ANSI AAMI 23500-2014 Guidance for the preparation and quality management of fluids for hemodialysis and related therapies.pdf

1、ANSI/AAMI 23500:2014Guidance for the preparation and quality management of fluids for hemodialysis and related therapiesAmerican National StandardAmerican National Standard ANSI/AAMI 23500:2014 Guidance for the preparation and quality management of fluids for hemodialysis and related therapies Appro

2、ved 21 July 2014 by Association for the Advancement of Medical Instrumentation Approved 15 August 2014 by American National Standards Institute, Inc. Abstract: Addresses the users responsibility for the dialysis fluid once the equipment used in its preparation has been delivered and installed. Inclu

3、des dialysis water used for the preparation of dialysis fluid and substitution fluid, dialysis water used for the preparation of concentrates at the users facility, as well as concentrates and the final dialysis fluid and substitution fluid. Keywords: concentrate, microbiological, monitoring, qualit

4、y, system, validation, water AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect preclude anyone, whether they have

5、approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. AAMI standards are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standard may be revised

6、 or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI, or by visiting the AAMI we

7、bsite at www.aami.org. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntar

8、y technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arli

9、ngton, VA 22203-1633 www.aami.org 2014 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document without the prior written permission of the

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11、vancement 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 D

12、rive, Suite 301, Arlington, VA 22203. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-550-7 Contents PageGlossary of equivalent standards . v US deviation to ISO 23500:2014 vii Introduction . viii1 Scope 1 1.1 General . 1 1.2 Inclusions . 1 1.3 Exclus

13、ions 1 2 Normative references 1 3 Terms and definitions 2 4 Summary of quality requirements of ISO 13958, ISO 13959 and ISO 11663 . 9 4.1 Dialysis water . 10 4.2 Requirements for concentrate 12 4.3 Requirements for dialysis fluid 12 4.4 Record retention 13 5 Critical aspects of system design 13 5.1

14、Technical aspects 14 5.2 Microbiological aspects 14 6 Validation of system performance . 15 6.1 Validation plan . 15 6.2 Installation and operational qualification 16 6.3 Performance qualification . 17 6.4 Routine monitoring and revalidation . 17 7 Quality management 18 7.1 General . 18 7.2 Monitori

15、ng of fluid quality . 18 7.3 Monitoring of water treatment equipment . 19 7.4 Monitoring of dialysis water storage and distribution 23 7.5 Monitoring of concentrate preparation 24 7.6 Monitoring of concentrate distribution 25 7.7 Monitoring of dialysis fluid proportioning . 25 8 Strategies for micro

16、biological control . 25 8.1 General . 25 8.2 Disinfection 26 8.3 Microbiological monitoring methods . 28 9 Environment . 31 10 Personnel . 31 Annex A (informative) Rationale for the development and provisions of this International Standard . 32 Annex B (informative) Equipment . 36 Annex C (informati

17、ve) Monitoring guidelines for water treatment equipment, distribution systems, and dialysis fluid . 55 Annex D (informative) Strategies for microbiological control 62 Annex E (informative) Validation . 67 Annex F (informative) Special considerations for home hemodialysis . 70 Annex G (informative) S

18、pecial considerations for acute hemodialysis . 76 Bibliography . 81 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. AAMI maintains a current list of each International Standard that has been adop

19、ted by AAMI (and ANSI). Available on the AAMI website at the address below, this list gives the corresponding U.S. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 23500:2

20、014 v Committee representationAssociation for the Advancement of Medical Instrumentation AAMI Renal Disease and Detoxification Committee This American National Standard was developed by the AAMI Renal Disease and Detoxification Committee. Approval of the American National Standard does not necessari

21、ly imply that all committee members voted for its approval. At the time this document was published, the AAMI Renal Disease and Detoxification Committee had the following members: Chairs: Conor Curtin David Roer, MD, FACP, FASN, FASH Members: G Steven Acres, MD, Carolina Regional Nephrology Associat

22、es James Weldon Baker, AmeriWater Alex Barten, Baxter Healthcare Corporation Christian Gert Bluchel, AWAK Technologies Pte Ltd. Karla S. Byrne, Rockwell Medical Inc Danilo B. Concepcion, CBNT, CCHT-A, St Joseph Hospital Renal Center Deborah A. Cote, MSN ,RN, CNN, National Renal Administrators Associ

23、ation Conor Curtin, Fresenius Medical Care North America Jim Curtis, Portland, OR R. Barry Deeter, RN MSN, University of Utah Dialysis Program Martin T. Gerber, Medtronic Inc. Gema Gonzalez, FDA/CDRH/ODE Elizabeth Howard, DaVita, Inc. Byron L. Jacobs, CBET, Sanford USD Medical Center Judith Kari, He

24、alth Care Financing Administration Kendall Larson, Mar Cor Purification Nathan W. Levin, MD, Renal Research Institute LLC Jo Ann Maltais, PhD, Maltais Consulting Duane Martz, B Braun of America, Inc. Lane McCarthy, CCHT, Hortense they are not intended as detailed design standards. Requirements for w

25、ater treatment equipment are provided in ISO 26722. The verbal forms used in this International Standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2:2004. For the purposes of this International standard, the auxiliary verb: “shall” means that compliance with a requirement

26、 or a test is mandatory for compliance with this International Standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this International Standard; “may” is used to describe a permissible way to achieve compliance with a requireme

27、nt or test. This International Standard reflects the conscientious efforts of healthcare professionals, patients, and medical device manufacturers to develop recommendations for handling water and concentrates and for the production and monitoring of dialysis fluid for hemodialysis. This Internation

28、al Standard is directed towards the healthcare professionals involved in the management or routine care of hemodialysis patients and responsible for the quality of dialysis fluid. The recommendations contained in this International Standard might not be applicable in all circumstances and they are n

29、ot intended for regulatory application. The guidance provided by this International Standard should help protect hemodialysis patients from adverse effects arising from known chemical and microbial contaminants that might be found in improperly prepared dialysis fluid. However, the physician in char

30、ge of dialysis has the ultimate responsibility for ensuring that the dialysis fluid is correctly formulated and meets the requirements of all applicable quality standards. The concepts incorporated in this International Standard should not be considered inflexible or static. The recommendations pres

31、ented here should be reviewed periodically in order to assimilate increased understanding of the role of dialysis fluid purity in patient outcomes and technological developments. viii 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 23500:2014 2014 Association for the Advanc

32、ement of Medical Instrumentation ANSI/AAMI 23500:2014 ix American National Standard ANSI/AAMI 23500:2014Guidance for the preparation and quality management of fluids for hemodialysis and related therapies 1 Scope 1.1 General This International Standard provides dialysis practitioners with guidance o

33、n the preparation of dialysis fluid for hemodialysis and related therapies and substitution fluid for use in online therapies, such as hemodiafiltration and hemofiltration. As such, this International Standard functions as a recommended practice. 1.2 Inclusions This International Standard addresses

34、the users responsibility for the dialysis fluid once the equipment used in its preparation has been delivered and installed. For the purposes of this International Standard, the dialysis fluid includes dialysis water (see 3.18 for definition) used for the preparation of dialysis fluid and substituti

35、on fluid, dialysis water used for the preparation of concentrates at the users facility, as well as concentrates and the final dialysis fluid and substitution fluid. The scope of this International Standard includes a) the quality management of equipment used to treat and distribute water used for t

36、he preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyzer or the point at which substitution fluid is infused, b) equipment used to prepare concentrate from powder o

37、r other highly concentrated media at a dialysis facility, and c) preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates. NOTE Because water used to prepare dialysis fluid is commonly prepared and distributed using the same equipment as the water used to re

38、process dialyzers, water used to reprocess dialyzers is also covered by this International Standard. 1.3 Exclusions This International Standard does not apply to sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous

39、renal replacement therapy that use prepackaged solutions, and systems and solutions for peritoneal dialysis. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edit

40、ion cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 23500:2014 1 ISO 11663:2014, Quality of dialysis fluid for hemodialysis and related therapies ISO 139

41、58:2014, Concentrates for hemodialysis and related therapies ISO 13959:2014, Water for hemodialysis and related therapies ISO 26722:2014, Water treatment equipment for hemodialysis applications and related therapies 3 Terms and definitions For the purposes of this document, the following terms and d

42、efinitions apply. 3.1 acetate concentrate concentrated solution of salts containing acetate, which, when diluted with dialysis water, yields bicarbonate-free dialysis fluid for use in dialysis Note 1 to entry: Acetate concentrate may contain glucose. Note 2 to entry: Sodium acetate is used to provid

43、e buffer in place of sodium bicarbonate. Note 3 to entry: Acetate concentrate is used as a single concentrate. 3.2 acid concentrate A-concentrate acidified concentrated mixture of salts that, when diluted with dialysis water and bicarbonate concentrate, yields dialysis fluid for use in dialysis Note

44、 1 to entry: The term “acid” refers to the small amount of acid (for example, acetic acid or citric acid) that is included in the concentrate. Note 2 to entry: Acid concentrate may contain glucose. Note 3 to entry: Acid concentrate may be in the form of a liquid, a dry powder, other highly concentra

45、ted media, or some combination of these forms. 3.3 action level concentration of a contaminant at which steps should be taken to interrupt the trend toward higher, unacceptable levels 3.4 additive spike small amount of a single chemical that, when added to the concentrate, will increase the concentr

46、ation of a single existing chemical by a value labelled on the additive packaging 3.5 bicarbonate concentrate B-concentrate concentrated preparation of sodium bicarbonate that, when diluted with dialysis water and acid concentrate, makes dialysis fluid used for dialysis 2 2014 Association for the Ad

47、vancement of Medical Instrumentation ANSI/AAMI 23500:2014 Note 1 to entry: Sodium bicarbonate is also known as sodium hydrogen carbonate. Note 2 to entry: Some bicarbonate concentrates also contain sodium chloride. Note 3 to entry: Bicarbonate concentrate may be in the form of a liquid or a dry powd

48、er. Note 4 to entry: Dry sodium bicarbonate, without added sodium chloride, is also used in concentrate generators to produce a concentrated solution of sodium bicarbonate used by the dialysis machine to make dialysis fluid. 3.6 biofilm microbially-derived sessile community characterized by cells th

49、at are irreversibly attached to a substratum or interface or to each other, are imbedded in a matrix of extracellular polymeric substances that they have produced, and exhibit an altered phenotype with respect to growth rate and gene transcription Note 1 to entry: The matrix, a slimy material secreted by the cells, protects the bacteria from antibiotics and chemical disinfectants. Note 2 to entry: A certain amount of biofilm formation is considered unavoidable in dialysis water systems. When the level of biofilm is such that the action levels for microorganisms