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Modernize the Orthopaedic Supply Chain: A Surgeon’s View

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Orthopaedic device manufacturers face increased pressure to assist their hospital customers with the shift to value and accompanying quality and cost mandates. Hospitals have responded to these pressures by supporting more surgeries with reduced hospital and vendor staff, making the implant management process ripe for errors.

As the Hospital for Special Surgery's Chief of Knee Services since 2006 and Co-Chairman of the Quality Coordinating Committee since 2008, Steven Haas, M.D., has experienced firsthand the way that tremendous inefficiencies in the implant delivery system impact surgical outcomes and lead to greater costs for the hospital and manufacturer. For orthopaedic device company attendees, Haas will offer recommendations to assist hospital partners in meeting quality and cost demands.

During his Keynote Address, Haas will explain how technology can modernize the orthopaedic supply chain, including inventory management and the device labeling process, and eliminate "never events."

We’re at a point in healthcare where every dollar is watched, and a more efficient supply chain could be used to offset the cost of newer or improved implants.

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Modernize the Orthopaedic Supply Chain: A Surgeon’s View

  1. 1. 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    
  2. 2. How  Does  A  PracHcing  Ortho  Surgeon   Get  Involved  With  Supply  Chain  
  3. 3. At  HSS   •  Chief  Knee  Service   •  Co-­‐Chief  Quality  Coordina6ng  Commi9ee  
  4. 4. Surgical  Errors  Problem  
  5. 5. 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  
  6. 6. § 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
  7. 7. California   InternaHonal  Problem  -­‐  Box  Labels  are  English   Medical  Error  &  Waste  –  Problem  In  Ortho  
  8. 8. 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
  9. 9. • 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  
  10. 10. 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.  !
  11. 11. Future of Healthcare Increased Transparency and Scrutiny
  12. 12. Future of Healthcare Increased Transparency and Scrutiny
  13. 13. The  Problem   • Current  Implant  Selec6on  Process  is: – Error  Prone – Backwards  compared  to  Pharmacy  etc.
  14. 14. 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 !!!
  15. 15. Why?????   What  is  Unique  to  Implant  Errors   • Time  Pressure   • Implant  Systems  Compa6bility  Rules   • Labeling      
  16. 16. 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
  17. 17. Rules for some newer systems even more complicated § Zimmer – Persona § Release in 2013 - Below are 5 of the 7 Persona compatibility charts
  18. 18. If that wasn’t confusing enough
  19. 19. Problems - Labeling § Labels Often Small & Difficult to Read § Labels - Different Fonts, Size & Location
  20. 20. How Boxes Look in OR • This is walking away from surgical field!
  21. 21. 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
  22. 22. Barcode Entry Used to Identify Implant Information §Nurse in OR Scans Barcode on Box
  23. 23. §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
  24. 24. e.Label Displayed on LCD in OR
  25. 25. e.Label Page - Nurse Points to Desired Implant then Scans Barcode .!
  26. 26. Check Compatibility with Patient Implant Part is WRONG Side
  27. 27. Changed to Correct Side
  28. 28. Check Compatibility with System Rules & Expiration Date
  29. 29. Error - Corrected with Recommended Insert
  30. 30. Example of Expired Implant Web Based e.Label Can Also Alert OR of PRODUCT RECALLS !!!
  31. 31. § 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
  32. 32. §QA and Risk Management – Pleased with Added Safety Example of Error! Identified/Prevented!
  33. 33. 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!
  34. 34. 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
  35. 35. • 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  
  36. 36. What We Discovered Along the Way to the Q/A Improvements Implant Suppy !Chain!
  37. 37. 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
  38. 38. § 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
  39. 39. Patient/Clinical! Implant Quality/! Supply Chain! ! ! ! Transmit case information (date, surgeon, implant systems) Transmit Quality Check Documentation (OrthoSecure)!
  40. 40. 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.
  41. 41. 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!
  42. 42. 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
  43. 43. 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
  44. 44. Surgeon  Schedule  &  Preferences  Maintained  
  45. 45. Smart  TemplaHng  &  Implant  SelecHon  
  46. 46. Results  –  Saving  $$$   • Reduced  Implant     • Implants  Picked  Night  before  Cases   – Decreased  Manpower   • More  efficient  Instrument  Usage   – Prepare  Selected  Instrumenta6on  
  47. 47. • Current  Process  is:   The  Problem  –  Mistakes  Happen  
  48. 48. 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  
  49. 49. 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!
  50. 50. • Current  Process  is:   – Proven  to  Prevent  Errors     – Track  Near  Misses  to  Improve  Systems   - Significant  Reduc6on  in  Wasted  Implants  
  51. 51. • 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    
  52. 52. The  Problem   Inefficient  Inventory  Management   • Manual  Process  –  Labor  Intensive   – Reconcilia6on  for  Chart  S6ck  Labels   • Implants   –  Not  Available     – Costly  Urgent  Order   • Oversupply   – Wasted  Consignment  -­‐  Expensive  
  53. 53. 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?
  54. 54. 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 ---------------------------------------------------------
  55. 55. Electronically  Sent  to  EMR,   Data  Base  &  Inventory  Management  
  56. 56. 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
  57. 57. 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
  58. 58. Savings from OpLogix Verify Alone!
  59. 59. 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  
  60. 60. 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  
  61. 61. • 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  
  62. 62. Conclusion - Technology Can Be Used to: § Prevent Operative Error § Safer & Better Surgery § Improved Efficiency to Significant Cost Savings § Hospital § Distributor / Rep § Manufacture
  63. 63. Thank you

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