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Medical Device Cybersecurity (PDF)

A Guide for HTM Professionals
AAMI Member:
$155.00
List Price:
$232.00
Your Price:
$232.00
Available for Immediate Download
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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
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Preparing For Success: Acute Hemodialysis Survey Readiness

This webinar promotes understanding of the applicable survey requirements and provides guidance in ways to build readiness so that acute hemodialysis services can be prepared for success in any inspection.
AAMI Member:
$15.00
List Price:
$20.00
Your Price:
$20.00
Available for Immediate Download
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Protective Barriers Resource Bundle (PDF)

AAMI Member:
$191.00
List Price:
$319.00
Your Price:
$319.00
Available for Immediate Download
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Sterile Processing: Preparing for Accreditation

Every central service or sterile processing department must be prepared for on-site surveys from their facility's accrediting body. How do you prepare for the survey and ensure your department's compliance? To answer this question and offer guidance on common things surveyors look for, AAMI is pleased to offer this 90-minute eLearning program. This interactive, self-paced training is derived from an education program provided to Joint Commission surveyors and has been adapted for the AAMI audience.
AAMI Member:
$99.00
List Price:
$130.00
Your Price:
$130.00
Available for Immediate Download
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The Quality System Compendium: CGMP Requirements and Industry Practice, Third Edition

Since the 2007 publication of the second edition, there have been substantial changes in medical device technology, medical device regulatory approaches, and FDA and international guidances and standards. This new third edition has been developed to provide accurate and useful information to the medical device community, updated to reflect the current status of the many rapidly evolving areas of the medical device environment.

AAMI Member:
$390.00
List Price:
$650.00
Your Price:
$650.00
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Wi-Fi Enabled Healthcare

Focusing on its recent proliferation in hospital systems, Wi-Fi Enabled Healthcare explains how Wi-Fi is transforming clinical work flows and infusing new life into the types of mobile devices being implemented in hospitals.
AAMI Member:
$85.00
List Price:
$108.00
Your Price:
$108.00
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Writing a Human Factors Engineering (HFE) Report

In 2011, the U.S. Food and Drug Administration (FDA) released a draft guidance document, Applying Human Factors and Usability Engineering to Optimize Medical Device Design, and this guidance calls for medical device manufacturers to include an HFE report when they apply for a 510(k) or PMA. The FDA goes so far as to provide a relatively detailed outline for the HFE report. However, many manufacturers are likely to have persisting questions about how to write an effective report.
AAMI Member:
$135.00
List Price:
$225.00
Your Price:
$225.00
Available for Immediate Download
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Writing Human Factors Plans and Reports Webinar

This webinar will fill a perceived gap in the guidance available to medical technology developers with sample work products and supplemental job aids that offer document preparation advice and have been peer-reviewed by a panel of HFE experts.
AAMI Member:
$149.00
List Price:
$249.00
Your Price:
$249.00
Available for Immediate Download
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