University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
History and Scope of Biomaterials
J. L. Ricci, Ph.D.
Department of Orthopaedics, UMDNJ
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Biomaterials Characterization Website
www.rci.rutgers.edu/~moghe/622.htm
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
What is a biomaterial?
Who uses biomaterials?
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Biomaterial — A biomaterial is a nonviable material used in a medical device intended to interact with biological systems.
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Device — an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article. including any component, part, or accessary, which is...
• as defined in Medical Device Amendments of 1976
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
• (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
• (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
• (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Examples of Devices
• prescription lenses and frames, hearing aids, intrauterine devices, surgical instruments, cardiac pacemakers, etc.
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Biomaterial — A biomaterial is a nonviable material used in a medical device intended to interact with biological systems. (see biocompatibility)
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Biocompatibility — The ability of a material to perform with an appropriate host response in a specific application.
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Host Response — The response of the host organism (local and systemic) to the implanted material or device.
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
What are biomaterials used for?
• Dentistry, surgery, drug delivery...
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Short-term implants
• Catheters (including balloon catheters)
• IVs
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Long-term implants
• Dental fillings, caps, crowns...• Opthalmic implants (lenses)• Orthopaedic total joint replacements (hips,
knees, fingers, shoulders, ankles)• Pacemakers, defibrillators, etc...• Cardiovascular stents
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Federal Food and Drug Administration Regulation
• Federal Food, Drug, and Cosmetic Act of 1938 — Drug premarket approval, removal of fraudulent devices, proper labeling.
• Medical Device Amendments of 1976 — regulation of development, testing, production, distribution, and use. Three classes of devices, Class I (least regulated) to Class III (most regulated).
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
• Safe Medical Devices Act of 1990 — expanded FDA authority in premarketing and postmarketing stages. Established tracking for some devices.
• Biomaterials Access Assurance Act of 1998 — limits liability of biomaterials suppliers.
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Classes of Devices• Class I — General controls. A device
for which controls other than standards and premarket approval are sufficient to assure safety and effectiveness.
• Examples — dental floss, tongue depressor, surgeon’s glove
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
• Class II — Performance Standards. General controls are insufficient but there is sufficient information for establishment of a performance standard.
• Examples — Oxygen mask, blood pressure cuff, ultrasound imager.
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
• Class III — Premarket Approval (PMA). Insufficient information for reasonable safety and effectiveness, required to have approved premarket approval application.
• Examples — Intraocular lenses, replacement heart valves, most orthopaedic and dental implants.
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Premarket notification for new or substantially modified devices — The 510(k) rule — substantial equivalence to a device already on the market prior to the 1976 amendments.
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
New devices — Premarket Approval (PMA) applications — nonclinical and clinical information establishing safety and effectiveness.
• Investigational Device Exemption (IDE) — needed to conduct clinical studies — nonsignificant or significant risk.
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Voluntary Standards
• American Society for Testing and Materials
• Examples — ASTM F-4 committee — implant devices
• Materials — ASTM F75 standard for cast cobalt-chromium-molybdinum alloy
• Test Methods — ASTM D638M Test method for tensile properties of plastics
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Additional Voluntary Standards
• AAMI — Association for Advancement of Medical Instrumentation
• ANSI — American National Standards Institute
• ISO — International Standards Organization
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Biomaterials — A Historical View
• Four generations of devices
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
First Generation Implants
• “ad hoc” implants
• specified by physicians using common and borrowed materials
• most successes were accidental rather than by design
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Examples — First Generation Implants
• gold fillings, wooden teeth, PMMA dental prosthesis
• steel, gold, ivory, etc., bone plates
• glass eyes and other body parts
• dacron and parachute cloth vascular implants
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Examples — First generation Implants
• breast implants
• titanium dental implants
• plaster of paris bone cements
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Second generation implants
• engineered implants using common and borrowed materials
• developed through collaborations of physicians and engineers
• built on first generation experiences
• used advances in materials science (from other fields)
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Examples — Second generation implants
• titanium alloy dental and orthopaedic implants
• cobalt-chromium-molybdinum orthopaedic implants
• UHMW polyethylene bearing surfaces for total joint replacements
• heart valves and pacemakers
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Examples — Second generation implants
• Most current implants fit this category
• Many represent second generation versions of first generation implants
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Third generation implants
• bioengineered implants using bioengineered materials
• few examples on the market
• some modified and new polymeric devices
• many under development
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Fourth generation implants• tissue engineered implants designed to
regrow rather than replace tissues• Integra LifeSciences artificial skin• Genzyme cartilage cell procedure• some resorbable bone repair cements• many new products under development —
genetically engineered “biological” components (Genetics Institute and Creative Biomolecules BMPs)
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Biomaterials Development and Marketing vs. Biomaterials
Characterization
• market pressures for new materials and devices
• cost of development and characterization
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Corporate biomaterials research
• characterization of new and licensed technologies for product development
• quality control (GMP)
University of Medicine and Dentistry of New JerseyJohn L. Ricci, Ph.D., Department of Orthopaedics
Academic biomaterials research
• development of new materials and application of advanced materials to biomedical applications
• new tissue engineered materials
• technology transfer
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