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is that, although both standards and TIRs are periodically reviewed, standards are either reaffirmed, revised or withdrawn usually every 5 years but at least by 10 years, TIRs every 5 years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

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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.

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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

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………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

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….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)

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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.”

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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.”

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ANSI/AAMI ST79:2010 and A1:2010

Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities

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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

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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

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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

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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

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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)

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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)

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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.)”

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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)”

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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)

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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)”

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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)

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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

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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.

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ANSI/AAMI ST58:2005/(R) 2010

Chemical sterilization and high-level disinfection in healthcare settings

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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

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Biological Indicators (continued)

Hydrogen Peroxide Gas Plasma

BI – Geobacillus stearothermophilus

Daily, preferably every load

Ozone

BI – Geobacillus stearothermophilus

Daily, preferably every load

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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

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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

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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.

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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.

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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.

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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.

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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)”

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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

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Noncritical Devices

Contact intact skin only

May be cleaned with a detergent or disinfected with a low level disinfectant

Examples: blood pressure cuffs, tables

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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

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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

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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.

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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.

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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)”

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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)”

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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)”

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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)”

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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)”

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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)”

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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

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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

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ANSI/AAMI ST77:2006

Containment devices for reusable medical device sterilization

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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)”

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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

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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)”

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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)”

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AAMI TIR 34:2007

Water for the reprocessing of medical devices

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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)”

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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)”

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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)”

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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)”

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ANSI/AAMI ST81:2004/(R)2010

Sterilization of medical devices – information to be provided by the manufacturer for the processing of resterilizable medical devices

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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

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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

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ST81

“At least one validated method for reprocessing the medical device shall be specified.”

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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

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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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