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Basic Concepts in Sterilization Processes: Verification, Validation, and Qualification (Set of book & PDF)

Buy both the book and PDF and save!

This textbook reaches beyond sterilization engineers to provide personnel working in both healthcare and medical device manufacturing with the background they need to navigate the topic of sterilization processes. Discusses the science of sterilization in plain language and describes the principles on which sterilization verification, validation, and qualification are based.

AAMI Member:
$220.00
List Price:
$360.00
Your Price:
$360.00
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Best Practices in Reprocessing Reusable Medical Devices

In this 90-minute webinar, we discuss the most current accreditation agencies' standards and practice guidelines from AAMI and AORN related to reprocessing of reusable medical devices.
AAMI Member:
$20.00
List Price:
$35.00
Your Price:
$35.00
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Building for the Future: Construction and Renovation of Sterile Processing Facilities, Part I: New Construction

The first of three presentations, this program focuses on understanding the design process to assist participants in collecting the most useful information and required planning data for making good design choices.
AAMI Member:
$20.00
List Price:
$35.00
Your Price:
$35.00
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Building for the Future: Construction and Renovation of Sterile Processing Facilities, Part II: Renovation

The second of three presentations, this program outlines several important planning elements required to manage and execute successful renovation projects in an existing sterile processing facility.
AAMI Member:
$20.00
List Price:
$35.00
Your Price:
$35.00
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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
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Checklists for Preventing Healthcare-Associated Infections

Key Considerations for the Purchase and Use of Reusable Medical Devices
AAMI Member:
$0.00
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Construction & Renov of Sterile Processing Facilities

Building for the Future: Construction and Renovation of Sterile Processing Facilities
AAMI Member:
$145.00
List Price:
$256.00
Your Price:
$256.00
Available for Immediate Download
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Design Control Requirements • Integrating the Quality System Regulation and ANSI/AAMI/ISO 13485

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This intensive 3 – day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience.

An optional exam is available online for 2 weeks following the end of the program.

Registration Fees:

  • AAMI Members: $2235
  • Nonmembers: $2535
  • Government Employees: $950

 

Program Outline

 


DAY 1 | 8 AM-5 PM 
Introduction to Design Control Scope and Applicability
Design Development and Planning
Design Input 

Risk Management
Design Output


DAY 2 | 8 AM-5 PM 
Design Review
Design Verification
Design Validation
Software Validation


DAY 3 | 8 AM-5 PM 
Design Changes 
Design History File
FDA Inspectional Approach
MDSAP





 

 

Program Objective

Upon completing this course, participants will be equipped with the information to able to evaluate the degree of compliance of a design control system, including identification of noncompliance issues, and be prepared to implement the improvements needed to meet requirements.

This highly interactive course engages the learner with in-depth discussion of industry best practices to learn how industry leaders address design control challenges. Exercises are designed to build a solid understanding for developing and applying design control requirements. Attendees will participate in structured discussions with their peers to develop solutions to solve current issues.

Examples of design control tools, templates, and practices, in use by medical device companies, stimulate discussion and provide a practical resource for future reference. Case studies and situation analyses are used throughout the program to help participants analyze potential areas of noncompliance, identify improvements, and evaluate the various methods of managing a design control program.

Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, and industry consultants.

Target Audience

Instruction is targeted to professionals involved in meeting design control requirements such as those in regulatory affairs, quality assurance, design engineering, manufacturing, operations, and members of research and development or new product development teams.

 

Materials

Fee includes a printed copy of the textbook, The Quality System Compendium, and electronic versions of the PowerPoint presentations and case studies, pertinent FDA documents, additional references, and access to the online exam.


Start Date:
Tuesday, December 10, 2019
End Date:
Thursday, December 12, 2019
Time:
8:00 AM - 5:00 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 - $2,235.00
List Price
$950.00 - $2,535.00


Developing a Robust Usability Engineering Process

Human Factors is a key component of the product development process. Throughout that process there are critical activities that take place at each phase of the product development life cycle. The webinar will detail out the activities for each process, discuss the advantages of each activity as well as give an overview of how documentation can be key to developing a robust usability engineering process. This session will address the integration of human factors into all phases of product life cycle. It will also give an overview of templates that your company can create for each human factors deliverable, including an outline of what is contained in each of those documents.
AAMI Member:
$135.00
List Price:
$225.00
Your Price:
$225.00
Available for Immediate Download
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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
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Endoscope Reprocessing Video

The Endoscope Reprocessing: Critical Training Steps to Promote Patient Safety video comes on a DVD. This 30-minute instructional video includes info on how endoscopes work, correct handling, guidance on reprocessing, and much more.
AAMI Member:
$132.00
List Price:
$220.00
Your Price:
$220.00
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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 - Industrial Process Control Individual Subscription

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Description Individual Subscription to Sterilization - Industrial Process Control Collection includes 50 standards and guidance documents and is intended primarily for manufacturers who ship sterile products.

To learn about eSubscription options for organizations, please visit Enterprise eSubscriptions.

AAMI Member:
$490.00
List Price:
$660.00
Your Price:
$660.00


Horizons 2017 Spring: Clinical Alarms

Managing the Overload

Including:
- Factors that Affect Design of Secondary Alam Notification Systems
-Alarm Management Lessons from the Process Industries
-Reduction of Nonactionable Alarms in Medical Intensive Care
AAMI Member:
$22.00
List Price:
$36.00
Your Price:
$36.00
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HTM Webinar Series: Part 1: Developing an HTM Specific Cybersecurity Framework

This is Part 1 of a 3 part webinar series. Medical device cybersecurity (application of processes/procedures, efforts, etc.) in healthcare technology management (HTM) is in its infancy. Many HTM professionals are unfamiliar with security and the framework necessary to incorporate good security practices into HTM service operations. Mayo Clinic has begun to bridge this divide by standing up an HTM Cybersecurity Team focused solely on developing a National Institute of Standards and Technology (NIST) based cybersecurity program. This webinar will provide insight into Mayo Clinic's approach and provide ideas on what to consider and how to develop an HTM Cybersecurity Program.
AAMI Member:
$0.00
List Price:
$0.00
Your Price:
$0.00
Available for Immediate Download
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HTM Webinar Series: Part 2 Developing an HTM Specific Cybersecurity Framework

This is Part 2 of a 3 part webinar series. Medical device cybersecurity (application of processes/procedures, efforts, etc.) in healthcare technology management (HTM) is in its infancy. Many HTM professionals are unfamiliar with security and the framework necessary to incorporate good security practices into HTM service operations. Mayo Clinic has begun to bridge this divide by standing up an HTM Cybersecurity Team focused solely on developing a National Institute of Standards and Technology (NIST) based cybersecurity program. This webinar will provide insight into Mayo Clinic's approach and provide ideas on what to consider and how to develop an HTM Cybersecurity Program.
AAMI Member:
$0.00
List Price:
$0.00
Your Price:
$0.00
Available for Immediate Download
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HTM Webinar Series: Part 3 Developing an HTM Specific Cybersecurity Framework

Medical device cybersecurity (application of processes/procedures, efforts, etc.) in healthcare technology management (HTM) is in its infancy. Many HTM professionals are unfamiliar with security and the framework necessary to incorporate good security practices into HTM service operations. Mayo Clinic has begun to bridge this divide by standing up an HTM Cybersecurity Team focused solely on developing a National Institute of Standards and Technology (NIST) based cybersecurity program. This webinar will provide insight into Mayo Clinic's approach and provide ideas on what to consider and how to develop an HTM Cybersecurity Program. This is Part 3 of a 3 Part webinar series.
AAMI Member:
$0.00
List Price:
$0.00
Your Price:
$0.00
Available for Immediate Download
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HTM Webinar Series: Using HTM Data to Drive High Reliability Healthcare

In this special HTM Week Webinar, HTM representatives from the Department of Veterans Affairs (VA) will present approaches to reduce variability of data and business processes across 170 medical centers. VA will share how it’s using data to improve patient safety, monitor/benchmark program performance, strategically plan for new medical technology, and manage medical equipment cybersecurity. VA will preview a works-in-progress model to project HTM resource/staffing needs.
AAMI Member:
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Human Factors for Medical Devices

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This 3-day course offers participants a comprehensive overview to human factors as it relates to medical devices. It includes regulatory requirements of FDA, specifically the interpretation from the Center for Devices and Radiological Health (CDRH) Human Factors Team, as they relate to human factors, and the process of applying human factors in design controls during the design of a medical device. The course also includes the regulatory perspective of the Center for Drug Evaluation and Research (CDER) and the impact of human factors on pharma.

 

Registration Fees:

  • AAMI Members: $2235
  • Nonmembers: $2535
  • Government Employees: $950

 

Program Outline

 


DAY 1 | 8 AM-5 PM 
  • Introduction and Overview 
  • Case Study 1
  • Preliminary Analysis: Uses, Users, Use Environments, and User Interfaces
  • Preliminary Analysis: Analytical Approaches to Identifying Use Related Risks
  • Preliminary Analysis: Use Related Risks Part 2, Task Analysis and PCA


DAY 2 | 8 AM-5 PM 
  • Preliminary Analysis: Analytical Methods, Empirical Methods
  • Formative Exercises and Reporting
  • Root Cause Analysis 
  • Risk Elimination and Reduction Standards 
  • Rosetta Stone


DAY 3 | 8 AM-5 PM 
  • FDA - CDRH and CDER
  • Validation Exercises
  • Group Presentations




 

 

Program Objective

A basic foundation for applying human factors will be set, with discussions on user models and task analysis; anatomy of use errors; and how task analysis forms the basis for planning human factors efforts. Course content will also include a review of human factors methodologies – contextual inquiry, heuristic evaluations, formative studies, and summative studies. Relevant human factors standards are discussed as well as human factors in the post-market arena. There are hands-on exercises as well as real-life case studies illustrating the application of human factors to medical devices.

 

Faculty

All course faculty have completed an instructor training program. On-going peer and participant evaluation ensure consistency and quality from course to course. The faculty team for each program includes a lead instructor and an industry expert(s).

 

Target Audience

This course is designed for quality and design engineers; research and development managers; risk managers; personnel from marketing, regulatory affairs, quality assurance, clinical/medical affairs, and customer service; and government regulators who are new to the application of human factors to medical devices. AAMI recommends this course for professionals who already have a basic understanding of the framework of quality management systems, particularly design control, risk management, and CAPA activities, but need more in-depth information about the concepts, science, processes, methodologies, and practical applications of human factors. It is recommended that human factors personnel who are new to the medical device industry have working knowledge of the Quality System regulation and design controls.

 

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



Start Date:
Tuesday, November 19, 2019
End Date:
Thursday, November 21, 2019
Time:
8:00 AM - 5:00 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 - $2,235.00
List Price
$950.00 - $2,535.00


Integrating Human Factors into Design Controls: AAMI TIR59

This 90-minute webinar provides an overview of AAMI TIR59, with a focus on the practical implementation of human factors engineering/usability engineering processes, activities and their corresponding applicability to a new or pre-existing quality system's design controls in accordance with 21 CFR 820.30 as well as ANSI/AAMI/IEC 62366-1:2015.
AAMI Member:
$135.00
List Price:
$225.00
Your Price:
$225.00
Available for Immediate Download
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