Effective management of surgical instruments

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Global Medical Device Industry

310 billion US $ in 2010; 434 billion US $ in 2017

Pharma: 290 billion; 370 billion US $ in 2017

Annual growth rate 7%

MD industry is covering a wide spectrum of products

Life-time of the products is short and research and development is high

New Areas including Tissue-Engineering products, Advanced therapy medi cinical products and Combination products

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Differences between Medical Devices and Drugs

Medical Devices • Physical objects: complex components

and assemblies; generally based on mechanical and electrical features

• Most act through physical interaction with body or body part

• Tend to require significant user interaction

• Heterogeneous group; range from pflasters to artificial organs

• Duration and nature of exposure varies widely

• Short market life (18-24 months) part

• Small and medium sized enterprizes (more than 80%)

Drugs • Pure molecules: based on pharmacology

and chemistry; now encompassing biotechnology, genetic engineering etc.

• Administered via the mouth, skin, eyes, lungs, or by injection; act through metabolic, pharmacologic or immunological means

• Generally little user interaction

• Tend to differ only in molecular structure

• Typically short half-life in body

• Long market life

• Generally little user interaction

Classification of Medical Devices

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Classification of medical devices

1) In accordance with: RKI, DGSV 2) The Regulations for Users of Medical Products refer to rules for preparation in §§ 2 and 4. It is clearly stated that preparation must be carried out in accordance with the regulations of the “MPBetreibV”, the generally recognised technical regulations and the occupational safety and accident prevention regulations (§ 2, Paragraph 1 “MPBetreibV”). Preparation may only be assigned to qualify personnel. (Source: Empfehlungen für die Überwachung der Aufbereitung von Medizinprodukten (Projektgruppe RKI-BfArM-Empfehlungen 22.01.2008)

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Spaulding's Classification of Medical Devices and Required Level of Processing/Reprocessing

Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011

Operation, which have been cancelled due to not sufficient reprocessed instruments

** 57/340 Datensätze * mit freundl. Genehmigung G.Shapp MP

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Locations: Blood and Body Fluid Exposures

http://www.cdc.gov/nhsn/PDFs/NaSH/NaSH-Report-6-2011.pdf

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Personnel: Exposed to Blood and Body Fluids

http://www.cdc.gov/nhsn/PDFs/NaSH/NaSH-Report-6-2011.pdf (Source: CDC 2003)

Health Care Workers with Documented and Possible Occupationally Acquired HIV/AIDS

CDC Database as of December 2002

* 3 dentists, 1 oral surgeon, 2 dental assistants

Documented Possible

Dental Worker 0 6 *

Nurse 24 35

Lab Tech, clinical 16 17

Physician, nonsurgical 6 12

Lab Tech, nonclinical 3 –

Other 8 69

Total 57 139

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BULLETS IN PLANES 2

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Challenges for surgical cleaners

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"...in the absence of careful physical cleaning, most disinfection and sterilization processes are likely to be ineffective. …only steam autoclaving can overcome the barrier effects of residual organic matter."

Source: Gastrointestinal Endoscopy Vol 50 no. 2 1999, pg 288

Removal of body tissue soils like blood, mucous, fats, and others

Reduction of biofilms

Soiled patient care equipment (needles, syringes, surgical instruments and other equipment) used for patient

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“Cleaning is always essential prior to disinfection or sterilization. An item that has not been cleaned cannot be assuredly

disinfected or sterilized.” Public Health Agency of Canada/Health Canada

Cleaning: The physical removal of foreign material (e.g., dust, soil) and organic material (e.g., blood, secretions, excretions, microorganisms). Cleaning physically removes rather than kills microorganisms. It is accomplished with water, detergents and mechanical action. Cleaning must be performed before high level disinfection or sterilization.


SOLUTIONS FOR MANAGEMENT AND QUALITY

ASSURANCE - TDOC

Basic Design of CSSD

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Steps in reprocessing critical medical equipment

AUTO WASHER

WORK TABLE

WELCOME TO

DECONTAM

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WELCOME TO

STERILE PROCESSING

READY FOR

STERILIZATION

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COUNT SHEETS OBSOLETE

EQUIP / INST

WORK AREA

Instructions for Cleaning, Sterilization ,Inspection and Maintenance of Osteosynthesis Medical Devices

Follow The Detailed Instructions step by step

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Verification of the Cleaning Process So…What is CLEAN?

Definitions from Guidelines and Standards:

- AAMI TIR 301: Removal of contamination from an item to the extent

necessary for further processing or the intended use.

- ASTM E23142: Removal of foreign materials, including organic soil (for example, protein) and microorganisms from medical instruments.

- CDC Guideline 20083: Removal of visible soil (e.g., organic and inorganic material) from objects and surfaces

See reference section for more info.

Verification of the Cleaning Process The Recommendation

ANSI/AAMI ST794 recommends:

- “Mechanical cleaning equipment should be tested upon installation, weekly (preferably daily) during routine use, and after major repairs”.

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PICTURE

Edit: Insert picture by clicking icon in plane.

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Reasons for cleaning

Blood fixation by sterilizing agents (glutaraldehyde, peracetic acid

Why cleaning of goods to be sterilized?

Removal of all visible dust and dirt, tissue, blood and foreign particles

Removal of breeding ground for surviving microorganisms

Reducing of the bioburden

Protection against corrosion

Ensure more safe free movement of equipment and materials

The Sterile Supply Cycle : Cleaning, Jan Huys 2004

http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WJP-4CBDC2F-2&_user=2984995&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000000715&_version=1&_urlVersion=0&_userid=2984995&md5=acba16e583f2240dea018b6848a4cd36

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The Soil on used surgical instruments

• Soil contain protein

– When heating > ± 50°C coagulation

• Is therefore is essential that :

– All these soils are removed before disinfection and / or sterilization

– The temperature of water

The bioburden

• By cleaning, the vast majority of the bioburden is removed. Thus Cleaning is considered the most essential step in the sterile supply cycle

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Proper cleaning is essential to reducing the risks associated with improper or inadequate medical device reprocessing

Cleaning Reusable Medical Devices: A Critical First Step By Susan Shoemake, BA and Kathleen Stoessel, RN, BSN, MS

Cleaning Key points

Cleaning, disinfection, and sterilization are the backbone of infection prevention and control.

Proper cleaning is essential before any disinfection or sterilization process.

Failure to sterilize or disinfect reusable medical devices properly may spread infections.

IFIC Basic Concepts of Infection Control by Syed Sattar

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Cleaning of Used Instruments

The most important step in instrument reprocessing is cleaning

Studies have demonstrated that dirty instruments cannot be effectively disinfected

Cleaning is the removal of visible soil (organic and inorganic material) from instruments and is normally accomplished manually or automatically using water and detergents with or without enzymes.

1. Alfa, et al. 1998 American Journal of Infection Control. 2. Rutala, 2008, CDC: “Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008”

Cleaning has three major objectives

Remove visible soil

Remove invisible soil

Remove as many harmful

microorganisms as possible

Managing Infection Control by Stephen M. Kovach, BS, CSPDT, February 2007

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Residues on surgical instruments

NORMAL SURFACES ARE NO

CLEANING PROBLEMS

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Cleaning problems

Technology Creates Cleaning Challenges

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COMPOSITION OF BLOOD

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Effect of the blood coagulation on cleaning Cleaning comparison

defibrinated blood / coagulated blood

Cleaning Behaviour

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Residues after Cleaning

What are bloodborne pathogens?

• Bloodborne pathogens are microorganisms that can cause disease when transmitted from an infected individual to another individual through blood and certain body fluids

• Causing serious illness and death

– Hepatitis B (HBV),

– Hepatitis C (HCV)

– Acquired immunodeficiency syndrome (AIDS) from HIV

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Brucellosis

Human

Immunodeficiency

Virus (HIV)

Include:

Hepatitis:

A, B, C, D, E

Execution

Types of Bloodborne Pathogens

Viruses or bacteria that are carried in blood and cause disease in People.

Syphilis

Malaria

Transmission of BBPs

Bloodborne pathogens can enter your body through:

Contaminated instrument injuries.

A break in the skin (cut, lesion, etc.).

Mucus membranes (eyes, nose, mouth).

Other modes.

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Residue of blood or hemoglobin in medical instrument

From left to right: 100μg, 10μg, 1μg and 0.1μg of blood residues

Bloodborne pathogen strike-through conversion chart

© 2003 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI ST35:2003

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A few hours A few days

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The problem with biofilms

• Biofilms are ubiquitous in nature and cause a variety of

problems including:

– Fouling of membranes

– Biological fouling in medical instruments, oil field injection

wells, and cooling towers

– Infections and disease in people (e.g., contamination of

drinking water and dental unit water)

– Oral care/plaque buildup

– Corrosion of metal surfaces by sulfur-reducing bacteria (SRB’s)

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Polysaccharides produced by bacteria in biofilms

EPS Polymer Linkage Bacteria

Alginates b-1,4 mannuronic acid

a-1,4 guluronic acid

Pseudomonas

Amylopectin a-1,4 & a-1,6 glucose Ecoli

Celluloses b-1,4 glucose Acetobacter

Colanic Acids Glucose, galactose, fucose, glucuronic acid, pyruvic acid

Salmonella, Ecoli

Dextrans a-1,6 & a-1,4 glucose Streptococcus, Acetobacter

Glycogen a-1,4 & a-1,6 glucose Bacillus, Pneumococci

Levans b-2,6 fructose Pseudomonas, Bacillus, Aerobacter

Polymannans b-1,4 mannose Desulfovibrio desulfuricans

CONTENT HOLDER 2

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GET FASTER BLOOD REMOVAL WITH ENZYMATIC DETERGENTS

Complete blood removal with proteases

NOVOZYMES PRESENTATION 54 5/14/2015

BLOOD IS THE MAIN AND MOST CRITICAL CONTAMINANT OF SURGICAL INSTRUMENTS AND IT IS USED IN THE INTERNATIONAL STANDARD ISO15883 AS CHOSEN TEST SOIL (TOSI TEST) TO CHECK THE EFFICACY OF

CLEANING PROCEDURES FOR SURGICAL INSTRUMENTATION REPROCESSING

Tim

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Test stopped

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CONTENT HOLDER 3


guide ,

Multi-enzyme solution can help detergents remove biofilm

THE SURGICAL INSTRUMENTS WERE SOAKED FOR 60 MIN AT 40°C

This data is based on the removal of Model Pseudomonas auerginosa biofilm, a common microbe found on surgical instruments

Unsoaked Soaked in detergent

Soaked in detergent + multi-enzyme solution

L* Values for Soaked Coupons Containing Pseudomonas Auerginosa biofilm

12

14

16

18

20

Detergent+E2 Detergent+E1 Detergent only No Soaking

Treatment

L*

What are PRIONS?

Chobin. Infection Control Today. April 2008.

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Intrinsic Resistance

• Prions demonstrate resistance to routine methods of decontamination and sterilization

• Prions are proteins, not microorganisms

Comparative Frequency of Infectivity in Organs, Tissue, and Body Fluids of Humans with Transmissible Spongiform Encephalopathies

(Creutzfeldt-Jakob Disease)

• Brain (including dura mater), spinal cord, posterior eye, pituitary tissue

High

• Cerebrospinal fluid, liver, lymph node, kidney, lung, spleen, placenta, olfactory epithelium

Low

• Peripheral nerve, intestine, bone marrow, whole blood, leukocytes, serum, thyroid gland, adrenal gland, heart, skeletal muscle, adipose tissue, gingiva, prostate, testis, tears, saliva, sputum, urine, feces, semen, vaginal secretions, milk, sweat

No Risk

infection control and hospital epidemiology february 2010, vol. 31, no. 2

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Relative Resistance of Different Microbial Types to Microbial Control Agents

More resistant

Prions

Bacterial endospores

Mycobacterium

Staphylococcus and Pseudomonas

Protozoan cysts

Protozoan trophozoites

Most gram-negative bacteria

Fungi and fungal spores

Nonenveloped viruses

Most gram-positive bacteria

Less resistant

Enveloped viruses

Efficacy of Sterilization Processes in Inactivating Prions


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Efficacy of Chemicals in Inactivating Prions


Instrument reprocessing – Deconex® 28 ALKA ONE-X destabilizes the infectious prion protein

The infectious prion protein is proteinase K resistant. A treatment of the brain extract with phosphate buffer (6) (neg. control) or with 0.5% deconex® 28 ALKA ONE-x + 0.15% deconex® TWIN ZYME at 55 °C (4) showed no effect on its proteinase K resistance. In contrast, proteinase K was able to digest the prion protein after the brain extract had been treated with deconex® 28 ALKA ONE-x at 0.5% / 70 °C (1) or 1.0% / 55 °C (2). When 1.0% deconex® 28 ALKA ONE-x together with 0.3% deconex® TWIN ZYME at 55 °C (3) was used for treatment, the (destabilized) prion protein was degraded through the action of the proteases in deconex® TWIN ZYME alone, without the additional action of proteinase K. The treatment of the brain extract with potassium hydroxide at pH 12 (5) however showed less effect on the prion protein as a residue of proteinase K resistant material on the Western Blot shows.

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TASS

Toxic anterior segment syndrome (TASS) is an acute inflammation of the anterior chamber, or segment, of the eye following cataract surgery

Toxic Anterior Segment Syndrome - TASS

• The Issue: serious damage to a patient’s intraocular tissue and vision loss as a result of contaminants in the eye during ophthalmic surgery

• Causes: contaminated irrigating fluids; antiseptics; antibiotic ointments; powder from surgical gloves “Most cases of TASS appear to result from inadequate instrument cleaning and sterilization”

Nick Mamalis, MD, Toxic Anterior Segment Syndrome Journal of Cataract and Refractive Surgery 2006; 32:324-333

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Cause TASS

Bacterial endotoxin residues

Viscoelastic residues

Exotoxins

Solutions and Intra Ocular

Fluids Preservatives Medication

Lenses / IOL Other Factors

Toxic Anterior Segment Syndrome - TASS

• Inadequate or inappropriate instrument cleaning

• “Detergents

• Heat stable endotoxin from overgrowth of gram-negative bacilli in water baths or ultrasonic cleaners

• Degradation of brass containing surgical instruments from plasma gas sterilization

• Impurities of autoclave steam”

Recommended practices for cleaning and sterilizing intraocular surgical instruments, J Cataract Refract Surg, Vol 33, June 2007

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AAMI ST79 2008 Amendments - Annex N (informative) Toxic anterior segment syndrome (TASS) and the processing of surgical

instruments

Follow Mfr’s. cleaning and sterilization instructions Adequate inventory-time for processing Designated cleaning area and dedicated equipment

• Precleaned immediately • Transport in closed containers • PPE • Appropriate cleaning agent & water of appropriate

quality as specified by the Mfr. • Sterilization according the Mfr’s. instructions • Maintenance of cleaning and sterilization equipment,

boilers and water filtration systems • Training

Known Contaminates

• Previous patient

• Water

Viable Microorganisms

• Previous patient

• Water

• Detergent

• Biofilm (washer or instruments)

Organic: Foreign Body Contaminate (FBC)

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Different methods for cleaning of instruments

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The cleaning circle

Comparing the contributions of the factors involved in manual cleaning and machine cleaning

www.wfhss.com/html/educ/sbasics/sbasics0102_en.php

Copyright IAHCSMM 2007

Basic Instrument Cleaning Procedures

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Basic Components of Cleaning Solutions

Water

Detergent

Surfactants Buffers

Chelating agents

Enzymes


Manual Cleaning of Used Instruments

www.henryschein.com/infectioncontrol

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Manual Cleaning

• “Lukewarm water-detergent solutions (at temperatures optimally in the range of 27º C to 44ºC [80º F to 110º F], but not to exceed 60º C [140º F]) will prevent coagulation and will thus assist in the removal of protein substances. The temperature of the soaking solution should be monitored and documented.

• Devices should be thoroughly rinsed to remove debris and detergent residues.(6.5.4.3.2)”

Working with your Automated Washer – Work Flow (Duties) TM

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Typical cleaning/disinfection process in an automatic washer disinfector

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Simplified diagram for typical batch type automatic washer disinfector

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Factors involved in Mechanical Cleaning

Detergent Chemistry :

• Chosen for the soil type

• Use optimal detergent

concentration

• Enzymes in the detergent

must be active

Temperature:

Too hot

• Blood coagulates and

becomes difficult to remove

• Enzymes may be inactivated

Too cold

• fats cannot be dissolved

• enzyme activity is decreased

Wash Time:

Too short

• Detergent does not have

enough time to remove soil

Mechanical Action:

• Involves water pressure,

spray arm rotation and

spray nozzle location

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Water and cleaning

• That it makes it so special : – It is a good solvent for a large number of substances

– It has a relative high boiling point

– It is stable

– It has a very high surface tension

• Problems related to cleaning with water : – Water prevents wetting of surfaces: surface tension

– Water cannot dissolve fats and oils

– Improving cleaning capability of water: Surfactants (tensides)



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pH-value of Water

• Tap-water : 7,0 – 8,0

• Softened water: 7,5 – 8,5

• Softened water (warm) : 8,0 – 9,0

• DI-water : 5,5 – 6,5

Composition of water: water quality


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A surplus of H O (or what is the same the H ) causes acidity. A surplus of OH causes a fluid to be basic. Acids typically add H cause and increase of acidity/thus

a lower Ph. Bases bring in OH ions and cause a fluid to basic, increasing the pH.


Effects of pH on Cleaning

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It all depends on the right type of water!

Variables that impact cleaning

• type of soil to be cleaned Target soil

• item to be cleaned Instrument design

• e.g., hardness, pH Water quality

• A low temperature at the start (to prevent denaturing) and higher temperature later (to maximize enzymatic solution or detergent) Temperature and time

• The ability of the cleaning solution to hydrolyze target soils Chemical activity

• the energy needed to clean (agitation) Mechanical action

• e.g., staff training, loading methods Human variables and intangibles

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Detergent: A synthetic cleansing agent that can emulsify oil and suspend soil. A detergent contains surfactants

that do not precipitate in hard water and may also contain protease enzymes (see Enzymatic Cleaner) and

whitening agents

Enzymatic Cleaner: A cleaning agent that contains enzymes which break down proteins such as blood, body

fluids, secretions and excretions from surfaces and equipment. Most enzymatic cleaners also contain a

detergent. Enzymatic cleaners are used to loosen and dissolve organic substances


An ideal cleaning agent

is nonabrasive

is low-foaming

is free-rinsing

is biodegradable and environmentally friendly

provides for rapid soil dispersion or suspension

is nontoxic in the specified use dilution

is effective on clinically relevant soils under specified use conditions

has a long shelf life

is cost-effective

can be tested for effective concentration and/or use life

© 2011 Association for the Advancement of Medical Instrumentation AAMI TIR30:2011

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Reprocessing Decision Chart

Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011 from the British Columbia (BC) Ministry of Health (the Ministry)

Most cleaning solutions for medical devices are composed of the following: water, detergents,

surfactants, buffers, chelating agents, and one or more enzymes


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What key professional organizations say about enzymatic cleaners

“Neutral detergents/enzymes with a pH of 7, that are low foaming and free-rinsing should be used for mechanical or manual cleaning of surgical instruments and equipment …Neutral pH detergents work well used in combination with enzymatic solutions as part of a cleaning regimen.” (PNDS: 170,175 AORN Association of periOperative Registered Nurses 2008)

The following factors for the proper use of enzymatic product in their Central Service Technical Manual-Seventh Edition: 1. Water temperature in the decontamination area 2. Room temperature in the decontamination area 3. Useful life and stability of the product being considered 4. Expiration date of product 5. The material used to construct the device to be cleaned (material compatibility) 6. Whether the detergent (enzyme) is approved and registered with the

Environmental Protection Agency (EPA) IAHCSMM (Association of Healthcare Central Services Materiel Management)

November 2008 • HEALTHCARE PURCHASING NEWS • www.hpnonline.com

What key professional organizations say about enzymatic cleaners (cont)

Published new guidelines in 2008 for the use of enzymatic cleaners on endoscopes in the GI Suites: 1. Medical grade, low foaming, neutral pH chemistry 2. Specially formulated bactericidal endoscope detergent designed

specifically to detach and destroy biofilm 3. An enzyme detergent designed for endoscopes 4. A detergent formulated to remove synthetic lipids 5. Free rinsing (SGNA Society of Gastroenterology Nurses and Associates 2008)

An ideal cleaning agent would : 1. be nonabrasive 2. be low-foaming 3. be free-rinsing 4. be biodegradable 5. rapidly dissolve/disperse soil 6. be nontoxic 7. be efficacious on all types of clinical soil 8. have a long shelf life 9. be cost-effective (AAMI Association for the Advancement of Medical Instrumentation 2006)

November 2008 • HEALTHCARE PURCHASING NEWS • www.hpnonline.com

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Types of enzymes used in enzymatic detergents

Enzyme Soil component Product

Proteases Proteins, oligopeptides, peptides Endopeptides and exopeptides

Lipases Acylglycerols Glycerol esters

Amylases Starch, glycogen α(1-4) and α(1-6) D-glucose

Cellulases Cellulose β(1-4) D-glucose

© 2011 Association for the Advancement of Medical Instrumentation AAMI TIR30:2011

Four basic types of enzymes are used to clean surgical instruments

• breaks down cellulosic materials such as wood, cotton and paper

• breaks down carbohydrates and starches

• breaks down protein

• breaks down fats and greases

Lipase Protease

Cellulose Amylase

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Characteristics and Clinical Benefits of Enzymatic Detergents

Enzymatic Detergent: Biofilm removal

Vickery et al Am J Infect Control 2004;32:170-6.

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Formulation types of surgical cleaners

Neutral pH Detergent (pH 6 – 8) Alkaline pH Detergent (pH 10-12)

Enzymatic Detergent (~Neutral, pH 7-8)

• Single enzyme (e.g., protease or lipase)

• Multi-enzyme (protease, lipase, amylase, cellulase…)

Selecting an Enzymatic Detergent

Water temperatures in

the decontamination

area

Room temperature in the

decontamination area

Useful life and stability of the

product

Expiration date of the product

The material used to construct the

device to be cleaned

Whether it is approved and

registered by the EPA

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The advantages and disadvantages of using enzymes are directly related to their properties:

Module 2 – Enzyme Technology / BiologyMad.com

Characteristics of Enzymes?

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Enzymes and Temperature

• Temperatures above 400C (1400F) can affect chemical reactions

• Cool temperatures may not activate the enzyme

• Monitor water temperature and check manufacturer instructions for specific temperature requirements

Enzymes in Depth

• Enzymes are the biological substance (proteins) that act as catalysts and help complex reactions occur everywhere in life

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Enzymes in Depth

• Factors that affect the strength of an enzyme:

– pH

– Temperature

– Concentration of enzymes

– Concentration of Substrate

• Also a range of temperature in which it will work

– When the temperature drops/cools, activity of enzyme decreases/slows down

– When temperature increases

1. Rate of reaction increases

2. Then decreases

3. Then stops (Denature)

– Most Biological Enzymes work in a temperature of 37°C

Temperature

• Temperature

– Each enzyme has an optimum temperature in which it works the best

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pH

• Most of biological enzymes work in a pH of 7, but there are some exceptions (Pepsin and Trypsin)

• Enzymes are affected by pH and have an optimum pH

• If the pH goes above or beyond the range, the enzyme becomes denatured

Effectiveness of Enzymatic Detergents

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Optimum Enzyme

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CONTENT HOLDER 2


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GET FASTER BLOOD REMOVAL WITH ENZYMATIC DETERGENTS

Complete blood removal with proteases

BLOOD IS THE MAIN AND MOST CRITICAL CONTAMINANT OF SURGICAL INSTRUMENTS AND IT IS USED IN THE INTERNATIONAL STANDARD ISO15883 AS CHOSEN TEST SOIL (TOSI TEST) TO CHECK THE EFFICACY OF

CLEANING PROCEDURES FOR SURGICAL INSTRUMENTATION REPROCESSING

Tim

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Test stopped

Protein fixation of High-Level Disinfectants

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Sterilization Categories

Medical Sterilization Methods – Mehul Patter

Sterilization Comparison Table

Medical Sterilization Methods – Mehul Patter

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Methods for disinfection and sterilization of patient-care items and environmental surfaces

NOTE. Modified from [13], [14], and [17]. AER, automated endoscope reprocessing; EPA, Environmental Protection Agency; ETO, ethylene oxide; FDA, US Food and Drug Administration; GI, gastrointestinal; glut, glutaraldehyde; HP, hydrogen peroxide; PA, peracetic acid; OPA, ortho-phthalaldehyde. a Consult FDA-cleared package inserts for information about FDA-cleared contact time and temperature; see text for discussion of why one product (2% glut) is used at reduced exposure (20 min at 20C). Increasing the temperature by using AER will reduce the contact time (e.g., for OPA, 12 min at 20C, but 5 min at 25C in AER). Tubing must be completely filled for high-level disinfection and liquid chemical sterilization. Compatibility of material should be investigated when appropriate (e.g., HP and HP with PA will cause functional damage to endoscopes

HEALTHCARE EPIDEMIOLOGY • CID 2004:39 (1 September)

Cleaning and sterilization

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Cleaning and sterilization

nobelbiocare.com/sterilization

Characteristics of the main disinfectant groups

Hospital hygiene and infection control

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Common disinfectants used for environmental cleaning in hospitals

Cleaning and High Level Disinfection of Medical Equipment Steps

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Cleaning and High Level Disinfection of Medical Equipment Steps

Steam sterilization with the autoclave

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Gas Sterilization

Ethylene oxide sterilization chamber

Alcohols

Dissolve membrane lipids, denatures proteins.

Used for skin degerming.

Ethanol, Isopropanol

70% concentration -most

effective

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ANSI/AAMI ST79 Section 10 Quality Control

Routine load release Testing of each non-implant and implant load

Routine sterilizer

efficacy monitoring

Establishing a regular pattern of testing the efficacy of

the sterilization process

Sterilizer qualification

testing Testing of the sterilizer after events occur which could

affect the ability of the sterilizer to perform

Periodic product

testing

Testing of routinely processed items to ensure the

effectiveness of the sterilization process and to avoid

wet packs

• Four levels of testing

What is a Cleaning Validation?

• Cleaning: Removal of soil residues.

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Validation Manual Cleaning

GUIDELINE FOR VALIDATION OF MANUAL CLEANING AND MANUAL CHEMICAL DISINFECTION MEDICAL DIVICES annex 9

Cleaning Validation Procedure

• Inoculate the device.

• Organic Soils

• Microorganisms

• Subject device to cleaning procedure.

• Usually with use of water and detergents.

• Extract remaining residues.

• Microbial, protein, hemoglobin, carbohydrate, endotoxin

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Cleaning Monitors: Quality Program

• Ensure Staff competency for Manual cleaning: – initial training verification

– updated for new scopes/instruments

– yearly competency assessment

• Ensure ongoing adequacy of automated washers & manual cleaning: – monitor flexible endoscope lumens

– monitor cleaning of mechanical washers

Frequency of Monitoring??

• Quality Assurance Program: ANSI/AAMI ST79 recommends weekly (preferably daily) monitoring of mechanical washer cleaning efficacy – Site implementation: -Establish site

baseline: initial daily testing of all automated washers for a short period of time-Ongoing each washer tested minimally 1/week

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Cleaning Validation Acceptance Criteria

• Visually Clean

• Microorganisms – minimum of 3-log reduction

• Residual Limits Levels:

• Protein < 6.4µg

• Hemoglobin < 2.2µg

• Carbohydrate < 1.8µg

• Endotoxin < 2.2µg

Chemical indicators for checking cavitation

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amount of blood shown from left to right: 100μg, 10μg, 1μg, 0.1μg, Blind control

1. G. Schrader, G. Görisch : The Limitations of Instrument Cleaning Based on Data Collected on vCJD-Risks Posed by Medical Instrument. Hygiene & Medizin August 2003, 28. Jahrgang S. 306-309

2. Louise M. Edmunds, Andrew Rawlinson: The effect of cleaning on blood contamination in the dental surgery following periodontal procedures. Australian Dental Journal 1998; 43: (5):349-353

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Protein detection methods in manual cleaning

What does a FAIL result indicate?

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Clogged spray

nozzles

Cracked and leaking spray arm

What does a FAIL result indicate?

• Hard water can clog and damage pipes and ultimately cause leaks.

• Calcium build-up in the washer could immobilize spray arms.

• Debris from surgical instruments can accumulate in the washer and eventually end up in spray nozzles.

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What does a FAIL result indicate? Chemical delivery problems

Crack in tubing

Plugged or kinked delivery tubing or expired

detergents

Leaky pump tubing

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Quality control for cleaning

Visual inspection

Fluorescent powder and fluids with Ultra Violet light

Test Object Surgical Instruments (TOSI)

Test object for hollow instruments

Test object for flexible endoscopes

Protein Test

The Sterile Supply Cycle : Cleaning, Jan Huys 2004

Quality improvement program cycle

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