Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids

Importancia y uso:

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.

Subcomité:

F04.15

Referida por:

F3129-16, F2847-17, F1875-98R22, F2665-21, F3018-17, F2884-21, F3047M-23, F3448-20, F2624-12R20, F1983-23, F2789-10R20, F3295-18, F2423-11R20, F2979-20, F3108-19, F2721-09R23, F1877-16, F1904-23, F2694-16R20

Volúmen:

13.01

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

ceramics; chemical analysis; composites; histology; implant retrieval; metals; particles; polymers;