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Uk1 On Q Hospital Committee Presentation

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Presentation presented to begin the process of establishing my product as a regular option for post-operative pain management.

Presentation presented to begin the process of establishing my product as a regular option for post-operative pain management.

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  • 1. University of Kentucky Medical Center Evaluation Meeting June 2, 2005
  • 2. I-Flow Corporation
    • Public company (symbol IFLO)
    • Incorporated in 1985
    • 2004 Revenue $71.1 Million
    • Over 700 Employees
      • Over 200 in Sales Team
      • Over 300 in Production
    • Market leader in ambulatory infusion pumps
      • Wound Site Pain Management
      • Homecare IV
      • Oncology
  • 3.
    • 80% of patients experienced acute pain after surgery
    • Most patients had moderate, severe or extreme pain
    • Ambulatory patients experienced more pain after discharge than when they were in facilities
    1 Anesthesia and Analgesia: 2003; 97:534-40 1
  • 4. Causes for Unanticipated Hospital Readmission Following Ambulatory Surgery 1
    • Pain
    • Excessive Bleeding
    • Intractable Vomiting
    • > 40% due to Pain or Narcotic Side Effects
    • Readmission Rates Increase with Age
    1 Gold BS Unanticipated admission to the hospital following ambulatory surgery, JAMA 1989 Dec 1: 262 (21):3008-10
  • 5. Narcotics Side Effects
    • Nausea and Vomiting
    • Ileus
    • Urinary retention
    • Respiratory depression
    • Restricted Ambulation
    • Sedation
    • Confusion
    • Constipation
    • Tolerance/Abuse
    Longer Hospital Stays & Increased Costs
  • 6. FDA Indications
    • Submitted clinicals as evidence
    • This therapy is significantly better than today’s standard of care (narcotics)
    Current Best Practice
  • 7. ON-Q Clinical Research Summary
    • 49 completed and presented studies
    • Results
      • 90%+ patient satisfaction
      • 1 to 3 day length of stay reduction
      • 40-70% reduction in narcotics
      • 8-30% reduction in treatment costs
      • 22% reduction in chronic pain at 6 months
      • Improved Shoulder Function at 2 ½ years
      • Infection rates less than national averages
      • Substantial reductions in pain scores
  • 8. Completed and Presented Studies
    • Dowling CABG
    • White CABG and Foot and Ankle
    • Dimaio Thoracotomy
    • Zimberg Total Abdominal Hysterectomy
    • Givens C-Section
    • Fredman C-Section
    • Sood GYN Oncology
    • Gottschalk Shoulder
    • Klein Rotator Cuff Repair
    • Rawal 2 Studies, Multiple procedures
    • Morrison/Jacobs Mastectomy
    • Thorson Colectomy
    • Cheong Colectomy
    • Wexner Colectomy
    • Kumar Hemorrhoidectomy
    • Hoenecke Shoulder and Knee Repairs
    • Stringer Laparascopy
    • Gupta Laparoscopic Cholecystectomy
    • Vintar Hernia
    • LeBlanc Hernia
    • Waxman Hernia
    • Patel Hand Assisted Nephrectomy
    • Schell Axillary Lymph Node Dissection
    • Pacik Breast Augmentation
    • Spann Breast Reconstruction
    • Lavand;homme C-Section
    • Caulry C-Section
    • Mills Abdominoplasty
    • Spann Breast Reconstruction
  • 9. Evolution of Pain Control
    • General Epidural
  • 10. Product Description
    • A simple pain relief system that automatically delivers a local anesthetic to a surgery site over multiple days
    • Provides better pain relief than traditional narcotics without the related side effects
  • 11. Cross-section of the pump
  • 12. Dual Model(s)
    • Soakers are pressured independently ensuring even distribution
    • Y-site on standard pump would result in med going to the lowest lying catheter
    • Competitive products do not operate on the same principle
  • 13. Diagram of Y-Site Design
  • 14. Patented Soaker Technology
    • Infuses medication over a wider area for enhanced distribution
    • Better pain control
  • 15. What does “Soaker” mean?
  • 16. System Features & Benefits
    • Patented Soaker Catheter Technology
      • Even distribution of drug across surgical site.
    • Preset Flow Rate
      • Eliminates runaway infusions
      • Patient cannot tamper with flow rate
    • Disposable/Non-electronic
      • No maintenance or alarm issues
      • No programming errors
      • Easy to teach patient and staff
  • 17. ON-Q C-Bloc
    • Models offered:
      • Flow rates
        • 10 ml/hr
        • 5 ml/hr
        • 5 ml/hr basal with 5 ml bolus/hr
        • 2-14 ml/hr adjustable
      • Volumes
        • 270 ml to 550 ml
      • Delivery from 1 to 5 days
  • 18. Dedicated Support
    • Sales People
      • 123 Territory Managers
      • 35 Sales Associates
      • 19 Nurses
      • 23 Billing Representatives
      • 10 Inside Sales Representatives
    • 24 Hour Nurse Hotline
    • Largest Volume of Support Materials
  • 19. Multiple Specialty Applications
    • Cardiovascular
    • Thoracic
    • Bariatric
    • OB/GYN
    • General
    • Urology
    • Plastic
    • Colorectal
    • Orthopedic
  • 20. Catheter Placements
  • 21. Nursing Quick Reference Guides
  • 22. Patient Brochures
  • 23. Economics
  • 24. Length of Stay Reduction 1.3 Breast Recon Spann .5 Iliac Crest Walker .5 Mastectomy Jacobs/Morrison 1 Colorectal Thorson 1 Hand assist Nephrectomy Patel 1-3 CABG Dowling 1 Foot and Ankle 1.5 CABG White 2 Abd. Hysterectomy Zimberg LOS Savings (days) Procedure Investigator
  • 25. Examples of Inpatient to Outpatient Conversion
    • TAH – Cleveland Clinic, FL
    • Total Hips – UPMC
    • Gastric Bypass – Baylor, Dallas
    • Foot and Ankle – UTSW
    • Breast Reconstruction – NY Presbyterian
    • Prostatectomy – St. Vincent's, Birmingham
    • Spine – St. Thomas, Nashville
    • Orthopedic (Rotator Cuff and ACL) – Nationwide
    • Mastectomy - Nationwide
  • 26. PCA Economics $600+ Total 3 day cost ? Narcotic Complications $100+ PONV Meds $50 Nursing Labor to maintain $50-200/2days Pharmacy Fill of Narcotic Bag $10/day Flushing supplies $10-60 IV catheter and tray $3-5 Admin Set $20-50/day Pump Costs Description
  • 27. Costs Associated with Ileus Reduction
  • 28. Actual Costs for One Hospital $3,005 10.59 $31,821 AAA $1,424 5.00 $7,124 Thoracotomy $1,548 13.63 $21,101 Colectomy $2,720 7.59 $20,646 CABG $1,929 3.73 $7,187 TAH $3,765 4.34 $16,326 Total Hip Average Cost/Day Average LOS Average Total Cost Procedure
  • 29. Projected Savings With ON-Q *Assumes last day is only 25% of Average Cost/Day **Assumes ON-Q costs $300 and a 1 day LOS reduction $241,000 Total $8,000 $6,000 $4,000 $53,000 $29,000 $141,000 Annualized Savings $3,005 $1,424 $1,548 $2,720 $1,929 $3,765 Average Cost/Day $451 $751 AAA $56 $356 Thoracotomy $87 $387 Colectomy $380 $680 CABG $182 $482 TAH $641 $941 Total Hip Savings with ON-Q ** 25% Last Day Cost * Procedure
  • 30. Projected Savings With ON-Q *Assumes last day is only 25% of Average Cost/Day **Assumes ON-Q costs $300 and a 1 day LOS reduction $241,000 Total $8,000 $6,000 $4,000 $53,000 $29,000 $141,000 Annualized Savings $3,005 $1,424 $1,548 $2,720 $1,929 $3,765 Average Cost/Day $451 $751 AAA $56 $356 Thoracotomy $87 $387 Colectomy $380 $680 CABG $182 $482 TAH $641 $941 Total Hip Savings with ON-Q ** 25% Last Day Cost * Procedure
  • 31. Higher Patient Volume
    • 1 day LOS reduction may mean 20% more patients can be treated
    • Revenues increase by 20% and Costs decrease
    • Profitability increases substantially
  • 32. Higher Patient Volumes: Example TAH Hypothetical example using LOS savings only. Additional profitability can come from reduced medications and complication treatments $37,810 $7005/case $266,190 $304,000 38 2.73 ON-Q +$161,040 +$13,420 -$182/case $50,580 +$64,000 8 1 Difference Annual Profit Gain $24,390 Monthly Profit $7187/case $215,610 Costs per Case per Month $240,000 Revenue ($8,000/case) 30 Monthly Patient Volume 3.73 LOS days PCA
  • 33. Bypass/Diversion Facts
    • 44% of Hospitals Lack Critical Care Beds
    • 24% have overcrowded ER’s
    • 14% lack Acute care beds
    • Reducing LOS one day is equivalent to adding 49 new beds to the facility
    Sources: Healthcare Financial Management March 2004 300 Bed Hospital at 85% census and average LOS 5.2 days Lewing Group Analysis
  • 34. What is ON-Q Cost Equivalent To?
    • ½ day of PCA or
    • ¼ day of Epidural or
    • 3 Zofran pills or
    • 4 hours of hospital stay or
    • 1 pharmacy refill of PCA Meds or
    • 12 minutes of ICU time or
    • 4 ¼ hours of nursing time or
    • 1 PT Visit or
    • 1/10 th Readmission or
    • 1/50 th Infection
  • 35. Total Billed Charges Capitation fixed negotiated rate paid per member per month for health care services Case Rate flat negotiated rate for a defined procedure & length of stay Per Diem flat negotiated daily rate defined by level of care Discounted Fee for Service % of total gross charges PPO Indemnity POS/EPO HMO % of All Payments <5% <10% Approx.30% Approx.30% Approx.30% The hospital will generate a bill for all charges for all services during a patient’s entire confinement, including ON-Q. Whether they will receive payment for billed charges for ON-Q will depend upon the particular payment arrangements in place with the particular payor .
  • 36. Facility Reimbursement
    • HCPS Coding
      • CPT or Level I has not been established yet.
      • A4306 Elastomeric Pump (Level II)
      • 99070 Misc. Surgical Supply (Level III)
  • 37. Summary
    • The ON-Q Post-Operative Pain Relief System is a win-win for patients and hospitals with substantial:
      • Clinical Benefits
      • Patient Satisfaction Benefits
      • Economic Benefits
  • 38.  
  • 39.
    • ON-Q Product Display
    • And In-Service planning
  • 40. CLAMPS Should remain open unless otherwise directed by M.D. If patient experiences any signs and symptoms of toxicity, clamp and call M.D. FILL PORT Sterile one way valve. Indicated for one time use. Completely closed system. TUBING Assess tubing for kinks. If previously clamped always massage tubing at site to open kink. AIR FILTER Labeled with flow rate (ml/hr). Do not tape down! Needs to be lose with free air flow. Do not place under dressing, binders, or ACE wraps FLOW RESTRICTOR Keep taped to skin! Designed to maintain preset flow rate at body temperature. CATHETER Patented soaker technology. Soaker portion is placed in surgical site and is marked at the distal and proximal ends. Can be connected to pump in OR or at PACU. (If connecting in recovery leave end caps on.) ON-Q PUMP 3 -layer balloon system: 1.) Outer layer is a PVC covering. 2.) Middle layer is latex. (Does not come in contact with patient or medicine.) 3.) Inner layer is made of an elastomeric tubing and contains the medicine. Depending on model of pump used patient will either have a clip or fanny pack to attach to themselves for transport. DRESSING Recommended to use some adhesive like Mastisol in combination with Steri-strips to anchor the catheter down and an occlusive dressing to cover. For Questions or Concerns please contact: 24 hour Nurse Hotline @ 1-800-444-2728. Or your local representatives at: --------------------------------------------------------- ---------------------------------------------------------
    • Post Operative Checklist
    • Check to be sure the ON/OFF clamp is open
    • Assure the transparent dressing over the catheter site remains clean and dry. Nursing may reinforce the dressing with another transparent dressing if needed.
    • Be sure the flow restrictor is secured by tape.
    • Do not tape over the in-line filter.
    • It is not necessary to squeeze the pump. The force to deliver the medication is provided by the pump.
    • Secure the ON-Q pump to the patient's gown, clothing or bed clothing with the clip or fanny pack.
    • Be sure the cap is on the pump.
    Diagram of the ON-Q SYSTEM
  • 41.
    • Check to be sure the ON/OFF clamp is open
    • Assure the transparent dressing over the catheter site remains clean and dry. Nursing may reinforce the dressing with another transparent dressing if needed.
    • Be sure the flow restrictor is secured by tape.
    • Do not tape over the in-line filter.
    • It is not necessary to squeeze the pump. The force to deliver the medication is provided by the pump.
    • Secure the ON-Q pump to the patient's gown, clothing or bed clothing with the clip or fanny pack.
    • Be sure the cap is on the pump.
    Post Operative Checklist
  • 42. Pumps either come with a Clip or Fanny Pack
  • 43.  
  • 44. Clinical Information
  • 45. Research History
    • Crile (1913) wound catheter can cut post-op pain and reduce mortality
    • Capelle (1935) described wound perfusion with local anesthetics through irrigation apparatus
    • Blades and Ford (1950) Used fine catheter for thoracotomy incisions
    • Thomas (1983) Intermittent or Continuous Marcaine Cholecystectomy
    • Levack (1986) Abdominal wound perfusion
    • Narinder Rawal (1996) bolus paper in multiple procedures
    • Oakley (1998) Day surgery hernias elastomeric pump
    • ON-Q launched in 1998
    • Klein (2000) Day surgery Interscalene Blocks for Shoulder Surgery
    • Rawal (2002) PCRA at home
    • Ilfeld (2002) Infraclavicular and popliteal blocks at home
    • White (2002/3) Popliteal
    • Dowling (2003) CABG
    • Currently there is an EXPLOSION in clinical research in this field
  • 46. What Have We Learned from Clinical Research?
    • The Therapy Works!
    • Dosage is Critical
    • Catheter Placement is Extremely Important
    • There is a Favorable Infection Story
    • Patients Go Home Sooner and are Happier
    • There is a Wide Margin of Safety
    • There is a Long Term Benefit to Using ON-Q
  • 47. Klein Interscalene
  • 48. Gottschalk – Shoulder ** ** ** ** ** **# ** ** **# Gottschalk A, Anesth Analg 2003; 97: 1086-91
  • 49. VAS Values During Mobilization ** ** # ** ** ## ** ** # **p<0.005 vs. Gr. S; ## p<0.005, # p<0.05 vs. Gr. R2 Gottschalk A, Anesth Analg 2003; 97: 1086-91
  • 50. Cumulative Narcotic Requirement ** * **p<0.005, *p<0.05 Gr. R2 and Gr. R3.75 vs. Gr. S
  • 51. White, Open Heart 0.5% Bupivacaine 0.25% Bupivacaine Saline Postoperative Time (h) Postoperative Time (h) White P, Use of a Continuous Local Anesthetic Infusion for Pain Management after Median Sternotomy, Anesthesiology, V99, No. 4, Oct 2003
  • 52. Patient Satisfaction % of patients satisfied with pain management Saline 0.5% Bupivacaine 0.25% Bupivacaine
  • 53. 0 1 2 3 4 5 6 7 0 1 6 12 24 48 56 Blood Levels (  g/mL) Hours Postoperative Mean Postoperative Blood Levels Bupivacaine Lidocaine Ropivacaine Bupivacaine & Lidocaine Toxicity Level Ropivacaine Toxicity Level Pump out 2 cc/hr through single catheter
  • 54. Washington County Total Joint Nausea Vomiting
  • 55. Washington County Total Joint
  • 56. Wound Infiltration after Knee-/Hip Arthroplasty Morphine/Ketorolac IV vs. Bolus Ropivacaine 0.5% 40ml+cont. Infusion Ropivacaine 0.2% 5 ml/h n=37 Bianconi M et al, Br J Anaesth 2003; 91: 830-5
  • 57. Infection Rates ** National Nosocomial Infection Surveillance (NNIS) System Report, data summary from January 1992 through June 2004, issued October 2004 Am J Incect Control 2004;32:470-85. Procedure   Published Rate** % Rate with ON~Q Pump [i] % Number of Patients Mastectomy 1.74 0 44 Thoracotomy 2.47 0 69 CABG 2.19 0 111 C-Section 4.14 0 186 Hysterectomy 2.32 0 432 Bariatric 8.34 0 100 Inguinal Hernia 0.8 0.7 968 Colorectal 8.54 4.4 251 Prostatectomy 0.81 0 226 Nephrectomy 1.04 0 69 Orthopedic Surgery 1.48 0 328 General Surgery 4.02 0.69 2456 All Surgery 2.6 0.61 2784
  • 58. Antimicrobial Properties of Local Anesthetics
    • Local Anesthetics have Bacteriostatic/Bacteriocidal and Fungistatic/Fungicidal Properties
      • 16 in-vitro (petri dish) studies
    • Pilot Study in Guinea Pigs
      • Lidocaine reduced bacteria over 70%
      • First study to demonstrate inhibition by a local anesthetic agent in an in-vivo (live) model of a surgical wound.
      • Suggests a possible role for local anesthetics in prophylaxis against surgical wound infection.
  • 59. Why are Infection Rates Potentially Lower with PainBuster?
    • Local anesthetic antimicrobial activity
    • Local anesthetic vasodilation
    • Reduced pain increases oxygen levels in tissue
    • Reduced pain improves immune responses
  • 60. Long Term Benefit
  • 61. Lavand’homme et al C-Section Residual Pain % of Patients Having Pain
  • 62. Schell, Breast Cancer Shoulder Pain and Disability Index Mean Follow-up: 2.4 ±0.01 years 0: No Difficulty 100: Requires Help SPADI Item p < 0.05 * p = ns * * * * *
  • 63. Orthopedic Protocols
  • 64. Orthopedic Applications
      • ACL’s, Lateral releases, Patella realignment, Regenerative Chrondoplasty, Meniscal repairs
      • Rotator Cuff Repairs, Bankart Repairs, Subacromial Decompression
      • Hand/Wrist
      • Foot/Ankle
      • Total Joints
      • Trauma
  • 65. Subacromial Placement
  • 66. Post TKA pain management
    • Product #: PM014 (270ml @ 5ml/hr)
    • Single catheter 2.5cm soaker (obese-dual)
    • Place catheter under Quads.
    • Fill the joint with 30cc of 0.5% Ropivacaine
    • Drugs: 0.5% Ropivacaine (unilateral TKA)
    • 0.25% Ropivacaine (bilateral TKA)