Significance and Use

The investigation of retrieved implantable medical devices and adjacent tissues can be of value in the assessment of clinical complications associated with the use of a specific prosthetic device design; can expand the knowledge of clinical implant performance and interactions between implants and the body; provide information on implant performance and safety; and thus further the development of biocompatible implant materials and devices with improved performance. Comparison of wear patterns and wear particle morphology observed with retrievals and those observed with in vitro joint simulator tests can provide valuable insight into the validity of the in vitro simulation.

A significant portion of the information associated with a retrieved implant is obtained with detailed studies of the device-tissue interface. Appropriate methods are provided to facilitate a study of the particles in the tissues, and chemical analysis for the byproducts of degradation of the implant, and histologic evaluation of the cellular response to the implant.

For the analysis to be accurate, it is essential that the device and associated tissues be removed without alteration of their form and structure. It is also essential that the tissues be handled in such a way as to avoid microbial contamination of the work place or the investigator. Standard protocols for the examination and collection of data are provided for retrieval and handling of implantable medical devices, as well as for specific types of materials in relation to their typical applications. For particular investigational programs, additional, more specific, protocols may be required. If special analytical techniques are employed, the appropriate procedures must be specified.

In order to interpret the analysis of materials and tissues, it is also essential to capture a minimum data set regarding the clinical findings and laboratory studies documenting device performance and reasons for removal.

Any destructive analysis of implants must be done so as to not destroy any features that may become the subject of litigation, as per Practice E860 . This standard recommendation should be applied in accordance with state or national regulations or legal requirements regarding the handling and analysis of retrieved implants and tissues.

1. Scope

1.1 This practice covers recommendations for the retrieval, handling, and analysis of implanted medical devices and associated specimens that are removed from patients during revision surgery, at postmortem, or as part of animal studies. This practice can also be used for analysis of specimens and lubrication fluids from in vitro wear tests and joint simulators. The aim is to provide guidance in preventing damage to the associated specimens which could obscure the investigational results, and in gathering data at the proper time and circumstance to validate the study.

1.2 This practice offers guidelines for the analysis of retrieved implants to limit damage to them, and to allow comparisons between investigational results from different studies. The protocols are divided into three stages, where Stage I is the minimum non-destructive analysis, Stage II is more complete non-destructive analysis, and Stage III is destructive analysis. Standard protocols for the examination and collection of data are provided for specific types of materials in relation to their typical applications. For particular investigational programs, additional, more specific, protocols may be required. If special analytical techniques are employed, the appropriate handling procedures must be specified.

1.3 This practice recommendation should be applied in accordance with national regulations or legal requirements regarding the handling and analysis of retrieved implants and excised tissues, especially with regard to handling devices which may become involved in litigation, as per Practice E860 .

1.4 A significant portion of the information associated with a retrieved implant device is often at the device-tissue interface or in the tissues associated with the implant and related organ systems. Attention should be given to the handling of adjacent tissues, so as not to interfere with study of the particles in the adjacent tissue, a chemical analysis for the byproducts of degradation of the implant, or a study of the cellular response to the implant.

1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6 This standard may involve hazardous materials, operations, and equipment. As a precautionary measure, explanted devices should be sterilized or minimally disinfected by an appropriate means that does not adversely affect the implant or the associated tissue that may be subject to subsequent analysis. A detailed discussion of precautions to be used in handling of human tissues can be found in ISO 12891-1. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

A262 Practices for Detecting Susceptibility to Intergranular Attack in Austenitic Stainless Steels

A751 Test Methods, Practices, and Terminology for Chemical Analysis of Steel Products

C20 Test Methods for Apparent Porosity, Water Absorption, Apparent Specific Gravity, and Bulk Density of Burned Refractory Brick and Shapes by Boiling Water

C158 Test Methods for Strength of Glass by Flexure (Determination of Modulus of Rupture)

C169 Test Methods for Chemical Analysis of Soda-Lime and Borosilicate Glass

C573 Methods for Chemical Analysis of Fireclay and High-Alumina Refractories

C623 Test Method for Youngs Modulus, Shear Modulus, and Poissons Ratio for Glass and Glass-Ceramics by Resonance

C633 Test Method for Adhesion or Cohesion Strength of Thermal Spray Coatings

C674 Test Methods for Flexural Properties of Ceramic Whiteware Materials

C730 Test Method for Knoop Indentation Hardness of Glass

C1069 Test Method for Specific Surface Area of Alumina or Quartz by Nitrogen Adsorption

C1161 Test Method for Flexural Strength of Advanced Ceramics at Ambient Temperature

C1198 Test Method for Dynamic Youngs Modulus, Shear Modulus, and Poissons Ratio for Advanced Ceramics by Sonic Resonance

C1322 Practice for Fractography and Characterization of Fracture Origins in Advanced Ceramics

C1326 Test Method for Knoop Indentation Hardness of Advanced Ceramics

C1327 Test Method for Vickers Indentation Hardness of Advanced Ceramics

D256 Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics

D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers--Tension

D570 Test Method for Water Absorption of Plastics

D621 Specification for Jute Rove and Plied Yarn for Electrical and Packing Purposes

D624 Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers

D638 Test Method for Tensile Properties of Plastics

D671 Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force

D695 Test Method for Compressive Properties of Rigid Plastics

D732 Test Method for Shear Strength of Plastics by Punch Tool

D747 Test Method for Apparent Bending Modulus of Plastics by Means of a Cantilever Beam

D785 Test Method for Rockwell Hardness of Plastics and Electrical Insulating Materials

D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials

D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement

D1004 Test Method for Tear Resistance (Graves Tear) of Plastic Film and Sheeting

D1042 Test Method for Linear Dimensional Changes of Plastics Under Accelerated Service Conditions

D1238 Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer

D1239 Test Method for Resistance of Plastic Films to Extraction by Chemicals

D1242 Test Methods for Resistance of Plastic Materials to Abrasion

D1505 Test Method for Density of Plastics by the Density-Gradient Technique

D1621 Test Method for Compressive Properties of Rigid Cellular Plastics

D1622 Test Method for Apparent Density of Rigid Cellular Plastics

D1623 Test Method for Tensile and Tensile Adhesion Properties of Rigid Cellular Plastics

D1708 Test Method for Tensile Properties of Plastics by Use of Microtensile Specimens

D2240 Test Method for Rubber Property--Durometer Hardness

D2842 Test Method for Water Absorption of Rigid Cellular Plastics

D2857 Practice for Dilute Solution Viscosity of Polymers

D2873 Test Method for Interior Porosity of Poly(Vinyl Chloride) (PVC) Resins by Mercury Intrusion Porosimetry

D2990 Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics

D3016 Practice for Use of Liquid Exclusion Chromatography Terms and Relationships

D3417 Test Method for Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry (DSC)

D3418 Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry

D3835 Test Method for Determination of Properties of Polymeric Materials by Means of a Capillary Rheometer

D3919 Practice for Measuring Trace Elements in Water by Graphite Furnace Atomic Absorption Spectrophotometry

D4000 Classification System for Specifying Plastic Materials

D4001 Test Method for Determination of Weight-Average Molecular Weight of Polymers By Light Scattering

D4065 Practice for Plastics: Dynamic Mechanical Properties: Determination and Report of Procedures

D4754 Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell

D5152 Practice for Water Extraction of Residual Solids from Degraded Plastics for Toxicity Testing

D5227 Test Method for Measurement of Hexane Extractable Content of Polyolefins

D5296 Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography

E3 Guide for Preparation of Metallographic Specimens

E7 Terminology Relating to Metallography

E8 Test Methods for Tension Testing of Metallic Materials

E10 Test Method for Brinell Hardness of Metallic Materials

E18 Test Methods for Rockwell Hardness of Metallic Materials

E45 Test Methods for Determining the Inclusion Content of Steel

E92 Test Method for Vickers Hardness of Metallic Materials

E112 Test Methods for Determining Average Grain Size

E120 Test Methods for Chemical Analysis of Titanium and Titanium Alloys

E135 Terminology Relating to Analytical Chemistry for Metals, Ores, and Related Materials

E168 Practices for General Techniques of Infrared Quantitative Analysis

E204 Practices for Identification of Material by Infrared Absorption Spectroscopy, Using the ASTM Coded Band and Chemical Classification Index

E290 Test Methods for Bend Testing of Material for Ductility

E353 Test Methods for Chemical Analysis of Stainless, Heat-Resisting, Maraging, and Other Similar Chromium-Nickel-Iron Alloys

E354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, and Cobalt Alloys

E386 Practice for Data Presentation Relating to High-Resolution Nuclear Magnetic Resonance (NMR) Spectroscopy

E407 Practice for Microetching Metals and Alloys

E562 Test Method for Determining Volume Fraction by Systematic Manual Point Count

E663 Practice for Flame Atomic Absorption Analysis

E860 Practice for Examining And Preparing Items That Are Or May Become Involved In Criminal or Civil Litigation

E883 Guide for Reflected-Light Photomicrography

E986 Practice for Scanning Electron Microscope Beam Size Characterization

E1188 Practice for Collection and Preservation of Information and Physical Items by a Technical Investigator

E1479 Practice for Describing and Specifying Inductively-Coupled Plasma Atomic Emission Spectrometers

F316 Test Methods for Pore Size Characteristics of Membrane Filters by Bubble Point and Mean Flow Pore Test

F619 Practice for Extraction of Medical Plastics

F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

F1044 Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings

F1147 Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings

F1854 Test Method for Stereological Evaluation of Porous Coatings on Medical Implants

F1877 Practice for Characterization of Particles

F2102 Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants

F2182 Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging

F2214 Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)

Other Document

Keywords

ceramics; chemical analysis; composites; histology; implant retrieval; metals; particles; polymers; Associated tissues (surgical implants); Biocompatibility; Ceramic surgical materials/applications; Composites--surgical implants; Implantable surgical materials/applications; Metallic surgical implant materials; Nondestructive evaluation (NDE)--surgical implants; Polymers (surgical applications); Revision implant surgery; Testing methods--surgical implants; Tissue reactions ;

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F0561-05AR10

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ASTM F561