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1、DRAFT FOR DEVELOPMENT DD ISO/TS 19218:2005 Medical devices Coding structure for adverse event type and cause ICS 03.120.10; 11.040.01 ? Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 04:27:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI DD ISO/TS 19218:2005 This
2、Draft for Development was published under the authority of the Standards Policy and Strategy Committee on 21 December 2005 BSI 21 December 2005 ISBN 0 580 46901 8 National foreword This Draft for Development reproduces verbatim ISO/TS 19218:2005. This publication is not to be regarded as a British S
3、tandard. It is being issued in the Draft for Development series of publications and is of a provisional nature because no state of the art model was available upon which a standard could be based. It should be applied on this provisional basis, so that information and experience of its practical app
4、lication may be obtained. Comments arising from the use of this Draft for Development are requested so that UK experience can be reported to the international organization responsible for the Technical Specification. A review of this publication will be initiated not later than 3 years after its pub
5、lication by the international organization so that a decision can be taken on its status at the end of its 3-year life. Notification of the start of the review period will be made in an announcement in the appropriate issue of Update Standards. According to the replies received by the end of the rev
6、iew period, the responsible BSI Committee will decide whether to support the conversion into an international standard, to extend the life of the Technical Specification for another 3 years or to withdraw it. Comments should be sent in writing to the Secretary of BSI Subcommittee CH/210/3, General t
7、erminology and symbols, at British Standards House, 389 Chiswick High Road, London W4 4AL, giving the document reference and clause number and proposing, where possible, an appropriate revision of the text. A list of organizations represented on this subcommittee can be obtained on request to its se
8、cretary. Cross-references The British Standards which implement international publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of
9、 British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Summary of pages This document comprises a front cover, an inside front cover, the ISO/TS title page, pages ii to v, a blank page, pa
10、ges 1 to 11 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 04:27:08 GMT+00:00 2006, Uncont
11、rolled Copy, (c) BSI Reference number ISO/TS 19218:2005(E) TECHNICAL SPECIFICATION ISO/TS 19218 First edition 2005-11-01 Medical devices Coding structure for adverse event type and cause Dispositifs mdicaux Structure de codage pour la cause et le type dvnement dfavorable DD ISO/TS 19218:2005 License
12、d Copy: London South Bank University, London South Bank University, Sat Dec 09 04:27:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 04:27:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI DD ISO/TS 19218:2005 iii Con
13、tents Page Foreword iv Introduction v 1 Scope 1 2 Terms and definitions .1 3 Code system and requirements .2 3.1 Adverse event type code 2 3.2 Adverse event cause code4 Annex A (informative) Coding system for describing adverse events 8 Annex B (informative) Examples of coding 9 Bibliography 11 Lice
14、nsed Copy: London South Bank University, London South Bank University, Sat Dec 09 04:27:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI DD ISO/TS 19218:2005 iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).
15、The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-g
16、overnmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2
17、. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a
18、vote. In other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to publish other types of normative document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO worki
19、ng group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a vote; 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
20、 the 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 f
21、urther 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 pate
22、nt rights. ISO/TS 19218 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices. Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 04:27:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI v Introduction T
23、he adverse event coding structure specified in this Technical Specification envisages that the reporting of medical device adverse events will originate from one of two sources, either the user or the manufacturer of the device concerned. Users, in this context, may be healthcare professionals, but
24、may also be the general public. This Technical Specification provides a coding structure by which an adverse event type and/or the observable cause/effect can be used so as to collect medical device surveillance information. The observable cause/effect comes from an initial assessment of the adverse
25、 event. It also enables this information to be easily exchanged on an international basis using the common codes. This Technical Specification can be utilized by the users, manufacturers and regulatory authorities in the following ways: Users can report to a manufacturer or a regulatory body a code
26、number to describe an adverse event that will be universally understood by both. Manufacturers and regulatory authorities can easily recognize universally understood adverse event types, can assign understood initial assessment cause/effect codes which can be globally recognized by regulatory author
27、ities. Both users and manufacturers can apply the use of these codes as part of a medical device surveillance or reporting system. This Technical Specification is not intended for the purpose of taking a decision whether an incident is reportable or not. DD ISO/TS 19218:2005 Licensed Copy: London So
28、uth Bank University, London South Bank University, Sat Dec 09 04:27:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 04:27:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 1 Medical devices Coding structure for adv
29、erse event type and cause 1 Scope This Technical Specification specifies requirements for a coding structure for describing adverse events related to medical devices. This code is intended for use by medical device users, manufacturers and regulatory authorities. 2 Terms and definitions For the purp
30、oses of this document, the following terms and definitions apply. 2.1 serious injury condition that results from life-threatening illness or injury; results in permanent impairment (2.2) of a body function or permanent damage (2.3) to a body structure; necessitates medical or surgical intervention t
31、o prevent permanent impairment (2.2) of a body function or permanent damage (2.3) to a body structure NOTE 1 Serious injury is also known as serious deterioration in state of health. NOTE 2 This definition is consistent with guidance in GHTF/N21R8:1999. 2.2 permanent impairment irreversible impairme
32、nt to a body structure or function, excluding minor impairment 2.3 permanent damage irreversible damage to a body structure or function, excluding minor damage 2.4 adverse event event associated with a medical device that leads to death or serious injury (2.1) of a patient, user or other person or m
33、ight lead to death or serious injury of a patient, user or other person if the event recurs NOTE This definition is consistent with guidance in GHTF/N21R8:1999. DD ISO/TS 19218:2005 Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 04:27:08 GMT+00:00 2006, Uncontr
34、olled Copy, (c) BSI 2 3 Code system and requirements 3.1 Adverse event type code The adverse event type code characterizes the observed use/malfunction/failure of the medical device at the time the event occurred. The code shall be a three-digit numerical code selected from Table 1. The single code
35、that most closely describes the adverse event should be used. However, multiple codes can sometimes be necessary to fully describe an adverse event. The adverse event type codes chosen to describe the adverse event at the time of the event should reflect the most up-to-date assessment of the adverse
36、 event and should take into account any additional information learned between the event and submission of the report. NOTE The adverse event type code can be useful in describing the hazard presented by an adverse event. It can also be useful in “user reporting systems”. When combined with the adve
37、rse event cause code, the adverse event is better characterized. Table 1 Adverse event (AE) type AE type code AE type term AE type description Examples 100 Abnormal or unexpected biological response An abnormal or unexpected biological response. Allergic reaction to a device containing natural rubbe
38、r latex (NRL), e.g. catheters, drains, or gloves. 110 Computer hardware Any medical device using computer hardware, (e.g. internal hard disc, external disc drives) where any malfunction of the hardware results in a device failure. Internal hard drive of the central monitoring system crashes causing
39、the system to no longer function and also resulting in the loss of individual patient information. 120 Connection An inappropriate capability for connection between: devices, parts, components, or joined elements; not intended to be joined together. Patient lead is inserted into an electrical outlet
40、. 130 Data output/readings Data provided by the device or through the use of a device is deficient, e.g. observed aberrant test result possibly leading to inappropriate action or treatment. Patient identification number is truncated on diagnostic device display unit. 140 Disconnection The unintended
41、 separation of a connection or an unstable connection between two or more parts, (e.g. electrical, mechanical, tubing) resulting in a device failure. Needles separating from hub. Suture wing separates from catheter. 150 Electrical An event associated with an electromedical device where an electrical
42、 malfunction results in a device failure (e.g. electrical circuitry, contact or component failed) even if the failure is intermittent. Overheating of electrical circuits, sparking of relays, break in instillation resulting in electrical shock. Overheating wires leading to a break in wire. 160 Enviro
43、nmental Device function is adversely influenced by temperature, user hygiene, transportation, storage, etc. Steam sterilization of hip prostheses results in surface roughening. Rubber or plastic materials become brittle due to extended high storage temperatures. DD ISO/TS 19218:2005 Licensed Copy: L
44、ondon South Bank University, London South Bank University, Sat Dec 09 04:27:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3 Table 1 (continued) AE type code AE type term AE type description Examples 170 Implantable device failure The migration, malfunction or failure of an implanted device (active o
45、r non-active) resulting in an invasive procedure which may lead to explantation, e.g. breast implants, pacemakers, intraocular lenses. Catheter for a venous access system becomes disconnected from the port. Two-piece orthopaedic device separates. Breast implant leaks. 180 Incompatibility The lack of
46、 compatibility between items intended to function properly together; leading to dysfunction between two or more devices, parts, components, joined elements, or between a device and the substance ( e.g. medicine, body fluid) it contains or transports. This type excludes disconnection. Universal conne
47、ctor will not attach securely to ventilator connection. 190 Instructions for use/labelling deficiency Inadequate, incorrect, instructions for use/labelling/packaging resulting in an event or device failure. Hex head of a screwdriver included in a kit is too large to fit the heads of the bone screws
48、also included. Labelled refractive power of a contact lens is not consistent with that of the lens in the package. 200 Intermittent malfunction The intermittent malfunction of unidentified origin resulting in a device failure. Monitor for a device periodically goes blank and then the image will reap
49、pear. 210 Material, component failure An event where part of, or the entire device or component is manufactured using material(s) of limited durability, (e.g. insulation, rubber) resulting in a device failure. Polymer coating on a reusable cable deforms during sterilization by user facility. 220 Mechanical component failure A mechanical component defect, including moving parts or subassemblies resulting in a device malfunction (e.g. breakage, deformation, obstruction) re