A Practical Guide to Decontamination in Healthcare E-Book

Gerald E. McDonnell

• Herausgeber: John Wiley & Sons
• Kategorie: Fachliteratur
• Sprache: Englisch

Seitenzahl: 1192

Veröffentlichungsjahr: 2012

Beschreibung

Prevention is the first line of defence in the fight against infection. As antibiotics and other antimicrobials encounter increasing reports of microbial resistance, the field of decontamination science is undergoing a major revival. A Practical Guide to Decontamination in Healthcare is a comprehensive training manual, providing practical guidance on all aspects of decontamination including: microbiology and infection control; regulations and standards; containment, transportation, handling, cleaning, disinfection and sterilization of patient used devices; surgical instrumentation; endoscopes; and quality management systems.

Written by highly experienced professionals, A Practical Guide to Decontaminationin Healthcare comprises a systematic review of decontamination methods, with uses and advantages outlined for each. Up-to-date regulations, standards and guidelines are incorporated throughout, to better equip healthcare professionals with the information they need to meet the technical and operational challenges of medical decontamination.

A Practical Guide to Decontaminationin Healthcare is an important new volume on state-of-the-art decontamination processes and a key reference source for all healthcare professionals working in infectious diseases, infection control/prevention and decontamination services.

Leseprobe

Contents

Foreword

Glossary of terms

Acknowledgements

1 Introduction

What is decontamination?

A brief history of decontamination

Goals of decontamination and the Spaulding classifi cation

The decontamination process

The design of a decontamination area

Where to start

2 Basic anatomy, physiology and biochemistry

Introduction

Anatomy terminology

The anatomical systems of the human body

3 Medical and surgical procedures and facilities

Introduction

Procedures and techniques

Medical disciplines and common procedures

Medical and diagnostic equipment

Surgical procedures

Introduction to endoscopic procedures

The operating/procedure room

4 Instrumentation

Introduction

Single-use and re-use instrumentation definition

Materials used in the manufacture of instruments

Device manufacturers and suppliers

Surgical instrument types and descriptions

Miscellaneous devices used medically

5 Microbiology and infection control/prevention

Introduction

Microorganism types

An introduction to infection prevention and control

6 Chemistry and physics

Introduction

Solids, liquids, gases and plasmas

Mixtures, formulations and solutions

Weights, measures and other physical considerations

The pH scale: defining acids and bases

Other common chemical measurement methods

Light, radiation and the electromagnetic spectrum

Safety considerations

How to choose and use a chemical product

Introduction to cleaning and accessory chemistries

Introduction to antimicrobial (disinfection/sterilization) chemistries

7 Post-procedure handling, containment and transport

Introduction

Post-procedure sorting

Point of use cleaning

Transportation post-procedure

Tracking and traceability

8 Cleaning

Introduction

Receiving and sorting

Disassembly and preparation for cleaning

Basic principles of cleaning

Manual cleaning

Automated cleaning

Special cleaning considerations

Cleaning guidelines, standards and testing

Troubleshooting cleaning problems

9 Disinfection

Introduction

Basic principles of disinfection

Physical disinfection

Chemical disinfection

Disinfection guidelines and standards

Special considerations

Prion disinfection

Troubleshooting disinfection problems

10 Inspection, packaging and loading for sterilization

Introduction

Inspection and packaging area design considerations

Inspection

Maintenance, repairs and replacements

Device and tray assembling

Medical grade packaging systems

Label identification of packaged devices

Loading and unloading sterilizers

11 Sterilization

Introduction

Basic principles of sterilization

Physical sterilization

Chemical sterilization

12 Storage and distribution

Introduction

Handling of non-packaged or non-sterilized devices

Sterile storage environment and layout

Storage and handling of sterile, packaged devices

Inventory control

Transport of sterile packaged items

Guidance at the point of use

Standards and guidelines

13 Safety

Introduction

Types of workplace safety hazards

Reducing safety risks and risk analysis

Specific safety considerations

14 Management principles

Introduction

Personnel management

Teamwork

Ethics and legal responsibility

Process management

Materials management

Quality management

15 Special interest topics

Water quality/purity

Endoscopes and other lumened devices

Single-use devices (SUDs)

Loan devices, sets and implants

Surgical and medical laundry

Devices known or suspected to be contaminated with prion material

Index

Advertisements

This edition first published 2012 © 2012 by Gerald McDonnell and Denise Sheard

Blackwell Publishing was acquired by John Wiley & Sons in February 2007. Blackwell’s publishing program has been merged with Wiley’s global Scientific, Technical and Medical business to form Wiley-Blackwell.

Registered officeJohn Wiley & Sons, Ltd, The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK

Editorial offices9600 Garsington Road, Oxford, OX4 2DQ, UKThe Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK111 River Street, Hoboken, NJ 07030-5774, USA

For details of our global editorial offices, for customer services and for information about how to apply for permission to reuse the copyright material in this book please see our website at www.wiley.com/wiley-blackwell

The right of the author to be identified as the author of this work has been asserted in accordance with the UK Copyright, Designs and Patents Act 1988.

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by the UK Copyright, Designs and Patents Act 1988, without the prior permission of the publisher.

Designations used by companies to distinguish their products are often claimed as trademarks. All brand names and product names used in this book are trade names, service marks, trademarks or registered trademarks of their respective owners. The publisher is not associated with any product or vendor mentioned in this book. This publication is designed to provide accurate and authoritative information in regard to the subject matter covered. It is sold on the understanding that the publisher is not engaged in rendering professional services. If professional advice or other expert assistance is required, the services of a competent professional should be sought.

The contents of this work are intended to further general scientific research, understanding, and discussion only and are not intended and should not be relied upon as recommending or promoting a specific method, diagnosis, or treatment by physicians for any particular patient. The publisher and the author make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties, including without limitation any implied warranties of fitness for a particular purpose. In view of ongoing research, equipment modifications, changes in governmental regulations, and the constant flow of information relating to the use of medicines, equipment, and devices, the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine, equipment, or device for, among other things, any changes in the instructions or indication of usage and for added warnings and precautions. Readers should consult with a specialist where appropriate. The fact that an organization or Website is referred to in this work as a citation and/or a potential source of further information does not mean that the author or the publisher endorses the information the organization or Website may provide or recommendations it may make. Further, readers should be aware that Internet Websites listed in this work may have changed or disappeared between when this work was written and when it is read. No warranty may be created or extended by any promotional statements for this work. Neither the publisher nor the author shall be liable for any damages arising herefrom.

Library of Congress Cataloging-in-Publication Data

McDonnell, Gerald E.A practical guide to decontamination in healthcare / Gerald McDonnell, Denise Sheard.p. cm.Includes bibliographical references and index.

ISBN 978-1-4443-3013-7 (hardcover : alk. paper)

1. Infection–Prevention. 2. Hospital buildings–Disinfection. 3. Disinfection and disinfectants. 4. Sterilization. I. Sheard, Denise. II. Title. QR69.S75M35 2012614.4′8–dc23

2012010293

A catalogue record for this book is available from the British Library.

Wiley also publishes its books in a variety of electronic formats. Some content that appears in print may not be available in electronic books.

Cover images: courtesy of Gerry McDonnellCover design by Steve Tompson

Foreword

Having spent a lifetime’s career in healthcare and in particular developing a great interest in the decontamination of medical devices and other patient associated equipment, I am greatly honoured and privileged to be invited to write this foreword.

This text book is intended for worldwide use as a reliable reference book for those interested in the science, technology and practice of decontaminating devices. As such, the book provides great detail, translated into easy reading and understanding.

In the opening chapter we see the scene set through a look at past notable events relating to decontamination practices. A basic introduction is then given to the asso­ciated areas of anatomy and physiology, microbiology, chemistry and the various types of medical/surgical devices the reader is likely to be confronted with in practice. This is followed by a detailed description of each step in the decontamination process, including cleaning, ­disinfection, inspection, sterilization and storage, with a final consideration being given to the key aspects of safety and management.

Bear in mind that although the principles of decontamination remain the same internationally, their interpretation is necessarily different according to where you are practicing. This is brought about by varying cultures, national economics, and availability of resources, both human and material, and the perception of safe healthcare in differing situations. Within this book, therefore, you will find a variety of solutions to similar problems aimed at giving the most appropriate advice to suit local circumstances.

The book provides a comprehensive approach and guide to all aspects of device decontamination and is essential reading for all involved in the reprocessing of re-usable devices either in healthcare or similar ­situations.

Gillian A. SillsConsultant and Director of Education IDSc (Institute for Decontamination Sciences)UK2012

Glossary of terms

For the purpose of discussion, many general terms are used throughout the book. These include words such as “cleaning”, “disinfection”, “sterilization”, “­decontamination”, etc. These are specifically defined here. They can have very specific meanings and are often misused. These definitions can vary from country to country or depending on their particular use in certain applications. In many cases there is currently no universal acceptance of some definitions, but wherever possible internationally accepted definitions have been used. Further definitions related to specific discussions in the book, for example in the chapters on anatomy, physiology and biochemistry (Chapter 2), microbiology and infection control/prevention (Chapter 5), and chemistry (Chapter 6) are provided in these respective chapters.

Anatomy The study of the structure of living things.

Anion Negatively charged atom or molecule, with examples being Cl− (the chloride ion) and OH− (the hydroxide ion).

Antibiotics Drugs that kill or inhibit the growth of ­bacteria and some fungi by interfering with their normal functions. They are used to prevent (“prophylactic”) or treat bacterial and some fungal infections.

Anti-infectives Drugs that can kill or inhibit the growth of infectious agents. These drugs are usually specific in the way they work; they are therefore classified as ­antibacterials, antifungals, antivirals and antiprotozoal agents.

Antimicrobial The ability of a process or product to be effective against microorganisms by either killing them or inhibiting their growth. Antimicrobials include drugs that are particularly used therapeutically within patients to control infections. These are often referred to as anti-infectives or “drugs” and include antibiotics, antifungals and antiviral agents. These are generally specific in their activity, being active against a very limited range of microorganisms. For example, antibiotics only work against some kinds of bacteria (and sometimes some fungi) and most antiviral agents only target certain classes of viruses. These are not discussed in any detail in this book. The antimicrobial chemicals that are used in disinfection and sterilization applications are often referred to as “biocides” or “microbiocides”.

Antisepsis Destruction or inhibition of microorganisms on the skin, mucous membranes or wounds. An antiseptic is a product used for this purpose. Hand hygiene is an example of antisepsis, including the use of hand washes (soap-based products, water-based applications) and hand rubs (alcohol-based products, waterless applications).

Antiseptic An antimicrobial product or process used on the skin or other living tissues. In some countries ­antiseptics are labelled as disinfectants or antiseptic disinfectants. They are often further classified based on their particular use, to include hand washes, hand rubs and hygienic hand disinfectants, pre-operative preparations (“pre-op preps”) and surgical scrubs (or “surgical hand disinfectants”).

Archaea A group of unicellular, prokaryotic micro­organisms that are distinct from bacteria. In general these microorganisms are not described as being pathogenic to man, plants or animals, but are found to survive in extreme environmental conditions (such as hot springs).

Aseptic Free of microorganisms. An aseptic process uses means to keep something free of microbial contamination.

Bacteria Also known as eubacteria. A class of micro­organisms that are prokaryotic (no defined nucleus) and unicellular (one-celled, in comparison to multicellular organisms). Examples include Bacillus, Staphylococcus and Pseudomonas.

Bioburden The “microbial load” or number and type of microorganisms on a surface or object. Note: the bioburden from patient-derived materials such as body fluids (or “soil”) may include non-viable (abiotic) ­substances such as proteins and lipids.

Biochemistry The study of the chemical processes in living organisms and the structure and function of cells and their components.

Biocide A general term referring to any chemical or physical antimicrobial agent that inhibits or inactivates life. Chemical biocides include chlorine, iodine, alcohols and hydrogen peroxide. Physical biocides include heat and radiation. “Microbiocides” or “microbicides” are those biocides that are effective against microorganisms. Sub-categories of microbicides include bactericides, ­bacteriostatic and viricidal or virucidal.

Biofilm Communities of microorganisms (either ­single or multiple types) that have developed on or with ­surfaces.

Carbohydrate An essential structural component of cells/microorganisms and a source of food/energy. They include sugars (such as sucrose, glucose) and starch. Also known as “saccharides”.

Cation Positively charged atom or molecule, with examples including Na+ (the sodium ion) and Ag+ (the silver ion).

Cell From the Latin “small room”, a cell is the basic structural and functional component of living organisms. Humans, for example, are multicellular organisms ­consisting of many billions of cells and cell types (such as muscle cells and skin cells), while bacteria are single-celled. They can be further sub-classified into two groups based on their basic, microscopic structure: prokaryotic cells (prokaryotes) and eukaryotic cells (eukaryotes). Prokaryotes are considered smaller and simpler in ­structure, while eukaryotes are larger and more ­compartmentalized.

Chelating agent A compound which attaches to a ­component (e.g. metal ion) and forms a stable complex. It therefore removes metal ions from water or another ­solution.

Chemical indicators (CI) Test systems that reveal a change in one or more pre-defined process variables based on a chemical or physical change resulting from exposure to a process (e.g. a color change).

Chemistry The study of chemicals and chemical ­reactions.

–cidal A suffix (the ending of a word) that means the ability to kill a group of microorganisms. As an example, sporicidal designates the ability to kill bacterial spores. Others include bactericidal (kills bacteria), fungicidal (kills fungi) and viricidal (kills viruses). In certain countries these terms are defined by the demonstration of being able to pass certain standardized tests (e.g. a known level of kill in a defined test against certain types of microorganisms). Compare –cidal, to –static.

Cleaner A formulation designed for cleaning purposes. Also referred to as a “detergent”, because it contains chemicals known as detergents (or surfactants).

Cleaning The removal of contamination (often referred to as “soil”) from a surface to the extent necessary for ­further processing (e.g. disinfection, sterilization) or for intended use.

Cleaning chemistry A formulation (or mixture of chemicals) designed for cleaning purposes. Cleaning chemistries are often referred to as “detergents”, but ­detergents are usually only one part of these mixtures that can include biocides, enzymes, buffers, chelating agents and other components.

Conductivity Measure of the concentration of ions and therefore various metals and molecules in solution.

Contamination The presence of dirt or “soil” that can include various materials, chemistries and bioburden (such as microorganisms). Depending on the situation, contamination may be visible (e.g. a blood spill) or ­invisible (e.g. the presence of microorganisms). Contamination of a device (e.g. an endoscope) following patient use is generally referred to as “soil”.

Cyst (or oocyst) In microbiology, a cyst or oocyst is the dormant form of a microorganism, particularly ­protozoa.

Decontamination Physical and/or chemical means to render a surface or item safe for handling, use or disposal. In many cases decontamination is at least a two or even three-step process, to include cleaning and disinfection and/or sterilization; however, cleaning alone or a multi-step process of cleaning, disinfection and sterilization may also be required for decontamination, depending on the final use of the surface/item. In this book, the terms “decontamination” and “reprocessing” are used ­interchangeably.

Detergent A compound, or a mixture of compounds, intended to assist cleaning. Detergents are a sub-class of surface active agents (“surfactants”). Also commonly referred to as cleaners or cleaning chemistries, but ­detergents are only one part of these mixtures.

Device Any instrument, apparatus, appliance, material or other article which is intended to be used for the ­purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease or other medical/surgical use. A re-usable device is designed to be used many times on different patients, being provided with detailed instructions on how it can be safely reprocessed between each patient. A single-use device (SUD) has been designed by a manufacturer to be used on a single patient only and then discarded. The terms device and instrument are used interchangeably throughout the book.

Diagnosis A variety of observations and/or tests that can be performed in order to identify (“diagnose”) the cause of a particular disease or medical problem, and ­providing the supporting evidence of such as the cause.

Disinfectant A physical or chemical product for disinfection.

Disinfection The antimicrobial reduction of the ­number of viable microorganisms on a product or surface to a level previously specified as appropriate for its intended further handling or use. Different levels of ­disinfection are traditionally defined, such as high, medium or low, which refers to the spectrum of microbicidal activity of a given product or process; the exact meaning and usage of these terms may vary from country to ­country. Other terms, such as pasteurization and ­antisepsis are forms of disinfection.

Endospores Types of spores that are produced within a cell, such as bacterial spores.

Endotoxin Components of certain types of ­microorganisms (e.g. lipopolysaccharides of Gram negative bacteria) that are released only upon the death and disintegration of their cells. Endotoxins can cause fever (pyrogenic) when injected.

Enzyme A protein molecule that speeds up a chemical reaction, but is not changed during the process. They are widely used in formulation with chemicals for cleaning applications (e.g. enzymatic cleaners) because of their ability to break down (or “digest”) various types of ­molecules found in soils (such as proteins, lipids and carbohydrates). Enzymes are classified based on mechanism of action, to include proteases (enzymes that break down proteins) and lipases (enzymes that break down lipids).

Epidemiology A branch of science dealing with the transmission and control of disease; an “epidemiologist” is a specialist in this area.

Eukaryotic Defines a type of cell that is much larger than that of bacteria and contains a well-defined nucleus and other organelles; examples of eukaryotic cells include those of fungi, protozoa, plants and humans (see the ­section on human cells).

Exotoxin A class of toxins produced and secreted by certain types of microorganisms (e.g. the tetanus toxin from Clostridium tetani) while they are fully functional.

Formulation A combination of ingredients, including active and inert ingredients, into a product for its intended use. Examples include liquid chemical cleaning and ­disinfection formulations. Although products used for antisepsis, disinfection and cleaning have common names such as “enzymatics”, “alkalines”, “peracetic acid” and “glutaraldehyde”, these only refer to the active ingredients and their individual activities can vary dramatically. The benefit of formulation is to optimize the activity of these ingredients while minimizing any negative effects (such as poor water quality and surface damage).

Fumigation The delivery of a disinfectant to an area by aerial dispersion, usually in the form of a gas, vapor or aerosol.

Fungi A group of cell wall-containing eukaryotic microorganisms, that can be further sub-divided into molds (or filamentous fungi, as they can form long ­filaments or lines of cells) and yeast (unicellular, single-celled forms).

Germ and germicide A germ is a general term referring to any microorganism, but is often used to refer to ­bacteria in particular (e.g. in the USA). Therefore, ger­micidal refers to a product or process which kills ­microorganisms, but sometimes only refers to bactericidal activity (as in US EPA disinfectant registrations). “Germ” is a colloquial term and its use is discouraged.

Guideline Document used to communicate recommended procedures, processes or usage of ­particular practices.

Hardness Concentration of calcium and magnesium ions in water, expressed as parts per million (ppm) or milligrams per liter (mg/L) of calcium carbonate (CaCO3) equivalents.

Helminths A large group of multicellular eukaryotic microorganisms that include worms (such as tapeworms and roundworms) and flukes. Examples include Ascaris and Taenia.

Hydrophilic (polar) Refers to “water-loving”, being a substance that attracts and can absorb water; similar to lipophilic, meaning “loves lipid”.

Hydrophobic (non-polar) A substance that repels and does not absorb water (“water-hating”); similar to ­lipophobic, meaning “lipid-hating”.

Inactivation Loss of ability of microorganisms to grow and/or multiply.

Infection The detrimental introduction and colonization of a host (human/animal) by a microorganism.

Infection prevention/control Discipline concerned with preventing the spread of microorganisms and infection; it is therefore part of the branch of the science known as epidemiology. Often used interchangeably, “prevention” is more correctly used to describe practices to prevent infection, while “control” may also include practices to control the infection after it has taken place (e.g. isolation precautions, antibiotic or other drug-based therapy, etc.). Prevention strategies including antisepsis, disinfection and vaccination; control strategies may include the use of anti-infectives (drugs) to treat or even prevent infections, investigating outbreaks and managing outbreaks of ­infection. Experts in this area may be known as infection control practitioners, infection preventionists or ­epidemiologists.

Inorganic Non-carbon based molecules. Inorganic chemistry is the study of non-carbon based molecules such as table salt (NaCl) or water (H2O). The exception to this rule is a group of chemicals like the carbonates (such as calcium carbonate, CaCO3, and sodium carbonate, Na2CO3) that are known as “inorganic carbon”.

ISO International Standards Organization.

Label An identification indication on a product or other article. This can include the manufacturer, their address, product/item identification (e.g. serial or part number), instructions for use, etc. A product label can include what is physically written on the product (the attached label), but also any other accessory information such as additional instructions for use, the material safety data sheets (MSDS) and technical literature.

Lipid An essential structural component of cells/microorganisms and a source of food/energy. They are generally described as being insoluble in water (­hydrophobic) and include fats, oils and cholesterol.

Material safety data sheets (MSDS) A document ­provided with a chemical product by the manufacturer/supplier that describes any chemicals that are present, and pertinent safety information including safe handling and emergency procedures.

Matter Any living or non-living thing that takes up space.

Medicine The science of and ability to heal. “Medical” refers to the study and practice of medicine.

Microbiology The study of microorganisms.

Microorganism Entity of microscopic size, including bacteria, fungi, protozoa and viruses.

Nucleic acid A class of macromolecules that make up the genetic material of cells and viruses. There are two main classes, DNA and RNA.

Oocyst See cyst.

Organic Carbon-based: organic chemistry is the study of carbon-based molecules, which are a diverse group including proteins, lipids and plastics like polyurethane and polypropylene. The exception to this rule is a group of chemicals, like the carbonates (such as calcium carbonate, CaCO3, and sodium carbonate, Na2CO3) that are known as “inorganic carbon”. Strictly speaking, “organic” refers to chemicals with carbon (C) and hydrogen (H).

Packaging system Combination of the sterile barrier system and protective packaging.

Parasite A microorganism that can live in or on a host (animal, plant or other organism), without benefiting or killing the host, but may cause damage/sickness.

Pasteurization A form of heat-based disinfection used to reduce the number of harmful microorganisms on a surface or in a liquid.

Pathogen Disease-causing microorganism.

pH A measure of the activity of hydrogen ions (H+) in a solution and, therefore, its acidity or alkalinity. The pH value is a number without units, between 0 and 14 that indicates whether a solution is acidic (<7), neutral (~7, generally 6–8) or basic/alkaline (>7).

Physiology The study of how living structures function.

PPE Personal protective equipment.

Preservation The prevention of the multiplication of microorganisms in products.

Pressure The effect that occurs when a force is applied on a surface or the force applied per unit area. For example, atmospheric pressure is the pressure exerted by the earth’s atmosphere and at sea level is known to be ~101.3 kPa (= 14.7 lb in−2, 1 bar, 760 mmHg or 760 Torr).

Prion Unusual transmissible agents considered to be composed only of protein.

Process A designed sequence of operations or events, possibly taking up time, space, expertise or other resources, which produces some outcome.

Prokaryote Defines a type of cell that is considered less organized in structure than eukaryotic cells; bacteria are the most common examples of prokaryotic cells.

Protein An essential structural component of cells/microorganisms and a source of food/energy. They are made up of nitrogen-containing molecules known as amino acids, and protein examples include enzymes, ­collagen and keratin.

Protozoa A diverse group of cell-wall free, unicellular, eukaryotic microorganisms. Examples include Cryptosporidium and Plasmodium.

Pyrogen A fever-producing substance. Many ­microorganisms produce pyrogens (known as toxins), which can be an important cause of disease or other patient complications. Examples include bacterial ­endotoxins and exotoxins.

Qualification Process of obtaining and documenting evidence. With decontamination equipment, this can include installation (IQ), operational (OQ) and performance qualification (PQ). Installation qualification refers to evidence that equipment has been provided and installed in accordance with its specification; OQ ­indicates that the installed equipment operates within predetermined limits when used in accordance with its operational procedures; and PQ refers to evidence that the equipment consistently performs in accordance with predetermined criteria and meets its specification.

Qualitative The quality of something, usually referring to the various types of chemicals present in a sample.

Quality A measure of meeting an expectation or a standard. In device decontamination, this will be to ­provide a device that is safe for patient use and to meet the requirements of those needing to use the device (medical/surgical staff). Quality control (QC) is a ­procedure or set of procedures to ensure that a manufactured product or performed service adheres to a defined set of criteria or meets the requirements of a customer. Quality assurance (QA) is similar, being a procedure or set of procedures intended to ensure that a product or service under development (before work is complete, as opposed to afterwards) meets specified requirements. QC and QA are often expressed together as quality ­assurance and control (QA/QC). A quality management system (QMS) describes the organizational structure, procedures, processes and resources needed to ­implement quality management in any facility.

Quantitative The amount of something (from “­quantity”), for example the various amounts of a chemical type in a given sample.

Regulation A rule or order issued by a country, ­community or administrative agency, generally under authority granted by statute, that enforces or amplifies laws enacted by the legislature and has the force of law.

Reprocessing See decontamination.

Resistance The ability (natural or acquired) of a ­microorganism to survive treatment with an anti-­infective or biocide.

Resistivity The ability of water (or any liquid) to resist the flow of electricity; a measure of the resistance of water and the inverse of conductivity (being the ability to ­transmit electricity).

Safety The condition of being protected from danger, harm or injury.

Soil Contamination on a surface following a patient procedure (also see contamination and bioburden).

Spore A stage in the reproductive cycle of certain types of bacteria and fungi where the cell becomes condensed in a thick coat. It is a dormant, reproductive structure of a microorganism that is adapted for dispersal and ­surviving for extended periods of time in unfavorable conditions. They form part of the life cycles of various types of fungi and bacteria. Bacterial spores are also known as endospores. Sporulated organisms can survive much longer in the environment and are also more resistant to inactivation by physical and chemical agents. Many spores are known to be highly resistant to disinfection and even sterilization methods.

Standard A document that specifies the minimum acceptable characteristics of a product or material, issued by an organization that develops such documents. Note: publication of standards can include international and/or local standards. Standard organizations include ISO (International Standards Organization).

–static A suffix (the ending of a word) that refers to the ability to inhibit the growth of a group of microorganisms, but not to kill. Examples include bacteriostatic (inhibits vegetative bacteria), fungistatic (inhibits the growth of fungi) and sporistatic (inhibits the growth of spores, generally bacterial and fungal spores).

Sterilant (or sterilizing agent) is a chemical or physical (e.g. heat) agent that can be used for sterilization, but is only effective for sterilization when provided as part of a defined process.

Sterile Free from viable organisms.

Sterile barrier system A package that provides a barrier to microorganisms and allows aseptic presentation of a product at the point of use.

Sterility assurance level (SAL) The probability of a ­single viable microorganism occurring on a product after sterilization. This is generally expressed as 10−n. For example, it is common in healthcare applications to use an SAL of 10−6, implying a <1 in a million chance that an item may be contaminated when a starting population of 106 of the test organism is present on the test surface.

Sterilization A defined and validated process to render an item free from viable microorganisms, including bacterial spores.

Surfactant Surface active agent: an agent that can emulsify oils and hold dirt in suspension. They are widely used in cleaning chemistries. Detergents are a sub-class of surfactants.

Surgery A specialty in medicine that investigates or treats disease or injury by an operative procedure. Surgical procedures (or “operations”, “surgery”) involves entering the body or body cavities by incision (breaking through the skin or other area of the body).

Total dissolved solids (TDS) Sum of all ions in a solution, often approximated by means of electrical conductivity or resistivity measurements.

Total organic carbon (TOC) Measure of organic (or carbon-based) substances that are present in a solution or on a surface. Strictly speaking, this excludes “inorganic carbon” such as carbonates. In water analysis it is usually residual carbon material from natural microbial, plant and animal decomposition.

Toxin A poisonous (“toxic”) substance produced by microorganisms and other life forms. Toxins produced by many types of pathogens are the primary cause of the signs and symptoms of infection, such as an increase in temperature and tissue damage. They can be further described in many ways, such as how they are produced by a microorganism (endotoxins or exotoxins) and by what type of microorganism they are produced by (e.g. mycotoxins are produced by certain types of fungi). Many toxins, such as endotoxins, are also “pyrogens”, referring to their ability to cause a dramatic rise in body ­temperature.

Validation Documented procedure for obtaining, recording and interpreting the results required to ­establish that a process will consistently yield a product complying with predetermined specifications.

Vegetative In microbiology, refers to an actively ­growing and multiplying form of a microorganism. The ­opposite of a vegetative microorganism would be a ­dormant form (e.g. bacterial and fungal spores or ­protozoan cysts).

Viable Indicates that something is alive and capable of reproducing.

Virus A class of microorganisms that cannot replicate without a living, susceptible host cell (human, plant or bacterial). They are, therefore, called “obligate parasites”. They have no cell structure typical of other ­microorganisms (see eukaryote and prokaryote).

Washer-disinfector A machine that cleans and ­disinfects medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice.

Acknowledgements

The authors would sincerely like to thank all those who critically reviewed various sections and chapters of the book. Their feedback was invaluable. They include:Georgia Alevizopoulou, Greece

Richard Bancroft, UK

Peter Burke, USA

Jackie Daly, USA

Anthony Fiorello, USA

John Harrison, UK

Xana Jardine, South Africa

Marietta Jungblut, Netherlands

Herbert Kaiser, USA

Terry McAuley, Australia

Susan Meredith, UK

Val O’Brien, UK

Birte Oskarsson, Sweden

Yaffa Raz, Israel

Wim Renders, Belgium

Syed Sattar, Canada

Richard Schule, USA

Gillian Sills, UK

Wayne Spencer, UK

Susan Springthorpe, Canada

Bengt Ternström, Sweden

Rene Viss, Netherlands

1Introduction

What is decontamination?

First “to do no harm”Of the Epidemics, Hippocrates ∼400 BC)

Health is an important subject to all. It affects us as ­individuals, our families and the communities in which we live. Our health is improved by promoting well-being and preventing disease or other negative health impacts. A disease may be defined as any effect that impairs/harms the body’s normal function and therefore has an impact on our health (mild, moderate or even severe). Diseases can be infectious or non-infectious (such as cancer, effects of drug abuse, stress, chemicals, etc.). Infectious diseases are a leading cause of sickness and death worldwide. They are caused by living creatures that cannot be seen by the naked eye, known as “microorganisms”, such as viruses and bacteria. It is estimated that infectious ­diseases affected our breathing, digestive and immune systems are responsible for ~17% of human death worldwide (the next highest cause of death is coronary heart disease at ~12%). These rates are estimated across the whole world, but are even higher in lower income regions. Examples of health efforts to reduce these risks in the general public include improving drinking water quality (chemical and microbiological), immunization (vaccination), and safe handling/disposal of waste. Many of these efforts influence our daily lives, but the risk of infectious disease significantly increases when we are sick or when our bodies are otherwise compromised (e.g. when undergoing a surgical procedure). For these reasons, healthcare institutions (such as hospitals and clinics) have many procedures and practices in place to control the spread of infectious disease within these facilities, and to protect patients, staff and the general public. It is an important philosophy in medical practice: First “to do no harm” or in Latin “primum non nocere”. These are collectively referred to as “safe” or “infection control/prevention” practices that prevent the spread of disease or other negative effects from one patient to another (or to/from staff or visitors within these ­facilities). These practices include:

Immunization

Isolation of patients with specific diseases

Decontamination of equipment and various surfaces

As “contamination” refers to something being “dirty” or “soiled”, “decontamination” is the means to render it safe for handling, use or disposal. Dirt or soil may include things like dust, patient materials (such as blood, feces, various tissues from surgical procedures, etc.) and associated microorganisms that can cause disease. In this book, the terms “decontamination” and “reprocessing” are used interchangeably. In healthcare facilities a variety of physical and/or chemical products or processes are used for decontamination. These include:

Cleaning, the removal of soil to make something “clean”

Disinfection, the antimicrobial reduction of micro­organisms; other widely used terms that refer to disinfection can include antisepsis, pasteurization, sanitization and fumigation

Sterilization, the complete eradication of all microorganisms

These are all methods of decontamination and are explained further in this book. Examples of specific decontamination practices will include:

Hand and skin hygiene, including routine hand ­disinfection and preparation of the skin for a surgical procedure