1、ANSI/AAMI ST65:2008/(R)2013Processing of reusable Surgical textiles for use in health care facilities American National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product standard or recommended pract
2、ice 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 application of current technologies to patient care, a
3、nd (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 provided that arbitrary and restrictive uses are a
4、voided. 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, and the measurement techniques that can be used
5、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 performance characteristics, instructions for use, wa
6、rnings 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 test methods to facilitate uniformity in reportin
7、g; 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 and the reasons for establishing the criteria mus
8、t 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 that will help ensure that a device is used safely a
9、nd 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. Similarly, even though a recommended practice is u
10、sually 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, provide guidelines to industrial personnel on suc
11、h 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 industrial practices. In determining whether an AAMI stan
12、dard 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 government regulatory or procurement authorities). The
13、 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 professionals and industrial representatives, whose wor
14、k 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 or recommended practice is limited, however, in t
15、he 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 responsible decision-making. Despite periodic review
16、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 and the specific rationale for each of its provis
17、ions. 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 procedures and practices. While observed or poten
18、tial 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 to identify a particular product as “unsafe“. A v
19、oluntary 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 analyzed in the context of the specific needs an
20、d 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 is truly useful only when it is used in conjunctio
21、n 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 must be made in writing, to the AAMI Vice President
22、, 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 of the Association only upon exhaustion of any app
23、eals 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 recommended practice which has not been develope
24、d and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI ST65:2008/(R)2013 (Revision of ANSI/AAMI ST65:2000) Processing of reusable surgical textiles for use in health
25、care facilities Developed by Association for the Advancement of Medical Instrumentation Approved 4 December 2008 and reaffirmed 2 December 2013 by American National Standards Institute Inc. Abstract: This recommended practice provides guidelines for the proper handling, processing, and preparation o
26、f reusable surgical textiles either on-site or off-site for use in health 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
27、 soiled surgical textiles; laundry processing considerations; transport 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,
28、surgical drapes, surgical gowns, wrappers AAMI Recommended Practice This Association for the Advancement of Medical Instrumentation (AAMI) recommended practice implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI recommended practice does not i
29、n any respect preclude anyone, whether they have approved the recommended practice or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the recommended practice. AAMI recommended practices are subject to periodic review, and users are cauti
30、oned to obtain the latest editions. CAUTION NOTICE: This AAMI recommended practice may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this recommended practice no later than five years from the date of publication. Interested partie
31、s may obtain current information on all AAMI documents by calling or writing AAMI. 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
32、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 responsible for enforcement of its rules and regulations. Published by Association for the Advancement of M
33、edical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 www.aami.org 2009 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
34、this document without 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 t
35、he prior written permission 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 AAMI at 1110 N. Glebe
36、 Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-336-9 Contents Page Glossary of equivalent standards . vii Committee representation.ix Foreword.xi Introduction: Need for the recommended practice . xii 1 Scop
37、e1 1.1 General 1 1.2 Inclusions .1 1.3 Exclusions 1 2 Definitions, symbols, and abbreviations 2 3 Design considerations.5 3.1 General rationale5 3.2 Work area design and functional work flow 6 3.2.1 Definitions of work areas6 3.2.2 Design criteria for work areas.7 3.2.3 Functional work flow patterns
38、.8 3.2.4 Traffic control .8 3.3 Physical facilities: laundry area 8 3.3.1 Space requirements.8 3.3.2 Mechanical systems.8 3.3.3 Floors, walls, ceilings, and vents8 3.3.4 Ventilation 9 3.3.5 Temperature and humidity control9 3.3.6 Lighting systems 9 3.3.7 Handwashing facilities9 3.3.8 Emergency eyewa
39、sh/shower equipment9 3.3.9 Soil-sort area10 3.3.10 Chemical storage area.10 3.3.11 Storage area for clean textile packs.10 3.3.12 Housekeeping 10 3.4 Physical facilities: surgical pack assembly area .11 3.4.1 Space requirements.11 3.4.2 Mechanical systems.11 3.4.3 Floors, walls, ceilings, and vents1
40、1 3.4.4 Ventilation 11 3.4.5 Temperature and humidity control11 3.4.6 Lighting systems 12 3.4.7 Hand hygiene facilities .12 3.4.8 Storage area for clean textile packs.12 3.4.9 Surgical pack sterilization area 12 3.4.10 Sterile storage area12 3.4.11 Housekeeping 12 4 Personnel considerations12 4.1 Ge
41、neral rationale12 4.2 Qualifications13 4.2.1 Supervisors/managers .13 4.2.2 Personnel.13 4.3 Training and education.13 4.4 Health and personal hygiene14 4.5 Attire.15 4.5.1 General 15 4.5.2 Personal protective equipment (PPE) 15 5 Receiving and handling of reusable surgical textiles.15 5.1 General r
42、ationale15 5.2 Newly purchased items 16 5.2.1 Identification and handling .16 5.2.2 Washing.16 5.3 Collecting and transporting soiled surgical textiles .16 5.3.1 Collecting soiled surgical textiles at the point of use 16 5.3.2 Transporting soiled surgical textiles .16 5.4 Sorting of soiled textiles
43、.17 5.4.1 General considerations 17 5.4.2 Pre-sort systems 17 5.4.3 Post-sort systems 17 6 Laundry processing recommendations .18 6.1 General rationale18 6.2 Washing .18 6.2.1 Procedures.18 6.2.2 Loading of washing equipment.18 6.2.3 Steps in the washing process: laundry formulas 18 6.3 Drying.20 6.
44、3.1 Procedures.20 6.3.2 Equipment loading .20 6.3.3 Steps in the drying process: drying formulas21 6.4 Process monitoring.21 6.4.1 Rationale for process monitoring21 6.4.2 Process monitoring: supplies .21 6.4.3 Process monitoring: equipment operation23 6.4.4 Process monitoring: finished products .23
45、 7 Inspection, testing, and maintenance of laundered textiles.24 7.1 General rationale24 7.2 Visual inspection 25 7.2.1 Quality standards .25 7.2.2 Stains.25 7.2.3 Physical defects .27 7.2.4 Chemical or thermal damage .27 7.2.5 Foreign debris 27 7.2.6 Labeling .28 7.2.7 Tracking system.28 7.3 Testin
46、g .28 7.3.1 Test procedures .28 7.3.2 Microbiological cleanliness.29 7.3.3 Effective life29 7.3.4 Important functional attributes29 7.4 Maintenance.31 7.4.1 Patching.31 7.4.2 Mending .31 7.4.3 Rewash31 7.4.4 Rejuvenation 32 7.4.5 Retirement or alternate use32 8 Preparation and packaging .32 8.1 Gene
47、ral rationale32 8.2 Procedures.32 8.3 Folding .32 8.3.1 General considerations 32 8.3.2 Guidelines for folding gowns 32 8.3.3 Guidelines for folding drapes .33 8.4 Pack assembly .34 8.5 Wrapping34 8.6 Labeling/identification of packs.34 9 Handling, transport, and storage of laundered textiles 35 9.1
48、 General rationale35 9.2 Procedures.35 9.3 Personnel attire and hygiene35 9.4 Handling clean/sterile textiles.35 9.5 Transport35 9.5.1 General considerations 35 9.5.2 Method of transport35 9.5.3 Separation of clean/sterile and soiled textiles 36 9.5.4 Laundry cart cleaning, disinfection, and loading
49、.36 9.5.5 Truck cleaning and loading 36 9.6 Storage.37 9.6.1 Storage conditions .37 9.6.2 Storage shelving 37 9.6.3 Stock rotation.37 10 Installation, operation, care, and maintenance of laundry equipment .37 10.1 General rationale37 10.2 Documentation .38 10.2.1 Identification.38 10.2.2 Safety.38 10.2.3 Manuals and installation/operating instructions38 10.3 Installation 38 10.3.1 General considerations 38 10.3.2 Utilities .39 10.4 Operation .40 10.4.1 General considerations 40 10.4.2 Washing, extraction, and drying equipment .40 10.4.3 Support systems 40 10.5 Routine care and maintenan
