ISO/TC 150/WG 10 - Use and retrieval of surgical implants

This document specifies methods for the analysis of retrieved surgical implants. This document describes the analysis of retrieved metallic, polymeric and ceramic implants. The analysis is divided into three stages which are increasingly destructive. This document can also be applied to other materials, e.g. animal tissue implants. NOTE National regulations or legal requirements regarding the handling and analysis of retrieved implants and tissues and associated biological material can also apply to specific topics covered in this document.

This document defines minimum data sets for implants to facilitate recording and international exchange of data for the purposes of implant tracking systems. This data can also be used to support retrieval analysis and implant registry. This document is applicable to the manufacturers and distributors of medical devices intended for implant via a surgical procedure and to those hospitals and other medical facilities which carry out implant or explant procedures. It specifies requirements for data items to be recorded by the manufacturers and distributors of implants and by hospitals and other medical facilities at both the time of implant event and at the time of any subsequent explant event. This document is intended to define a minimum data set to be recorded for all implant and explant events, as well as providing for the timely retrieval of minimum implant data related to specific subsets of patients who have received specific identified devices or devices within a specified range of lot, batch or serial codes, for the purpose of patient follow up. It is not the intent of this document to provide a means of data recovery which is related to specific medical practitioners, medical facilities or manufacturers for purposes other than patient follow up or product recall in the event of unforeseen device malfunction.

ISO 12891-1:2015 specifies the method to be followed for the retrieval and handling of surgical implants and associated tissues and fluids. In particular, it specifies the essential steps to be followed for the safe and proper obtaining of the clinical history, pre-explantation checks and examinations, collection, labelling, cleaning, decontamination, documentation, packing and shipping. It also provides guidance on infection control. NOTE National or other regulations, which can be more stringent, can apply. ISO 12891-1:2015 does not apply in cases of explantation where there is no intention to collect retrieval data. However, many clauses give useful information which can apply in these cases also.

ISO 8828:2014 specifies the recommended procedures for handling orthopaedic implants, hereafter referred to as implants, from receipt at the hospital until they are implanted or discarded. This guidance applies to implants (such as currently used metal, ceramic, or polymeric implants) and also to acrylic resin and other bone cements. This guidance does not apply to the implant manufacturer. However, it contains references to the stocking of implants that can be useful for manufacturers and especially for third-party suppliers.

ISO 12891-2:2014 specifies methods for the analysis of retrieved surgical implants. ISO 12891-2:2014 describes the analysis of retrieved metallic, polymeric and ceramic implants. The analysis is divided into three stages which are increasingly destructive. ISO 12891-2:2014 can also be applied to other materials, e.g. animal tissue implants. ISO 12891-2:2014 can be applied in accordance with national regulations or legal requirements regarding the handling and analysis of retrieved implants and tissues and associated biological material.

ISO 12891-1:2011 specifies the method to be followed for the retrieval and handling of surgical implants and associated tissues and fluids. In particular, it specifies the essential steps to be followed for the safe and proper obtaining of the clinical history, pre-explantation checks and examinations, collection, labelling, cleaning, decontamination, documentation, packing and shipping. ISO 12891-1:2011 also provides guidance on infection control. ISO 12891-1:2011 does not apply in cases of explantation where there is no intention to collect retrieval data. However, many clauses give useful information which can apply in these cases also.

This standard gives guidance on the procedures for receiving, storing, transporting, handling, cleaning and sterilization of the implants in the clinical range. Guidance on cautions necessary for preparing implants for the use are also outlined. It does not apply to the implant manufacturer.