1、ANSI/AAMI/ ISO TIR 19218-2:2012Technical Information ReportMedical devices Hierarchal coding structure for adverse events Part 2: Evaluation codesAn ANSI Technical Report prepared by AAMI ANSI/AAMI/ISO TIR19218-2:2012 (Partial revision of ANSI/AAMI/ISO TIR19218:2005) Medical devices - Hierarchical c
2、oding structure for adverse events - Part 2: Evaluation codes Approved 20 August 2012 by Association for the Advancement of Medical Instrumentation Registered 19 November 2012 by American National Standards Institute, Inc. Abstract: Specifies requirements for a hierarchical coding structure for char
3、acterizing the results of the analysis or evaluation describing adverse events relating to medical devices. Keywords: adverse event reporting, coding Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2012 by
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7、e, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1-57020-469-1 AAMI Technical Information Report A technical information report (TIR) is a publication of the Association for the Advancement of Medical Instrumentation (
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16、 for enforcement of its rules and regulations. Comments on this technical information report are invited and should be sent to AAMI, Attn: Standards Department, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. ANSI Technical Report This AAMI TIR has been registered by the American Nationa
17、l Standards Institute as an ANSI Technical Report. Publication of this ANSI Technical Report has been approved by the accredited standards developer (AAMI). This document is registered as a Technical Report series of publications according to the Procedures for the Registration of Technical Reports
18、with ANSI. This document is not an American National Standard and the material contained herein is not normative in nature. Comments on the content of this document should be sent to AAMI, Attn: Standards Department, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Contents Page Glossary
19、of equivalent standards . v Committee representation. viii Background of AAMI adoption of ISO/TS 19218-2:2012 x Foreword . xi Introduction . xii 1 Scope. 1 2 Terms and definitions 1 3 Adverse event evaluation code requirements 2 4 Adverse event evaluation codes 2 Annex A Coding system structure 13 B
20、ibliography 14 Table 1 Adverse-event evaluation codes . 2 Figure A.1 Coding system structure 13 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR19218-2:2012 v Glossary of equivalent standards International Standards adopted in the United States may include normative
21、references to other International Standards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard. NOTE: Documents are sorted by international designation. The code in
22、 the U.S. column, “(R)20xx” indicates the year the document was officially reaffirmed by AAMI. For example, ANSI/AAMI/ISO 10993-4:2002/(R)2009 indicates that 10993-4, originally approved and published in 2002, was reaffirmed without change in 2009. Other normatively referenced International Standard
23、s may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 ANSI/AAMI ES60601-1:2005/(R)2012 Major technical variations IEC 60601-1:2005/A1:2012 ANSI/AAMI ES60601-1:2005/A1:2
24、012 A1 identical IEC Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005/C1:2009/(R)2012 (amdt) C1 identical to Corrigendum 1 an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of th
25、e members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a furt
26、her three years, at which time it must either be transformed into an International Standard or be withdrawn. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent
27、rights. ISO/TS 19218-2 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices. This first edition of ISO/TS 19218-2, together with ISO/TS 19218-1, cancels and replaces ISO/TS 19218:2005, which has been technically revised. ISO 19218 c
28、onsists of the following parts, under the general title Medical devices Hierarchical coding structure for adverse events: Part 1: Event-type codes Part 2: Evaluation codes xii 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR19218-2:2012 Introduction It is envisaged t
29、hat the adverse-event evaluation codes specified in this part of ISO 19218 will originate primarily from the manufacturer of the device concerned. This Technical Specification provides a structure by which adverse-event evaluations can be used to collect medical device surveillance information in th
30、e post-market phase. It will also enable this information to be easily exchanged on an international basis using the common codes. It can be used by healthcare providers and other users of the devices; however, a number of the evaluation codes characterize the results of analyses or investigations c
31、onducted by the manufacturer or regulatory authorities, who can use it to recognize the results of analyses or investigations of adverse events by means of globally recognized evaluation codes, and apply these codes as part of a medical device surveillance or reporting system. Annex A shows how adve
32、rse-event codes can be used in conjunction with other data elements in order to facilitate global data exchange between regulatory bodies. 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR19218-2:2012 1 AAMI Technical Information Report ANSI/AAMI/ISO TIR19218-2:2012Me
33、dical devices Hierarchical coding structure for adverse events Part 2: Evaluation codes 1 Scope This part of ISO 19218 specifies requirements for a hierarchical coding structure for characterizing the results of the analysis or evaluation of adverse events relating to medical devices. The codes are
34、intended primarily for use by medical device manufacturers and regulatory authorities. They can also be used for coding the results of the analysis or evaluation of events other than those related to death or serious injury, as well as malfunctions that could lead to death or serious injury. This pa
35、rt of ISO 19218 is not intended to be used to decide whether or not an incident is reportable. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 adverse event event associated with a medical device that has led to the death or serious injury of
36、 a patient, user or other person, or that might lead to the death or serious injury of a patient, user or other person if it were to reoccur NOTE 1 This definition is consistent with guidance in GHTF/SG2/N54/R8:20065. NOTE 2 It includes the malfunction or deterioration of a device which has not yet
37、caused death or serious injury, but which could lead to death or serious injury. NOTE 3 This definition is not intended to be used in determining if an event is reportable to a regulatory authority. 2.2 serious injury serious deterioration in state of health that constitutes either a life threatenin
38、g illness or injury, or a permanent impairment of a body function or permanent damage to a body structure, or a condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure NOTE 1 “Permanent” here means irreversib
39、le impairment or damage, excluding minor impairment or damage. NOTE 2 This definition is consistent with guidance in GHTF/SG2/N54/R8:20065. 2 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR19218-2:2012 2.3 intended use intended purpose objective intent of the manufa
40、cturer regarding the use of a product, as reflected in the specifications, instructions or information provided by the manufacturer NOTE This definition is consistent with GHTF/SG1/N41/R9:20056. 3 Adverse-event evaluation code requirements The adverse-event evaluation code characterizes the latest c
41、onclusions of an analysis or investigation of the adverse event. The code shall be a five-digit numerical code selected from Table 1. NOTE 1 Multiple codes can be necessary to fully describe the results of the evaluation of an adverse event. NOTE 2 The adverse-event evaluation code can be useful for
42、 manufacturers and regulatory authorities when following up on reported adverse events. When combined with the adverse-event-type code, the characteristics of the adverse event are succinctly communicated. NOTE 3 The latest conclusions characterize the event at any stage of an analysis or investigat
43、ion. 4 Adverse-event evaluation codes Table 1 specifies adverse-event evaluation codes. Table 1 Adverse-event evaluation codes Level 1 Level 2 Code Term Definition Code Term Definition 25000 Biological Event relating to, caused by or affecting life or living organisms 25001 Abnormal or unexpected ph
44、ysiological response Abnormal or unexpected physiological response such as hypersensitivity 25002 Biocompatibility Device causes cellular or tissue responses that elicit an undesirable local or systemic effect in the recipient or beneficiary of that therapy see ISO 10993 (all parts) 25003 Biological
45、 material Presence of biological material(s) in a device resulting in a reaction other than immediate hypersensitivity 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR19218-2:2012 3 Level 1 Level 2 Code Term Definition Code Term Definition 25004 Contamination by fore
46、ign material Presence of extraneous material that renders a device impure or potentially harmful. NOTE Excludes contamination during production (see level 2 code 26503). 25005 Genotoxic problem Devices ability to cause damage to genetic material, e.g. leading malignant tumors see ISO 10993 (all part
47、s) 25006 Hematologic problem Device affects or impacts the blood or its components see ISO 10993 (all parts) 25007 Endotoxin contamination The undesirable presence of toxins associated with certain bacteria (e.g. gram negative bacteria) 25008 Microbiological contamination Undesirable presence of mic
48、roorganisms or microbes such as bacteria and fungi (yeasts and molds) 25009 Material or material leachate pyrogenic problem Undesirable presence of pyrogens or fever-producing organisms resulting from materials that permeate through the device 25100 Counterfeiting Event associated with the reproduct
49、ion of a genuine medical device or the forging of labeling or product information with the intent to deceptively misrepresent the genuine medical product 25101 Counterfeit Imitation of a genuine medical device with the intent to deceive 25102 Forged product information Product labeling or other information that is not provided or authorized by the company responsible for labeling the device 25300 Design Event associated with the failure of a medical device to achieve its intended function due to inadequate design or develo
