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Medical Device Integration and Informatics Compendium

Integration of medical devices with information systems
AAMI Member:
$0.00
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Medical Device Risk Management and Safety Assurance Cases

The FDA recently reported that class I recalls have increased from an average of 25 per year before 2008 to 50 in 2011 and 57 in 2012 (1). A class I recall is a situation in which there is a reasonable probability that use, or exposure to, a medical device will cause serious adverse health consequences or death. As the complexity and sophistication of medical technology and health care infrastructure continue to increase, assuring proper identification and adequate risk controls of these potential recall situations (i.e. hazardous situations) prior to the device being placed on the market is becoming more and more critical and challenging. How effective are the existing medical device risk management practices in assuring proper identification and controls of risks? Are there any gaps and opportunities? How can these gaps be addressed? What is FDA’s view on this issue?
AAMI Member:
$119.00
List Price:
$199.00
Your Price:
$199.00
Available for Immediate Download
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Patient Safety Seminar - May 20, 2016

What system, structural, and technological changes are necessary to capture real-time, critical data of early deterioration in adult postoperative inpatients, to prevent failure to rescue?

Does Continuous Vital sign Monitoring Detect Early Deterioration of Patients Receiving Parenteral Opioids?

Obtain a nursing Continuing Education credit.

This online seminar presents the work from Johns Hopkins Hospital about its improvements in the area of continuously monitoring patients on parenteral opioids in the general care setting.


AAMI Member:
$25.00
List Price:
$25.00
Your Price:
$25.00
Available for Immediate Download
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Premarket Risk Management

For New Medical Device Companies
AAMI Member:
$117.00
List Price:
$153.00
Your Price:
$153.00
Available for Immediate Download
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Purchase CE for Seminar - August 8, 2016

Raising the Bar on Infusion Safety: Patient Safety Initiatives at Western Maryland Health System and Cameron Memorial Community Hospital

Learn how two hospitals approached the challenges in improving compliance with the use of their smart-pump drug libraries.

Speakers:
Christine Ruhl, BSN. MBA, CCRN Director, Critical Care Services Western Maryland Health System
Cumberland, MD

Andrew Aldred, PharmD, MBA Director of Pharmacy and Materials Management Cameron Memorial Community Hospital
Angola, IN
AAMI Member:
$25.00
List Price:
$25.00
Your Price:
$25.00
Available for Immediate Download
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Purchasing Controls & Supply Chain Management-June 2019

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This 2½ day course provides extensive information on effective implementation of supplier selection and controls. This detailed course covers the key aspects of supplier controls, from planning for supplier assessment/selection, to defining acceptance activities, to monitoring supplier performance. Each topic is presented from a practical perspective, with links to the requirements of the Quality System regulation, the ISO 13485 standard, risk management considerations, and pertinent Global Harmonization Task Force guidance.

The course also covers life-cycle management approaches for a medical device manufacturing organization’s supply chain. The course includes substantial “hands-on” exercises to allow attendees to apply concepts and interact with colleagues, and provides specific industry examples.

Registration Fees:

  • AAMI Members: $2135
  • Nonmembers: $2435
  • Government Employees: $950

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM

Definitions and Regulatory Requirements

Planning

Supplier Selection



DAY 2 | 8 AM-5 PM

Supplier Selection Continued

Defining Supplier Controls

Day-to-Day Operations

Communications and Improvements



DAY 3 | 8 AM-12 PM

Integrating Supplier Controls Throughout the Quality Management Systems

Supply Chain Management

Submissions and Compliance






 

 

Program Objective

Upon completing this course participants will be able to evaluate their organization's compliance with FDA's requirements for purchasing controls and acceptance activities, and consider appropriate risk mitigation strategies for supplied products and services.

 

Target Audience

This course is targeted to professionals involved in establishing supplier agreements, supplier quality management, purchasing activities, Quality System compliance, and regulatory submissions for significantly outsourced products.

 

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. td>

Start Date:
Wednesday, June 19, 2019
End Date:
Friday, June 21, 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 - $2,135.00
List Price
$950.00 - $2,435.00


Risk and Reliability in Healthcare and Nuclear Power: Learning from Each Other

AAMI Member:
$35.00
List Price:
$60.00
Your Price:
$60.00
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Risk and Reliability in Healthcare and Nuclear Power: Learning from Each Other (PDF Format)

AAMI Member:
$35.00
List Price:
$60.00
Your Price:
$60.00
Available for Immediate Download
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RTLS: Tracking Assets and Beyond

Real Time Location Systems have brought savings and efficiencies and are best known for tracking equipment and asset management. The systems now promote more efficient work and patient flow, enable nurse call and hand hygiene compliance, and monitor environmental conditions. As new applications are being developed, healthcare technology management (HTM) professionals play a key role in the assessment and selection of RTLS systems, and more departments and stakeholders looking to HTM to provide information and insights about the technologies.
AAMI Member:
$0.00
List Price:
$85.00
Your Price:
$85.00
Available for Immediate Download
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Selling HF: The Business Case for Human Factors in Industry

The purpose of this webinar is to share real-life experiences in “selling” Human Factors/Ergonomics (HF/E) to teams and to management that have not had HF/E experience in the past, or have an incorrect perception of what HF/E can offer.
AAMI Member:
$135.00
List Price:
$225.00
Your Price:
$225.00
Available for Immediate Download
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Spring 2014 Horizons: Cybersecurity in Healthcare: What You Need to Know

AAMI Member:
$22.00
List Price:
$36.00
Your Price:
$36.00
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ST90: Quality Management Systems for Sterile Processing

This 90-minute webinar will show you how AAMI's new standard, ANSI/AAMI ST90, Processing of health care products—Quality management systems for reprocessing in health care facilities, provides the necessary framework for a quality management system for sterile processing departments.
AAMI Member:
$20.00
List Price:
$35.00
Your Price:
$35.00
Available for Immediate Download
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The Benefits of UDI for Healthcare Technology Management

This webinar addresses the benefits of Unique Device Identification (UDI), UDI requirements in the U.S., challenges healthcare facilities are facing with UDI implementation, and the overall impact to quality and quality systems for both manufacturers and healthcare facilities.
AAMI Member:
$0.00
List Price:
$85.00
Your Price:
$85.00
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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WEBINAR: Bluetooth in the Healthcare Setting

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Description: Bluetooth® wireless technology (Bluetooth) is everywhere today, and is widely used in medical devices in hospital ranging from IT platforms to implanted devices. Bluetooth technology is also brought into the hospital with patients and their visitors in the form of smartphones, headsets, and gaming devices.  This Webinar provides a high-level overview of the technology and key features of Bluetooth for Health Technology Management (HTM) professionals and technology professionals.
NOTE: In registering for this webinar, attendees give AAMI the right to share email contact information with the sponsor of this event.

Date:
Tuesday, February 19, 2019
Time:
2:00 PM - 3:00 PM Eastern Standard Time
Speakers:
William Saltzstein
President
Code Blue Communications Inc
Steve Baker, PhD
Senior Engineer
Welch Allyn

AAMI Member
$0.00
List Price
$0.00


WEBINAR: Monthly Workload Tracker by Technician Using Data Modeling

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Description: Managers have a slew of reports and things to track from Preventative Maintenance, Corrective Maintenance, Incoming inspection, hazard alerts and projects. Often times, these reports are independent of one another and do not provide a comprehensive understanding of the time demands on each technician. As JC requirements have changed to 100% pm completion rate, a data model is required to assist management in ensuring that work assigned can feasibly be completed on time. This tool can be used to equitably redistribute workload among technicians while factoring in complexity and variances of work types.
NOTE: In registering for this webinar, attendees give AAMI the right to share email contact information with the sponsor of this event.

Date:
Tuesday, July 16, 2019
Time:
3:00 PM - 4:00 PM Eastern Daylight Time
Speakers:
Arleen Thukral, MSBME CHTM
VISN 20 Biomedical Engineer
VA Puget Sound Health Care System

AAMI Member
$0.00
List Price
$0.00


WEBINAR: Part 1 - Developing an HTM Specific Cybersecurity Framework

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Description: 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 1 of a 3 part series.
NOTE: In registering for this webinar, attendees give AAMI the right to share email contact information with the sponsor of this event.

Date:
Tuesday, January 29, 2019
Time:
2:00 PM - 3:00 PM Eastern Standard Time
Speakers:
Kurt Griggs
SR Info Security Analyst - HTM
Mayo Clinic - HTM
Odutola Amusan
SR Info Security Analyst - HTM
Mayo Clinic - HTM
Theresa A. Peters
Sr Info Security Engineer - HTM
Mayo Clinic - HTM

AAMI Member
$0.00
List Price
$0.00


WEBINAR: Part 2 - Developing an HTM Specific Cybersecurity Framework

Generic Event Image
Description: Description: 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 2 of a 3 part series.
NOTE: In registering for this webinar, attendees give AAMI the right to share email contact information with the sponsor of this event.

Date:
Tuesday, February 05, 2019
Time:
2:00 PM - 3:00 PM Eastern Standard Time
AAMI Member
$0.00
List Price
$0.00


WEBINAR: Part 3 - Developing an HTM Specific Cybersecurity Framework

Generic Event Image
Description: 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 series.
NOTE: In registering for this webinar, attendees give AAMI the right to share email contact information with the sponsor of this event.

Date:
Tuesday, April 16, 2019
Time:
2:00 PM - 3:00 PM Eastern Daylight Time
AAMI Member
$0.00
List Price
$0.00


Writing an Effective Human Factors Engineering Procedure

This webinar discusses the need for medical device companies to create a human factors engineering (HFE) procedure that conforms to current HFE standards as well as the standards and expectations of the FDA and other regulators. Learn how an HFE procedure must be closely tied to a company’s risk management process (e.g., ISO 14971) and ways to turn a general procedure into a detailed and properly scaled one to guide a particular product development effort. This webinar serves the remedial benefit of explaining the purpose of the myriad HFE activities comprising a complete procedure. This webinar will enable audience members to immediately prepare appropriate procedures for their own organization.
AAMI Member:
$135.00
List Price:
$225.00
Your Price:
$225.00
Available for Immediate Download
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