CSA EXP06-2015 Evaluating emerging materials and technologies for infection prevention and control (First Edition).pdf

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1、EXP06-2015Evaluating emerging materials andtechnologies for infection prevention andcontrolLegal NoticeThis document is provided by the Canadian Standards Association (operating as “CSA Group”) as aconvenience only.Disclaimer and exclusion of liabilityThis document is provided without any representa

2、tions, warranties, or conditions of any kind, expressor implied, including, without limitation, implied warranties or conditions concerning this documentsfitness for a particular purpose or use, its merchantability, or its non-infringement of any third partysintellectual property rights. CSA Group d

3、oes not warrant the accuracy, completeness, or currency ofany of the information published in this document. CSA Group makes no representations orwarranties regarding this documents compliance with any applicable statute, rule, or regulation.IN NO EVENT SHALL CSA GROUP, ITS VOLUNTEERS, MEMBERS, SUBS

4、IDIARIES, OR AFFILIATEDCOMPANIES, OR THEIR EMPLOYEES, DIRECTORS, OR OFFICERS, BE LIABLE FOR ANY DIRECT, INDIRECT,OR INCIDENTAL DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES, HOWSOEVER CAUSED, INCLUDINGBUT NOT LIMITED TO SPECIAL OR CONSEQUENTIAL DAMAGES, LOST REVENUE, BUSINESSINTERRUPTION, LOST OR DAMAGE

5、D DATA, OR ANY OTHER COMMERCIAL OR ECONOMIC LOSS,WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR ANY OTHER THEORY OFLIABILITY, ARISING OUT OF OR RESULTING FROM ACCESS TO OR POSSESSION OR USE OF THISDOCUMENT, EVEN IF CSA GROUP HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES,INJURY, LOS

6、S, COSTS, OR EXPENSES.In publishing and making this document available, CSA Group is not undertaking to renderprofessional or other services for or on behalf of any person or entity or to perform any duty owed byany person or entity to another person or entity. The information in this document is di

7、rected tothose who have the appropriate degree of experience to use and apply its contents, and CSA Groupaccepts no responsibility whatsoever arising in any way from any and all use of or reliance on theinformation contained in this document.Intellectual property rights and ownershipAs between CSA G

8、roup and the users of this document (whether it be in printed or electronic form),CSA Group is the owner, or the authorized licensee, of all works contained herein that are protectedby copyright, all trade-marks (except as otherwise noted to the contrary), and all inventions and tradesecrets that ma

9、y be contained in this document, whether or not such inventions and trade secrets areprotected by patents and applications for patents. Without limitation, the unauthorized use,modification, copying, or disclosure of this document may violate laws that protect CSA Groups and/or others intellectual p

10、roperty and may give rise to a right in CSA Group and/or others to seek legalredress for such use, modification, copying, or disclosure. To the extent permitted by licence or bylaw, CSA Group reserves all intellectual property rights in this document.Patent rightsAttention is drawn to the possibilit

11、y that some of the elements of this document may be the subjectof patent rights. CSA Group shall not be held responsible for identifying any or all such patent rights.Users of this document are expressly advised that determination of the validity of any such patentrights is entirely their own respon

12、sibility.Use of this documentThis document is being provided by CSA Group for informational and non-commercial use only. If youdo not agree with any of the terms and conditions contained in this Legal Notice, you may not usethis document. Use of this document constitutes your acceptance of the terms

13、 and conditions of thisLegal Notice.Standards Update ServiceEXP06-2015December 2015Title: Evaluating emerging materials and technologies for infection prevention and controlTo register for e-mail notification about any updates to this publication go to shop.csa.ca click on CSA Update ServiceThe List

14、 ID that you will need to register for updates to this publication is 2424364.If you require assistance, please e-mail techsupportcsagroup.org or call 416-747-2233.Visit CSA Groups policy on privacy at www.csagroup.org/legal to find out how we protect yourpersonal information.ISBN 978-1-4883-0310-4

15、2015 CSA GroupAll rights reserved. No part of this publication may be reproduced in any form whatsoeverwithout the prior permission of the publisher.Published in December 2015 by CSA GroupA not-for-profit private sector organization178 Rexdale Boulevard,Toronto, Ontario, Canada M9W 1R3To purchase st

16、andards and related publications, visit our Online Store at shop.csa.caor call toll-free 1-800-463-6727 or 416-747-4044.TMA trade-mar k of the Canadian S tandards Association, operating as “CSA Group”Evaluating emerging materials andtechnologies for infectionprevention and controlEXP06-2015EXP06-201

17、5Evaluating emerging materials and technologies for infectionprevention and controlDecember 2015 2015 CSA Group 1ContentsDevelopment Committee on Emerging Materials and Technologies for Infection Prevention andControl 2Preface 30 Introduction 41 Scope 51.1 General 51.2 Intended users 52 References 5

18、3 Evaluating characteristics of emerging materials and technologies 74 Limitations on evaluation and implementation of materials and technologies for infectionprevention and control 11EXP06-2015Evaluating emerging materials and technologies for infectionprevention and controlDecember 2015 2015 CSA G

19、roup 2Development Committee on EmergingMaterials and Technologies for InfectionPrevention and ControlE. Bryce Vancouver General Hospital,Vancouver, British ColumbiaG. Burrill Teegor Consulting,Fredericton, New BrunswickM. DiFonzo IPAC-Canada,Toronto, OntarioB. HuntClass 1 Inc./CHAIR,Cambridge, Ontar

20、ioM. Keen St. Michaels Hospital,Toronto, OntarioA. McGeer Mount Sinai Hospital,Toronto, OntarioI. Pequegnat STERIS Canada Inc.,Mississauga, OntarioJ. Polisena CADTH,Ottawa, OntarioL. Wilson Orr Parkin Architects Ltd.,Toronto, OntarioN. Bestic CSA Group,Toronto, OntarioProgram ManagerJ. Kraegel CSA G

21、roup,Toronto, OntarioProject ManagerThe Development Committee wishes to acknowledge Dr. Michael Noble and Barry Hunt for initiatingthis project in consultation with CSA Group staff.EXP06-2015Evaluating emerging materials and technologies for infectionprevention and controlDecember 2015 2015 CSA Grou

22、p 3PrefaceThis is the first edition of CSA EXP06, Evaluating emerging materials and technologies for infectionprevention and control. This Express Document is not a consensus product; that is, it is not a Standardand it has not been formally reviewed or approved by a CSA Technical Committee.This Exp

23、ress Document has been prepared and reviewed by the Development Committee on EmergingMaterials and Technologies for Infection Prevention and Control.Notes:1) Use of the singular does not exclude the plural (and vice versa) when the sense allows.2) Although the intended primary application of this Do

24、cument is statement in its introduction, it is important tonote that it remains the responsibility of the users of the Document to judge its suitability for their particularpurpose.3) To submit a proposal for change, please send the following information to inquiriescsagroup.org andinclude “Proposal

25、 for change” in the subject line:a) designation (number);b) relevant section, table, and/or figure number;c) wording of the proposed change; andd) rationale for the change.EXP06-2015Evaluating emerging materials and technologies for infectionprevention and controlDecember 2015 2015 CSA Group 4EXP06-

26、2015Evaluating emerging materials andtechnologies for infection prevention andcontrol0 IntroductionContaminated patient environments can contribute to the transmission of potential pathogens such asmethicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus spp (VRE), andCl

27、ostridium difficile. Evidence to support the role of the environment in the transmission of pathogensincludes documentation of room contamination with antibiotic-resistant organisms or multidrug-resistant organisms, the environmental persistence of many of these pathogens, the frequency withwhich gl

28、oved and ungloved hands are contaminated during contact with surfaces and equipment,intervention studies illustrating decreased infections with improved cleaning, and outbreakreports.(1,2,3,4,5)In particular, there is a growing body of evidence to support the view that prior room occupancy bypatient

29、s with antimicrobial-resistant organisms (AROs) or multidrug-resistant organisms poses anadditional risk to subsequent patients.(1,6,7)Manual cleaning and disinfection has been the mainstay forenvironmental cleaning but can be suboptimal.(8,9)Currently, the health-care system relies on human operato

30、rs to select the appropriate chemical agent inthe correct concentration, apply it in the proper sequence to all surfaces and equipment, and leave thedisinfectant for the requisite contact time to ensure effectiveness, consistently room-by-room and day-to-day. There are many studies documenting varia

31、bility in the cleaning process including breaches incleaning protocol, errors in dilution of chemicals and their application, and inadequate contact withsurfaces and equipment.(10,11,12,13,14)As a result, throughout North America, new materials and devicesare being evaluated as supplemental technolo

32、gies to combat health-care acquired infections (HAIs)(15).This Express Document (herein referred to as “this Document”) is intended to provide guidance in theassessment of emerging materials and technologies that fall into the following two categories:a) surface active materials (also referred to as

33、 self-disinfecting or self-sanitizing surfaces); andb) no-touch room disinfection.This Document does not name specific materials and technologies, since new products are constantlybeing introduced and creating a definitive list would be impossible. Rather, it is meant to provide ameans for facilitie

34、s to gather useful information for deciding among the various products available.The information gathered in this Document can be used for organizational decision support tools suchas cost/benefit analysis, risk analysis, etc. It is understood that such tools sometimes require assigningrelative weig

35、hts to the criteria. The checklists included in this Document do not assign weights to thedifferent attributes being considered, since these would vary in importance depending on theinstitution; however, weights can be easily added as part of the evaluation process by inserting anothercolumn in the

36、checklists.EXP06-2015Evaluating emerging materials and technologies for infectionprevention and controlDecember 2015 2015 CSA Group5The emerging materials and technologies addressed in this Document are meant to supplement thecurrently accepted cleaning and disinfection practices for patient care en

37、vironments. Further researchand development of these materials and technologies, as well as third-party clinical studies andevaluation of their operational impact, are encouraged. Use of these new technologies does not replacethe need for manual cleaning and/or disinfection.1 Scope1.1 GeneralThis Do

38、cument provides guidance in the evaluation of new materials and technologies in the physicalenvironment. It is intended to help reduce health-care acquired infections (HAIs) and addresses thefollowing topics:a) potential risks to patients, staff, and the environment;b) physical impacts; andc) human

39、factors.1.2 Intended usersThis Document is intended to be used bya) architects;b) biomedical experts;c) cleaning and environmental services departments both outsourced and internal (includinghousekeeping);d) contractors;e) facility maintenance staff;f) facility engineering staff;g) health-care admin

40、istrators;h) infection prevention and control staff and departments;i) logistics and purchasing;j) manufacturers and suppliers;k) ministries of health;l) ministries of labour;m) occupational health and safety professionals and committees;n) patient safety departments;o) researchers and academics; an

41、dp) standards developers.2 ReferencesThe following publications are referenced in this Document:1 Hamel, M., Zoutman, D., OCallaghan, C. 2010. Exposure to hospital roommates as a risk factorfor health care-associated infection. American Journal of Infection Control. 38(3), 173-181.2 Otter, J.A.,Yezl

42、i, S., Salkeld, J.A., French G.L. 2013. Evidence that contaminated surfacescontribute to the transmission of hospital pathogens and an overview of strategies to addresscontaminated surfaces in hospital settings. American Journal of Infection Control. 41(5 Suppl),S6-S11.EXP06-2015Evaluating emerging

43、materials and technologies for infectionprevention and controlDecember 2015 2015 CSA Group 63 Huslage, K., Rutala,W.A., Gergen, M.F., Sickbert-Bennett, E.E.,Weber, D.J. 2013. Microbialassessment of high-, medium-, and low-touch hospital room surfaces. Infection Control &Hospital Epidemiology. 34(2),

44、 211-212.4 Stiefel, U., Cadnum, J.L., Eckstein, B.C. Guerrero, D.M.,Tima, M.A., Donskey, C.J. 2011.Contamination of hands with methicillin-resistant Staphylococcus aureus after contact withenvironmental surfaces and after contact with the skin of colonized patients. Infection Control& Hospital Epide

45、miology. 32(2), 185-187.5 Morgan, D.J., Rogawaski, E., Thom, K.A., Johnson, J.K., Perencevich, E.N., Shardell, M., Leekha,S., Harris, A.D. 2012. Transfer of multidrug-resistant bacteria to healthcare workers gloves andgowns after patient contact increases with environmental contamination. Critical C

46、areMedicine. 40(4), 1045-1051.6 Huang, S.S., Datta, R., Platt, R. 2006. Risk of acquiring antibiotic-resistant bacteria from priorroom occupants. Archives of Internal Medicine. 166(18), 1945-1951.7 Drees, M., Snydman, D.R., Schmid, C.H., Barefoot, L., Hansjosten, K.,Vue, P.M., Cronin, M.,Nasraway, S

47、.A., Golan,Y. 2008. Prior environmental contamination increases the risk ofacquisition of vancomycin-resistant enterococci. Clinical Infectious Diseases. 46(5), 678-685.8 Hayden, M.K., Blom, D.W., Lyle, E.A., Moore, C.G.,Weinstein, R.A. 2008. Risk of hand or glovecontamination after contact with pat

48、ients colonized with vancomycin-resistant enterococcus orthe colonized patients environment. Infection Control & Hospital Epidemiology. 29(2), 149-154.9 Carling, P.C., Parry, M.F., Bruno-Murtha, L.A., Dick, B. 2010. Improving environmental hygienein 27 intensive care units to decrease multidrug-resi

49、stant bacterial transmission. Critical CareMedicine. 38(4), 1054-1059.10 Weber, D.J., Anderson, D., Rutala,W.A. 2013. The role of the surface environment inhealthcare-associated infections. Current Opinion in Infectious Diseases. 26(4), 338-344.11 Bellamy, E. 2012. An audit of cleaning effectiveness using adenosine triphosphate (ATP)bioluminescence assay following outbreaks of infection. Journal of Infection Prevention. 13(5),154-157.12 Xu, H., Jin, H., Zhao, L.,Wei, X., Hu, L., Shen, L.,Wei, L., Xie, L., Kong, Q.,Wang,Y., Ni, X. 2015. Arand

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