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What’s That Sign? Signs and Symbols for Sterile Processing
What’s That Sign? Signs and Symbols for Sterile Processing
Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT
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SEAVEY HEALTHCARE CONSULTING® STERILE PROCESSING SURGICAL SERVICES .
Established in 2003
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Learning Objectives
• Explain the need for multiple signs and symbols in medical device labeling.
• Describe the meaning behind symbols found on medical device packaging, instruments, and equipment.
• List resources available that help identify the requirements and definition for commonly used symbols.
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What’s That Sign? Signs and Symbols for Sterile Processing
Objective 1
Explain the need for multiple signs and symbols in medical device labeling.
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Why So Many Symbols?
Worldwide marketing Communicate important information globally
• Internationally recognized symbols
• Graphics
• Pictograms
• Icons
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What’s That Sign? Signs and Symbols for Sterile Processing
Many Languages
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Easily Defined?
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What’s That Sign? Signs and Symbols for Sterile Processing
Countless Symbols
• Applicable to a broad spectrum of devices
• Can be found On the device itself
On the package
In the associated documentation such as instructions for use (IFU)
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What’s That Sign?
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What’s That Sign? Signs and Symbols for Sterile Processing
What’s That Sign?
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ANSI/AAMI/ISO 15223-1:2012
Medical devices – Symbols to be used with medical device labels, labeling, and information to be supplied –
Part 1: General requirements
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What’s That Sign? Signs and Symbols for Sterile Processing
Who Is ANSI?
• American National Standard InstituteOrganization
• Officially represents the U.S. in international standards setting
• Coordinates the development and promotion of all U.S. standards
• Approves AAMI standards as American National Standards
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Who Is AAMI
Association for the Advancement of Medical Instrumentation
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What’s That Sign? Signs and Symbols for Sterile Processing
Purpose of AAMI
• Assist healthcare professionals and industry in U.S. and abroad with the: Use
Acceptance
Advancement of medical technology
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AAMI Organization
• Nonprofit organization
• Founded in 1967
• Nearly 6,000 members around the world
• Common goal of members Increase understanding and beneficial use of
medical instrumentation
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What’s That Sign? Signs and Symbols for Sterile Processing
AAMI Organization
• Recognized as one of the foremost voluntary standards-setting organizations in the U.S.
• AAMI Standards and Recommended Practices represent a national consensus
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International Organization for Standardization (ISO)
• Founded in 1947
• Develop and publish international standards through global consensus Help to break down barriers to international trade
• Publish more than 19,500 International Standards in aspects of technology and business Food safety Computers Agriculture Healthcare
http://www.iso.org/iso/home.htm
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What’s That Sign? Signs and Symbols for Sterile Processing
Harmonized Standards
• So far, only a few AAMI standards developed for medical device manufacturers have been harmonized with ISO
• Why?Healthcare facilities standards have not been
harmonized because of major differences in sterilization practices between the U.S. and parts of Europe
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Harmonized Standard Example
ANSI/AAMI/ISO 11140-1:2005/(R)2010
Sterilization of health care products-Chemical Indicators-Part 1: General requirements
• Specifies performance requirements for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances
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What’s That Sign? Signs and Symbols for Sterile Processing
Harmonized Standard Example
ANSI/AAMI/ISO 15223-1:2012 Medical devices –Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
• Identifies requirements for the development and use of symbols that may be used to convey information on the safe and effective use of medical devices.
• It also lists symbols that satisfy the requirements of this part of ANSI/AAMI/ISO 15223.
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Terms and DefinitionsSection 3
3.2 descriptionnormative text which defines the purpose, application, and use of the symbol
3.3 labelwritten, printed, or graphic information provided upon the medical device itself
3.5 symbol used in medical device labelinggraphical representation appearing on the label and/or associated documentation of a medical device that communicates characteristic information without the need for the supplier or receiver of the information to have knowledge of the language of a particular nation or people
ANSI/AAMI/ISO 15223-1:2012 Medical devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
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What’s That Sign? Signs and Symbols for Sterile Processing
Section 4.2
Requirements for usage
• Symbols shall comply with graphical ISO 7000 with respect to dimensions, line thickness, orientation, and shaded areas. (Table 1 symbol graphics)
• Important that symbols are used properly. (Annex B guidance on usage)
• Manufacturer shall ensure that no additional risk is incurred by using symbol.
ANSI/AAMI/ISO 15223-1:2012 Medical devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
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Objective 2
Describe the meaning behind symbols found on medical device packaging,
instruments, and equipment.
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What’s That Sign? Signs and Symbols for Sterile Processing
Requirements for Usage
Section 4.2
“When risk management shows it to be appropriate for symbols to be used to convey information essential for proper use on the medical device, on its package or in associated documentation, the symbols given in Table 1 may be used.”
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ANSI/AAMI/ISO 15223-1:2012 Medical devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
3/6/2014 © 2014 Association for the Advancement of Medical Instrumentation www.aami.org
Table 1
Symbols to Convey Information Essential for Proper Use
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Symbols categorized in sections
5.1 Manufacturer
5.2 Sterility
5.3 Storage
5.4 Safe Use
5.5 IVD (in vitro diagnostic)
5.6 Transfusion
5.7 Other
ANSI/AAMI/ISO 15223-1:2012 Medical devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
3/6/2014 © 2014 Association for the Advancement of Medical Instrumentation www.aami.org
What’s That Sign? Signs and Symbols for Sterile Processing
Table 1
Symbols to Convey Information Essential for Proper Use
Reference number or symbol
Title of symbol
Description of symbol
Requirements
Informative notes
Restrictions for use
Additional requirements
ISO7000 Reg. no
5.2 Sterility
5.2.1 Sterile Indicates a medicaldevice that hasbeen subjected to asterilization process.
NOTE Use of thissymbol precludes the use ofsymbols 5.2.2 to 5.2.5.
In Europe, this symbol isrestricted to use onterminally sterilized medicaldevices (4.1 ofEN 556-1:2001 applies,including its associatednote).
2499
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ANSI/AAMI/ISO 15223-1:2012 Medical devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
3/6/2014 © 2014 Association for the Advancement of Medical Instrumentation www.aami.org
Manufacturer Symbol Examples
Date of Manufacturer• Accompanied the date of manufacture
• Date located adjacent to the symbol• Expressed as:
• Four digits for the year, and where appropriate,
• Two digits for the month, and
• Two digits for the day.
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2005
2005-09-15
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What’s That Sign? Signs and Symbols for Sterile Processing
Manufacturer SymbolsUse by date
Accompanied by a date devices should be used by
Batch code (lot number) ABC123Accompanied by the manufacturers batch code
Catalog number ABC123
Accompanied by the catalog number
Serial number (specific identification for medical device)Accompanied by the serial number ABC123
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2005-09-15
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Storage Environment Limitations Examples
Keep away from sunlight (or heat)• Indicates a medical device that needs
protection from light sources.
Protect from heat and radioactive sources (or sunlight and radioactive sources)
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What’s That Sign? Signs and Symbols for Sterile Processing
Storage Environment Limitations
Keep dry (or away from rain) • Indicates a medical device that needs to be
protected from moisture.
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Storage Environment Limitations
Humidity limitations• Limits of humidity are indicated
adjacent to the horizontal lines.
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90%
10%
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What’s That Sign? Signs and Symbols for Sterile Processing
Storage Limitations
Atmospheric pressure limitations• Indicates the range of atmospheric
pressure to which the medical device can be safely exposed.
kPa - Kilopascals. A metric unit used to measure pressure. 1 Kilopascal equals 1000 pascals, and approximately 0.1450 psi.
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106 kPa
50 kPa
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Storage Temperature Limitation Examples
• Lower limit of temperature
• Upper limit of temperature
• Upper and lower temperature limitations
Limits of temperature are indicated adjacent to the horizontal lines
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90oF32oF
20oF
100oF
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What’s That Sign? Signs and Symbols for Sterile Processing
Safe Use Examples
• Do not re-use Indicates a medical device that is intended for one use, or for
use on a single patient during a single procedure.
• Synonyms for:• Single use
• Use only once
• Do not resterilize Indicates a medical device that
is not to be resterilized.
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Safe Use Examples
• Single patient useUse indicated for one patient only
No multiple patient use
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What’s That Sign? Signs and Symbols for Sterile Processing
Sterility ExamplesPackage Cautions
Do not use if package is damaged• Device should not be used if the package has been
damaged or opened.
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Sterility ExamplesPackage Cautions
Non-sterile• Device has not been subjected to a sterilization
process. Used to distinguish between devices sold in sterile and non-
sterile conditions.
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What’s That Sign? Signs and Symbols for Sterile Processing
Biological and Biohazard
Biological Risk• Indicates that there are potential biological risks associated
with the medical device
• This symbol is not to be confused with the “Biohazard” sign intended to be used in the workplace.
• Use eye protection.
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Sterility Examples
• Sterilized using aseptic processing techniques
• Sterilized using ethylene oxide
• Sterilized using irradiation
• Sterilized using steam or dry heat
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What’s That Sign? Signs and Symbols for Sterile Processing
Sterility Examples
• Sterilizable up to the temperature specified
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Cautions and IFU Examples
• Caution, consult accompanying documents Information needed for the proper use of the device
• Consult instructions for use (operating instructions) Information needed for the proper use of the device
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What’s That Sign? Signs and Symbols for Sterile Processing
Storage Caution Examples
• Fragile, handle with care Indicates a medical device that can
be broken or damaged if not handled carefully.
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Packaging Examples
• CE mark Product conforms with the essential requirements
in the European Medical Devices Directive 93/42/EEC.
• Do not open packaging using a knife/blade
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What’s That Sign? Signs and Symbols for Sterile Processing
Packaging Examples
• Recyclable
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Safe Use Examples
• Contains or presence of natural rubber (latex) Indicates the presence of natural rubber (not
synthetic rubber) or dry natural rubber latex as a material of construction within the medical device or the packaging of a medical device.
• Product does not contain natural rubber (latex)
• Latex Free
• Irritant – May cause inflammation to the skin or other mucous membranes
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IRRITANT
LF
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What’s That Sign? Signs and Symbols for Sterile Processing
Safety Signs
• No Pushing
• No sitting
• No stepping on surface
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Safety Symbols
Product must be collected separately. Do not dispose of as unsorted municipal waste. Contact local distributor for disposal information.
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What’s That Sign? Signs and Symbols for Sterile Processing
Safety Symbols
• Warning electricity
• Dangerous voltage
• Emergency stop
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Dentistry equipment
• Dental turbine air motor with illumination
• Dental turbine low voltage electric motor with illumination
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ANSI/AAMI/IEC TIR60878:2003 Graphical symbols for electrical equipment in medical practice
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What’s That Sign? Signs and Symbols for Sterile Processing
Dentistry equipment
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• Water-cooling
• Air-cooling
ANSI/AAMI/IEC TIR60878:2003Graphical symbols for electrical equipmentin medical practice
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IVD–Specific Examples
• In vitro diagnostic medical device Intended to be used as an in vitro diagnostic medical device.
In vitro diagnostics are tests that can detect diseases, conditions, or infections. Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home. FDA
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What’s That Sign? Signs and Symbols for Sterile Processing
IVD–Specific Examples
• Control material intended to verify the performance characteristics of another medical device.
• Control intended to verify the resultsin the expected negative range.
• Control intended to verify the resultsin the expected positive range.
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Transfusion/Infusion Examples
• Sampling site (processing application)(Not the site on the patient where samples are taken)
• Fluid path Indicates the presence of a fluid path.
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What’s That Sign? Signs and Symbols for Sterile Processing
Transfusion/Infusion Examples
• Non-pyrogenic Indicates a medical device that is non-pyrogenic
(Pyrogen - a fever-producing substance)
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Transfusion/InfusionExamples
• Drops per milliliter20 is the example – replaced by appropriate
number of drops
• Liquid filter with pore sizeContains a filter of a particular nominal
pore size• 15 is the example used
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What’s That Sign? Signs and Symbols for Sterile Processing
Transfusion/InfusionExamples
• One-way valveAllows flow in only one direction
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Other Example
• Patient number• Indicates a unique number associated
with an individual patient
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What’s That Sign? Signs and Symbols for Sterile Processing
Other Example
• Substitute for…
• Replaces …
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Objective 3
List resources available that help identify the requirements and definition for
commonly used symbols.
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What’s That Sign? Signs and Symbols for Sterile Processing
ISO Symbols Are Everywhere
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http://www.iso.org/iso/graphical-symbols_booklet.pdf
The international language of
ISO graphical symbols
ISO graphicalsymbols help us every day.
Find out how!
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Everyday ISO Symbols and Safety Signs
• Accessible elevator
• Way out or exit
• Evacuation assembly point
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http://www.iso.org/iso/graphical-symbols_booklet.pdf
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What’s That Sign? Signs and Symbols for Sterile Processing
Everyday ISO Symbols and Safety Signs
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• Fire alarm
• Emergency exit
• Hospital
http://www.iso.org/iso/graphical-symbols_booklet.pdf
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Everyday ISO Symbols and Safety Signs
• Slippery surface
• Not drinking water
• No access for persons with pacemakers
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http://www.iso.org/iso/graphical-symbols_booklet.pdf
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What’s That Sign? Signs and Symbols for Sterile Processing
One of my favorite international signs!
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Resources Used• ANSI/AAMI/ISO 15223-1:2012 Medical devices – Symbols to be used with
medical device labels, labeling, and information to be supplied – Part 1: General requirements.
• ANSI/AAMI/ISO 15223-1:2007 and ANSI/AAMI/ISO 15223-1:2007/A1:2008 Medical devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
• ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
• ANSI/AAMI/IEC TIR60878:2003 Graphical symbols for electrical equipment in medical practice
• ISO 11140-1:2005 Sterilization of health care products - Chemical indicators -Part 1: General requirements
• http://www.iso.org/iso/graphical-symbols_booklet.pdf
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What’s That Sign? Signs and Symbols for Sterile Processing
Other Online Resources
• http://media.intersurgical.com/global/documents/support/Symbol_Explanation.pdf
• http://www.champcohen.com/extranet/blog/121211/WarningSymbolsViaChampCohenDesign.pdf
• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085404.htm
• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085404.htm
• http://www.gpo.gov/fdsys/pkg/FR-2013-04-19/pdf/2013-09175.pdf
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New AAMI Documents Being Developed
• New Technical Information Reports (TIR) being developed AAMI TIR54 Human Factors for Medical Device
Reprocessing AAMI TIR55 Endoscope Reprocessing AAMI TIR Standardized Instructions for Use
• TIR is not a recommended practice Review of an important technical issue or healthcare
practice Statement of expert opinion released by a technical
committee
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What’s That Sign? Signs and Symbols for Sterile Processing
Other New AAMI Resources
• Sterile Processing Benchmarks (SPB) Web-based tool
Partner with IAHCSMM
• Sterile Processing In Healthcare Facilities:Preparing for Accreditation Surveys (Rose Seavey)
• Building for the Future: Construction and Renovation of Sterile Processing Facilities (Cynthia Hubbard)
• Leading Practice Integrated Process Flow and Automationin the Modern Central Sterile Supply Department (Mark Duro)
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Questions?
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Type your question in the Q&A box on the left side of your screen and press Enter
What’s That Sign? Signs and Symbols for Sterile Processing
Closing Reminders
• Please be sure to fill out the evaluation form at: http://aami.confedge.com/ap/survey/s.cfm?s=SignsandSymbols
• AAMI is planning the following webinars that may be of interest to you:• May 13: Best Practices in Cleaning and Decontamination
• June 25: Preparing for a Sterile Processing Accreditation Survey
• July 8: Immediate-Use Steam Sterilization (IUSS)
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