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Webinars

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A Guide for Medical Device Manufacturers: Understanding and Applying the FDA Processes, Terminology, and Informational Databases for U.S. Medical Device Classification

This webinar provides a comprehensive overview of the FDA processes, terminology, and informational databases established for U.S. medical device classification.

AAMI Member:

$119.00

List Price:

$199.00

Available for Immediate Download

A Practicum for Healthcare Technology Management

Just revised, this textbook is the go to resource for new and seasoned biomedical professionals. It covers everything from The Joint Commission accreditation process and managing medical device safety to human factors engineering and evidence-based medical equipment maintenance management. Based on Les Atles' best-selling "A Practicum for Biomedical Engineering and Technology Management" and written by experts in the profession.

AAMI Member:

$164.00 - $169.00

List Price:

$273.00 - $283.00

AAMI 40th Anniversary Book

This commemorative coffee-table style book, published in recognition of AAMI’s 40th anniversary in 2007, examines the evolution of AAMI and the medical device industry over the last four decades. Using pictures and narrative from pioneers in the field, this keepsake explores the role of device regulation, the engineering community, the standards program, and quality systems initiatives.

AAMI Member:

$22.00

List Price:

$36.00

AAMI TIR21:2017 (PDF)

Systems used to forecast remaining pacemaker battery service life

AAMI Member:

$125.00

List Price:

$222.00

Available for Immediate Download

AAMI TIR29:2012/(R)2017 (PDF)

Guide for process characterization and control in radiation sterilization of medical devices

AAMI Member:

$122.00

List Price:

$214.00

Available for Immediate Download

AAMI TIR36:2007 (PDF)

AAMI Member:

$150.00

List Price:

$266.00

Available for Immediate Download

AAMI TIR56:2013/(R)2016 (PDF)

AAMI Member:

$87.00

List Price:

$152.00

Available for Immediate Download

AAMI TIR58:2014

Water testing methodologies

AAMI Member:

$129.00

List Price:

$214.00

Available for Immediate Download

AAMI TIR66:2017

Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms

AAMI Member:

$107.00

List Price:

$188.00

AAMI TIR71:2017 (PDF)

Guidance for logging of alarm system data

AAMI Member:

$69.00

List Price:

$123.00

Available for Immediate Download

AAMI/IEC TIR80001-2-5:2014

Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance for distributed alarm systems

AAMI Member:

$107.00

List Price:

$188.00

AAMI/ISO TIR16775:2014

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2

AAMI Member:

$150.00

List Price:

$266.00

AAMI/ISO TIR17137:2014 (PDF)

Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants

AAMI Member:

$87.00

List Price:

$152.00

Available for Immediate Download

AAMI/ISO TIR19024:2016 (PDF)

Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass

AAMI Member:

$87.00

List Price:

$152.00

Available for Immediate Download

AAMI/ISO TIR23810:2012/(R)2015

Cardiovascular implants and artificial organs - Checklist for preoperative extracorporeal circulation equipment setup.

AAMI Member:

$104.00 - $107.00

List Price:

$183.00 - $188.00

AAMI/ISO TIR24971:2013/(R)2016

Medical devices - Guidance on the application of ISO 14971.

AAMI Member:

$69.00

List Price:

$123.00

AAMI/ISO TIR80002-2:2017 (PDF)

Medical device software—Part 2: Validation of software for medical device quality systems

AAMI Member:

$150.00

List Price:

$266.00

Available for Immediate Download

Alarms Part I: The Joint Commission’s National Patient Safety Goal on Alarm Management: How Do We Get Started?

Clinical alarms are a high-frequency, high-risk patient safety hazard for all hospitals. This is the first of a series of seven webinars on alarms. By the end of the series, healthcare delivery organization alarm management teams will be prepared to comply with The Joint Commission’s (TJC) new National Patient Safety Goal (NPSG) on Alarm Management. This first webinar will set the stage for the series and outline the complexity of issues related to alarm systems and the events that have led to the spotlight on alarm systems and alarm fatigue. It will cover the overall scope of TJC's NPSG, the timeline for meeting the requirements, and how the series will help the participant start to meet the NPSG.

AAMI Member:

$0.00

List Price:

$0.00

Available for Immediate Download

Alarms Part II: How to Identify the Most Important Alarm Signals to Manage

This on demand webinar will help the participant to use alarm system data to identify their highest priority alarm conditions and corresponding signals.

AAMI Member:

$0.00

List Price:

$0.00

Available for Immediate Download

Alarms Part IV: Use of Middleware in Alarm Management: Ancillary Notification and Obtaining Alarm Data

This streaming webinar archive will address the use of middleware as an ancillary alarm notification system and as a tool to collect alarm data. This webinar will cover: definition of middleware and how it works; overview of ancillary alarm notification systems including: necessary components for implementation, use of these systems for alarm integration of multiple devices, and process for sending alarms to communication device; human factors considerations; how to use middleware to acquire alarm data; how to determine the best ancillary alarm notification approach for your organization, including selection of wireless communication device; and a case study on use of an ancillary alarm notification system for alarm integration of monitor, ventilator, bed exit, and nurse call system alarms.

AAMI Member:

$0.00

List Price:

$0.00

Available for Immediate Download