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ASTM F561 - 19
Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
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Significance and Use
5.1 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.
5.2 A significant portion of the information associated with a retrieved implant is obtained with detailed studies of the device-tissue interface healing response. 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.
5.3 For the analysis to be accurate, it is essential that the device and associated tissues be removed minimizing as best as possible alteration of their form and structure. It is also essential that the tissues be handled in such a way as to avoid microbial or viral contamination of the work place or the investigator. The tissue-device interface may need to be stabilized with chemical fixation prior to separation of the device from it’s in-situ position. It is also highly recommended to document detailed information about the tissue specimens, including location of extraction. 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.
5.4 In order to interpret the analysis of materials and tissues, it is also essential to capture a minimum data set regarding the reason for device removal, method of removal, method and timing preservation and clinical findings and laboratory studies documenting device performance.
5.5 Planning of the overall retrieval analyses prior to execution of any of the protocols or methods within this practice is essential to maximize the overall effectiveness of the analyses. The plan shall be based on initial observations from the available clinical information, tissues, and implants. Subsequently, the plan may need to be revised based on results obtained throughout the analyses. Due to the potential interferences described in Section 6, protocols and methods should be executed in a sequence such as to minimize the impact of interferences
5.6 Any destructive analysis of implants must be done so as to not destroy any features that may become the subject of litigation, in accordance with 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 human and animal subjects during revision surgery and at postmortem. This practice may be used for the analysis of any implant including inert, bioactive, resorbable, and tissue engineered products. This practice can also be used for analysis of specimens and fluids from in vitro tests, including those from wear tests and joint simulators. The aim is to provide guidance to minimize iatrogenic damage during the recovery and handling of the associated specimens which could obscure the investigational results. This practice is also intended to provide guidance as to gathering data at the proper time and circumstance.
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. Note that regulations for handling of patient information, tissues, and retrieved devices will vary by geography.
1.3 This practice should be applied in accordance with pertinent regulations or legal requirements regarding the handling of patient data as well as the handling and analysis of retrieved implants and excised tissues, especially with regard to handling devices which may become involved in litigation, as in accordance with Practice E860. Note that regulations for handling of patient information, tissues, and retrieved devices will vary by geography
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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
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 ElastomersTension
D624 Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers
D638 Test Method for Tensile Properties of Plastics
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
D1238 Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
D1239 Test Method for Resistance of Plastic Films to Extraction by Chemicals
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 PropertyDurometer Hardness
D2842 Test Method for Water Absorption of Rigid Cellular Plastics
D2857 Practice for Dilute Solution Viscosity of Polymers
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
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
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 [Metric] E0008_E0008M
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 Methods for Vickers Hardness and Knoop Hardness of Metallic Materials
E112 Test Methods for Determining Average Grain Size
E135 Terminology Relating to Analytical Chemistry for Metals, Ores, and Related Materials
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
E407 Practice for Microetching Metals and Alloys
E539 Test Method for Analysis of Titanium Alloys by X-Ray Fluorescence Spectrometry
E562 Test Method for Determining Volume Fraction by Systematic Manual Point Count
E860 Practice for Examining And Preparing Items That Are Or May Become Involved In Criminal or Civil Litigation
E883 Guide for ReflectedLight 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
E2451 Practice for Preserving Ignitable Liquids and Ignitable Liquid Residue Extracts from Fire Debris Samples
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 Insertion into 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
F1635 Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
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 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)
F2502 Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
F2739 Guide for Quantifying Cell Viability within Biomaterial Scaffolds
F2977 Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
Other Document
ISO 12891-1, Retrieval and Analysis of Implantable Medical Devices, Part 1: Standard Practice for Retrieval and HandlingICS Code
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code
UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)
Referencing This Standard
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DOI: 10.1520/F0561-19
Citation Format
ASTM F561-19, Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids, ASTM International, West Conshohocken, PA, 2019, www.astm.org
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