the role of standards in biomedical device testing: a ... · ¾wrong medication or dose: 16% ......
TRANSCRIPT
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Joshua J. Jacobs, MDJoshua J. Jacobs, MD
Professor of Orthopaedic SurgeryProfessor of Orthopaedic Surgery
Rush Medical CollegeRush Medical College
Chicago, IL USAChicago, IL USA
THE ROLE OF STANDARDS IN BIOMEDICAL DEVICE
TESTING: A SURGEON’S PERSPECTIVE
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Perspectives
Standards Committee Chairman (ASTM F04)Standards Committee Chairman (ASTM F04)
Biomedical ResearcherBiomedical Researcher
Orthopaedic SurgeonOrthopaedic Surgeon
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Medical Technological Advancements
Rapidly acceleratingRapidly accelerating
Sources of improved understanding of diseaseSources of improved understanding of disease
Sources of improved treatment modalitiesSources of improved treatment modalities
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Medical Technological Advancements
Novel materialsNovel materials
ComputerComputer--assisted surgeryassisted surgery
Growth factors (BMP, TGFGrowth factors (BMP, TGF--ββββββββ))
Tissue EngineeringTissue Engineering
Minimally invasive surgeryMinimally invasive surgery
MolecularMolecular--based diagnosticsbased diagnostics
Implantable sensors/nanotechnologyImplantable sensors/nanotechnology
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Medical Technological Advancements
Many have unproven clinical outcomesMany have unproven clinical outcomes
Financial stress on health care systemsFinancial stress on health care systems
Clinical ResearchClinical Research
ReimbursementReimbursement
Challenge for regulatorsChallenge for regulators
Adverse impact on patient safety?Adverse impact on patient safety?
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PATIENT SAFETY
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IOM ReportsIOM Reports
To Err is Human, 1999To Err is Human, 1999
Crossing the Quality Chasm, Crossing the Quality Chasm, 20012001
Nationwide MovementNationwide Movement
Public Public -- National Patient Safety National Patient Safety FoundationFoundation
Private Private -- Leapfrog GroupLeapfrog Group
Governmental Governmental -- President: “Top President: “Top PriorityPriority””
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To Err is HumanInstitute of Medicine Report
Patient Deaths Due to Medical ErrorsPatient Deaths Due to Medical Errors“at least 44,000”“at least 44,000”“possibly as high as 98,000”“possibly as high as 98,000”
Figures Imply Medical ErrorsFigures Imply Medical Errors88thth leading cause of death (1977 figures)leading cause of death (1977 figures)AidsAids 16,51616,516Breast CancerBreast Cancer 42,29742,297MVA’sMVA’s 43,45843,458
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How Does the Public Perceive Health Care in the US
Satisfied with health care: 8% (1 in 12)Satisfied with health care: 8% (1 in 12)
Confidence in getting care in the future:Confidence in getting care in the future:
•• NO: 15% (good health)NO: 15% (good health)
•• NO: 24% (Fair or poor health)NO: 24% (Fair or poor health)
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How Does the Public Perceive Health Care in the US
Individual or family member experienced Individual or family member experienced error: 22%error: 22%
23 million people23 million people
Wrong medication or dose: 16%Wrong medication or dose: 16%
Serious: 22% (8 million people)Serious: 22% (8 million people)
Commonwealth Fund, April 2002Commonwealth Fund, April 2002
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More recent research indicates that 40% of Patients Have
Experienced a Medical Error (directly or through a family
member or friend)
New England Journal of Medicine, 12/12/02New England Journal of Medicine, 12/12/02
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SIX SIGMA GOAL
To set tolerance levels for To set tolerance levels for defective products/defective products/
services at fewer thanservices at fewer than
3.4 defects per million unit 3.4 defects per million unit opportunitiesopportunities..
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Where Does Medicine Fall in This Analysis?
Medicine, Generally: 4 SIGMAMedicine, Generally: 4 SIGMA
•• 6,210 errors/million events6,210 errors/million events
Medications: 2 SIGMAMedications: 2 SIGMA
•• 308,000 errors/million events308,000 errors/million events
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Health Care Error Rate = 1%
Ten Times the Error Rate of Ten Times the Error Rate of IndustryIndustry
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Patient Safety: Medical Devices
83.7 Adverse Medical Device Events (AMDE) 83.7 Adverse Medical Device Events (AMDE) per 1000 admissions using more extensive per 1000 admissions using more extensive modes of surveillance than previous studies.modes of surveillance than previous studies.For ICDFor ICD--9 coding9 coding--based flags for hospital based flags for hospital admission, orthopaedic devices comprised admission, orthopaedic devices comprised 25%, vascular devices 19%, and dialysis 15%.25%, vascular devices 19%, and dialysis 15%.“The high rate of“The high rate of AMDEsAMDEs suggests thatsuggests thatAMDEsAMDEs are an important patient safety are an important patient safety issue…”issue…”
Samore et al JAMA 291:325, 2004.
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Benefits of Standards for Biomedical Engineering Materials and Devices
RegulatoryRegulatoryLegalLegalCommerceCommerceResearchResearchDevelopmentDevelopment
Technology TransferTechnology TransferClinical PracticeClinical Practice
Patient SafetyPatient Safety
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THE BIOLOGICAL REVOLUTION MEETS
ADULT RECONSTRUCTIVE ORTHOPAEDIC SURGERY
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NIH Consensus Conference 1994
“Total hip replacement is an option for nearly all “Total hip replacement is an option for nearly all
patients with diseases of the hip that cause patients with diseases of the hip that cause
chronic discomfort and significant functional chronic discomfort and significant functional
impairment. Most patients have an excellent impairment. Most patients have an excellent
prognosis for longprognosis for long--term improvement in term improvement in
symptoms and physical function.”symptoms and physical function.”
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Survivorship
THATHA
9 years9 years 94 94 -- 97%97%
17 years 8117 years 81-- 86%86%
Swedish Registry 1979 Swedish Registry 1979 -- 19961996
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Total Hip Arthroplasty
1996 1996 -- 138,000138,000
(81,000 F; 57,000 M)(81,000 F; 57,000 M)
2030 (proj.) 2030 (proj.) -- 248,000248,000
(142,000 F; 106,000 M)(142,000 F; 106,000 M)
National Center for Health StatisticsNational Center for Health Statistics
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Osteolysis and Aseptic Loosening:Etiology
Mechanical FactorsMechanical Factors•• DesignDesign•• FixationFixation•• Surgical TechniqueSurgical Technique
Biological FactorsBiological Factors•• Particulate LoadParticulate Load•• Host ResponseHost Response•• Anatomic VariabilityAnatomic Variability
Mechanical/Biological SynergyMechanical/Biological Synergy
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Osteolysis and Aseptic Loosening:Proposed Solution
REDUCE VOLUMETRIC WEARREDUCE VOLUMETRIC WEAR
“Conventional UHMWPE”: 30 “Conventional UHMWPE”: 30 -- 120 mm120 mm33/yr /yr
CeramicCeramic--onon--ceramic bearings: 0.04 ceramic bearings: 0.04 mmmm33/yr/yr
MetalMetal--onon--metal bearings: 6 metal bearings: 6 mmmm33/yr/yr
XX--linked UHMWPE:linked UHMWPE: 55 55 mmmm33/yr/yr
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Osteolysis and Aseptic Loosening:Proposed Solution
REDUCE VOLUMETRIC WEARREDUCE VOLUMETRIC WEAR
Is this sufficient?
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PATHOGENESIS
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Question:What are the variables that
determine the bioreactivity of a particle?
Macrophage / Particle Interactions: Effect of Size, Composition and Surface Area. Shanbhag, A.S., Jacobs, J.J., Black, J. Galante, J.O.,andGlant, T.T. J Biomed Mater. Res. 28:81-90, 1994
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Cum
ulat
ive
Perc
ent25 100
0.0 0.5 1.0 1.5 2.00
5
10
15
20
0
20
40
60
80
1 micron
92 %
Particle Size (µm)
Freq
uenc
y (%
)THR Femoral
Ref: Shanbhag, Jacobs, Glant, et al., J Bone Joint Surg (1994)
Retrieved UHMWPE Debris
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4000
800
1600
2400
3200
0.1 X 1 X 10 X controlspg/ml
Cell Surface Area
mean +/- SE** p < 0.001
Zymosan
PMA
NS cells
TiAlV
CpTi
Ti-22
**
****
f PE
r PE
**
Interleukin-1ß Release
Ref: Shanbhag, Jacobs, Black, et al., J Orthop Res (1995)
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Fundamental Principle of Cell/Particle Biology
•• The cellular response to The cellular response to particle challenge is size, particle challenge is size, composition and dosecomposition and dose--dependentdependent
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Highly Crosslinked UHMWPE Debris
Ilgen Ilgen et al (ORS 2003)et al (ORS 2003)
Particle sizeParticle size
Highly crosslinked 0.11 Highly crosslinked 0.11 µµµµµµµµmmConventional 0.20 Conventional 0.20 µµµµµµµµmm
Cell responseCell response
TNFTNF--αααααααα , VEGF , VEGF No difference between highly No difference between highly crosslinked and conventionalcrosslinked and conventional
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Highly Crosslinked UHMWPE Debris
Ingham et al (ORS 2003)Ingham et al (ORS 2003)
Increased cellular response to Increased cellular response to highly crosslinked UHMWPE highly crosslinked UHMWPE vs. conventionalvs. conventional
TNFTNF--αααααααα
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UHMWPE Debris: Effect of Morphology
Sieving et al (ORS 2003)Sieving et al (ORS 2003)
Particles of similar areaParticles of similar areaCell response determined by Cell response determined by proliferation assayproliferation assayOrder of reactivity (descending) Order of reactivity (descending)
Rough fibrillar > rough round, Rough fibrillar > rough round, smooth fibrillar > smooth roundsmooth fibrillar > smooth round
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Net Biological Activity
The product of the normalized The product of the normalized biological activity (“specific biological activity (“specific biological activity” of Fisher) per biological activity” of Fisher) per particle and the number of particles particle and the number of particles of that size, integrated over all size of that size, integrated over all size ranges.ranges.
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Debris From Metal-Metal Bearings
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In Vivo Degradation Products
ParticlesParticles
Free metallic ionsFree metallic ions
Colloidal organometallic complexesColloidal organometallic complexes
Inorganic metal salts/oxidesInorganic metal salts/oxides
Organic storage forms (Organic storage forms (egeg. Hemosiderin). Hemosiderin)
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Doorn et al JBMR 42:103, 1998
13 patients with M/M 13 patients with M/M prosthesesprosthesesIn situIn situ 7 7 -- 300 months 300 months TEMTEM
••Most particles < 50 Most particles < 50 nanometersnanometers
••Range: 6 Range: 6 –– 834 834 nanometersnanometers
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Metal-on-Metal ParticlesWillert CORR 1996
Cr/Co ratio in periprosthetic tissue (~1/2 in alloy)Cr/Co ratio in periprosthetic tissue (~1/2 in alloy)
9:1 (AAS), 5:1 (ICP9:1 (AAS), 5:1 (ICP--MS)MS)Suggests a preponderance of corrosion products in the Suggests a preponderance of corrosion products in the tissue tissue
QuickTime™ and a TIFF (Uncompressed) decompressor are needed to see this picture.
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Hallab et al JBMR 2003
Differential Differential protein adsorption protein adsorption for CoCr vs. Ti for CoCr vs. Ti particlesparticles
~ 140 ~ 140 kD kD protein protein associated with associated with CoCr alloyCoCr alloy
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Challenges/Opportunities for the 21st Century: Pathogenesis
Particle characterizationParticle characterization
Composition of adsorbed proteinsComposition of adsorbed proteins
Particle isolationParticle isolation
Particle fabricationParticle fabrication
“Designer” wear debris“Designer” wear debris
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DIAGNOSTICS
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Individual Bioreactivity Paradigm: TNF-αααα Promoter
TNFTNF--αααααααα gene located within major gene located within major histocompatibility complexhistocompatibility complex
Several polymorphisms identified Several polymorphisms identified inside inside TNFTNF--αααααααα promoterpromoter
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TNF2 TNF2 allele correlated with allele correlated with enhanced spontaneous and enhanced spontaneous and stimulated TNFstimulated TNF--αααααααα productionproduction
Louis et al Louis et al Clin Clin Exp Exp ImmunalImmunal 1998; 4011998; 401--406406
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--238A 238A allele correlated with allele correlated with osteolysis and aseptic looseningosteolysis and aseptic loosening
Wilkinson et al Wilkinson et al J Bone Min ResJ Bone Min Res (2003)1995(2003)1995--20012001
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Hypersensitivity Reactions
10 10 –– 15% of population have 15% of population have cutaneous metal allergy (Type IVcutaneous metal allergy (Type IV--DTH)DTH)
25% in patients with TJR25% in patients with TJR
50% in patients with failed TJR50% in patients with failed TJR
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Question:Are there systemic markers of
prosthetic performance?
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MONTHS0 3 6 12 36 295
CO
NC
EN
TR
AT
ION
(P
PB
)
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5Conserve Plus SA-M/MPerfecta THRs McMinn/Wagner SA-M/MMcKee-Farrar THR-M/MHybrid THR-M/PCementless CoCr THR-M/PCementless Ti/CoCr head THR-M/PControl D.L.
D.L.
SERUM CHROMIUM (ng/ml)
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Serum Titanium (ng/ml or ppb)
SubjectSubject 12031203
Primary TiPrimary Ti--alloy THRalloy THR 44
ControlControl < 2< 2
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Serum Titanium > 8 ppb
> 750 measurements THR and TKR> 750 measurements THR and TKR
Aseptic LooseningAseptic Loosening
Multiple ImplantsMultiple Implants
Accelerated Wear Against CFRPEAccelerated Wear Against CFRPE
PE “WearPE “Wear--Through”, Including Through”, Including Delaminated MetalDelaminated Metal--Backed PatellaeBacked Patellae
Normal THR < 4 ppb; Controls < 2 ppb
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Leopold et. al. J Arthrop 15:938, 2000
67 yo Male, cementless TKR 198867 yo Male, cementless TKR 1988Excellent function for 10+ years Excellent function for 10+ years (HSS Knee Score 96 (HSS Knee Score 96 -- 100)100)Presented in 1999 with effusion, Presented in 1999 with effusion, mild pain with standingmild pain with standingNo palpable or audible crepitusNo palpable or audible crepitus
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Leopold et. al. J Arthrop 15:938, 2000
XX--rays: mild screw lysis, no loosening, skyline rays: mild screw lysis, no loosening, skyline view unchanged from preview unchanged from pre--opopTi levels:Ti levels:
1990 2.4 PPB1990 2.4 PPB1998 5.5 PPB (contralateral TKR in 1998 5.5 PPB (contralateral TKR in 1992)1992)1999 536.8 PPB1999 536.8 PPB
Well-Functioning MG TKR: 3.34 PPB (<2.1 - 5.28);Failed Metal-Backed Patella: 135.6 PPB (24.1 - 716.9)
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Markers of Bone Turnover and TJR
Tauber Tauber et al. (1989): vitamin D et al. (1989): vitamin D metabolites and implant looseningmetabolites and implant looseningJoering Joering et al. (1993): serum collagen et al. (1993): serum collagen metabolites after THR and TKRmetabolites after THR and TKRSchneider et al. (1998): crossSchneider et al. (1998): cross--links and links and implant looseningimplant looseningGranchi Granchi et al. (1998): serum cytokines et al. (1998): serum cytokines and implant looseningand implant loosening
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Pyr
Time (months)
0 3 6 12 24 36
% b
asel
ine
50
100
150
200
250
300
350
400
450cementless CoCr stems cementless Ti6Al4V stemscemented CoCr stemsControl
Qureshi et al J Bone Miner Res 2002
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Wilkinson et al: JOR 2003
Subjects with femoral loosening had Subjects with femoral loosening had higher levels of the bone resorption higher levels of the bone resorption marker Nmarker N--telopeptides of typetelopeptides of type--I collagenI collagen? Early diagnosis of osteolysis/loosening? Early diagnosis of osteolysis/loosening? Response to pharmacological treatment ? Response to pharmacological treatment of osteolysisof osteolysis
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Other Putative Markers of Prosthetic Performance
ProPro--inflammatory cytokinesinflammatory cytokines
IlIl--1, Il1, Il--6, TNF6, TNF--ααααααααChemokinesChemokines
MCPMCP--1, Il1, Il--88Matrix Matrix metalloproteinasesmetalloproteinases
Collagenase, stromelysinCollagenase, stromelysinOsteoclast activatorsOsteoclast activators
RANKLRANKLGene Gene microarraysmicroarrays
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Challenges/Opportunities for the 21st Century: Diagnostics
Develop genetic databases on patients with TJR Develop genetic databases on patients with TJR to correlate performance with genotypeto correlate performance with genotypeDevelop reliable preoperative screening tests to Develop reliable preoperative screening tests to dictate material selection in patients undergoing dictate material selection in patients undergoing TJRTJRDevelop diagnostic tests which are reliable early Develop diagnostic tests which are reliable early surrogate markers for prosthetic performancesurrogate markers for prosthetic performance
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THERAPEUTICS
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Treatments to Inhibit Osteolysis
Canine THR ModelCanine THR ModelControls (n=8)Controls (n=8)Debris (n=8)Debris (n=8)Debris + Rx (n=8); Debris + Rx (n=8);
Alendronate (Fosamax, 5 Alendronate (Fosamax, 5 mg/day)mg/day)
Rx started on post-op day 7
End-point: 24 weeks post-op
Wear debris introduced intra-op
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Debris Debris+Rx
Inhibiting Osteolysis
Alendronate (Fosamax, Alendronate (Fosamax, Merck)Merck)
(5 mg orally /day)(5 mg orally /day)
24 weeks post24 weeks post--op.op.
Shanbhag et al.Shanbhag et al.Clin Clin Ortho (1997)Ortho (1997)
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Challenges/Opportunities for the 21st Century: Therapeutics
Establish translational research protocols to Establish translational research protocols to determine if putative therapeutic/preventive determine if putative therapeutic/preventive agents are effective in animal models of TJRagents are effective in animal models of TJREstablish clinical research protocols to determine Establish clinical research protocols to determine if agents effective in animal models are effective if agents effective in animal models are effective in humansin humansDevelop novel methods of periprosthetic drug Develop novel methods of periprosthetic drug delivery, including gene therapy, to minimize delivery, including gene therapy, to minimize systemic impact of treatmentsystemic impact of treatment
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ASTM Committee F04:Divisions
I. ResourcesI. Resources
II. Orthopaedic DevicesII. Orthopaedic Devices
III. Medical/Surgical DevicesIII. Medical/Surgical Devices
IV. Tissue Engineered Medical IV. Tissue Engineered Medical ProductsProducts
IX. AdministrativeIX. Administrative
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Division I: Resources
Polymeric MaterialsPolymeric Materials
Metallurgical MaterialsMetallurgical Materials
Ceramic MaterialsCeramic Materials
Composite MaterialsComposite Materials
Materials Test MethodsMaterials Test Methods
Biocompatibility Test MethodsBiocompatibility Test Methods
Device Retrieval AnalysisDevice Retrieval Analysis
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Division II: Orthopaedic Devices
OsteosynthesisOsteosynthesis
ArthroplastyArthroplasty
Spinal DevicesSpinal Devices
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Division III: Medical/Surgical Devices
Cardiovascular StandardsCardiovascular Standards
Neurosurgical StandardsNeurosurgical Standards
Plastics and Reconstructive SurgeryPlastics and Reconstructive Surgery
Medical/Surgical InstrumentsMedical/Surgical Instruments
Urological Materials and DevicesUrological Materials and Devices
GI EndoscopesGI Endoscopes
Cotton Products for Medical UseCotton Products for Medical Use
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Division IV: Tissue Engineered Medical Products
Classification and Terminology for Classification and Terminology for TEMPsTEMPs
Biomaterials and Biomaterials and BiomoleculesBiomolecules
Cells and Tissue Engineered ConstructsCells and Tissue Engineered Constructs
AssessmentAssessment
SafetySafety
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Division IX: Administration
ExecutiveExecutiveAwardsAwardsPlanningPlanningUS TAG ISO/TC 150US TAG ISO/TC 150FinanceFinanceISO/TC 168ISO/TC 168ISO/TC 194ISO/TC 194EditorialEditorial
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Producer
User&
General InterestASTM
Classification & Balance
Technical Committees are balanced. There are no more Producer voters than User & General Interest voters. This ensures the development of fair, consensus, technically sound documents. It protects the documents from bias.
ASTMwww.astm.orgwww.astm.org
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FDAMA (1997)
SEC. 204. DEVICE STANDARDS.“….the Secretary shall, by publication in the Federal Register, recognize all or part of an appropriate standard established by a nationally or internationally recognized standard development organization for which a person may submit a declaration of conformity in order to meet apremarket submission requirement or other requirement under this Act to which such standard is applicable”.
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Types of ASTM Documents
ClassificationClassificationGuideGuidePracticePracticeSpecificationSpecificationTerminologyTerminologyTest MethodTest Method
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ASTM F 561-97
Practice for Retrieval and Analysis Practice for Retrieval and Analysis of Implanted Medical Devices, and of Implanted Medical Devices, and Associated TissuesAssociated Tissues
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ASTM F 1877-98
Standard Practice for Standard Practice for Characterization of ParticlesCharacterization of Particles
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ASTM F 1875-98
Standard Practice for Fretting Standard Practice for Fretting Corrosion Testing of Modular Corrosion Testing of Modular Implant Interfaces: Hip Femoral Implant Interfaces: Hip Femoral HeadHead--Bore and Cone Taper Bore and Cone Taper InterfaceInterface
-1.500
-1.000
-0.500
0.000
0.500
1.000
1.500
2.000
-8.0 -7.0 -6.0 -5.0 -4.0 -3.0 -2.0
Log Current Density (A/cm2)
Po
tent
ial (
V) v
s E
ref
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SERUM CHROMIUM
MONTHS0 12 36 60 84
CO
NC
EN
TR
AT
ION
(P
PB
)
0.00
0.05
0.10
0.15
0.20
0.25
0.30
0.35
0.40
1/2D.L.
Grp 1: HybridGrp 2: Cementless CoCrGrp 3: Cementless TiGrp 4: Control1/2 D.L.
*Different than controls (p<0.05)
*
*
(P<0.02)
* **
*
**
(P<0.04)
*
*
*
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ASTM F 1537-00
Standard Specification for Wrought Standard Specification for Wrought CobaltCobalt--28 Chromium28 Chromium--6 Molybdenum 6 Molybdenum Alloys for Surgical ImplantsAlloys for Surgical Implants
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Benefits of Standards for Biomedical Engineering Materials and Devices
RegulatoryRegulatoryLegalLegalCommerceCommerceResearchResearchDevelopmentDevelopment
Technology TransferTechnology TransferClinical PracticeClinical Practice
Patient SafetyPatient Safety
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Acknowledgements
NIH/NIAMS AR39310NIH/NIAMS AR39310
Crown Family Chair of Orthopaedic Crown Family Chair of Orthopaedic Surgery, Rush Medical CollegeSurgery, Rush Medical College
Zimmer, IncZimmer, Inc
Rush Arthritis and Orthopaedics Rush Arthritis and Orthopaedics InstituteInstitute
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