ANSI TIR12417-2011 Cardiovascular implants and extracorporeal systems C Vascular device-drug combination products.pdf

1、ANSI/AAMI/ISO TIR12417:2011 Association for the Advancementof Medical InstrumentationCardiovascular implants and extracorporeal systems Vascular device-drug combination productsObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses

2、 of an AAMI product standard or recommended practice are clearly understood. The objectives of AAMIs technical development program derive from AAMIs overall mission: the advancement of medical instrumentation. Essential to such advancement are (1) a continued increase in the safe and effective appli

3、cation of current technologies to patient care, and (2) the encouragement of new technologies. It is AAMIs view that standards and recommended practices can contribute significantly to the advancement of medical instrumentation, provided that they are drafted with attention to these objectives and p

4、rovided that arbitrary and restrictive uses are avoided. A voluntary standard for a medical device recommends to the manufacturer the information that should be provided with or on the product, basic safety and performance criteria that should be considered in qualifying the device for clinical use,

5、 and the measurement techniques that can be used to determine whether the device conforms with the safety and performance criteria and/or to compare the performance characteristics of different products. Some standards emphasize the information that should be provided with the device, including perf

6、ormance characteristics, instructions for use, warnings and precautions, and other data considered important in ensuring the safe and effective use of the device in the clinical environment. Recommending the disclosure of performance characteristics often necessitates the development of specialized

7、test methods to facilitate uniformity in reporting; reaching consensus on these tests can represent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establishment of minimum safety and performance criteria, referee tests must be provided

8、and the reasons for establishing the criteria must be documented in the rationale. A recommended practice provides guidelines for the use, care, and/or processing of a medical device or system. A recommended practice does not address device performance per se, but rather procedures and practices tha

9、t will help ensure that a device is used safely and effectively and that its performance will be maintained. Although a device standard is primarily directed to the manufacturer, it may also be of value to the potential purchaser or user of the device as a frame of reference for device evaluation. S

10、imilarly, even though a recommended practice is usually oriented towards healthcare professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also, some recommended practices, while not addressing device performance criteria,

11、provide guidelines to industrial personnel on such subjects as sterilization processing, methods of collecting data to establish safety and efficacy, human engineering, and other processing or evaluation techniques; such guidelines may be useful to health care professionals in understanding industri

12、al practices. In determining whether an AAMI standard or recommended practice is relevant to the specific needs of a potential user of the document, several important concepts must be recognized: All AAMI standards and recommended practices are voluntary (unless, of course, they are adopted by gover

13、nment regulatory or procurement authorities). The application of a standard or recommended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommended practice reflects the collective expertise of a committee of health care profes

14、sionals and industrial representatives, whose work has been reviewed nationally (and sometimes internationally). As such, the consensus recommendations embodied in a standard or recommended practice are intended to respond to clinical needs and, ultimately, to help ensure patient safety. A standard

15、or recommended practice is limited, however, in the sense that it responds generally to perceived risks and conditions that may not always be relevant to specific situations. A standard or recommended practice is an important reference in responsible decision-making, but it should never replace resp

16、onsible decision-making. Despite periodic review and revision (at least once every five years), a standard or recommended practice is necessarily a static document applied to a dynamic technology. Therefore, a standards user must carefully review the reasons why the document was initially developed

17、and the specific rationale for each of its provisions. This review will reveal whether the document remains relevant to the specific needs of the user. Particular care should be taken in applying a product standard to existing devices and equipment, and in applying a recommended practice to current

18、procedures and practices. While observed or potential risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard, professional judgment must be used in applying these criteria to existing equipment. No single source of information will serve

19、to identify a particular product as “unsafe“. A voluntary standard can be used as one resource, but the ultimate decision as to product safety and efficacy must take into account the specifics of its utilization and, of course, cost-benefit considerations. Similarly, a recommended practice should be

20、 analyzed in the context of the specific needs and resources of the individual institution or firm. Again, the rationale accompanying each AAMI standard and recommended practice is an excellent guide to the reasoning and data underlying its provision. In summary, a standard or recommended practice i

21、s truly useful only when it is used in conjunction with other sources of information and policy guidance and in the context of professional experience and judgment. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standards and recommended practices mu

22、st be made in writing, to the AAMI Vice President, Standards Policy and Programs. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Board. The interpretation will become official and representation o

23、f the Association only upon exhaustion of any appeals and upon publication of notice of interpretation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterization or explanation of a standard or

24、 recommended practice which has not been developed and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. An ANSI Technical Report prepared by AAMI ANSI/AAMI/ISO TIR12417:2011 Cardiovascular implants and e

25、xtracorporeal systems Vascular device-drug combination products Approved 8 December 2010 by Association for the Advancement of Medical Instrumentation Registered 5 December 2010 by American National Standards Institute, Inc. Abstract: Covers products that deliver a drug (e.g. drug eluting stent) or

26、a drug that is “permanently“ bound on the device surface (e.g. Heparin coated stent), and gives technical guidance for device manufacturers and assessors regarding typical drug-device interface problems (e.g. EO residuals limits are different for drugs and devices). Shall not include products whose

27、main function is drug delivery (e.g. syringes). Keywords: analysis, biocompatibility, design, drug, evaluation, matrix, performance, pharmaceutical, VDDCP Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 20

28、11 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO, ANSI, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior writt

29、en permission of AAMI. All requests pertaining to this document should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the

30、Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at www.aami.org or contact AAMI at 4301 N. Fairfax

31、 Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1-57020-411-X AAMI Technical Information Report A technical information report (TIR) is a publication of the Association for the Advancement of Medical Instrumentat

32、ion (AAMI) Standards Board that addresses a particular aspect of medical technology. Although the material presented in a TIR may need further evaluation by experts, releasing the information is valuable because the industry and the professions have an immediate need for it. A TIR differs markedly f

33、rom a standard or recommended practice, and readers should understand the differences between these documents. Standards and recommended practices are subject to a formal process of committee approval, public review, and resolution of all comments. This process of consensus is supervised by the AAMI

34、 Standards Board and, in the case of American National Standards, by the American National Standards Institute. A TIR is not subject to the same formal approval process as a standard. However, a TIR is approved for distribution by a technical committee and the AAMI Standards Board. Another differenc

35、e is that, although both standards and TIRs are periodically reviewed, a standard must be acted onreaffirmed, revised, or withdrawnand the action formally approved usually every five years but at least every 10 years. For a TIR, AAMI consults with a technical committee about five years after the pub

36、lication date (and periodically thereafter) for guidance on whether the document is still usefulthat is, to check that the information is relevant or of historical value. If the information is not useful, the TIR is removed from circulation. A TIR may be developed because it is more responsive to un

37、derlying safety or performance issues than a standard or recommended practice, or because achieving consensus is extremely difficult or unlikely. Unlike a standard, a TIR permits the inclusion of differing viewpoints on technical issues. CAUTION NOTICE: This AAMI TIR may be revised or withdrawn at a

38、ny time. Because it addresses a rapidly evolving field or technology, readers are cautioned to ensure that they have also considered information that may be more recent than this document. All standards, recommended practices, technical information reports, and other types of technical documents dev

39、eloped by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is respon

40、sible 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 Na

41、tional 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 Rep

42、orts 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 Glos

43、sary of equivalent standards vi Committee representation. viii Background of AAMI adoption of ISO/TS 12417:2011 ix Foreword x Introduction xi 1 Scope. 1 2 Normative references 2 3 Terms and definitions 2 4 General requirements 6 4.1 Classification 6 4.2 Intended clinical location 6 5 Intended perfor

44、mance . 6 6 Design attributes 6 6.1 General 6 6.2 Drug-containing part of the VDDCP (DCP) 7 6.2.1 General 7 6.2.2 Matrix . 7 6.2.3 Active pharmaceutical ingredient (API) . 8 7 Materials 8 8 Design evaluation 8 8.1 General 8 8.2 Sampling . 9 8.3 Conditioning of test samples 10 8.4 Reporting 10 8.5 Te

45、sting of the device part of the VDDCP . 11 8.6 Testing of the drug-containing part of the VDDCP . 11 8.7 Requirements for the drug-containing part of the VDDCP 11 8.7.1 Ability to access . 11 8.7.2 Ability to deploy the VDDCP and deliver the API from the DCP . 12 8.7.3 Ability to withdraw . 14 8.7.4

46、 Functionality . 15 8.7.5 Compatibility with procedural fluids 16 8.7.6 Corrosion 16 8.7.7 Magnetic resonance imaging (MRI) safety and compatibility . 16 8.7.8 Biocompatibility . 17 8.8 Preclinical in vivo evaluation 17 8.8.1 Purpose . 17 8.8.2 Specific aims 17 8.8.3 Protocol . 18 8.8.4 Data acquisi

47、tion . 20 8.8.5 Test report and additional information 22 8.9 Clinical evaluation 22 8.9.1 Purpose . 22 8.9.2 Specific aims 23 8.9.3 Clinical-investigation plan 23 8.9.4 Data acquisition . 24 8.9.5 Final report . 26 9 Post-market surveillance 27 10 Manufacturing 27 10.1 General 27 10.2 Raw-material

48、analysis and reporting for the API 28 10.3 Raw-material analysis and reporting for excipients . 28 10.4 VDDCP batch release testing 29 11 Sterilization . 29 11.1 Products supplied sterile 29 11.1.1 Labeling 29 11.2 Products supplied non-sterile 30 11.3 Sterilization residuals 30 12 Packaging . 30 12

49、.1 Protection from damage during storage and transport . 30 12.1.1 General 30 12.1.2 Unit container . 30 12.1.3 Shipping container . 30 12.1.4 Maintenance of sterility in transit . 30 12.2 Marking . 31 12.2.1 VDDCP label(s) . 31 12.2.2 Record label 32 12.3 Information supplied by the manufacturer 32 12.3.1 General 32 12.3.2 Information and instructions for use (IFU) 32 Annex A (informative) Definitions of potential clinical events 34 Annex B (informative) Information on device- and drug-related aspects Applicable documents for local guidance 39 Bibliography 46 vi 2011 Associa