modernize the orthopaedic supply chain: a surgeon’s view

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

How Does A PracHcing Ortho Surgeon Get Involved With Supply Chain

At HSS

•  Chief Knee Service

•  Co-‐Chief Quality Coordina6ng Commi9ee

Surgical Errors Problem

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

§ 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

California

InternaHonal Problem -‐ Box Labels are English

Medical Error & Waste – Problem In Ortho

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

• 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

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. !

Future of Healthcare Increased Transparency and Scrutiny

The Problem

• Current Implant Selec6on Process is:– Error Prone

– Backwards compared to Pharmacy etc.

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 !!!

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

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

Rules for some newer systems even more complicated

§ Zimmer – Persona§ Release in 2013 - Below are 5 of the 7 Persona compatibility charts

If that wasn’t confusing enough

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

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

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

Barcode Entry Used to Identify Implant Information

§Nurse in OR Scans Barcode on Box

§Manufacturers’ RulesApplied through ComputerAlgorithm

§All Manufacturers’ ImplantsDisplayed with Common§“e.Tag”

§“e.Tag” is SMART§ Checks Side, Compatibility of

Parts and Expiration

e.Label Displayed on LCD in OR

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

.!

Check Compatibility with Patient Implant Part is WRONG Side

Changed to Correct Side

Check Compatibility with System Rules & Expiration Date

Error - Corrected with Recommended Insert

Example of Expired Implant

Web Based e.Label Can Also Alert OR of PRODUCT RECALLS !!!

§ 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 AddedEfficiency & Safety

§ Embraced by Nursing Staff§ Feel More Confident & Safe about OpeningImplants

RESULTS

§QA and Risk Management – Pleased with Added SafetyExample of Error!

Identified/Prevented!

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!

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

• Current Process is:

with

– Creates e.Tag on large LCD screen in OR –• Easy to Read e.Tag• All Implant Systems DisplayedSame Format

–  e.Tagis a SMART Label –• Checks Side• Compa6bility of Parts• Expira6on• Recalls

What We Discovered Along the Way to the Q/A Improvements

Implant Suppy !Chain!

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

§ OpLogix leverages “Intelligence” and Knowledge embedded inOrthoSecure§ Knows all compatibility§ Knows all inventory

§ Implants Scanned as Part of Routine Implant “Time Out”§ Accurate§ No duplicate entry

Patient/Clinical!Implant Quality/!Supply Chain!!!!

Transmit case information

(date, surgeon, implant systems)

Transmit Quality Check

Documentation

(OrthoSecure)!

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.

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!

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

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

Surgeon Schedule & Preferences Maintained

Smart TemplaHng & Implant SelecHon

Results – Saving $$$ • Reduced Implant • Implants Picked Night before Cases

– Decreased Manpower

• More efficient Instrument Usage – Prepare Selected Instrumenta6on


The Problem – Mistakes Happen

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

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!

• Current Process is: – Proven to Prevent Errors – Track Near Misses to Improve Systems

- Significant Reduc6on in Wasted Implants


• 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

The Problem Inefficient Inventory Management

• Manual Process – Labor Intensive – Reconcilia6on for Chart S6ck Labels

• Implants – Not Available – Costly Urgent Order

• Oversupply – Wasted Consignment -‐ Expensive

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?

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

---------------------------------------------------------

Electronically Sent to EMR, Data Base & Inventory Management

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

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

Savings from OpLogix Verify Alone!

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

Implant Management: In-sourced Model


PaHent


• Record Implants in mul6ple systems

• Reorder Implants • Analyze/Reconcile Data


(complex cases)




• 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

• Predict Implant Usage • Confirm Supply • Pick/Deliver Implants • Verify Compa6bility • Facilitate Resupply

Implant Management: OpLogix Model


PaHent


• Reorder Implants


(complex cases)




Conclusion - Technology Can Be Used to:

§ Prevent Operative Error§ Safer & Better Surgery

§ Improved Efficiency to Significant Cost Savings§ Hospital§ Distributor / Rep§ Manufacture

Thank you

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modernize the orthopaedic supply chain: a surgeon’s view

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