CSA SPE 1112-2014 Medical Device Reprocessing in Community Health Care Settings.pdf

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1、SPE 1112-14Medical Device Reprocessing in Community Health Care SettingsLegal NoticeThis document is provided by the Canadian Standards Association (operating as “CSA Group”) as a convenience only. Disclaimer and exclusion of liabilityThis document is provided without any representations, warranties

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15、utes your acceptance onullthe terms and conditions onullthis nullgal nulltice.Standards Update ServiceSPE 1112-14March 2014Title: Medical Device Reprocessing in Community Health Care SettingsPagination: 94 pages (v preliminary and 89 text), each dated March 2014To register for e-mail notification ab

16、out any updates to this publicationgo to shop.csa.caclick on CSA Update ServiceThe List ID that you will need to register for updates to this publication is 2422979.If you require assistance, please e-mail techsupportcsagroup.org or call 416-747-2233.Visit CSA Groups policy on privacy at csagroup.or

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18、416-747-4044Visit our Online Store at shop.csa.caSPE 1112-14Medical Device Reprocessing in Community Health Care Settings100%ISBN 978-1-77139-554-0 2014 CSA GroupAll rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of the publisher.To

19、 purchase standards and related publications, visit our Online Store at shop.csa.ca or call toll-free 1-800-463-6727 or 416-747-4044.CSA Group prints its publications on Rolland Enviro100, which contains 100% recycled post-consumer fibre, is EcoLogo and Processed Chlorine Free certified, and was man

20、ufactured using biogas energy.Page iii 2014 CSA Group Medical Device Reprocessing in Community Health Care SettingsTable of contentsPart 1 Introduction . 11 Purpose 12 Importance of Medical Device Reprocessing (MDR) and impact of MDR failure . 1Part 2 Background . 2Chapter One Microorganisms and the

21、 transmission of infection 21 Microorganisms . 22 Spread of infection 33 Chain of infection . 43.1 The infectious agent or pathogen . 43.2 Susceptible host 53.3 Reservoir . 53.4 Portal of entry and exit . 53.5 Mode of transmission 54 Breaking the chain of infection 6Chapter Two Routine Practices . 8

22、1 Overview 82 Hand hygiene . 82.1 Importance of hand hygiene . 82.2 Hand hygiene using AlcoholBased Hand Rubs . 92.3 Performing Hand Hygiene Using an AlcoholBased Hand Rub (ABHR) 102.4 Hand hygiene using soap and water .102.5 To Perform Hand Hygiene Using Soap and Water .113 Sharps Management 113.1

23、SingleUse Sharps 113.2 Reusable Sharps .124 Personal Protective Equipment (PPE) 124.1 Guidelines for Using Gloves .124.2 Gowns .134.3 Face (Mucous Membrane) Protection 134.4 Putting on and Removing PPE14Chapter Three Policies and Procedures 19Chapter Four MDR Staff 201 Responsibilities to Patients/C

24、lients .212 Responsibilities to Coworkers .21Part 3 Medical Device Reprocessing Overview . 22Chapter One Introduction 22Chapter Two Determining reprocessing requirements .231 Overview .232 Categorizing the medical devices in use within your practice .243 Flexible endoscopes 25Page iv 2014 CSA Group

25、Medical Device Reprocessing in Community Health Care SettingsChapter Three Choosing a Reprocessing Method .261 Overview .262 Reprocessing Equipment Selection .262.1 Mechanical/Instrument washers 272.2 Ultrasonic cleaners 272.3 Tabletop steam sterilizers .283 Reprocessing Product Selection 304 Medica

26、l Device Selection 305 Manufacturers Instructions for Use (MIFUs) 30Chapter Four Setting up a Reprocessing area .321 Oneway workflow to prevent crosscontamination 322 Location and Design 323 Materials 324 Ventilation .335 Sink design 336 Cleaning and Preparation of the Reprocessing Area 33Part 4 Med

27、ical Device Reprocessing Steps in the Process .351 Overview .352 Cleaning 362.1 Point of use preparation for soiled transportation 372.2 Sorting 372.3 Soaking .372.4 Washing 382.4.1 Manual Washing 392.5 Rinsing 392.6 Mechanical cleaning . 402.6.1 Mechanical washers . 402.6.2 Ultrasonic washers . 403

28、 Disinfection 413.1 Liquid chemical disinfectants (LCDs) 433.2 High Level Disinfection (HLD) . 443.2.1 Using an HLD 453.3 Low Level Disinfection (LLD) . 483.3.1 Using an LLD .494 Preparation and Packaging for Steam Sterilization .504.1 Overview 504.2 Drying 504.3 Inspecting .514.4 Lubricating (if re

29、quired) 514.5 Packaging for sterilization 514.6 Packaging with paper/plastic pouches 544.7 Rigid sterilization containers 555 Operating a steam sterilizer .555.1 Overview 555.2 Loading 555.3 Conditions for steam sterilization .565.4 Tabletop steam sterilizers .575.5 Unloading the sterilizer 61Page v

30、 2014 CSA Group Medical Device Reprocessing in Community Health Care Settings5.6 Monitoring and Documenting Steam Sterilization .625.6.1 Displays and printouts 635.6.2 Chemical Indicators (CIs) 655.6.3 Biological Indicators (BIs) 675.7 Documenting test results 705.8 Responding to failed indicator re

31、sults 716 Storage and Transportation to pointofuse 726.1 Storage .726.2 Transport to point of use .72Chapter 5 MDR Quality Assurance .741 Overview .74Annexes .75Page 1 2014 CSA Group Medical Device Reprocessing in Community Health Care SettingsPart 1 Introduction1 PurposeThis handbook is intended to

32、 be a comprehensive guideline for medical device reprocessing (MDR) in a variety of community health care settings (e.g., dental, surgicentre, and physicians offices). However, it is not meant to replace the use of available MDR standards and guidelines (see Annex B).In recent years, a number of inf

33、ection prevention and control issues related to MDR have been developing outside of hospitals. They includeo A trend to performing various medical and surgical procedures in outpatient clinics and in the offices of physicians and other health professionals. The oversight of the reprocessing of devic

34、es used in these areas is often much less than it would be within a hospitalbased setting. o An increasing awareness on the part of clients/patients regarding both the emergence of new infections such as Severe Acute Respiratory Syndrome (SARS), H1N1 influenza A, and Clostridium difficile, as well a

35、s a number of wellpublicized reprocessing failures. Such events remind us of how important it is to ensure that safe practices are followed in all clinical settings in order to prevent the spread of infections to our clients and staff. The importance of infection prevention and control and the role

36、that MDR plays cannot be overemphasized. The impact of a transmitted infectious disease can be both individually devastating and socially costly. Health care and service providers are responsible for ensuring that the patient or client is not put at risk when reusable medical devices are used during

37、 their care. 2 Importance of Medical Device Reprocessing (MDR) and impact of MDR failureTo help you to prevent patient harm from contaminated medical devices, this handbook describeso Background information that you need to know in order to ensure patientsafe reprocessing practices o Preparation and

38、 maintenance of a safe reprocessing environmento Cleaning, disinfection, and sterilization practices for a clinic/community settingThe handbook is useful to all people who are responsible for infection prevention and control in a community health care practice. Page 2 2014 CSA Group Medical Device R

39、eprocessing in Community Health Care SettingsPart 2 Background Chapter One Microorganisms and the transmission of infectionThe purpose of this section is to provide the reader with a basic understanding of how infection can be transmitted and preventive measures that can be taken. An infection is a

40、disease that is passed from one person to another. It is most often caused by microorganisms, which are very small living organism that cannot be seen by the naked eye. 1 MicroorganismsWhether or not a microorganism causes an infection depends on a number of factors including the following.a) Pathog

41、enicityThis is the ability of a microorganism to cause injury to healthy cells and tissues. Some microorganisms are more pathogenic and therefore cause disease more readily than others. Some microorganisms are completely nonpathogenic (i.e., they do not cause disease at all and some are even benefic

42、ial to humans). b) Minimal infectious doseThis is the minimum number of microorganisms required to cause an infection. The minimal infectious dose varies from microorganism to microorganism and from host to host. Some pathogenic microorganisms can cause an infection with just a small dose while othe

43、rs do not cause an infection unless there are a large number of microorganisms present. The overall health and age of a person harbouring the microorganisms (the host) can have an effect on the number of microorganisms that are required to cause an infection. c) Mode of transmissionThis is the way m

44、icroorganisms are transferred from place to place. The longer the microorganism is able to survive outside of a host, the easier it is for it to be transmitted to a new host.Knowing what causes an infection and how it can be spread will help you to understand reprocessing issues related to handling

45、contaminated equipment and devices, choosing the correct products for cleaning and disinfecting, and for protecting the sterility of processed devices. This is the theory that will guide your practice. Page 3 2014 CSA Group Medical Device Reprocessing in Community Health Care Settings2 Spread of inf

46、ectionIt is important to remember that a person may carry an infection without showing any active signs of it. Such individuals are particularly hazardous from the standpoint of infection prevention and control because when someone looks normal, proper precautions are not often taken. For an infecti

47、on in one person to become harmful to others, the pathogenic microorganisms require a place to survive and a means of moving from person to person. The set of circumstances that allows this to happen is called the chain of infection. A good infection prevention and control program includes procedure

48、s that eliminate or reduce the ability of infectious microorganisms to survive and spread, effectively breaking the chain of infection. The elements in the chain of infection are the following:o Infectious agent /pathogeno Susceptible hosto Portal of entryo Reservoiro Portal of exito Mode of transmi

49、ssionAll elements in the chain must be present for the transmission of an infection to occur. See Figure 1. Infecg415ous agentReservoirsPortalofexitSuscepg415blehostModeof transmissionPortalofentryFigure 1 The chain of infectionPage 4 2014 CSA Group Medical Device Reprocessing in Community Health Care Settings3 Chain of infection3.1 The infectious agent or pathogenMicroorganisms, some of which cause infections, are classified into various groups. The types of infectious microorganisms that are of most concern