Decontamination and Device Processing in Healthcare E-Book

Gerald E. McDonnell

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

Seitenzahl: 1420

Veröffentlichungsjahr: 2025

Beschreibung

Prevent infections within healthcare spaces with safe and effective device decontamination and processing

Prevention is the first line of defense against infection, particularly in a world where microbial resistance to anti-infectives like antibiotics is a growing threat. Few aspects of managing a healthcare facility are more immediately important to patient care than the safe use of equipment and devices. Although some devices are designed for single use, many more are designed to be reused and there have been increasing reports of infections and other adverse patient reactions due to these devices, in particular when regarding surgical and endoscopic procedures. The decontamination or processing of various surfaces, spaces, and devices associated with patient care is a life-saving discipline demanding dedicated resources and education.

Decontamination and Device Processing in Healthcare, Second Edition meets this demand as a comprehensive training and reference manual for the decontamination and processing of equipment and devices used in patient care environments. This book is ideal for medical staff involved in the management of devices within healthcare facilities, including those purchasing, using, and processing devices on patients, and those responsible for their safety. Now fully updated to reflect the latest international regulations, standards, and best practices, this text is an invaluable tool for meeting the challenges of the modern medical facility.

Readers of the second edition of Decontamination and Device Processing in Healthcare will also find within the text

• Up-to-date information based off the current guidelines, standards, and regulations of Regulatory organizations include the US-FDA, EU-MDR, NMPA and other similar international organizations. Standard organizations including ISO, CEN, AAMI, BSI, DIN and international professional organizations in device processing (WFHSS, HPSA, CAMDR etc), nursing (AORN, EORNA, ESGENA), infection prevention (WHO, CDC, ECDC) and more
• Detailed discussion of topics including surgical suite management, infection prevention and control, essentials of anatomy and microbiology, safety, endoscopy and outpatient areas, quality management, and many more
• Description of the steps in device processing ranging from equipment to surgical devices, including cleaning, disinfection, and sterilization
• Information written to be of value to healthcare educators and administrators as well as clinical professionals

Written by experienced professionals with a systematic grasp of key methods and their advantages, Decontamination in Healthcare offers a wealth of information for every member of a clinical team.

Leseprobe

Table of Contents

Cover

Table of Contents

Title Page

Copyright Page

Foreword to the second edition

Foreword to the first edition

Glossary of terms

Acknowledgments

1 Introduction

What is device processing?

A brief history of decontamination

Goals of decontamination and the Spaulding classification

The decontamination process

The design of a decontamination area

Where to start

2 Basic anatomy, physiology, and biochemistry

Anatomy terminology

The anatomical systems of the human body

3 Medical and surgical procedures and facilities

Procedures and techniques

The medical team

Types of medical disciplines

Medical equipment

Surgical procedures

Surgical team members

Surgical techniques

The operating/procedure room

Principles of aseptic (or “sterile”) technique

4 Instrumentation

Single‐use, limited‐use, and reusable medical devices

Materials used in the manufacture of instruments

Device manufacturers and suppliers

Surgical instrument types and descriptions

Miscellaneous devices used medically

5 Microbiology and infection prevention/control

Microorganism types

An introduction to infection prevention and control

6 Chemistry and physics

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

Safety considerations

How to choose and use a chemical product

Introduction to cleaning and accessory chemistries

Introduction to antimicrobial (disinfection/sterilization) chemistries

7 Point‐of‐use treatment and transport

Post‐procedure sorting

Point‐of‐use treatment

Transportation post procedure

Tracking and traceability

8 Cleaning

Receiving and sorting

Disassembly and preparation for cleaning

Basic principles of cleaning

Manual cleaning

Automated cleaning

Immersion, including ultrasonic baths

Automated washers/washer‐disinfectors

Tunnel (or continuous process) washers

Multi‐chamber washers

Single‐chamber washers

Special cleaning considerations

Cleaning guidelines, standards, and testing

Troubleshooting cleaning problems

9 Disinfection

Basic principles of disinfection

Physical disinfection

Chemical disinfection

Disinfection guidelines and standards

Special considerations

Troubleshooting disinfection problems

10 Inspection, assembly, and packaging

Area design

Maintenance, repairs, and replacements

Device and tray assembly

Medical‐grade packaging systems

Label identification of packaged devices

Loading and unloading sterilizers

11 Sterilization

Basic principles of sterilization

Physical sterilization

Chemical sterilization

12 Storage and distribution

Handling of non‐packaged or non‐sterilized devices

Sterile storage environment and layout

Inventory control

Transport of sterile packaged items

Guidance at the point of use

Standards and guidelines

13 Safety

Types of workplace hazards

Microbiological hazards

Chemical hazards

Device and equipment hazards

Physical and emotional hazards

Reducing safety hazards and risk analysis

Specific safety considerations

Disaster planning and management

14 Management and quality

Planning

Personnel management

Teamwork

Legal and ethical responsibilities

Process management

Materials management

Measurements

Quality management

15 Special interest topics

Water quality/purity

Endoscopy

Single‐use devices

Loan devices, sets, and implants

Surgical and medical laundry

Devices known or suspected to be contaminated with prion material

Sustainability

Index

End User License Agreement

List of Tables

Chapter 1

Table 1.1 Examples of various standard and guideline publishing organizatio...

Table 1.2 Examples of international standards that consider various deconta...

Chapter 2

Table 2.1 The various human body structures and examples.

Table 2.2 Examples of the four biomolecules that make up cellular structure...

Table 2.3 A summary of the anatomical systems of the human body.

Table 2.4 A summary of the major primary endocrine glands and secondary org...

Table 2.5 The various types of bones in the skeletal system.

Chapter 3

Table 3.1 Types and descriptions of medical disciplines.

Table 3.2 Common medical procedures.

Table 3.3 Various types of surgical techniques.

Table 3.4 Examples of specific surgical procedures.

Table 3.5 Examples of various types of endoscopic procedures.

Chapter 5

Table 5.1 Examples of microbial pathogens and their associated diseases.

Table 5.2 Examples of human diseases caused by viruses.

Table 5.3 Examples of human diseases caused by bacteria (pathogenic bacteri...

Table 5.4 Various types of toxins produced from bacteria and their effects ...

Table 5.5 Examples of groups/types of antibiotics.

Table 5.6 Fungal pathogens and their respective diseases.

Table 5.7 Protozoa and associated diseases.

Table 5.8 Helminths and associated diseases.

Table 5.9 Examples of infection control and prevention measures.

Table 5.10 Examples of personal protective equipment that can be used to re...

Chapter 6

Table 6.1 Chemistry is the basis of living and non‐living materials (known ...

Table 6.2 Various different chemical components used in formulations for cl...

Table 6.3 Examples of various common components that can be found in water....

Table 6.4 The SI (metric) units of measurements and other units commonly us...

Table 6.5 Commonly used prefixes in the SI/metric system for units of measu...

Table 6.6 Conversion factors for common units of measurement. Note that it ...

Table 6.7 Examples of various components of soil found on devices following...

Table 6.8 Various types and examples of enzymes commonly used for cleaning ...

Table 6.9 Examples of the basic types of chemicals (biocides) used for anti...

Table 6.10 Classification and examples of various types of biocides based o...

Table 6.11 Major types of biocides used in antiseptic products. Note that t...

Table 6.12 Major types of biocides used in disinfectant products. Note that...

Table 6.13 Examples of sterilization processes using chemical biocides.

1

Th...

Chapter 8

Table 8.1 Examples of various components of soil found on devices following...

Table 8.2 Manual versus automated cleaning.

Table 8.3 Various internationally used cleaning guidelines and standards. T...

Table 8.4 Acceptance criteria for cleaning efficacy for semi‐critical and c...

Table 8.5 Various types of test soils used for testing cleaning efficacy.

Chapter 9

Table 9.1 A summary of the Spaulding classification system, recommending va...

Table 9.2 Examples of disinfection and sterilization methods. These are giv...

Table 9.3 Examples of A

0

values and their practical application in disinfec...

Table 9.4 Examples of label claims on glutaraldehyde and ortho‐phthalaldehy...

Table 9.5 Examples of disinfection guidance documents.

Table 9.6 Examples of published and widely used disinfection test methods....

Table 9.7 The classification of chemical indicators.

1

Table 9.8 International and regional endoscopy organizations.

Chapter 10

Table 10.1 Summary of the various types of packaging materials/systems.

Table 10.2 Examples of packaging standards and guidance documents.

Chapter 11

Table 11.1 A list of different sterilization methods and their most resista...

Table 11.2 An example of results from studying the antimicrobial activity o...

Table 11.3 The classification of chemical indicators. Defined based on ISO ...

Table 11.4 Typical steam sterilization conditions. The related temperatures...

Table 11.5 Common steam sterilization problems, causes, and potential solut...

Table 11.6 Examples of problems frequently associated with color changes on...

Table 11.7 Examples of steam sterilization guidelines and standards.

Table 11.8 Examples of guidelines and standards considering dry heat steril...

Table 11.9 Examples of radiation sterilization standards used for industria...

Table 11.10 Examples of ethylene oxide (EO) gas sterilization processes, hi...

Table 11.11 Ethylene oxide (EO) sterilization guidelines and standards.

Table 11.12 Examples of guidelines and standards for formaldehyde steriliza...

Table 11.13 Standards and guidelines applicable to hydrogen peroxide gas st...

Table 11.14 Standards and guidelines applicable to liquid peracetic acid st...

Table 11.15 Types of bacterial spores used for testing and monitoring of ch...

Table 11.16 Examples of acceptable immediately dangerous to life or health ...

Chapter 12

Table 12.1 Standards and guidelines for the storage and distribution of dev...

Chapter 13

Table 13.1 Examples of segregated healthcare wastes based on type. Note tha...

Chapter 14

Table 14.1 An example of forecasting workload.

Table 14.2 An example of labor requirements.

Table 14.3 Advantages and disadvantages of holding too little or too much c...

Table 14.4 Examples of various monitoring methods used in a processing area...

Table 14.5 The classification of chemical indicators. Based on ISO 11140

St

...

Table 14.6 Sterilization methods and types of bacterial spores used in biol...

Chapter 15

Table 15.1 Examples of components that can be found in water. Some componen...

Table 15.2 Examples of common chemical water quality problems and how they ...

Table 15.3 A guideline for recommended levels of water contaminants at vari...

List of Illustrations

Chapter 1

Figure 1.1 Processing cycle.

Figure 1.2 Examples of decontamination area/facility workflow plans. On the ...

Figure 1.3 The layout of a modern decontamination facility, designed to have...

Chapter 2

Figure 2.1 Human cell structure. Examples are given (top) of the various dif...

Figure 2.2 The chemical structure of glucose and starch, types of sugars or ...

Figure 2.3 Common and anatomical names for various parts of the human body....

Figure 2.4 The most common directional anatomical terms used in anatomy.

Figure 2.5 Major and minor human body cavities. Note that the abdominal and ...

Figure 2.6 The cardiovascular system.

Figure 2.8 The digestive system.

Figure 2.10 The integumentary (or “skin”) system.

Figure 2.12 The major components of the lymphatic system, a parallel transpo...

Figure 2.13 The muscular system.

Figure 2.14 The nervous system.

Figure 2.16 The reproductive system, showing the major components of (A) the...

Figure 2.17 The respiratory system, consisting of the upper and lower tracts...

Figure 2.18 The skeletal system.

Figure 2.20 The main components of the urinary system.

Figure 2.7

(A, B)

The position and structure of the heart.

Figure 2.9 The endocrine system. The location of the major endocrine glands ...

Figure 2.11 The structure of the skin, with associated components.

Figure 2.15 The basic structure of the brain, with main sections indicated....

Figure 2.19 The dental system. (A) The permanent teeth of an adult human (th...

Figure 2.21

(A, B)

The external and internal structures of the eye.

Figure 2.22 The external and internal structures of the ear.

Chapter 3

Figure 3.1 Examples of the various types of facilities in which medical and ...

Figure 3.2 Examples of (A) rigid and (B) flexible endoscopes used for endosc...

Figure 3.3 A typical scrub area, showing sinks and available antiseptics for...

Figure 3.4 A typical operating room design with room equipment highlighted....

Figure 3.5 An air‐handling system, showing the flow of air (as arrows) throu...

Figure 3.6 An operating room (OR) integration system is designed to simplify...

Figure 3.7 The three areas of a restrictive procedure room.

Figure 3.8 Setting up for a surgical procedure within the operating room.

Chapter 4

Figure 4.1 Examples of older surgical device designs.

Figure 4.2 The internationally recognized symbols for (A) do not reuse the d...

Figure 4.3 Examples of labeling systems used with medical devices/instrument...

Figure 4.4 A pair of surgical scissors.

Figure 4.5 Examples of dissecting forceps.

Figure 4.6 Examples of retractors, showing (A) handheld and (B) self‐retaini...

Figure 4.7 Examples of dilators.

Figure 4.8 A suction nozzle.

Figure 4.9 A needle holder. A gold handle on scissors, forceps, or needle ho...

Figure 4.10 Examples of serrated instruments.

Figure 4.11 Various types of joints on instruments.

Figure 4.12 (A) A scalpel blade and associated BP handle. Also shown are exa...

Figure 4.13 The various parts of a pair of scissors. Note the gold handle on...

Figure 4.14 Various types of surgical scissors. (A) Mayo curved scissors. (B...

Figure 4.15 A double‐action bone cutter (also known as a rongeur or nibbler)...

Figure 4.16 Other types of instruments used to cut into or from bone. (A) Os...

Figure 4.17 Other types of sharp dissectors. (A) Tonsil snare; (B) types of ...

Figure 4.18 Volkmann's bone curette.

Figure 4.19 Various types of forceps. (A) Dissecting forceps; (B) clip appli...

Figure 4.20 Examples of (A) Adson; (B) Gillies; and (C) Kocher curve (shown ...

Figure 4.21 (A) Russian, (B) Lane, and (C) Jean forceps.

Figure 4.22 (A) Bayonet‐shaped diathermy forceps, shown (B) being used in a ...

Figure 4.23 Long and short, non‐toothed diathermy forceps.

Figure 4.24 Other types of forceps, with their patient‐end tips shown. (A) L...

Figure 4.25 Various types of bone holder forceps.

Figure 4.26 (A) Wrigley forceps and (B) their use during childbirth.

Figure 4.27 Sponge/swab‐holding forceps.

Figure 4.28 (A) Backhaus towel clamp has a blunt tip and is ideal to use to ...

Figure 4.29 Various parts of a needle holder, shown as an example. The inser...

Figure 4.30 Various types of hemostatic forceps (“hemostats”). (A) Artery; (...

Figure 4.31 The patient end of a Maingot clamp.

Figure 4.32 Examples of vascular clamps, with types of jaws shown. (A) Coole...

Figure 4.33 Various types of retractors. (A) Langenbeck; (B) Czerny; (C) Doy...

Figure 4.34 Malleable copper retractors used in the mouth.

Figure 4.35 (A) Blunt and (B) sharp hooks.

Figure 4.36 Examples of self‐retaining retractors. (A) ALM; (B) Weitlaner.

Figure 4.37 (A) A Balfour retractor with screws attached and associated with...

Figure 4.38 A needle and suture, used for suturing.

Figure 4.39 Types of needle holders. (A) DeBakey; (B) Thompson‐Walker, with ...

Figure 4.40 Clip appliers.

Figure 4.41 Types of specula. (A) Nasal; (B) vaginal; (C) anal.

Figure 4.42 Suction nozzle.

Figure 4.43 Examples of dilators used in surgery. Sets of (A) Hegar uterine ...

Figure 4.44 A surgical depth gauge.

Figure 4.45 Examples of (A) manual and (B) digital calipers.

Figure 4.46 An example of a frame‐type device used on the head for stereotac...

Figure 4.47 Examples of powered instruments. (A) Orthopedic handpieces; (B) ...

Figure 4.48 (A) A surgical mallet, (B) being used during orthopedic surgery....

Figure 4.49 Example of a mixture of single‐use and reusable devices, in this...

Figure 4.50 Examples of microsurgical instruments, including needle holder, ...

Figure 4.51 An example of (A) a dental extraction (wisdom tooth) instrument ...

Figure 4.52 Examples of dental surgery devices. (A) Dental syringe with anes...

Figure 4.53 Types of rigid endoscopes. (A) Arthroscope; (B) cystoscope, with...

Figure 4.54 Example of assembly of a rigid endoscope (surgeon end shown), on...

Figure 4.55 A typical laryngoscopy set. (A) Laryngoscope; (B) laryngoscope b...

Figure 4.56 Types of flexible endoscopes. All devices shown are video endosc...

Figure 4.57 The main parts of a flexible endoscope. (A) Light guide connecto...

Figure 4.58 Zooming in on the control handle/head/body of a flexible endosco...

Figure 4.59 Examples of various single‐use procedure valves. (A) Suction val...

Figure 4.60 Examples of control heads and light guide connectors of flexible...

Figure 4.61 Sets of endoscopes used in procedures. (A) Cystoscopic procedure...

Figure 4.62 Da Vinci robotic system. (A) A surgical table with the surgeon d...

Figure 4.63 Examples of various types of robotic surgical devices and associ...

Figure 4.64 A tattooing gun and handle.

Figure 4.65 Examples of commonly used devices for routine medical use. (A) T...

Chapter 5

Figure 5.1 The prion theory. The accumulation and precipitation of protein l...

Figure 5.2 The basic structure of viruses. Viruses display a wide range of s...

Figure 5.3 Examples of the variety of viral structures. These examples are n...

Figure 5.4 The basic structure of bacteria. (A) Examples of bacterial shapes...

Figure 5.5 An overview of the sporulation process in bacteria.

Figure 5.6 Biofilm development: free‐living bacteria attach or become associ...

Figure 5.7 Microscopic examples of fungi, including filaments of cells and s...

Figure 5.8 Examples of various types of protozoal structures.

Figure 5.9 Examples of various types of helminth structures. Helminths grow ...

Figure 5.10 Sources of microbial contamination. From the top left this inclu...

Figure 5.11 A recommended hand‐washing technique with water to ensure that i...

Chapter 6

Figure 6.1 The periodic table of elements.

Figure 6.2 (A–C) The three principal forms or phases of water commonly found...

Figure 6.3 Phase (or state) changes of matter. As energy increases the phase...

Figure 6.4 The relationship between temperature and pressure. The relationsh...

Figure 6.5 The pH scale. Note: it is correct to write the p in lower case an...

Figure 6.6 Examples of methods used to measure pH. (A) pH paper and its asso...

Figure 6.7 Example of a titration kit for chlorine analysis.

Figure 6.8 Example of a handheld conductivity meter.

Figure 6.9 Various forms of light or the electromagnetic spectrum. As you mo...

Figure 6.10 Some examples of widely used internationally standardized chemic...

Figure 6.11 Various types of personal protective equipment (PPE).

Figure 6.12 The mechanism of action of enzymes. Note: target molecules (e.g....

Figure 6.13 Resistance levels of microorganisms to inactivation. Traditional...

Figure 6.14 Definition of various levels of disinfectants, based on their ac...

Figure 6.15 Examples of typical critical, semi‐critical, and non‐critical de...

Chapter 7

Figure 7.1 A typical range of disposal and reusable items following a surgic...

Figure 7.2 Correct disassembly and handling of single‐use blades from reusab...

Figure 7.3 Examples of various practices of point‐of‐use treatment. (A) Devi...

Figure 7.4 Examples of point‐of‐use treatment with specific‐purpose products...

Figure 7.5 Examples of the care of devices with complex features at the poin...

Figure 7.6 (A) The internationally recognized symbol for a biological or bio...

Figure 7.7 Examples of various types of transport systems, including example...

Figure 7.8 Examples of (A) manual and (B) automated systems for processing t...

Chapter 8

Figure 8.1 An example of a set of instruments, including container and trays...

Figure 8.2 An example of typical personal protective equipment (PPE) used du...

Figure 8.3 Safe sorting of surgical devices using a swab holder. Items are h...

Figure 8.4 Examples of automated/computerized device tracking systems.

Figure 8.5 Disassembly and preparation for cleaning.

Figure 8.6 Examples of devices used in complex orthopedic sets.

Figure 8.7 (A) Ultrasonic baths of various sizes, used to aid in manual clea...

Figure 8.8 (A) A typical double‐bay and (B) a triple‐bay sink system used fo...

Figure 8.9 Rusting present on a device. Rusting is a sign of damage on a dev...

Figure 8.10 An example of “scaling” due to water hardness (A) in a washer‐di...

Figure 8.11 Various types of automated washers and washer‐disinfectors. Thes...

Figure 8.12 (A) Foaming and (B) an example of excessive foaming in a washer‐...

Figure 8.13 Various types of accessories (racks and trays) used with automat...

Figure 8.14 (A) Overloading and improper assembly of a device tray. (B) A be...

Figure 8.15 Examples of personal protective equipment...

Figure 8.16 Ultrasonic baths.

Figure 8.17 Examples of various types of loading/unloading systems. They ran...

Figure 8.18 Examples of tunnel washers. (A) A laundry washer and (B) an inst...

Figure 8.19 Multi‐chamber washer‐disinfectors. (A) A representation showing ...

Figure 8.20 Endoscope washer‐disinfectors.

Figure 8.21 Single‐chamber surgical and dental device washer‐disinfectors.

Figure 8.22 Cart or large‐chamber washers.

Figure 8.23 An example of an orthopedic loan set. Sets can include reusable ...

Figure 8.24 Examples of robotic systems that can include attachments...

Figure 8.25 An example of an endoscopic system. This is a typical flexible e...

Figure 8.26 Bedside procedure with a flexible endoscope showing the device l...

Figure 8.27 Flexible endoscope soaking caps (three different designs shown)....

Figure 8.28 Flexible endoscope leak tester. (A) Manual and (B) electrical ex...

Figure 8.29 Manual cleaning (brushing) of a flexible endoscope. (A) The brus...

Figure 8.30 Examples of specially designed brushes and sponges used for clea...

Figure 8.31 Examples of single‐chamber and tunnel washer‐disinfectors used f...

Figure 8.32 Visual inspection of a device set following a cleaning process....

Figure 8.33 Two types of commercially available test soils.

Figure 8.34 Various types of soil‐detection kits.

Figure 8.35 Various types of washer indicators used to test cleaning process...

Figure 8.36 Examples of various types of surface changes commonly observed f...

Chapter 9

Figure 9.1 The resistance of microorganisms to inactivation. Microorganisms ...

Figure 9.2 A commonly used classification system for disinfectants, describi...

Figure 9.3 An example of a thermal disinfection process in a washer‐disinfec...

Figure 9.4 Examples of thermal disinfection methods. On the far left are var...

Figure 9.5 Dry heat disinfection ovens.

Figure 9.6 Mechanisms of physical removal of microorganisms by filtration. (...

Figure 9.7 Examples of types of filters. (A) Air filters, with a high‐effici...

Figure 9.8 The various sizes of microorganisms, particles, and chemicals and...

Figure 9.9 Various types of disinfectants, from antiseptics (used on the ski...

Figure 9.10 A glutaraldehyde‐based disinfectant chemical indicator, used to ...

Figure 9.11 Examples of super‐oxidized or activated water generators.

Figure 9.12 Various types of hydrogen peroxide gas‐ or aerosol‐generating sy...

Figure 9.13 Various types of peracetic acid (PAA)‐containing disinfectants a...

Figure 9.14 An ozonated water–generating system. In this system the ozone is...

Figure 9.15 Temperature distribution testing within a washer‐disinfector cha...

Figure 9.16 Example of a surrogate test device for demonstration of disinfec...

Figure 9.17 Examples of two different types of chemical indicators and their...

Figure 9.18 Various types of manual and automated flexible endoscope disinfe...

Figure 9.19 Manual immersion safety, showing (A) a covered soaking bath and ...

Figure 9.20 Flexible endoscope storage. (A) When not in use, flexible endosc...

Figure 9.21 Examples of ozone generators used for laundry applications.

Figure 9.22 Examples of various types of antiseptics. (A) With permission of...

Chapter 10

Figure 10.1 (A) Use of an optical aid (lighted magnifying glass) to inspect ...

Figure 10.2 (A) Example of a borescope for inspection of lumens. (B) Example...

Figure 10.3 Sharpness testing with red THERABAND.

Figure 10.4 (A) An example of a delicate microsurgical device; note that thi...

Figure 10.5 Checking endoscope light transmission. Broken light fibers are s...

Figure 10.6 Examples of device damage. Rusting (top left) and staining (bott...

Figure 10.7 Examples of device tray and set checklists. A variety of differe...

Figure 10.8 Various types of device accessories, trays, and containers. At t...

Figure 10.9 Various types of pouches and reels used as sterilization barrier...

Figure 10.10 A general guide in assembling a tray. Note: not all steps are r...

Figure 10.11 Do not overload device trays/sets.

Figure 10.12 (A) Assembly and packaging workstations. (B) Devices inspected ...

Figure 10.13 Examples of reusable, rigid containers with tamper‐proof locks ...

Figure 10.14 An example of the sequential square/parallel wrapping process o...

Figure 10.15 Examples of chemical indicator tapes used for steam sterilizati...

Figure 10.16 Examples of (A) heat‐sealing apparatuses, benchtop design; and ...

Figure 10.17 Examples of manual labeling systems.

Figure 10.18 Examples of automated labeling systems.

Figure 10.19 (A) Loading a steam sterilizer using (B) heatproof gauntlets/gl...

Figure 10.20 Examples of (A) good and (B) poor loading of a sterilizer. The ...

Chapter 11

Figure 11.1 A commonly used classification system for disinfection and steri...

Figure 11.2 The spore reduction results in Table 11.2 shown in graph form, w...

Figure 11.3 Demonstration of a sterility assurance level (SAL) of 10

−6

Figure 11.4 Various types of biological indicators (BIs). (A) They may be pr...

Figure 11.5 Example of widely used, self‐contained, and rapid‐readout biolog...

Figure 11.6 Various types of chemical indicators used for monitoring sterili...

Figure 11.7 Various types of process challenge devices.

Figure 11.8 The relationship between temperature and pressure of water accor...

Figure 11.9 An example and the basic design of an upward displacement steam ...

Figure 11.10 Examples and the basic design of a downward displacement steam ...

Figure 11.11 Examples and the basic design of vacuum‐assisted steam steriliz...

Figure 11.12 Simplified examples of different types of steam conditioning cy...

Figure 11.13 (A) Typical design of a medium‐sized steam sterilizer, showing ...

Figure 11.14 Examples of air removal tests for dynamic (including vacuum‐ass...

Figure 11.15 Examples of water hardness deposits associated with steam. (A) ...

Figure 11.16 Examples of (A) minor and (B) excessive rusting observed due to...

Figure 11.17 Examples of test apparatus used for testing (A) non‐condensable...

Figure 11.18 Examples of incorrect and correct loading of steam sterilizers....

Figure 11.19 Examples of incinerators, ranging from simple burning furnaces ...

Figure 11.20 Examples of ethylene oxide sterilization processes. On the left...

Figure 11.21 Examples of ethylene oxide (EO) sterilizers and supply canister...

Figure 11.22 Ethylene oxide gas sensors and monitoring equipment. These incl...

Figure 11.23 A gas safety cabinet and typical warning signs used for ethylen...

Figure 11.24 A variety of ethylene oxide (EO) sterilizer designs. They can c...

Figure 11.25 The basic design of a traditional, chamber‐based or batch‐type ...

Figure 11.26 A typical low‐temperature steam formaldehyde (LTSF) sterilizati...

Figure 11.27 Various types of formaldehyde gas sensors.

Figure 11.28 Examples of formaldehyde‐based sterilization processes. (A) Ben...

Figure 11.29 The basic design of a low‐temperature steam formaldehyde (LTSF)...

Figure 11.30 Examples of liquid formaldehyde solution delivery systems. (A) ...

Figure 11.31 Examples of hydrogen peroxide gas (VH2O2) sterilization process...

Figure 11.32 Examples of liquid hydrogen peroxide supply methods used in dif...

Figure 11.33 (A–F) Examples of hydrogen peroxide gas (VH2O2) sterilizers. Th...

Figure 11.34 Typical basic design of a hydrogen peroxide gas sterilizer. A p...

Figure 11.35 Typical components of a peracetic acid–based solution shown in ...

Figure 11.36 An example of a peracetic acid (PAA) sterilant formulation deli...

Figure 11.37 An example of a peracetic acid (PAA) sterilization process, inc...

Figure 11.38 A typical design of a peracetic acid–based sterilization system...

Chapter 12

Figure 12.1 Examples of temporary storage methods used for flexible endoscop...

Figure 12.2 Shelving systems used for sterile pack storage. (A) Some storage...

Figure 12.3 Examples of closed and open trolleys for sterile goods transport...

Figure 12.4 Examples of lifts used to transport items to and from a processi...

Figure 12.5 Example of a dedicated transport vehicle separating clean and di...

Figure 12.6 Examples of damaged, sterile packaged goods that may be compromi...

Chapter 13

Figure 13.1 An example of a healthcare facility's standard precaution recomm...

Figure 13.2 Examples of the front pages of two safety data sheets (SDSs). No...

Figure 13.3 Examples of widely used internationally standardized chemical sa...

Figure 13.4 Various types of personal protective equipment.

Figure 13.5 Protective footwear. (A)

Inappropriate

(although comfortable) fo...

Figure 13.6 Electrical hazards. (A) A typical electrical hazard sign and (B,...

Figure 13.7 (A, B) Standing or sitting close to a work surface at the right ...

Figure 13.8 Pushing or pulling overloaded or heavy transport carts or liftin...

Figure 13.9 Height‐adjustable chairs and workbenches.

Figure 13.10 A typical example of surgical waste requiring segregation at th...

Figure 13.11 (A) The international symbol for an infectious substance and (B...

Figure 13.12 (A) The international symbol for a cytotoxic hazard and (B) exa...

Figure 13.13 (A–C) Examples of sharps disposal containers. Note that in (A) ...

Figure 13.14 (A) The international symbol for radioactivity and (B) examples...

Figure 13.15 Disposal of a waste bag.

Figure 13.16 Examples of hazardous waste storage area signs.

Figure 13.17 Examples of fire‐associated signs.

Chapter 14

Figure 14.1 Graph (histogram) showing the theoretical number of trays proces...

Figure 14.2 Examples of (A) out‐of‐balance and (B) in‐balance processing cap...

Figure 14.3 An example of a simple value stream with a process flow diagram ...

Figure 14.4 An example of a matrix that can be used to grade risks identifie...

Figure 14.5 Examples of 1D and 2D barcodes used for device/set identificatio...

Figure 14.6 Example of a GS1 unique identification code for a reusable devic...

Figure 14.7 Examples of scanning systems for surgical instruments and tray i...

Figure 14.8 (A–D) Different ways of presenting quality defects in processing...

Figure 14.9 (A–D) Examples of process measurements during device processing....

Figure 14.10 Various types of soil‐detection kits. On the left and center ar...

Figure 14.11 Examples of cleaning indicators.

Figure 14.12 Examples of cleaning test soils.

Figure 14.13 An example of an ultrasonic cavitation test. The indicator is p...

Figure 14.14 Ultrasonic bath aluminum foil test. (A) Test strips of foil are...

Figure 14.15 Examples of disinfectant chemical indicators.

Figure 14.16 Examples of the inspection of sterilizer‐recorded data (printou...

Figure 14.17 Example of the color change with a type 1 (process) chemical in...

Figure 14.18 Positioning of chemical indicators within a load. The lower loc...

Figure 14.19 (A) Examples of biological indicators (BIs), in this case color...

Chapter 15

Figure 15.1 Examples of problems associated with water quality/purity. They ...

Figure 15.2 Examples of various types of water treatment or purification met...

Figure 15.3 A flexible endoscope with various accessories. Included are (A) ...

Figure 15.4 Endoscope processing technician holding the control head, the li...

Figure 15.5 Point‐of‐use treatment of a flexible endoscope; a disposable spo...

Figure 15.6 Manual cleaning of a flexible endoscope.

Figure 15.7 (A) Example of a borescope for inspection of lumens. (B) Example...

Figure 15.8 The internationally recognized symbols used with single‐use devi...

Figure 15.9 Examples of single‐use devices provided sterile (left) and non‐s...

Figure 15.10 A set of loaned orthopedic screw implants.

Figure 15.11 Various stages of a laundry process.

Guide

Cover Page

Table of Contents

Title Page

Copyright Page

Foreword to the second edition

Foreword to the first edition

Glossary of terms

Acknowledgments

Begin Reading

Index

WILEY END USER LICENSE AGREEMENT

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Decontamination and Device Processing in Healthcare

Second Edition

Gerald McDonnell

Vice President of Microbiological Quality and Sterility Assurance at Johnson & Johnson

Georgia Alevizopoulou

Senior Clinical & Education Manager at STERIS Corporation

This edition first published 2025© 2025 John Wiley & Sons Ltd

Edition History[1e in 2012 by Wiley Blackwell]

All rights reserved, including rights for text and data mining and training of artificial technologies or similar technologies. 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 law. Advice on how to obtain permission to reuse material from this title is available at http://www.wiley.com/go/permissions.

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Limit of Liability/Disclaimer of WarrantyWhile the publisher and authors have used their best efforts in preparing this work, they 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 merchantability or fitness for a particular purpose. No warranty may be created or extended by sales representatives, written sales materials or promotional statements for this work. This work is sold with the understanding that the publisher is not engaged in rendering professional services. The advice and strategies contained herein may not be suitable for your situation. You should consult with a specialist where appropriate. The fact that an organization, website, or product is referred to in this work as a citation and/or potential source of further information does not mean that the publisher and authors endorse the information or services the organization, website, or product may provide or recommendations it may make. Further, readers should be aware that websites listed in this work may have changed or disappeared between when this work was written and when it is read. Neither the publisher nor authors shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages.

Library of Congress Cataloging‐in‐Publication DataNames: McDonnell, Gerald, author. | Alevizopoulou, Georgia, author.Title: Decontamination and device processing in healthcare / Gerald McDonnell, Georgia Alevizopoulou.Other titles: Practical guide to decontamination in healthcareDescription: Second edition. | Hoboken, NJ : John Wiley & Sons Ltd., 2025. | Preceded by: A practical guide to decontamination in healthcare / Gerald McDonnell, Denise Sheard. 2012. | Includes bibliographical references and index.Identifiers: LCCN 2024046213 (print) | LCCN 2024046214 (ebook) | ISBN 9781394206162 (paperback) | ISBN 9781394206179 (adobe pdf) | ISBN 9781394206186 (epub)Subjects: MESH: Cross Infection–prevention & control | Infection Control–methods | Equipment Contamination–prevention & control | Decontamination–methods | Safety ManagementClassification: LCC RA761 (print) | LCC RA761 (ebook) | NLM WX 167 | DDC 614.4/8–dc23/eng/20241204LC record available at https://lccn.loc.gov/2024046213LC ebook record available at https://lccn.loc.gov/2024046214

Cover Design: WileyCover Image: © Gerald McDonnell

Foreword to the second edition

Much has changed in the areas of decontamination and device processing since the publication of the first edition, A Practical Guide to Decontamination in Healthcare. First, there has been a better appreciation of the impact of device processing – including best practices in cleaning, disinfection, and sterilization – on patient safety. Reports about lapses in device decontamination and processing have been published, including instances of microbial contamination of devices used in surgical, medical, and endoscopic procedures that, in some instances, led to patient infections. Of note were multiple reports of device‐associated transmission of antibiotic‐resistant strains of bacteria (such as carbapenem‐resistant Gram‐negative bacteria and methicillin‐resistant Gram‐positive bacteria). In addition, other impacts on patient safety were reported due to undetected device damage and device‐associated toxicity from lapses in best practices (e.g. inadequate device inspection, lack of attention to device manufacturer’s instructions for use, and inappropriate use of chemicals and antimicrobial processes during device processing). Therefore, similar to the central tenets of infection prevention and control and public health, we must continue to evolve the basic principles and practices for safe medical device use.

Given these reports about device‐related contamination and associated risks, it is no surprise that there has been a concerted effort to improve and even innovate the way we can comply with best practices. Examples include the harmonization of requirements internationally; the focus on dedicated education, training, and career advancement for device processing professionals who often dedicate their careers to this area; the development and introduction of new technologies to ensure reliable processes in equipment and device processing; and the emphasis on collaboration between device manufacturers, testing labs, regulatory agencies, and device users. Standard nomenclature is also important. For example, the word “decontamination” can encompass the removal of contaminants (including microorganisms and other materials such as blood) to specified levels, but the more recent universal term “processing” is now internationally accepted as referring to all activities to prepare a new or used healthcare product for its intended use. Both terms are now reflected in the title of the book. Other recent standard requirements include the harmonization of requirements for instructions for use (with particular emphasis on device processing in standards such as ISO 17664 Parts 1 and 2), cleaning endpoints, and disinfection. Ensuring that staff in processing areas are educated, trained, and competent will ensure that they can benefit from a strong career pathway and that they will be considered essential healthcare employees who are valued throughout for their vital contributions to patient care and infection prevention.

International best practices have been subsequently published or updated, including those from the World Health Organization (WHO) and the World Federation for Hospital Sterilisation Sciences (WFHSS), as well as those from the United States such as from the Association for the Advancement of Medical Instrumentation (AAMI). Further, professional organizations, such as the Healthcare Sterile Processing Association (HSPA), lend valuable support, education, certification, and other resources for device processing professionals worldwide. Finally, the surgical, medical, and device processing profession is experiencing technological and procedural innovations, such as robotic surgery and innovative equipment and automation tools, as well as a heightened emphasis on the environmental and safety impacts of products and processes. Many of these related requirements and best practices have now been incorporated in this second edition.

With these valuable updates, Decontamination and Device Processing in Healthcare, 2nd edition, will continue to serve as an essential reference for students interested in learning and understanding the basics of decontamination, processing, and infection prevention.

Damien Berg, BA, BS, CRCST, AAMIF

Vice President of Strategic InitiativesHSPA (Healthcare Sterile Processing Association)USA, 2024

Foreword to the first edition

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 practising. This is brought about by varying cultures, national economics, and availability of resources, both human and material, and the perception of safe health‐care 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. Sills Consultant and Director of Education

IDSc (Institute for Decontamination Sciences)UK, 2012

Glossary of terms

Many general terms are used throughout the book, such as “cleaning,” “disinfection,” “sterilization,” “decontamination,” and so on. These are specifically defined here. They can have very specific meanings and are often misused in the literature, including in regulations. Definitions can vary from country to country or depending on their use in certain applications. Some definitions continue to evolve, but wherever possible internationally accepted definitions are used here. 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 the respective chapters.

Aeration

Removal of volatile chemical residuals to a predetermined level.

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).

Antibiotic

Drug that kills or inhibits 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‐infective

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

Antimicrobial

Ability to inactivate or suppress the growth of microorganisms. This can include a process (e.g. application of heat) or a product (e.g. drugs or disinfectants). Antimicrobials include drugs that are particularly used therapeutically within patients to control infections. These are called anti‐infectives 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 further detail in this book. The antimicrobial chemicals that are used in disinfection and sterilization applications are called “biocides” or “microbiocides.”

Antisepsis

Inactivation or inhibition of microorganisms in or on living tissues, such as 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

Chemical, product, or process used for antisepsis. In some countries antiseptics are labeled as disinfectants or antiseptic disinfectants. They are often further classified based on their particular use, to include hand washes, hand rubs, 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 humans, plants, or animals, but are found to survive in extreme environmental conditions (such as hot springs).

Asepsis

Prevention from contamination with microorganisms.

Aseptic technique

Activities designed to limit the risk of the introduction of microbial contamination.

Assurance of sterility

Qualitative concept comprising all activities that provide confidence that a product is sterile. This implies an end‐to‐end concept that considers all processes that are required in the development, manufacture, and delivery of a sterile labeled product for its intended use.

Bacteria

Also known as

eubacteria

. A class of microorganisms that are prokaryotic (no defined nucleus) and unicellular (one‐celled, in comparison to multi‐cellular organisms). Examples include

Bacillus

,

Staphylococcus

, and

Pseudomonas

.

Bactericidal

Ability to inactivate bacteria. This term applies to any agent or product that can kill vegetative bacteria, but may not include bacterial spores (see

sporicide

).

Bioburden

Population of viable (or detectable) microorganisms on or in a product or other material. Note: the bioburden from patient‐derived materials such as bodily 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

Chemical or physical agent that can inactivate living organisms. 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 and viricides.

Biofilm

Community of microorganisms (either single or multiple types). They often develop on or in association with types of surfaces or interfaces.

Biological indicator (BI)

Test system containing viable microorganisms providing a defined resistance to a specified sterilization or disinfection process.

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 for “small room,” a cell is the basic structural and functional component of living organisms. Humans, for example, are multi‐cellular 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 often simpler in structure, while eukaryotes are larger and more compartmentalized.

Chelating agent

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

Chemical indicator (CI)

Test system that reveals 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. Other terms 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

.

Clean

Visually free of soil and quantified as being below specified levels of analytes. Soil can be any unwanted contaminant(s), including patient materials and process residues. Analytes can include any chemical substance that is the subject of chemical analysis, such as detergents or human tissue components (e.g. proteins, hemoglobin). In many applications a visually clean endpoint might be acceptable and might not require the quantification of specified analytes, but in other cases more defined chemical (or analyte) analysis is required.

Cleaner

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

Cleaning

Removal of soil to the extent necessary for further processing (e.g. disinfection, sterilization) or for intended use. “Soil” most often consists of various forms of contaminants, as we typically observe in device processing.

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 (such as water).

Contaminant

Material (e.g. chemical, biochemical, or microbiological) not intended to be part of a product or process. Examples of contaminants include soils, protein, dirt, detergents, product residuals, particulates, and microorganisms.

Contamination

Presence of material (e.g. chemical, biochemical, or microbiological) not intended to be part of a product or process. The presence of dirt or “soil” can include various materials, chemistries, and bioburden 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 being “soiled.”

Critical water

Water that is extensively treated to ensure that microorganisms and inorganic/organic materials are removed to meet a defined specification.

Cyst (or oocyst)

In microbiology, a dormant form of a microorganism, particularly made by protozoa.

Decontamination

Removal of contaminants to specified levels. A decontamination process can include a cleaning (physical removal) and/or an antimicrobial (e.g. disinfection) process, depending on the defined level previously specified as being appropriate for a specified purpose, and is often a combination of these processes. Decontamination is intended 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 and in the literature, the terms “decontamination” and “processing” or “reprocessing” are often 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 that is intended to be used for the purpose of diagnosis, prevention, monitoring, treatment, or alleviation of disease or other medical/surgical use. A reusable 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 provide the supporting evidence of such as the cause.

Disinfectant

Chemical and/or physical agent used for disinfection. Other terms can be used internationally to refer to disinfectant types such as “germicide,” “fumigant,” “high‐, intermediate‐, or low‐level disinfectant” and “sterilant” (see

disinfection)

.

Disinfection

Process to inactivate viable microorganisms to a level previously specified as being appropriate for a defined purpose. Other terms, such as pasteurization, sanitization, and antisepsis, are forms of disinfection. Methods include the use of chemicals, combinations of chemicals, and/or non‐chemical disinfectant modalities such as using heat. Different “levels” of disinfection have been defined for specific applications, such as high‐, intermediate‐, and low‐level disinfection. The exact meaning and usage of these terms may vary from country to country. A low‐level disinfectant is expected to inactivate vegetative bacteria (except mycobacteria), enveloped (lipid) viruses, and fungi, but not necessarily fungal or bacterial spores. An intermediate‐level disinfectant is expected to inactivate all vegetative bacteria, including tubercle bacilli, lipid and some non‐lipid viruses, and fungal spores, but not bacterial spores. A high‐level disinfectant is expected to inactivate all forms of microbial life except for large numbers of bacterial spores, when used in sufficient concentration and under suitable exposure conditions.

Drug

A medicine that has a physiological effect when ingested or otherwise introduced into the body.

D value

Time or dose required under stated conditions to achieve inactivation of 90% of a population of the test microorganisms.

Endospores

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

Endotoxin

Components of certain types of microorganisms that are released only on the death and disintegration of their cells. The most common are high molecular weight complexes that contain lipopolysaccharide (LPS), protein, and phospholipid originating from the outer membrane of Gram‐negative bacteria. Although these are naturally occurring, even in the body (e.g. from bacteria in the intestine), higher levels of endotoxins can cause fever (pyrogenic) when injected into the body.

Environmental control

Application of engineering and/or procedural systems to maintain conditions in a defined space within specified limits. An example is the use of cleanrooms and air filtration systems to reduce contamination in a room/environment.

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

Toxin produced from a microorganism while it is fully functional (e.g. the tetanus toxin from

Clostridium tetani

).

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 a formulation is to optimize the activity of these ingredients while minimizing any negative effects (such as poor water quality, surface damage, and loss of activity over time).

Fumigation

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, which 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 United States). Therefore, germicidal refers to a product or process that kills microorganisms, but sometimes only refers to bactericidal activity (as in US Environmental Protection Agency disinfectant registrations). As “germ” is a general term for a microorganism; its use in decontamination is discouraged as it can be misleading.

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 (CaCO

3

) equivalents.

Helminths

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

Ascaris

and

Taenia

.