instrument testing and validation

Testing and Validation of Disposable / Single-

Procedure Surgical Instruments & Procedural Kits

By James B. Schultz

Executive Vice President1

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

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Disposable instrument and sterile-pack kit adoption

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Products Indication

Spine

Extremity

Trauma

Sterile-Packed Surgery Ready Instruments & Kits

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ECA’s Product Design & Development

Engineering Stage Book/Step Process

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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

SounderBone Awl

Nut Driver

Shaft

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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

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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

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Design & Development Process Includes

Simulation, Automated and Manual Testing

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FEA testing

Manual Torque testing

Shaft/driver Torsion testingAutomated Torque testing

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

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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!

http://www.ecamedical.com/

Instrument Testing and Validation Session

Clinical Re-Processing Cycles

June 15, 2016 David M. Blakemore

BoneSim Laboratories

BoneSim Laboratories~~~TM

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



Clinical Re-processing Definition • Moving a surgical instrument from patient to patient.



Clinical Re-processing Definition • Moving a surgical instrument from patient to patient.

• Identification and preparation

• Surgical Use

• Cleaning and Sterilization

• Storage



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



Clinical Re-processing Cycles (CRC)


• 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


Clinical Re-processing Cycles (CRC) SPD processing (Sterile Processing Department)


•Rinsing •Cleaning - manual

Detergent or Enzymatic detergent with manual brushing and removal of debris


Clinical Re-processing Cycles (CRC) SPD processing (Sterile Processing Department)


•Cleaning - Ultrasonic

Detergent or Enzymatic detergent with high energy cavitation ambient or elevated temperatures


Clinical Re-processing Cycles (CRC


•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.




•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.


Clinical Re-processing Cycles (CRC) - Why is it important to us


Material Selection


Clinical Re-processing Cycles (CRC) - Why is it important to us


Processing Instructions i.e., etching, material choice, passivation and passive layer compromise


Clinical Re-processing - FDA


Longevity of efficacy and sterility guarantee.


Clinical Re-processing - FDA


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


Clinical Re-processing - FDA Guidance Document



Clinical Re-processing – How do we respond?


• Rely on clinically relevant data • Careful material selection • Best design practices • Test Data


Clinical Re-processing


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…….


Clinical Re-processing - Why is it important to us


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




Two Choices: • Run CRC studies at IFU parameters

• Run CRC studies at worst case known Facility parameters

So what CRC cycles should we run?




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

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



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


Clinical Re-processing – Bonesim Laboratories


• 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


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


TM

Thank You


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.


http://www.csspdmanager.com/photo6_1.html

June 15, 2016

Kevin J. Knight

Knight Mechanical Testing

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

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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

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.”

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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

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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

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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)


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.”

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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.

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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

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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


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)

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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

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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

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instrument testing and validation

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