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1、American National Standard ANSI/AAMI ST65:2000 AAMI Association for the Advancement of Medical Instrumentation Processing of reusable surgical textiles for use in health care facilities Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licen
2、see=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:49:36 MDTNo reproduction or networking permitted without license from IHS -,-,- American National StandardANSI/AAMI ST65:2000 Processing of reusable surgical textiles for use in health care facilities Developed by Associat
3、ion for the Advancement of Medical Instrumentation Approved 20 January 2000 by American National Standards Institute, Inc. Abstract:This recommended practice provides guidelines for the proper handling, processing, and preparation of reusable surgical textiles either on-site or off-site for use in h
4、ealth care facilities. This recommended practice specifically addresses design criteria for functional work areas; staff qualifications, education, training, dress codes, and other personnel considerations; receiving and handling of soiled surgical textiles; laundry processing considerations; transp
5、ort of both soiled and clean surgical textiles; installation, care, and maintenance of laundry equipment; quality control; and regulatory considerations. Definitions of terms and a bibliography are also provided. Keywords:laundry, linens, surgical drapes, surgical gowns, wrappers Copyright Associati
6、on for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:49:36 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI Recommended Practice This AAMI recommended
7、 practice implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI recommended practice does not in any respect preclude anyone, whether they have approved the recommended practice or not, from manufacturing, marketing, purchasing, or using product
8、s, processes, or procedures not conforming to the recommended practice. AAMI recommended practices are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI recommended practice may be revised or withdrawn at any time. AAMI procedures require th
9、at action be taken to reaffirm, revise, or withdraw this recommended practice no later than 5 years from the date of publication. Interested parties can obtain current information on all AAMI recommended practices by calling or writing AAMI. Published by Association for the Advancement of Medical In
10、strumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-5762 2000 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
11、the prior written permission of the Association for the Advancement of Medical Instrumentation is strictly prohibited by law. 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 permi
12、ssion of the Association for the 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, contact Kurt C. Larrick, Director, Technical Publis
13、hing, at AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201. Phone: (703) 525-4890, Ext. 239; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-128-5 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IH
14、S Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:49:36 MDTNo reproduction or networking permitted without license from IHS -,-,- Contents Page Committee representationvii Acknowledgments.ix Foreword . x Introduction: Need for the recommended practicexi 1Scope.1 1.1General1 1.2
15、Inclusions 1 1.3Exclusions .1 2Definitions, symbols, and abbreviations.2 3Design considerations5 3.1General rationale.5 3.2Work area design and functional work flow.5 3.2.1Definitions of work areas.5 3.2.2Design criteria for work areas .7 3.2.3Functional work flow patterns7 3.2.4Traffic control 7 3.
16、3Physical facilities: laundry area .8 3.3.1Space requirements8 3.3.2Mechanical systems8 3.3.3Floors, walls, ceilings, and vents.8 3.3.4Ventilation .8 3.3.5Temperature and humidity control 8 3.3.6Lighting systems .8 3.3.7Handwashing facilities.9 3.3.8Emergency eyewash/shower equipment.9 3.3.9Soil-sor
17、t area.9 3.3.10Chemical storage area9 3.3.11Storage area for clean textile packs10 3.3.12Housekeeping.10 3.4Physical facilities: surgical pack assembly area10 3.4.1Space requirements10 3.4.2Mechanical systems10 3.4.3Floors, walls, ceilings, and vents.10 3.4.4Ventilation .10 3.4.5Temperature and humi
18、dity control 11 3.4.6Lighting systems .11 3.4.7Handwashing facilities.11 3.4.8Storage area for clean textile packs11 3.4.9Surgical pack sterilization area .11 3.4.10Sterile storage area.11 3.4.11Housekeeping.11 4Personnel considerations.12 4.1General rationale.12 4.2Qualifications.12 4.2.1Supervisor
19、s/managers 12 4.2.2Personnel12 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:49:36 MDTNo reproduction or networking permitted without license from IHS -,-
20、,- 4.3Training and education12 4.4Health and personal hygiene.13 4.5Attire13 4.5.1General .13 4.5.2Personal protective attire 14 5Receiving and handling of reusable surgical textiles .14 5.1General rationale.14 5.2Newly purchased items .14 5.2.1Identification and handling 14 5.2.2Washing14 5.3Collec
21、ting and transporting soiled surgical textiles15 5.3.1Collecting soiled surgical textiles at the point of use.15 5.3.2Transporting soiled surgical textiles15 5.4Sorting of soiled textiles.15 5.4.1Pre-sort systems .15 5.4.2Post-sort systems16 6Laundry processing recommendations16 6.1General rationale
22、.16 6.2Washing 16 6.2.1Procedures16 6.2.2Loading of washing equipment .16 6.2.3Steps in the washing process: laundry formulas.16 6.3Drying18 6.3.1Procedures18 6.3.2Equipment loading 19 6.3.3Steps in the drying process: drying formulas 19 6.4Process monitoring19 6.4.1Rationale for process monitoring
23、19 6.4.2Process monitoring: supplies20 6.4.3Process monitoring: equipment operation.21 6.4.4Process monitoring: finished products21 7Inspection, testing, and maintenance of laundered textiles .22 7.1General rationale.22 7.2Visual inspection .23 7.2.1Quality standards 23 7.2.2Stains23 7.2.3Physical d
24、efects24 7.2.4Chemical/thermal damage24 7.2.5Foreign debris.24 7.2.6Labeling.24 7.2.7Tracking system25 7.3Testing.25 7.3.1Test procedures 25 7.3.2Microbiological cleanliness25 7.3.3Effective life.26 7.3.4Important functional attributes.26 7.4Maintenance27 7.4.1Patching27 7.4.2Mending 27 7.4.3Rewash
25、.28 7.4.4Rejuvenation .28 7.4.5Retirement/alternate use.28 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:49:36 MDTNo reproduction or networking permitted
26、without license from IHS -,-,- 8Preparation and packaging28 8.1General rationale.28 8.2Procedures28 8.3Folding.29 8.4Pack assembly 29 8.5Wrapping.29 8.6Labeling/identification of packs .29 9Handling, transport, and storage of laundered textiles.30 9.1General rationale.30 9.2Procedures30 9.3Personnel
27、 attire and hygiene.30 9.4Handling clean/sterile textiles30 9.5Transport.30 9.5.1General .30 9.5.2Method of transport.31 9.5.3Separation of clean/sterile and soiled textiles.31 9.5.4Laundry cart cleaning and loading31 9.5.5Truck cleaning and loading.32 9.6Storage32 9.6.1Storage conditions 32 9.6.2St
28、orage shelving .32 9.6.3Stock rotation32 10Installation, operation, care, and maintenance of laundry equipment32 10.1General rationale.32 10.2Documentation 33 10.2.1Identification33 10.2.2Safety33 10.2.3Manuals and installation/operating instructions 33 10.3Installation .33 10.3.1General .33 10.3.2U
29、tilities.34 10.4Operation.34 10.4.1General .34 10.4.2Washing/extraction and drying equipment34 10.4.3Support systems .35 10.5Routine care and maintenance .36 10.5.1Routine care36 10.5.2Scheduled (preventive) maintenance37 10.5.3Unscheduled maintenance (repairs).37 10.5.4Calibration.37 10.5.5Recordke
30、eping37 11Quality control 38 11.1General rationale.38 11.2General quality control criteria.38 11.2.1Functional performance criteria.38 11.2.2Verification of laundry processes38 11.3Policies and procedures38 11.4Barrier efficacy.39 11.5Tracking uses of reusable surgical textile products.40 11.6Proces
31、s performance 40 11.6.1Quality assessment.40 11.6.2Quality process .40 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:49:36 MDTNo reproduction or networkin
32、g permitted without license from IHS -,-,- 12Medical device regulatory considerations 41 Annexes AMedical device regulatory considerations 42 A.1Introduction42 A.2Medical device law and regulations.42 A.3Establishment registration.42 A.4Classification of medical devices.42 A.5Premarket clearance and
33、 premarket approval requirements 42 A.6Good manufacturing practice (GMP) requirements: the quality system regulation .43 A.6.1Processing guidelines.43 A.6.2Quality assurance .43 A.7Complaint handling and MDR44 A.7.1Complaint handling .44 A.7.2Medical device reporting .44 A.8Federal auditing of proce
34、dures and controls.45 A.9Outcomes45 BBibliography .46 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:49:36 MDTNo reproduction or networking permitted witho
35、ut license from IHS -,-,- 2000 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI ST65:2000vii Committee representation Association for the Advancement of Medical Instrumentation Sterilization Standards Committee This recommended practice was developed and balloted by the AAMI Re
36、usable Surgical Textile Processing Working Group under the auspices of the AAMI Sterilization Standards Committee. Committee approval of the recommended practice does not necessarily imply that all working group members voted for its approval. The AAMI Sterilization Standards Committee has the follo
37、wing members: Cochairs:Virginia C. Chamberlain, PhD William E. Young Members:Zoe Z. Aler, RN, Timonium, MD Trabue D. Bryans, Viromed Biosafety Labs Virginia C. Chamberlain, PhD, Hendersonville, NC Anne M. Cofiell, CRCST, International Association of Healthcare Central Service Materiel Management Nea
38、l E. Danielson, Wichita, KS Dorothy M. Fogg, RN, BSN, MA, Association of Perioperative Registered Nurses Lisa Foster, Ion Beam Applications James M. Gibson, Jr., JM Gibson Associates Barbara J. Goodman, RN, BS, CNOR, Rising Sun, MD Joel R. Gorski, PhD, NAMSA Susan Hadfield, Standards Council of Cana
39、da Victoria Hitchins, PhD, U.S. Food and Drug Administration Gretchen Keenan, 3M Health Care Sue Kuhnert, STS duoTEK Byron J. Lambert, PhD, Guidant Corporation Paul S. Malchesky, DEng, STERIS Corporation Patrick McCormick, PhD, Bausch “should” indicates that among several possibilities one is recomm
40、ended as particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required, or that (in the negative form) a certain possibility or course of action should be avoided but is not prohibited; “may” is used to indicate that a cou
41、rse of action is permissible within the limits of the recommended practice; and “can” is used as a statement of possibility and capability. “Must” is used only to describe “unavoidable” situations, including those mandated by government regulation. The provisions of this recommended practice should
42、be reviewed by various department managers, as applicable, and adapted to the needs of their particular institutions. Written policies and procedures should be developed and implemented in consultation with representatives of end users. The concepts incorporated in this recommended practice should b
43、e considered flexible and dynamic. The recommendations set forth in this document are reviewed and updated periodically to assimilate progressive technological developments. AAMI policies and procedures require that AAMI standards and recommended practices be reviewed and, if necessary, revised at l
44、east once every 5 years. Suggestions for improving this recommended practice are invited. Comments and suggested revisions should be sent to Technical Programs, AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-5762. NOTEThis foreword does not contain provisions of the American National Stand
45、ard, Processing of Reusable Surgical Textiles for Use in Health Care Facilities (ANSI/AAMI ST65:2000), but it does provide important information about the development and intended use of the document. Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license
46、with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:49:36 MDTNo reproduction or networking permitted without license from IHS -,-,- 2000 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI ST65:2000xi Introduction: Need for the recommended
47、practice Hospital-owned laundries, as well as those providing outsourcing services to health care facilities, are providing clean surgical textiles, nonsterile reusable surgical textile packs, and/or sterile reusable surgical textile packs to health care facilities. The ability of service providers
48、to furnish reusable products that meet the performance requirements of end users while providing quality patient care has been enhanced by technological advances in reusable textiles and processing equipment. Current and future advancements in this segment of the industry may necessitate modified or alternative processing techniques. This recommended practice is intended to provide guidelines that will help materiel managers, laundry managers, central service managers, and other health care professionals implement effective quality assurance