malpractice defense costs are real (2012) The Incidental Economist, 2.Medical malpractice costs continue to climb (2011), Medical Economics !
3. Surgical never events in the United States (2011) Johns Hopkins: 4. To Curb Malpractice Costs, Judges Jump In Early, (2011) NY Times New York !
5. Availability of Consumer Prices From US Hospitals for a Common Surgical Procedure, (2013), JAMA Internal Medicine Review. !

12. Future of Healthcare
Increased Transparency and Scrutiny

13. Future of Healthcare
Increased Transparency and Scrutiny

14. The
Problem
• Current
Implant
Selec6on
Process
is:
– Error
Prone
– Backwards
compared
to
Pharmacy
etc.

15. Error
Observed
-­‐
Despite
Elaborate
TradiHonal
Measures
• Mandatory
Time
Out
• Restric6ons
of
Who
Can
Pick
Implants
• Extensive
Training
&
Reinforcement
• Implants
Checked
by
Nurse
&
Surgeon
• Video
Cameras
&
Monitors
Errors Still Occur !!!

16. Why?????
What
is
Unique
to
Implant
Errors
• Time
Pressure
• Implant
Systems
Compa6bility
Rules
• Labeling

17. Problems
Implant Systems Compatibility Rules
§Implant Systems are Governed by a Set of Rules
§Each Implant System has a Very Different Rule Set
§Can Be Complex & Confusing
§While Surgeon Knows System Rules...
§ Nurses Can’t Be Expected to Know Rules For All Systems
§ Hospital is Reliant on Company Reps in OR

18. Rules for some newer systems
even more complicated
§ Zimmer – Persona
§ Release in 2013 - Below are 5 of the 7 Persona compatibility charts

19. If that wasn’t confusing enough

20. Problems - Labeling
§ Labels Often Small & Difficult to Read
§ Labels - Different Fonts, Size & Location

21. How Boxes Look in OR
• This is walking away from surgical field!

22. What Has Been Done in Other
Areas of Medicine
§ Let’s Look at the Pharmacy
§ Computers Detect Drug Interactions, Allergies, Dosing, etc.
§ Significant Reduction in Errors
Why Not Use Computer Software to Prevent
Implant Errors

23. Barcode Entry Used to Identify Implant Information
§Nurse in OR Scans Barcode on Box

24. §Manufacturers’ Rules
Applied through Computer
Algorithm
§All Manufacturers’ Implants
Displayed with Common
§“e.Tag”
§“e.Tag” is SMART
§ Checks Side, Compatibility of
Parts and Expiration

25. e.Label Displayed on LCD in OR

26. e.Label Page - Nurse Points to Desired Implant then Scans Barcode
.!

27. Check Compatibility with Patient
Implant Part is WRONG Side

28. Changed to Correct Side

29. Check Compatibility with
System Rules & Expiration Date

30. Error - Corrected with Recommended Insert

31. Example of Expired Implant
Web Based e.Label Can Also Alert OR of PRODUCT RECALLS !!!

32. § Scanning Implants Is Rapid
§ < 4 sec per Implant with Total Scan Time < 30 sec
§ Time Saving Compared to Conventional Process
§ Surgeons Pleased with Readability of e.Tag
§ Hospital Management – Pleased with Added
Efficiency & Safety
§ Embraced by Nursing Staff
§ Feel More Confident & Safe about Opening
Implants
RESULTS

33. §QA and Risk Management – Pleased with Added Safety
Example of Error!
Identified/Prevented!

34. 0.00
1.00
2.00
3.00
4.00
5.00
6.00
Conventional Ortho.Secure
Conventional
Ortho.Secure
Percent of Cases with Wasted Part!
0.8%
5.7%
In Addition to Preventing Critical Error in Study!

35. Results HSS
4,619 THA & TKA
§ Near Miss – Mismatch Detected
§ Identified in 1.5% Cases
§Wrong Side Implant in TKR
§Mismatching head size (head didn’t match liner)
§Mismatching tibia insert (incomp. with tibia or femur)
§Liner not matching acetabular shell
§Wrongs system femur scanned (Same manufacturer)
§ System Prevented ALL ERROR

36. • Current
Process
is:
with
– Creates
e.Tag
on
large
LCD
screen
in
OR
–
• Easy
to
Read
e.Tag
• All
Implant
Systems
Displayed
Same
Format
– e.Tagis
a
SMART
Label
–
• Checks
Side
• Compa6bility
of
Parts
• Expira6on
• Recalls

37. What We Discovered Along the Way
to the Q/A Improvements
Implant Suppy !Chain!

38. Inefficient and Wasteful Supply Chain
§Marked Inefficiency
§Wasted Space
§ Too much inventory
& equipment
§Wasted Time & Manpower
§ Manual data entry
§ Inefficient use of Manpower
§ Hospital
§ Vendor / Reps
§Wasted Money

40. § OpLogix leverages “Intelligence” and Knowledge embedded in
OrthoSecure
§ Knows all compatibility
§ Knows all inventory
§ Implants Scanned as Part of Routine Implant “Time Out”
§ Accurate
§ No duplicate entry

41. Patient/Clinical!
Implant Quality/!
Supply Chain!
!
!
!
Transmit case
information
(date, surgeon,
implant
systems)
Transmit
Quality Check
Documentation
(OrthoSecure)!

42. OpLogix Suite
41
A cloud-based software application that efficiently ensures that
the right medical devices are available, ready and implanted
during joint replacement surgeries.

43. What if Amazon Worked Like Implants
I plan to purchase ONE pair -!
Please send me All Shoes in!
Pink and Brown in !
ALL Sizes!
!
!
!
!
Free Shipping!

44. Large Savings Available
by Improving Efficiency
§ Hospital
§ Decrease in Cost of Implants
§ Decrease Cost of Managing Inventory and Documentation
§ Distributor / Rep
§ Less Inventory
§ More Efficient Use of Reps
§ Manufacturer
§ Cost Saving
§ Allows Continuation of Technology Improvements

45. Inventory management – TOO MUCH INVENTORY
§Large Inventory kept on shelf or brought to hospital for case
§Implant size selection usually made in OR
at time of surgery
§No advanced inventory planning
§Inventory not based on needed implant sizes
§Instruments – ALL SIZES
§Inefficient & Costly for Manufacturer, Distributor & Hospital
The Problem – Marked Inefficiency

48. Surgeon
Schedule
&
Preferences
Maintained

49. Smart
TemplaHng
&
Implant
SelecHon

50. Results
–
Saving
$$$
• Reduced
Implant
• Implants
Picked
Night
before
Cases
– Decreased
Manpower
• More
efficient
Instrument
Usage
– Prepare
Selected
Instrumenta6on

51. • Current
Process
is:
The
Problem
–
Mistakes
Happen

52. Even
When
Errors
are
Recognized
Prior
to
ImplantaHon……there
is
a
cost
•
Significant
Cost
to
These
Wasted
Implants
•
Range
in
Price
of
Individual
Parts
–
Femoral
Implant
$2,000
-­‐
>
$8,000
–
Tibial
Insert
$1,500
-­‐
>$3,000

53. Wasted
Implants
are
a
Significant
Cost
to
Health
Care
System
• Annualized
Cost
of
Wasted
Implants
in
the
United
States*
–
$36,000,000
to
>
$100,000,000
Zyweil M et al J of Arthropalsty 2010!
Ast M et al J Arthroplasty 2013!

56. • Current
Process
is:
– Proven
to
Prevent
Errors
– Track
Near
Misses
to
Improve
Systems
- Significant
Reduc6on
in
Wasted
Implants

57. • Current
Process
is:
• Manual
EMR
documenta6on
and
Billing
• Documenta6on
is
TIME
CONSUMING
&
INACCURATE
• Requires
nurse
in
OR
to
document
in
EMR
• Stock
#,
Descrip6on,
Disposi6on,
Part
#,
Quan6ty,
Site,
Manufacturer,
Descrip6on,
Lot
/
Serial
#,
Expira6on
Date
The
Problem
Inefficient
EMR
DocumentaHon

58. The
Problem
Inefficient
Inventory
Management
• Manual
Process
–
Labor
Intensive
– Reconcilia6on
for
Chart
S6ck
Labels
• Implants
–
Not
Available
– Costly
Urgent
Order
• Oversupply
– Wasted
Consignment
-­‐
Expensive

59. PR ORDER
I PLA' TS
SCHEDU E
PROCEDURE
�elution
DELIVER
IMPLANTS 0
OPERATNG
VER FY
IMPLA TS
OOM
PROCUREMENT
REQU ST
CONSU
IMPLA
TIME 0
R O DER?

61. OpLogix Supply Oplogix"
VERIFY
Consumed
Implants
• Streamlines procurement by
eliminating manual process
of sticker records and
reconciliation
• Automatically updates on­
hand balances
• Tracks supply with minimal
effort - providing visibility
into consigned inventory
supply
�---------------------------------------------------------
Reduces
On-Hand
Balance for
Each Item
SUPPLY
Electronic
"Bill and Replace"
Purchase Order Request
For Consumed Implants
Electronic
Purchase
Order
Increases
On-Hand
Balance for
Each Item
"One-Click"
Receipt
Supply
---------------------------------------------------------

62. Electronically
Sent
to
EMR,
Data
Base
&
Inventory
Management

63. EMR Documentation, Billing, Inventory/Reordering –
OpLogix Integrated to EMR & Implant Ordering
§ OpLogix Integration Module
§Nurse - NO NEED for manual entry
§ LESS COST & MORE ACCURATE
§Electronically completes EMR, Billing System
§ Used Inventory Sent to Invetory System
§ Automatic Reordering Used at Some Hospitals
§No need for costly reconciliation of Inventory Mgt to EMR
§ Currently integrated with “Picis”,“Epic”, QSight

64. Results – Saving $$$ - Manpower & Satisfaction
§ Manpower
§ Time Saving for Nurses
§ Accurate Data
§ Efficient Use Manpower
§ Greater Satisfaction
§ Improved Inventory Management
§ Less Wastage
§ No Shortages despite more lean inventory

65. Savings from OpLogix Verify Alone!

66. Implant Management:
Outsourced Model
PROPRIETARY & CONFIDENTIAL 65
PaHent
Hospital
Staff
• Prepare/Assist
Surgery
• Record
Implants
in
mul6ple
systems
• Reorder
Implants
• Analyze/Reconcile
Data
Supplier
• Prepare/Assist
Surgery
New
applica6ons
leverage
Internet,
Smart
Phones,
tablets
to
enhance
communica6ons
between
key
par6es…
…but
they
mostly
speed
up
the
exis6ng
process
Surgeon
• Diagnose
• Schedule
• Determine
System,
Size
&
Special
Needs
• Perform
surgery
• Track
outcome
• Supplier-­‐reliant,
inefficient
process
• Accountability
unclear
• Changes/requests
not
always
communicated
• Missing
parts
can
cause
case
delays/
rescheduling
• No
visibility
into
consigned
inventory
–
hospitals
carry
excessive
amounts
• Incorrect
devices
implanted
(up
to
1%
of
cases)
• Predict
Implant
Usage
• Confirm
Supply
• Pick/Deliver
Implants
• Verify
Compa6bility
• Facilitate
Resupply

67. Implant Management:
In-sourced Model
PROPRIETARY & CONFIDENTIAL 66
PaHent
Hospital
Staff
• Prepare/Assist
Surgery
• Record
Implants
in
mul6ple
systems
• Reorder
Implants
• Analyze/Reconcile
Data
Supplier
• Prepare/Assist
Surgery
(complex
cases)
Surgeon
• Diagnose
• Schedule
• Determine
System,
Size
&
Special
Needs
• Perform
surgery
• Track
outcome
• Predict
Implant
Usage
• Confirm
Supply
• Pick/Deliver
Implants
• Verify
Compa6bility
• Facilitate
Resupply
To
reduce
costs
and
clarify
accountability,
hospitals
can
take
on
tradi6onal
Supplier
responsibili6es,
but
must
“sole
source”
AND
increase
staff

68. • Predict
Implant
Usage
• Confirm
Supply
• Pick/Deliver
Implants
• Verify
Compa6bility
• Facilitate
Resupply
Implant Management:
OpLogix Model
PROPRIETARY & CONFIDENTIAL 67
PaHent
Hospital
Staff
• Prepare/Assist
Surgery
• Reorder
Implants
Supplier
• Prepare/Assist
Surgery
(complex
cases)
Surgeon
• Diagnose
• Schedule
• Determine
System,
Size
&
Special
Needs
• Perform
surgery
• Track
outcome

69. Conclusion - Technology Can Be Used to:
§ Prevent Operative Error
§ Safer & Better Surgery
§ Improved Efficiency to Significant Cost Savings
§ Hospital
§ Distributor / Rep
§ Manufacture

70. Thank you