Follow the Yellow Brick Road…….an overview of AAMI
standards
7 June 2011 - MHCSMACathy Rocco, RN, MSN, CNOR
Senior Clinical Education Consultant
&
AAMI
The Association for the Advancement of Medical Instrumentation (AAMI), founded in 1967, is a nonprofit, international membership organization dedicated to improving the safety and efficacy of medical instrumentation and healthcare technologies
AAMI is the recognized developer of medical device standards worldwide – managing over 150 technical committees and publishing more that 100 technical documents
Offers guidance on all sterilizers, wrapping, containers, weight limitations, and practices
AAMI
AAMI is the nation's premier developer of standards on the safety, performance, and marketability of medical devices
The Association is also a strong voice on regulatory policies and healthcare reform decisions that affect its industry
AAMI Standards have a major impact on the practice of sterilization in healthcare facilities
American National Standards Institute (ANSI)
Formed in 1918 from 5 engineering societies and 3 government agencies
Coordinates U.S. standards with international standards so that American products can be used worldwide
Does not develop standards – accredits the procedures for openness, balance, consensus and due process
TIR (Technical Information Report)
A TIR is not subject to the same formal approval process as a standard
Another difference is that, although both standards and TIRs are periodically reviewed, standards are either reaffirmed, revised or withdrawn usually every 5 years but at least by 10 years, TIRs every 5 years
If information is not useful, the TIR is removed from circulation as it addresses a rapidly evolving field or technology, readers are cautioned to ensure that they have also considered information that may be more recent than the document
page 5
AAMI’s Membership
Industry representatives
Government agency representatives (FDA)
Individuals/Users
Students
Statewide biomedical societies
Professional organizations (AORN, APIC, SGNA)
Follow the yellow brick road….
Objectives
1. To increase the awareness and understanding of specific AAMI standards as they relate to activities found in the perioperative arena and endoscopy centers
2. To assist in identifying those standards that can assure compliance with established regulations.
page 7
Follow the yellow brick road…..
Standards vs guidelines
Key points for OR
Key points for SPD
Key points for GI
Spaulding classification
High-level disinfection
Environmental concerns
Chemical/biological indicators
page 8
………a few Standards
ANSI/AAMI ST79:2010
Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities
ANSI/AAMI ST58:2005/(R) 2010
Chemical sterilization and high-level disinfection in healthcare settings
page 9
….a few more Standards
ANSI/AAMI ST77:2006
Containment devices for reusable medical device sterilization
ANSI/AAMI ST81:2004/(R)2010
Sterilization of medical devices – information to be provided by the manufacturer for the processing of resterilizable medical devices
AAMI TIR 34:2007
Water for the reprocessing of medical devices
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“A standard or recommended practice is an important REFERENCE in responsible decision making, but it should never REPLACE responsible decision making.” (AAMI Introduction)
page 11
Terms
Shall – indicates requirements to be followed strictly to conform to the standard
Should – indicated that among several possibilities one is recommended as particularly suitable but does not exclude others
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Terms (continued)
May – used to indicate that a course of action is permissible within the limits of the standard
Can – is used as a statement of possibility and capability
Must – is used only to describe “unavoidable” situations including those mandated by government regulation
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Example (MAY) ST79 8.9.1
“Sterility maintenance covers (dust covers) MAY be used to protect and extend the shelf life of properly packaged and sterilized items that could be subjected to environmental challenges or multiple handling before use.”
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Example (SHALL) ST79 Annex H
“Employers SHALL ensure that employees wash hands immediately or as soon as feasible after removal of gloves or other personal protective equipment.”
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Example (SHOULD & CAN) ST79 7.5.9.
“Rigid container systems SHOULD be cleaned carefully before sterilization even if they are to be returned immediately to use.”
“Container systems CAN be cleaned by either manual or mechanical means.”
page 16
Example (MUST) – ST79 7.5.9
“Personnel who manually clean containers and contaminated contents of containers MUST wear appropriate PPE for the task they are performing.”
page 17
ANSI/AAMI ST79:2010 and A1:2010
Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities
page 18
History of ST79 Replaced (2006)
ST46 – Steam sterilization & sterility assurance
ST37 – Flash sterilization
ST42 – Tabletop sterilization
ST33 – Guidelines for rigid reusable containers
ST35 – Safe handling of biological decontamination
page 19
ST79 – What Does it Address?
Selection and use of rigid containers: how to evaluate them and biologically test them in your facility
Use of flash sterilization containers, including how to perform biological testing
Biological testing of steam sterilizers, including recommendations for routine monitoring, implantable devices, and testing after major repairs and installation or relocation of sterilizers
Classification, selection, and use of chemical indicators and integrators
page 20
ST79 Continued
Steam quality and purity
Prevention of wet packs
Selection of packaging materials, including proper set configuration and wrapping techniques
Correct loading and unloading of steam sterilizers
Product testing
page 21
Quality Monitoring of the Sterilization Process
Physical, chemical and biological monitors are all part of a quality monitoring program
Physical monitors:
printouts
gauges
digital readings
graphs
page 22
Chemical Indicators
Class 1 – Process indicator
Class 2 – Bowie-Dick
Class 3 – Single variable indicator
Class 4 – Multiple variable indicator
Class 5 – Integrating indicator
Class 6 – Emulating indicator
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Class 6 Emulating Indicators
“Class 6 emulating indicators are designed to react to all critical variables of specified sterilization cycles, they do not directly measure the lethality of a cycle and they are not intended to be used as the sole means of routinely verifying sterilizer efficacy or of qualifying sterilizer performance after installation, repair, or relocation”. (10.5.3.2)
page 24
Chemical Indicators – Class 6
Cycle verification indicator designed to react to all critical variable of specified sterilization cycles
- One for each cycle – labeled with specific time and temperature
- Not interchangeable – use only in cycle for which its is labeled
- Suited for prion cycle (outside of the US)
- Relatively new to the U.S. market
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Chemical Indicators – Class 6
“At this time, there are no commercially available PCDs containing a BI and a Class 6 emulating indicator, and there are no guidelines on how health care personnel can create or verify one. (10.5.4)”
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Chemical Indicators
Center of every package
Each level of multi-layer containers
Opposite corners of rigid containers
(AORN 2011 Recommended Practices)
page 27
Monitoring - Sterilizer Efficiency (ST79)
“If a steam sterilizer is designed to be used for multiple types of cycles then each sterilization cycle type used should be tested. If a sterilizer will run the same type of cycle (e.g., dynamic-air-removal at 132 degrees C to 135 degrees C (270 – 275 F) for different exposure times, e.g., four (4) minutes and 10 minutes, then only the shortest cycle time needs to be tested. (10.8.1)”
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Pouches
“Paper or plastic pouches are not appropriate for use within wrapped sets or containers (8.3.4.)”
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Double Peel Pouching
“Double packaging in paper–plastic pouches should not be performed without documentation from the manufacturer that the paper–plastic pouch has been validated for this use (8.3.4.)”
page 30
Instruments with Lumens
“Moisture should not be added to any lumen prior to sterilization unless recommended by device manufacturer
- moisture could restrict diffusion
- if moisture indicated, should be with distilled or deionized water (8.3.8)”
page 31
Drying Before Sterilization
“After chemical disinfection, the medical device should be thoroughly rinsed of all chemicals and then dried before undergoing sterilization. Any chemical residues left on a medical device could affect the sterilization process and potentially harm the patient or personnel.” (7.6.2.1)
“Excess moisture from cleaning and rinsing should be removed using filtered, medical-grade, compressed air. (8.4.1)
page 32
Labeling Packages
“If a marking pen is used to label paper-plastic pouches, the labeling information should be written only on the plastic side of the pouch. If a marking pen is used to label wrapped packs, basins, instruments, or other surgical supplies, the ink should be nontoxic, and the labeling information should be written on the indicator tape or affixed labels (8.3.2)”
page 33
Temperature
General work areas should have a temp controlled between 20°C and 23°C (68°F and 73°F)
Decontamination area should have a temp controlled between 16°C and 18°C (60°F and 65°F)
Temperature in sterilization equipment access rooms should be controlled between 24°C and 29°C (75°F and 85°F)
(e.g., toilets, showers, locker rooms) may be as high as 24°C (75°F) (3.3.6.5)
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Air Exchanges
“American Institute of Architects (AIA) (2006) recommends four air exchanges per hour in the preparation and packaging area. However, an air exchange rate of 10 air exchanges per hour was judged by the AAMI committee to be more appropriate because the preparation and packaging area is contiguous with the sterilizer loading area, where the recommended air exchange rate is 10 air exchanges per hour.(3.3.6.4)”
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ST79 - The Very Latest
November 2010 meeting working group for ST79 voted to adopt a multi-society position statement on “Immediate-use steam sterilization”
Statement arose out of multiple questions related to the “Update:The Joint Commission’s Position on Steam Sterilization”
(www.aami.org)
page 36
Annexes of ST79
Workplace design
Infection transmission
Processing CJD items
Cleaning processes
Use of chemical disinfectants
Release of implants
Steam quality
Occupational exposure
Development of the 16 towel PCD
Toxic Anterior Segment Syndrome
page 37
Impact of Improper Cleaning
Toxic anterior segment syndrome (TASS)
“Can be associated with specific products such as contaminated balanced salt solution, detergent residues, endotoxin, denatured ophthalmic viscoelastic devices (OVDs), preservatives, foreign matter, and residues from sterilization processes
Particular care must be taken in the processing of intraocular surgical instruments to ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.”(ST79, annex N & TIR 34) Covered under ST79 – Annex N and also TIR 34.
page 38
ANSI/AAMI ST58:2005/(R) 2010
Chemical sterilization and high-level disinfection in healthcare settings
page 39
Biological Monitors – True Test of a Sterilizer
Steam –
BI – Geobacillus stearothermophilus, PCD must contain a BI, may also contain a CI
Weekly, preferable daily, full load
Flash – empty chamber – PCD is the tray
ETO –
BI – Bacillus atropheus
Every load in PCD
page 40
Biological Indicators (continued)
Hydrogen Peroxide Gas Plasma
BI – Geobacillus stearothermophilus
Daily, preferably every load
Ozone
BI – Geobacillus stearothermophilus
Daily, preferably every load
page 41
LCS/HLD – Liquid chemical sterilant/high-level disinfection
Chemical sterilants can be classified into two basic categories
1. LCSs/HLDs in which the items to be processed are immersed manually or processed in an automated system under defined conditions; and
2. Gaseous chemical sterilants that are used in a sterilizer under defined cycle conditions
page 42
Sterilization and Disinfection
Three categories/classifications of devices
Spaulding Classification determines when to sterilize and when to disinfect
Classifications – critical, non-critical and semi-critical
page 43
Classes of Medical Devices
There are 3 FDA regulatory classifications of medical devices: Class I, Class II and Class III. The classifications are assigned by the risk the medical device presents to the patient and the level of regulatory control the FDA determines is needed to legally market the device.
page 44
Class I Medical Device
Class I medical devices have the least amount of regulatory control. Class I devices present minimal potential harm to the patient. Class I devices are typically simple in design, manufacture and have a history of safe use. Examples include tongue depressors, arm slings, and hand-held surgical instruments.
page 45
Class II
Class II medical devices are devices where General Controls are not sufficient to assure safety and effectiveness and existing methods/standards/guidance documents are available to provide assurances of safety and effectiveness.
Class II -Examples include physiologic monitors, x-ray systems, gas analyzers, pumps, and surgical drapes, container systems, sterilizers.
page 46
Class III
Class III medical devices have the most stringent regulatory controls.
Examples of Class III are heart valves – those devices that support or sustain human life.
page 47
Liquid Chemical Sterilants
“Liquid chemical sterilants are most often used for high-level disinfection of semicritical medical devices or for sterilization of critical or semicritical medical devices that are not amenable to physical sterilization processes (e.g., steam, dry heat, radiation) or gaseous chemical sterilization processes (e.g., EO, hydrogen peroxide gas plasma, ozone). (5.2)”
page 48
High-Level Disinfection
Earle Spaulding developed a classification system looking at how devices were used and what impact they had on transmitting infections.
Defined in 1968, still used today
Noncritical devices
Semi-critical devices
Critical devices
page 49
Noncritical Devices
Contact intact skin only
May be cleaned with a detergent or disinfected with a low level disinfectant
Examples: blood pressure cuffs, tables
page 50
Semi-critical Devices
Contact intact mucous membranes, do not penetrate body surfaces
Require high-level disinfection or sterilization
Examples: cystoscopes, respiratory therapy equipment, anesthesia equipment, bronchoscopes, GI endoscopes
page 51
Critical Devices
Introduced into bloodstream or other normally sterile areas
Risk of infection high
Sterilization is required
Examples: surgical instruments, biopsy forceps, laparoscopes, cardiac and urinary catheters
page 52
Did you know that………?
Discrepancies within guidelines exist!
For example – a cystoscope – is considered a semi-critical device yet…..needs to be sterile….when?
On the sterile back table, but once it enters through the urethra – should never be placed back onto a sterile area.
page 53
How often should flexible devices be processed even if they aren’t used?
According to AAMI – no set times
AORN Recommended Practices - “Flexible endoscopes should be reprocessed before use if unused for more than five days.” (2009 – Cleaning and Processing Endoscopes)
Urological Association – White Paper (2009) – Flexible cystoscopes that undergo HLD and then are stored overnight should repeat HLD prior to use.
page 54
How often should flexible devices be processed even if they aren’t used?
According to the multi-society guideline for reprocessing flexible gastrointestinal endoscopes –
“Although reuse within 10 to 14 days appears to be safe, the data are insufficient to provide a maximal duration for use of appropriately cleaned, reprocessed, dried and stored flexible endoscopes. (2011)”
page 55
Containment area/Traffic Control
“The space used for cleaning/decontamination should be separate from the space used for chemical sterilization or high-level disinfection of medical devices, and these spaces should be separate from patient procedure areas and personnel support areas (3.2).
Traffic in all areas in which decontamination, preparation and packaging, high-level disinfection and sterilization, sterile storage, and distribution are carried out should be restricted to authorized personnel.(3.3)”
page 56
Decontamination and Preparation of Instruments
“Detailed section - Disposable items that have been opened or that have damaged packaging should be discarded; such items should not be reprocessed by the healthcare facility.
NOTE—Unused items returned from the OR or other areas with controlled environments should be transported on a clean closed or covered cart and should not enter the decontamination area. (6.3.2)”
page 57
Transporting Contaminated Items
“Immediately after use, items should be kept moist in the transport container by adding a towel moistened with water (not saline) or a foam, spray, or gel product specifically intended for this use. Transporting contaminated items in liquid should be avoided; if items are soaked in water or an enzymatic solution at the point of use, the liquid should be discarded by properly attired personnel before transport. (6.3.4)”
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Device Manufacturer’s Responsibility
“Device manufacturers have the responsibility to provide complete and comprehensive written instructions for the decontamination of their products, as well as a summary and interpretation of test results verifying that their products can be safely and effectively decontaminated. (6.5.1.d)”
page 59
Cleaning Agents
“Fibrin filaments in coagulated blood pack themselves into microscopic irregularities in the surface of instruments and have to be mechanically scrubbed away or chemically treated in order to be removed. High pH detergents, enzymatic cleaning solutions, mechanical scrubbing, and high pressure water spray perform this function. Neutral pH detergents do not dissolve fibrin filaments but work well in combination with enzymatic cleaning solutions. (6.5.4.2)”
page 60
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)”
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Annexes
Annex A – Microbial lethality, material compability
Annex B – Glutaraldehyde
Annex C – Hydrogen Peroxide solutions
Annex D – ortho-phthaladehyde
Annex E – Peracetic acid-hydrogen peroxide
Annex F – Sodium hypochlorite
Annex G – Chemical vapor sterilants using alcohol and formaldehyde
page 62
Annexes (continued)
Annex H – Hydrogen peroxide gas plasma sterilization
Annex I – Ozone sterilization
Annex J – Government regulations
Annex K – Occupational exposure
Annex L – User verification of cleaning process
Annex M – Example of documentation of premature release of implants
Annex N - Bibliography
page 63
ST77 – Weight of Containments (Filled)
“The combined weight of the containment device, the instruments, and any accessories or wrappers shall not exceed 25 pounds when the containment device load is configured according to the manufacturer’s instructions.(4.3.5)”
page 65
Rigid Container Systems
Vary in design, mechanics, and construction materials
Ongoing instruction and in-service education help ensure the effective use of rigid sterilization container systems
page 66
Container Systems
“Containment devices shall allow for decontamination of the containment device itself and its reusable accessories by means of either a manual or automated method. If reusable accessories are intended by the manufacturer to allow for decontamination of specific instrumentation within the accessory, then the accessory shall be validated for this purpose, and appropriate instructions shall be provided to the user. (4.3.2)”
page 67
Evaluation of Container Efficacy
“Specific recommendations shall be made, in the instructions for use, regarding the type, placement, internal stacking (if applicable), and loading of items in the containment device for each different sterilization process. If weight, size, or other limitations of items affect sterilization efficacy within the containment device, the limitations shall be stated. (4.4.1.1)”
page 68
Rinsing Water – Critical Medical Devices
“Medical devices that are critical, should be sterilized unless there are parts that cannot withstand the rigors of sterilization, in which case high-level disinfection may be used (FDA, 2006a). In addition, FDA recommended that sterile water—not tap water—should always be used to rinse such devices after high-level disinfection. (3.2.2)”
page 70
TASS
“Toxic anterior segment syndrome (TASS) is an inflammatory reaction in the eye that may lead to permanent loss of vision after cataract surgery as a result of adverse reaction to organic or inorganic matter introduced into the anterior chamber of the eye.
Manufacturers of ophthalmic surgical instruments recommend that devices used for cataract surgery be thoroughly rinsed with sterile distilled water before sterilization. (3.2.3.1)”
page 71
pH of Water
“The pH of water used in device reprocessing can directly affect the medical device by causing pitting or corrosion.
The pH can also indirectly affect the device by interfering with the effectiveness of the detergents (especially enzymatic detergents), disinfectants, or sterilants used in reprocessing (i.e., the water pH is not compatible with the detergent, disinfectant, or sterilant). (3.2.3.4)”
page 72
Hardness of Water
“Hard water is caused by the presence of dissolved salts (typically calcium and magnesium) that deposit as hard mineral layers (lime-scale) when the water is heated or evaporated. Very hard water can decrease the effectiveness of most detergents and disinfectants; for example, components of hard water bind with detergent surfactants, preventing them from dispersing soils. Very hard water can also adversely affect the performance of medical washers. (3.2.3.5)”
page 73
ANSI/AAMI ST81:2004/(R)2010
Sterilization of medical devices – information to be provided by the manufacturer for the processing of resterilizable medical devices
page 74
ST81
“This standard applies to those medical devices which are intended for multiple use and require processing to take them from their state at the end of one use to the state of being sterile and ready for their subsequent use”
- Preparation, cleaning, disinfecting
- Drying
- Inspecting, maintenance and testing
- Packaging, sterilizing, and storage
page 75
Sterilization Modalities (A-1 Table)
Sterilization Moist heat (preferred method)
a) Gravity displacement
b) Dynamic air-removal
Ethylene oxide (ETO)
Dry heat
Liquid sterilant
H2O2 gas plasma
page 76
ST81
“At least one validated method for reprocessing the medical device shall be specified.”
page 77
References
Perioperative Standards and Recommended Practices. Association of periOperative Registered Nurses. AORN Standards, Recommended Practices, and Guidelines, 2009
Association for the Advancement of Medical Instrumentation. Sterilization Edition, 2010
Society of Gastroentrology Nurses and Associates, Inc. Standards of infection control in reprocessing of flexible gastrointestional endoscopes, 2009
page 78
References
American Urological Association Education and Research, Inc. and the Society of Urologoic Nurses and Associates, Joint AUA/SUNA White Paper on Reprocessing of Flexible Cystoscopes, 2009
Multi-society guideline for reprocessing flexible gastrointestinal endoscope. Position statement. Volume 73, No 6: 2011
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