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Instrument Testing and Validation

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Predicting an instrument's performance over time is essential to the design phase. This session will cover reliability testing and performance deterioration, including recommendations for tests that should be performed to ensure that an instrument will function through a lifetime of use, and ways to collect measurable outputs of the instrument from initial use to the end of its lifecycle.

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Instrument Testing and Validation

  1. 1. Testing and Validation of Disposable / Single- Procedure Surgical Instruments & Procedural Kits By James B. Schultz Executive Vice President 1
  2. 2. Disposables in the O.R.– The Way of the Future  Advent of single-procedure torque-limiting, fixed driver and related instruments and procedural kits offers viable substitute or alternative today  Clinical and economic value realized  Pristine instrument set for every surgery  Perfect instrument calibration  Eliminate re-processing costs/hassles  Annuity revenue potential  Customized products tailored to OEM specifications  Applied across all ortho implants—both new and legacy product lines  Embraced by major ortho/spine OEMs  A value add solution for ASCs with high volume, low complexity procedures and emerging markets instrumentation  23M surgeries per year at ASCs and over 18% are ortho/spine 2
  3. 3. Disposable instrument and sterile-pack kit adoption 3 Products Indication Spine Extremity Trauma
  4. 4. Sterile-Packed Surgery Ready Instruments & Kits 4
  5. 5. ECA’s Product Design & Development Engineering Stage Book/Step Process 5
  6. 6. Sterile-Packed Instrument Kit Testing & Validations Example of a 100% Disposable Sterile-Packed Procedural Kit Testing & Validations ECA’s Intelligent Implant Systems Revolution® Spinal Implant Kit  FDA-approved complete spinal implant instrumentation kit that is 100% disposable  Reduced 4 trays and 40 instruments to 11 instruments in one sterile-pack tray for single & 2 level fusions  Instrument EVT and DVT testing Packaging, Transportation, Aging and Bio/Cyto Validations  Listed with FDA  CE Mark ready  Product in market since Sept 2015 with scores of successful surgeries Pedicle Probe Bi-directional cannulated ratchet Torque Limiter Offset T-Handle Counter Torque Shaft Template Compression Distraction Shaft Fixed Driver T-Handle Introducer Sounder Bone Awl Nut Driver Shaft 6
  7. 7. Key Reliability and Validation Tests  Design verification  Engineering Validation Test (EVT) and Design Verification Test (DVT) stages of development, proto builds, pilot runs, vendor selection, BOM freeze  Design validation  Validate production equivalency, customer V&V testing  Packaging validation  Sterile Barrier Systems (SBS) baseline (tray/lid) includes bubble, peel testing  Distribution testing  Distribution to ISTA 2 standard  Sterilization validation  Validate to SAL 10-6 with gamma, ISO standard compliance  Assembled in ISO Class 7 cleanroom 7
  8. 8. Key Reliability and Validation Tests  Biocompatibility testing  FTIR, LAL and TOC  Corrosion resistance testing for stainless steel components  Citric or nitric passivation and immersion testing  Aging of packaging and instrumentation  2 year or more shelf life for packaging and instruments  NPI production hand-off  cGMP mass production implemented 8
  9. 9. Design & Development Process Includes Simulation, Automated and Manual Testing 9 FEA testing Manual Torque testing Shaft/driver Torsion testingAutomated Torque testing
  10. 10. Summary  Disposable instruments and procedural kits undergo comprehensive PD process to meet quality and regulatory / compliance requirements  Clinical robustness  DFMEA, PFMEA  Product Development Stage Gates  Design Inputs & Outputs  Validation and Verification testing  Full validations/reports & documentation (aging, bio/cyto, packaging, sterilization, transportation, labels, cleaning process, etc.)  OEM Checklists  NPI and cGMP process / handoffs  Pilot production  Manufacturer of Record, Traceability  Pristine instrument or procedural kit for every surgery and patient 10
  11. 11. CONFIDENTIAL ECA MEDICAL INSTRUMENTS 11 ECA Medical Instruments Corporate Headquarters 2193 Anchor Court Thousand Oaks, CA 91320 USA Tel: +1 (805) 376-2509 Fax: +1 (805) 376-2189 www.ecamedical.com Thank You!
  12. 12. Instrument Testing and Validation Session Clinical Re-Processing Cycles June 15, 2016 David M. Blakemore BoneSim Laboratories BoneSim Laboratories~~~ TM
  13. 13. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Agenda: • What is Clinical Re-processing • Why is it important • How does it affect us • How do we respond BoneSim Laboratories~~~ TM
  14. 14. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Clinical Re-processing Definition • Moving a surgical instrument from patient to patient. BoneSim Laboratories~~~ TM
  15. 15. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Clinical Re-processing Definition • Moving a surgical instrument from patient to patient. • Identification and preparation • Surgical Use • Cleaning and Sterilization • Storage BoneSim Laboratories~~~ TM
  16. 16. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Clinical Re-processing Cycles (CRC) •Instruments are Identified, Inspected, Functionally checked and placed on OR/Mayo stand •FDA calls this the Point Of Use Processing BoneSim Laboratories~~~ TM
  17. 17. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Clinical Re-processing Cycles (CRC) BoneSim Laboratories~~~ TM • Point of use The next speakers will cover much of the this subject but suffice it to say that it is put thru its paces. • Surgical intervention • Mechanical loading, bending, torque, axial, etc. • Exposure to blood, lipids, fats, etc. • Then placement in saline or enzyme solution
  18. 18. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Clinical Re-processing Cycles (CRC) SPD processing (Sterile Processing Department) BoneSim Laboratories~~~ TM •Rinsing •Cleaning - manual Detergent or Enzymatic detergent with manual brushing and removal of debris
  19. 19. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Clinical Re-processing Cycles (CRC) SPD processing (Sterile Processing Department) BoneSim Laboratories~~~ TM •Cleaning - Ultrasonic Detergent or Enzymatic detergent with high energy cavitation ambient or elevated temperatures
  20. 20. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Clinical Re-processing Cycles (CRC BoneSim Laboratories~~~ TM •Cleaning/disinfecting - automatic Rinse, enzymatic soak, detergent wash, rinse, heated dry Hospital SPDs use longest, highest temp. cycles when IFU is unclear, not available or considered not to be to their standard.
  21. 21. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Clinical Re-processing Cycles (CRC) BoneSim Laboratories~~~ TM •Terminal Sterilization autoclave, chemical, ETO, etc. Focusing on steam sterilization Hospital SPDs use longest, highest temp. cycles when IFU is unclear, not available or considered not to be to their standard.
  22. 22. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Clinical Re-processing Cycles (CRC) - Why is it important to us BoneSim Laboratories~~~ TM Material Selection
  23. 23. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Clinical Re-processing Cycles (CRC) - Why is it important to us BoneSim Laboratories~~~ TM Processing Instructions i.e., etching, material choice, passivation and passive layer compromise
  24. 24. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Clinical Re-processing - FDA BoneSim Laboratories~~~ TM Longevity of efficacy and sterility guarantee.
  25. 25. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Clinical Re-processing - FDA BoneSim Laboratories~~~ TM What’s New in the 2015 Final Guidance(vs the 1996 Guidance) Expanded to include information pertaining to validation of reprocessing methods and instructions • Specific emphasis on importance of proper cleaning & cleaning validation, IMPORTANCE OF WORST-CASE TESTING, importance of device designs that are less challenging to reprocess • Human factors considerations when validating reprocessing methods and instructions • Provides greater clarity on documentation to be provided in the different premarket submissions: 510(k), PMA, de novo, HDE, IDE
  26. 26. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Clinical Re-processing - FDA Guidance Document BoneSim Laboratories~~~ TM
  27. 27. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Clinical Re-processing – How do we respond? BoneSim Laboratories~~~ TM • Rely on clinically relevant data • Careful material selection • Best design practices • Test Data
  28. 28. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Clinical Re-processing BoneSim Laboratories~~~ TM Let’s look at potential costs and time. 5 Year lifecycle test (500 CRC only) Point of Use cycling $30/ea Washer/disinfector cycling $85/ea Autoclave cycling $130/ea $245 x 500 = $122,500.00 2-3 cycles per day shift, 5 days per week, blue sky…. 34 weeks for one design…….
  29. 29. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Clinical Re-processing - Why is it important to us BoneSim Laboratories~~~ TM Let’s look at potential costs and time. $122,500.00 cost and 34 weeks for one design……. This needs to be changed by a factor of 4/5 to make it feasible for companies and projects to move forward $25-35K and 8 weeks is more palatable, bundling projects/device designs also makes sense 100 cycle iterations brings it to <$10K and 1.5 weeks
  30. 30. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Clinical Re-processing Cycles (CRC) BoneSim Laboratories~~~ TM Two Choices: • Run CRC studies at IFU parameters • Run CRC studies at worst case known Facility parameters So what CRC cycles should we run?
  31. 31. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Clinical Re-processing Cycles (CRC) BoneSim Laboratories~~~ TM Pros •Creates data set at nominal conditions •Allows reporting valid findings •Minimizes risk of over designed components Run cycles at IFU parameters – pros/cons Cons •Does not address excursions •Burdens study timeline •May increase cost of study
  32. 32. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles BoneSim Laboratories~~~ TM Pros •Creates data set at worst case conditions (maybe) •Minimizes risk of failures from facilities over processing •Allows standards to be set for CRC •Reduces cost and timeline Choose worst case known Facility parameters – pros/cons Cons •Failures in testing may not be representative of design •Potential over design •May have subjective findings Clinical Re-processing Cycles (CRC)
  33. 33. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles BoneSim Laboratories~~~ TM •Create standard(s) to allow high throughput studies - 24/7 lab with large chambers/washers/baths always processing •Create central database for material and design parameters - Already done at some of the largest OEMs •Create artificial CRC aging procedures - Comparative data will take time to harvest What do we do today? Clinical Re-processing Cycles (CRC) Potential Opportunities
  34. 34. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Clinical Re-processing – Bonesim Laboratories BoneSim Laboratories~~~ TM • Soiling, ATS, DBLSO, serums • Pre-soaks, saline, enzyme • Manual cleaning/brushing • Ultrasonics • Automated cleaner/disinfectors • Repeat autoclaves – gravity/prevac • Dry cycles and cool-down • Lube cycles • Tap, RO/DI water rinses • Functional/assembly testing • US and European solutions • Pre/post/iterative photo documentation • Lab Certification and/or Technical Memorandum
  35. 35. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles BoneSim Laboratories~~~ TM • 24/5/7 operations • 100 CRC data in 1 week • Functional Testing – Mechanical w/partner Lab • Full Quality System • Immediate response – no waiting BoneSim Laboratories does not provide sterilization validation; this is to reduce overhead/costs that is passed to the customer Clinical Re-processing – Bonesim Laboratories
  36. 36. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles BoneSim Laboratories~~~ TM Thank You
  37. 37. OMTEC 2016 Instrument Testing and Validation Session Clinical Re-Processing Cycles Clinical Re-processing Definition • But as we move on, we find an abundance of articles addressing biofilm and prions, including the increased risk posed by the breakdown of surgical instruments’ passivation layer, leading to the formation of corrosion and rust, giving way to hidden microbial growth. It’s been well documented that surface corrosion will harbor microorganisms that can be reanimated after sterilization and cause nosocomial (hospital) infections. Ref. http://www.csspdmanager.com/photo6_1.html •As a result, there is no one process that is followed from state to state, let alone hospital to hospital. At annual conferences we hear the complaints over and over again, but keep accepting the fact that we do not follow the same process. The recommendations have been written by AAMI, ANSI, AORN, and OSHA as to what we should be doing, but can be interpreted in many ways •Moreover, there are some that add phosphoric acid rust and stain removers by the gallon to their sonic washers with little understanding as to the damage this causes to the passivation layer on stainless steel surgical instruments. Neither sonic or washer are designed to handle these types of process, let alone the surgical instruments. BoneSim Laboratories~~~ TM
  38. 38. June 15, 2016 Kevin J. Knight Knight Mechanical Testing
  39. 39.  Focus Today:  Reusable instruments  Class I devices, no published ASTM/ISO test methods  Surgical instruments that are designed to be cleaned, sterilized, and reused for subsequent surgeries  Typical materials:  Stainless steel:17-4PH, 18-8, 316L, high strength alloys  Durable polymers: PEEK, silicone, Radel®, Delrin  Three categories of instruments generally tested:  Impaction instruments  Torsional drivers  Cutting instruments 2
  40. 40. 3  Instruments engineered with impact in mind:  Broach/Rasp Handles  Impactors (cup, femoral knee)  Abusive environment  Impact forces range from 500lb (placement) to 6000 lb (seating) intraoperatively  Repetitive assembly/disassembly, cleaning, autoclave  Many points of potential failure  Numerous small welds  Springs, detents, u-joints, locking features, screw threads  Etchings, ID, tolerances
  41. 41.  MAUDE Database Reported Failures  Broach Handle: “During surgery the broach handle disengaged. The ball bearing and spring came out. The ball bearing fell into the patient.”  Cup Impactor: “Intraoperatively, the impaction plate broke.”  Femoral Impactor: “The impactor broke during impaction of the femoral trial.” 4
  42. 42.  Cyclic impact testing  Impact forces based off of literature or bench testing (3000 lb – 6000 lb)  Typical cycle life requirement = 5000 up to 20,000 impact cycles (typical 5 year life)  Impacts interspersed with disassembly, cleaning, and sterilization to simulate use  Post-test NDT (dye penetrant) to inspect for invisible failures 5
  43. 43. 6  Impact testing failure examples:  Fracture of the weld connecting the strike plate to the main shaft of hip stem inserter  Example of weld fracture only visible after dye penetrant inspection  T-handle elastic nail inserter – fracture of crossbar
  44. 44. 7  Two main types:  Interface directly with implant  Thread a screw into bone  Apply final tightening torque to a screw or locking component  Drive a cutting instrument  Wide variety of “quick connect” shafts for different cutting instruments  Flexible shafts for reamers and drills  Challenging environment  Designed to apply torque, but may also see off axis loading (bending, axial load)  Could see many fatigue cycles per surgery (drill speeds, 250-750RPM)  Subjected to harsh reprocessing environment (cleaning, autoclave)
  45. 45.  MAUDE Database Reported Failures  Screwdriver: “During surgery the tip of the screwdriver broke off into the screw.”  T-handle: “T handle stripped during surgery and would not lock onto the reamers.”  Reamer Adapter: “It was reported during an unknown patient procedure that the handle broke at the power adapter end while the surgeon was reaming the acetabulum.” 8
  46. 46.  Repetitive torque testing for screwdrivers and torque setting devices  Special attention paid to wear of tip over time, as well as functionality of screw retention features  Torsional ultimate strength testing for torsional drivers to ensure expected torque load is within linear elastic range  Rotational testing for instruments and adapters driven by powered drills  Internal components effected by repetitive re- processing, liquid intrusion, wear, galling, etc. 9
  47. 47.  Typical torque test set ups:  Hexalobe driver fracture from cyclic torsional loading  Torque specification life cycle evaluation for continuously rotating “click type” torque limiting T-handle  Simulated use testing for flexible reamer with application of cyclic torque at constant RPM 10
  48. 48. 11  Commonly tested for cutting efficiency over time:  Drills  Reamers  Harsh environment  High torsional loads encountered while cutting hard bone  Possible high temperatures during drilling/reaming  Repetitive cleaning and autoclave  Two potential failure modes  Fracture from unexpectedly high torque  Dulling over time
  49. 49.  MAUDE Database Reported Failures  Drill Bit: “During the procedure, the drill bit fractured in the patient and all the pieces could not be retrieved.”  Dull drills and reamers may not be reported as failures, but could be more damaging to the patient:  Prone to skiving - leading to inaccurate cuts, poor implant placement, damage to surrounding tissue  More axial force leads to uncontrolled breakthrough  Creates excessive heat that kills bone (necrosis) 12
  50. 50.  Testing consists of repetitive cutting cycles in bone analog  Appropriate bone analog should be chosen:  Bovine or porcine bone is often used to get an close approximation of actual cutting forces encountered, but is not appropriate for high volume testing  Sawbones foam – most commonly used, readily available and relatively inexpensive. Variety of densities to roughly approximate differing types and quality of bone but with polymer (local melting) limitations.  BoneSim bone analog – Expensive, but better approximation of cortical and cancellous bone properties, and more amenable to high volume testing than animal bone  Cutting efficiency can be characterized with axial force, torsional load, and/or resulting feed rate  Can be evaluated prior to and following repetitive cutting cycles, or monitored continuously 13
  51. 51.  Typical cutting efficiency set ups:  Drill bit efficiency test – torque and axial force monitored continuously  Cyclic tibial post drill evaluation - cutting efficiency and fixture/drill galling  Cyclic reamer efficiency test – torque and axial force monitored continuously 14

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