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==''Introduction to Implants: Devices, Procedures, and Conditions Requiring Them'' (Volume 2) ==
==''Introduction to Implants: Devices, Procedures, and Conditions Requiring Them'' (Volume 2) ==
This is the second of two volumes on the topic of implantable medical devices. [[:Book:Introduction to Implants, Volume 1|Volume 1]] included articles on what a medical device and an implant are, types of implants, and the biomaterials used in the manufacture or implants. This volume continues on with articles about medical procedures and techniques related to implants, medical conditions necessitating or caused by an implant, terminology, regulatory information, and implant-related resources.
This is the second of two volumes on the topic of implantable medical devices. [[:Book:Introduction to Implants, Volume 1|Volume 1]] included articles on what a medical device and an implant are, types of implants, the biomaterials used in the manufacture or implants, and medical procedures utilizing them.. This volume continues on with articles about medical conditions necessitating or caused by an implant, implant terminology, regulatory information, and implant-related resources.
;4. Medical Procedures and Techniques Related to Implants
:[[Ankle replacement]]
:[[Aortic valve replacement]]
:[[Buttock augmentation]]
:[[Cheek augmentation]]
:[[Chin augmentation]]
:[[Cotrel–Dubousset instrumentation]]
:[[Deep brain stimulation]]
:[[Diaphragm pacing]]
:[[Functional electrical stimulation]]
:[[Graft (surgery)|Grafting]]
:[[Hip replacement]]
:[[In vivo bioreactor]]
:[[Joint replacement]]
:[[Knee replacement]]
:[[Mitral valve replacement]]
:[[Nano-scaffold|Nanno-scaffolding]]
:[[Neuromodulation (medicine)]]
:[[Neurostimulation]]
:[[Percutaneous aortic valve replacement]]
:[[Occipital nerve stimulation]]
:[[Optogenetics]]
:[[Shoulder replacement]]
:[[Sinus lift]]
:[[Sonomicrometry]]
:[[Surgery for the dysfunctional sacroiliac joint]]
:[[Unicompartmental knee arthroplasty]]
:[[Valve replacement]]
:[[Vertebral fixation]]
 
;5. Implant-related Medical Conditions
;5. Implant-related Medical Conditions
:[[Adhesion (medicine)]]
:[[Adhesion (medicine)]]
:[[Aneurysm]]
:[[Aneurysm]]
Line 72: Line 41:
:[[Organ dysfunction]]
:[[Organ dysfunction]]
:[[Osteoarthritis]]
:[[Osteoarthritis]]
:[[Otitis media]]
:[[Otosclerosis]]
:[[Otosclerosis]]
:[[Paraplegia]]
:[[Paraplegia]]
Line 94: Line 64:
:[[Ventricular tachycardia]]
:[[Ventricular tachycardia]]
:[[Visual impairment]]
:[[Visual impairment]]
;6. Implant-related Terminology
;6. Implant-related Terminology
 
:[[Adverse event]]
:[[Biocompatibility]]
:[[Biocompatibility]]
:[[Biofilm]]
:[[Biofunctionalization]]
:[[Capsular contracture]]
:[[Capsular contracture]]
:[[Cell encapsulation]]
:[[Cell encapsulation]]
:[[Chemistry of biofilm prevention]]
:[[Heart nanotechnology]]
:[[Heart nanotechnology]]
:[[Implant failure]]
:[[Implant failure]]
Line 110: Line 82:
:[[Surface chemistry of neural implants]]
:[[Surface chemistry of neural implants]]
:[[Surface and bulk erosion]]
:[[Surface and bulk erosion]]
:''Manufacturing and Distribution''
:''Manufacturing and Distribution''
:[[3D bioprinting]]
:[[3D bioprinting]]
Line 119: Line 90:
:[[Electron beam additive manufacturing]]
:[[Electron beam additive manufacturing]]
:[[Crystal structure|Lattice structure]]
:[[Crystal structure|Lattice structure]]
:[[Medical device manufacturing]]
:[[Medical logistics]]
:[[Medical logistics]]
:[[Metallic microlattice]]
:[[Metallic microlattice]]
Line 128: Line 100:
:[[Safety engineering]]
:[[Safety engineering]]
:[[Sintering]]
:[[Sintering]]
:[[Software reliability testing]]
:[[Stereolithography]]
:[[Sterility assurance level]]
:[[Sterility assurance level]]
;7. Regulatory Considerations
;7. Regulatory Considerations
:[[21 CFR Part 11]]
:[[21 CFR Part 11]]
:[[Center for Devices and Radiological Health]]
:[[Center for Devices and Radiological Health]]
Line 161: Line 133:
:[[Medicines and Healthcare Products Regulatory Agency]]
:[[Medicines and Healthcare Products Regulatory Agency]]
:[[Medsafe]]
:[[Medsafe]]
:[[MedWatch]]
:[[Ministry of Food and Drug Safety]]
:[[Ministry of Food and Drug Safety]]
:[[Notified body]]
:[[Notified body]]
:[[Office of Global Regulatory Operations and Policy]]
:[[Pharmaceuticals and Medical Devices Agency]]
:[[Pharmaceuticals and Medical Devices Agency]]
:[[Postmarketing surveillance]]
:[[Postmarketing surveillance]]
Line 169: Line 143:
:[[Regulatory affairs]]
:[[Regulatory affairs]]
:[[Safe Medical Device Amendments of 1990]]
:[[Safe Medical Device Amendments of 1990]]
:[[Software of unknown pedigree]]
:[[Therapeutic Goods Administration]]
:[[Therapeutic Goods Administration]]
:[[Therapeutic Products Directorate]]
:[[Therapeutic Products Directorate]]
:[[Type approval]]
:[[Type approval]]
;8. Resources
;8. Resources
:''Manufacturers''
:''Manufacturers''
:[[Abbott Laboratories, Inc.]]
:[[Vendor:Abbott Laboratories, Inc.|Abbott Laboratories, Inc.]]
:[[Abiomed, Inc.]]
:[[Vendor:Abiomed, Inc.|Abiomed, Inc.]]
:[[Alcon, Inc.]]
:[[Vendor:Alcon, Inc.|Alcon, Inc.]]
:[[Allergan, Plc]]
:[[Vendor:Allergan, Plc|Allergan, Plc]]
:[[Bausch & Lomb, Inc.]]
:[[Vendor:Bausch & Lomb, Inc.|Bausch & Lomb, Inc.]]
:[[Bayer AG]]
:[[Vendor:Bayer AG|Bayer AG]]
:[[Berlin Heart GmbH]]
:[[Vendor:Berlin Heart GmbH|Berlin Heart GmbH]]
:[[Biotronik SE & Co. KG]]
:[[Vendor:Biotronik SE & Co. KG|Biotronik SE & Co. KG]]
:[[Boston Scientific Corporation]]
:[[Vendor:Boston Scientific Corporation|Boston Scientific Corporation]]
:[[DePuy Synthes, Inc.]]
:[[Vendor:DePuy Synthes, Inc.|DePuy Synthes, Inc.]]
:[[Glaukos Corporation]]
:[[Vendor:Glaukos Corporation|Glaukos Corporation]]
:[[Intersect ENT, Inc.]]
:[[Vendor:Intersect ENT, Inc.|Intersect ENT, Inc.]]
:[[Medtronic PLC]]
:[[Vendor:Medtronic PLC|Medtronic PLC]]
:[[Mentor Worldwide, LLC]]
:[[Vendor:Mentor Worldwide, LLC|Mentor Worldwide, LLC]]
:[[MetaCure Ltd.]]
:[[Vendor:MetaCure Ltd.|MetaCure Ltd.]]
:[[Navilyst Medical, Inc.]]
:[[Vendor:Navilyst Medical, Inc.|Navilyst Medical, Inc.]]
:[[Novartis International AG]]
:[[Vendor:Novartis International AG|Novartis International AG]]
:[[Smith & Nephew PLC]]
:[[Vendor:Smith & Nephew PLC|Smith & Nephew PLC]]
:[[St. Jude Medical, Inc.]]
:[[Vendor:St. Jude Medical, Inc.|St. Jude Medical, Inc.]]
:[[Stryker Corporation]]
:[[Vendor:Stryker Corporation|Stryker Corporation]]
:[[SynCardia Systems, Inc.]]
:[[Vendor:SynCardia Systems, Inc.|SynCardia Systems, Inc.]]
:[[Teva Pharmaceutical Industries Ltd.]]
:[[Vendor:Teva Pharmaceutical Industries Ltd.|Teva Pharmaceutical Industries Ltd.]]
:[[Zimmer Biomet Holdings, Inc.]]
:[[Vendor:Zimmer Biomet Holdings, Inc.|Zimmer Biomet Holdings, Inc.]]
 
:''Organizations''
:''Organizations''
:[[AdvaMed]]
:[[AdvaMed]]
Line 208: Line 180:
:[[Cyborg Foundation]]
:[[Cyborg Foundation]]
:[[MedTech Europe]]
:[[MedTech Europe]]
 
:''Publications and awards''
:''Publications''
:''[[Expert Review of Medical Devices]]''
:''[[Expert Review of Medical Devices]]''
:''[[Journal of Medical Marketing]]''
:''[[Journal of Medical Marketing]]''
:''[[MD&DI]]''
:''[[MD&DI]]''
:''[[Medical & Biological Engineering & Computing]]''
:''[[Medical & Biological Engineering & Computing]]''
:[[Medical Design Excellence Awards]]


<!--Place all category tags here-->
<!--Place all category tags here-->
[[Category:LIMSwiki books on healthcare]]
[[Category:LIMSwiki books on healthcare]]
[[Category:LIMSwiki books on medical devices]]

Latest revision as of 00:35, 12 April 2024

Introduction to Implants:
Devices, Procedures, and Conditions Requiring Them (Volume 2)
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Introduction to Implants: Devices, Procedures, and Conditions Requiring Them (Volume 2)

This is the second of two volumes on the topic of implantable medical devices. Volume 1 included articles on what a medical device and an implant are, types of implants, the biomaterials used in the manufacture or implants, and medical procedures utilizing them.. This volume continues on with articles about medical conditions necessitating or caused by an implant, implant terminology, regulatory information, and implant-related resources.

5. Implant-related Medical Conditions
Adhesion (medicine)
Aneurysm
Ascites
Atrial septal defect
Bone fracture
Bradycardia
Breast cancer
Cancer
Cataract
Chronic pain
Diabetes mellitus
Disfigurement
Dystrophic calcification
Epilepsy
Erectile dysfunction
Fecal incontinence
Gastroesophageal reflux disease
Gastroparesis
Glaucoma
Hearing loss
Heart failure
Hydrocephalus
Hypertrophic cardiomyopathy
Keratoconus
Laryngeal cancer
Metallosis
Obesity
Organ dysfunction
Osteoarthritis
Otitis media
Otosclerosis
Paraplegia
Parkinson's disease
Pulmonary embolism
Respiratory failure
Retinitis pigmentosa
Rheumatoid arthritis
Scoliosis
Sinusitis
Sleep apnea
Spinal stenosis
Spondylolisthesis
Syncope (medicine)
Treatment-resistant depression
Unintended pregnancy
Urinary incontinence
Urinary retention
Valvular heart disease
Ventricular fibrillation
Ventricular septal defect
Ventricular tachycardia
Visual impairment
6. Implant-related Terminology
Adverse event
Biocompatibility
Biofilm
Biofunctionalization
Capsular contracture
Cell encapsulation
Chemistry of biofilm prevention
Heart nanotechnology
Implant failure
Nanotopography
Neuromechanics of orthoses
Neurotechnology
Osseointegration
Pacemaker failure
Staphylococcus epidermidis
Surface chemistry of neural implants
Surface and bulk erosion
Manufacturing and Distribution
3D bioprinting
3D printing
Bioburden testing
Biomedical engineering
Direct metal laser sintering
Electron beam additive manufacturing
Lattice structure
Medical device manufacturing
Medical logistics
Metallic microlattice
Microextrusion
Minusheet perfusion culture system
Package testing
Polymer solution casting
Reliability engineering
Safety engineering
Sintering
Software reliability testing
Stereolithography
Sterility assurance level
7. Regulatory Considerations
21 CFR Part 11
Center for Devices and Radiological Health
Central Drugs Standard Control Organization
China Food and Drug Administration
Design controls
Design history file
Federal Food, Drug, and Cosmetic Act
Food and Drug Administration Amendments Act of 2007
Food and Drug Administration Modernization Act of 1997
Food and Drug Administration
Global Harmonization Task Force
Global Medical Device Nomenclature
Humanitarian Device Exemption
IEC 60601
IEC 62304
IEC 62366
ISO 10993
ISO 13485
ISO 14155
ISO 14971
ISO/IEEE 11073
ISO/TC 215
Italian Device Registration
Medical Device Radiocommunications Service
Medical Device Regulation Act
Medical device reporting
Medical Devices Directive
Medicines and Healthcare Products Regulatory Agency
Medsafe
MedWatch
Ministry of Food and Drug Safety
Notified body
Office of Global Regulatory Operations and Policy
Pharmaceuticals and Medical Devices Agency
Postmarketing surveillance
QSIT
Regulation of therapeutic goods
Regulatory affairs
Safe Medical Device Amendments of 1990
Software of unknown pedigree
Therapeutic Goods Administration
Therapeutic Products Directorate
Type approval
8. Resources
Manufacturers
Abbott Laboratories, Inc.
Abiomed, Inc.
Alcon, Inc.
Allergan, Plc
Bausch & Lomb, Inc.
Bayer AG
Berlin Heart GmbH
Biotronik SE & Co. KG
Boston Scientific Corporation
DePuy Synthes, Inc.
Glaukos Corporation
Intersect ENT, Inc.
Medtronic PLC
Mentor Worldwide, LLC
MetaCure Ltd.
Navilyst Medical, Inc.
Novartis International AG
Smith & Nephew PLC
St. Jude Medical, Inc.
Stryker Corporation
SynCardia Systems, Inc.
Teva Pharmaceutical Industries Ltd.
Zimmer Biomet Holdings, Inc.
Organizations
AdvaMed
American Society for Artificial Internal Organs
Association for the Advancement of Medical Instrumentation
Canadian Medical and Biological Engineering Society
COCIR
Cyborg Foundation
MedTech Europe
Publications and awards
Expert Review of Medical Devices
Journal of Medical Marketing
MD&DI
Medical & Biological Engineering & Computing
Medical Design Excellence Awards