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Building for the Future: Construction and Renovation of Sterile Processing Facilities, Part III: New Equipment Planning and Staff Development/Training

The third of three presentations, this program discusses the importance of planning and selecting the appropriate equipment mix for a healthcare sterile processing environment.
AAMI Member:
$20.00
List Price:
$35.00
Your Price:
$35.00
Available for Immediate Download
↑/↓ Full Details


Disinfection and Sterilization: Conquering Accreditation Surveys

This presentation is intended to help healthcare professionals prepare for a Joint Commission, Centers for Medicare and Medicaid Services, or other accrediting agency survey as it relates to sterile processing of surgical instruments and other medical devices in healthcare settings.
AAMI Member:
$20.00
List Price:
$35.00
Your Price:
$35.00
Available for Immediate Download
↑/↓ Full Details


eSubscription: All Standards Individual User

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Description Individual user access to nearly 250 comprehensive national and international standards and technical documents covering sterilization, dialysis, biological evaluation of medical devices, quality systems, and medical equipment. Any updates are automatically available on the site. The site provides interactive tools that allow you to search, bookmark, comment and share.
AAMI Member:
$1,395.00
List Price:
$1,955.00
Your Price:
$1,955.00


eSubscription: All Sterilization Individual User

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Description This eSubscription provides access to all sterilization standards and technical documents for hospitals and healthcare facilities, manufacturers and users of sterilization equipment and for manufacturers who ship sterile products.
AAMI Member:
$820.00
List Price:
$1,220.00
Your Price:
$1,220.00


eSubscription: ST79:2017 Individual

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Description Individual user access for eSubscription to the standard ANSI/AAMI ST79:2017. The eSusbcription renews on a 12 month basis.

Reorganized and Easier to Use

ST79 is THE go-to reference for steam sterilization and sterility assurance in all healthcare facilities, regardless of sterilizer or facility size. Developed by industry experts, regulators, and sterilization professionals, ST79:2017 will guide you through every step of the steam sterilization process. The updated standard includes the following:
  • A reorganization of the content to make it easier to use
  • New guidance on setting temperature and humidity parameters
  • New text on following manufacturers' instructions
  • Additional material in the annex about the types of cleaning equipment that may be used in a sterile processing department (SPD)
  • Guidance on the use of ultrasonic cleaners

Use ST79:2017, the best available guidance for steam sterilization and sterility assurance, to help you stay in compliance with accrediting bodies.

To preview this file click here.

AAMI Member:
$346.00
List Price:
$396.00
Your Price:
$396.00


eSubscription: Sterilization in Healthcare Facilities

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Description Individual user subscription to Sterilization in Healthcare Facilities includes 14 sterilization standards and guidance documents, including TIR11, TIR12, TIR30, TIR34, TIR63, ST40, ST41, ST58, ST65, ST79 (plus a new self-assessment tool), ST90, ST91, and PB70.
AAMI Member:
$535.00
List Price:
$749.00
Your Price:
$749.00


Healthcare Sterilization Horizons

This special publication is dedicated to sharing the expertise of sterilization specialists with all healthcare professions. Articles focus on ST79, sterilization monitoring indicators, flash sterilization, extended cycles, cleaning practices, central service certification, and more.
AAMI Member:
$22.00
List Price:
$36.00
Your Price:
$36.00
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Horizons 2012 Spring: Sterilization and Reprocessing

Spring 2012 Horizons: Sterilization and Reprocessing

There is increasing concern that inadequately reprocessed devices are responsible for a host of hospital-acquired infections. “Sterilization and Reprocessing--A Matter of Patient Safety” offers the latest practices, expert advice, and practical tips from manufacturers, regulators, clinicians, sterile processing experts, and other healthcare technology professionals.
AAMI Member:
$22.00
List Price:
$36.00
Your Price:
$36.00
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Horizons 2016 Spring: Sterilization & Reprocessing

Sterilization & Reprocessing: Overcoming Challenges, Safeguarding Patients

AAMI Member:
$22.00
List Price:
$36.00
Your Price:
$36.00
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Industrial Ethylene Oxide Sterilization for Medical Devices Workshop - August 2019

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This highly interactive 3.5-day, advanced course assumes that participants are experienced in working with an established ethylene oxide sterilization process, but are now challenged with ensuring the continued effectiveness and assessing change for the product or process. The program combines classroom lecture with real-life scenarios to illustrate concepts and situational analyses that provide participants with the opportunity to apply what they learn to actual sterilization scenarios. Some of the topics to be covered are: validation and requalification; validation reports, protocols, and documentation; product adoption; troubleshooting; process changes and process equivalency; product release methods; and optimization of sterilization process.

Registration Fees:

  • AAMI Members: $2335
  • Nonmembers: $2635
  • Government Employees: $950

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM
Validation and Requalification
Protocols and Reports


DAY 2 | 8 AM-5 PM
Product Release Methods 
Process Specifications
Troubleshooting

DAY 3 | 8 AM-5 PM
Ethylene Oxide Residuals
Optimization of Sterilization Process


DAY 4 | 8 AM-12 PM
Product Change
Process Changes / Equivalence



 

 

Program Objective

Upon completion of this course, participants will be able to: improve development and routine turn-around time; make changes to product, equipment, process, and sterilizer location; determine if validation or requalification is necessary; troubleshoot cycle anomalies; and optimize the ethylene oxide sterilization process.

 

Target Audience

This course is designed for professionals that have responsibility for making decisions related to the ethylene oxide sterilization process such as introduction of new/modified products, sterilization process improvements, failure investigation, requalification, and validation. AAMI recommends this course for those who are experienced in working with an established ethylene oxide sterilization process and NOT professionals that are new to ethylene oxide sterilization.

 

Format

A combination of situation analyses, case study exercises, and both formal and informal discussions are used throughout the program to provide maximum opportunity for the application of information.

 

Materials

Fee includes presentations, pertinent FDA documents, additional references, and case studies.


Start Date:
Tuesday, August 27, 2019
End Date:
Friday, August 30, 2019
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Address:
AAMI Center for Excellence (ACE)
901 North Glebe Road Suite 300
Arlington, VA 22203
UNITED STATES
AAMI Member
$950.00 - $2,335.00
List Price
$950.00 - $2,635.00


Industrial Sterilization for Medical Devices - May 2019

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Industrial Sterilization for Medical Devices is a comprehensive 4 day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more.

Registration Fees:
  • AAMI Members: $2535
  • Nonmembers: $2835
  • Government Employees: $1050

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM
Introduction
Key Concepts/Definitions
Microbes & Sterilization
Test Method Validation
Inactivation of Microorganisms


DAY 2 | 8 AM-5 PM
Sterile Packagin
Radiation Sterilization - Introduction
Radiation Sterilization - Process
Definition and Dose Establishment
Radiation Exercises
Radiation Sterilization - Product
Definition and Routine Processing 



DAY 3 | 8 AM-5 PM
Moist Heat & Ethylene Oxide Product 
Moist Heat Sterilization
Ethylene Oxide Sterilization



DAY 4 | 8 AM-5 PM
Ethylene Oxide Sterilization
Contract Sterilizers & Laboratories
FDA Perspectives 






 

 

Program Objective

Participants will learn how to apply the principles of sterilization and address requirements during product design. Participants will also determine how to select and implement an appropriate sterilization process and how to identify the elements of a successful sterilization validation. Students will participate in the design of process validation for moist heat, ethylene oxide (EO), and radiation sterilization processes and compare and contrast sterilization cycle developments based on product bioburden and those based on combined bioburden/overkill methods.

 

Target Audience

This program is recommended for professionals relatively new to the sterilization process environment who need information to help them better understand the principles and science of sterilization. This course is designed for design and process engineers, operations managers and technicians, corporate quality assurance and regulatory compliance personnel, or others directly involved in sterilization processes and responsible for meeting industry standards and FDA requirements.

 

Format

This highly interactive program combines classroom lecture with situational analyses that provide participants with the opportunity to apply what they learn to actual sterilization scenarios. In addition, participants will work through a series of case studies illustrating problematic situations. Case studies will cover various aspects and phases of sterilization processes...from design, to cycle development, to validation, to process control, to product release.

 

 

Materials

As part of the course materials, attendees receive copies of standards on the validation and routine control for industrial moist heat sterilization, ethylene oxide sterilization, and radiation sterilization as well as standards and a technical information report on packaging for terminally sterilized devices.


Start Date:
Tuesday, May 14, 2019
End Date:
Friday, May 17, 2019
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
AAMI Center for Excellence (ACE)
901 North Glebe Road Suite 300
Arlington, VA 22203
UNITED STATES
AAMI Member
$1,050.00 - $2,535.00
List Price
$1,050.00 - $2,835.00


Industrial Sterilization for Medical Devices - October 2019

http://my.aami.org/aamiresources/images/events/901-Glebe.jpg

Industrial Sterilization for Medical Devices is a comprehensive 4 day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more.

Registration Fees:
  • AAMI Members: $2535
  • Nonmembers: $2835
  • Government Employees: $1050

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM 
Introduction
Key Concepts/Definitions
Microbes & Sterilization
Test Method Validation
Inactivation of Microorganisms


DAY 2 | 8 AM-5 PM 
Sterile Packagin
Radiation Sterilization - Introduction
Radiation Sterilization - Process
Definition and Dose Establishment
Radiation Exercises
Radiation Sterilization - Product
Definition and Routine Processing 



DAY 3 | 8 AM-5 PM 
Moist Heat & Ethylene Oxide Product 
Moist Heat Sterilization
Ethylene Oxide Sterilization



DAY 4 | 8 AM-5 PM 
Ethylene Oxide Sterilization
Contract Sterilizers & Laboratories
FDA Perspectives 






 

 

Program Objective

Participants will learn how to apply the principles of sterilization and address requirements during product design. Participants will also determine how to select and implement an appropriate sterilization process and how to identify the elements of a successful sterilization validation. Students will participate in the design of process validation for moist heat, ethylene oxide (EO), and radiation sterilization processes and compare and contrast sterilization cycle developments based on product bioburden and those based on combined bioburden/overkill methods.

 

Target Audience

This program is recommended for professionals relatively new to the sterilization process environment who need information to help them better understand the principles and science of sterilization. This course is designed for design and process engineers, operations managers and technicians, corporate quality assurance and regulatory compliance personnel, or others directly involved in sterilization processes and responsible for meeting industry standards and FDA requirements.

 

Format

This highly interactive program combines classroom lecture with situational analyses that provide participants with the opportunity to apply what they learn to actual sterilization scenarios. In addition, participants will work through a series of case studies illustrating problematic situations. Case studies will cover various aspects and phases of sterilization processes...from design, to cycle development, to validation, to process control, to product release.

 

 

Materials

As part of the course materials, attendees receive copies of standards on the validation and routine control for industrial moist heat sterilization, ethylene oxide sterilization, and radiation sterilization as well as standards and a technical information report on packaging for terminally sterilized devices.



Start Date:
Tuesday, October 01, 2019
End Date:
Friday, October 04, 2019
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
AAMI Center for Excellence (ACE)
901 North Glebe Road Suite 300
Arlington, VA 22203
UNITED STATES
AAMI Member
$1,050.00 - $2,535.00
List Price
$1,050.00 - $2,835.00


Industrial Sterilization: Research from the Field

This book presents 11 articles from leading experts on Industrial Ethylene Oxide Sterilization, Microbiological Methods, Steam Sterilization, and Quality Management Systems and Sterility Assurance.
AAMI Member:
$68.00
List Price:
$113.00
Your Price:
$113.00
↑/↓ Full Details


Industrial Sterilization: Research from the Field (PDF)

This book presents 11 articles from leading experts on Industrial Ethylene Oxide Sterilization, Microbiological Methods, Steam Sterilization, and Quality Management Systems and Sterility Assurance. PDF format.
AAMI Member:
$68.00
List Price:
$113.00
Your Price:
$113.00
Available for Immediate Download
↑/↓ Full Details


Investigation of Sterilization Process Failures Video

This 35-minute instructional video provides information essential to the understanding of sterilization process failures.

Earn .5 credit hour CE through CBSPD and IAHCSMM.

The script was written by Rose Seavey, MBA, BS, CNOR, CRCST, CSPDT. It includes practical guidance on:
- Essential elements of sterility assurance
- Product sterilization identification and traceability
- Sterilization process monitoring tools
- Correct actions to take when physical monitors, chemical indicators, or biological indicators indicate a sterilization failure
- Available tools to clarify steps and guide the investigation of sterilization process failures
- Product recall process
- Ways to help prevent sterilization process failures
AAMI Member:
$132.00
List Price:
$220.00
Your Price:
$220.00
↑/↓ Full Details


Personnel Safety in Sterile Processing Departments Video

This 60-minute instructional video provides information essential to the promotion of personnel safety in sterile processing departments.

Earn 1 credit hour CE through CBSPD and IAHCSMM.

The script was written by P. Richard Warburton, PhD, JD; CTO & General Counsel, ChemDAQ, Inc. It includes practical guidance on:
- Legal duties and who's who among the relevant regulatory agencies and professional organizations
- Common hazards encountered in the sterile processing department
- Bloodborne pathogens and infection prevention
- Proper selection, use, and disposal of personal protective equipment (PPE)
- Relevant standards that pertain to the use of PPE, steam and chemical sterilization, and ethylene oxide
- Safe storage, handling, and disposal of contaminated items and chemical agents
- Key elements of engineering controls that promote safe handling of sterilants and high-level disinfectants
- Appropriate labelling of chemicals
- Responsibilities of employers and staff in preventing, managing, and reporting accidents in the workplace
AAMI Member:
$132.00
List Price:
$220.00
Your Price:
$220.00
↑/↓ Full Details


Radiation Sterilization for Medical Devices - November 2019

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This 3.5-day program covers principles, processes, industry best practices, and industry standards in radiation sterilization for medical devices. Some of the topics covered are: FDA expectations regarding successful submissions and inspections, recalls, problem solving, and risk avoidance; scientific theory and principles of radiation sterilization; and the 11137 series radiation sterilization standards.

Registration Fees:

  • AAMI Members: $2335
  • Nonmembers: $2635
  • Government Employees: $950

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM
Overview of ANSI/AAMI/ISO 11137-1
Microbiological Quality Tests
Gamma - Design & Operation
e-Beam & X-Ray
SAL
FDA Perspective Part 1



DAY 2 | 8 AM-5 PM
Process Definitions
Dosimetry
FDA Perspective Part 2


DAY 3 | 8 AM-5 PM
Sterilizer Equipment Validation
Maintenance of Validation
Routine Processing
FDA Perspective Part 3
Process Definition Sterilization Doze Method



DAY 4 | 8 AM-12 PM
Contract Sterilizers & Laboratories
Maintenance of Validation - Equipment
Changing Radiation Sterilization and/or Manufacturing Sites
FDA Perspective Part 4






 

 

Program Objective

Participants will understand FDA expectations regarding successful submissions and inspections, recalls, problem solving, and risk avoidance and scientific theory and principles of radiation sterilization. The course examines the global ANSI/AAMI/ISO 11137 series on radiation sterilization standards. Participants will learn integration of industry standards with the Quality System regulation, auditing processes for contract laboratories and sterilizers, and radiation sterilization processing, including safety precautions, characteristics, constraints, and impact of radiation operations


Target Audience

This course is for professionals currently working in or with sterilization processes, particularly related to radiation sterilization. This includes design and process engineers, manufacturing and operations managers, and members of research and development or new product development teams. For participants to gain the maximum benefit from this course, it is recommended they have a working knowledge of general sterilization principles.

 

Format

This course is designed to be highly interactive between faculty and participants and will include relevant real-life examples and “hands-on” exercises from a broad spectrum of medical device products.

 

Materials

Fee includes electronic versions of the PowerPoint presentations and case studies, pertinent FDA documents, and additional references.


Start Date:
Tuesday, November 05, 2019
End Date:
Friday, November 08, 2019
Time:
8:00 AM - 12:00 PM Eastern Standard Time
Address:
AAMI Center for Excellence (ACE)
901 North Glebe Road Suite 300
Arlington, VA 22203
UNITED STATES
AAMI Member
$950.00 - $2,335.00
List Price
$950.00 - $2,635.00


Steam Sterilization in Health Care Facilities: A Review of ANSI/AAMI ST79:2017 (Webinar On Demand)

This webinar, led by two ST79 committee members, will discuss the process used to update ST79 and identify new and modified material in ST79:2017.
AAMI Member:
$20.00
List Price:
$35.00
Your Price:
$35.00
Available for Immediate Download
↑/↓ Full Details




Sterilization Resource Kit

AAMI Member:
$423.00
List Price:
$652.00
Your Price:
$652.00
↑/↓ Full Details