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Introduction to Updated IEC 62366 - Parts 1 & 2

In 2015, the International Electrotechnical Commission (IEC) is expected to release an updated version of IEC 62366:2007, Medical devices -- Application of usability engineering to medical devices. The updated version will have two parts. Part 1 will focus on medical device’s use-safety, describing usability engineering (aka human factors engineering) activities and end-products that will be the basis of future compliance assessments. Part 2 will have more of a tutorial nature, complementing Part 1 by describing best practices in the usability engineering of medical devices.
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Managing Internal and External Customer Service Relationships

In today’s healthcare environment, patient satisfaction is more important than ever. Learning to work together and understanding everyone’s role is key to a successful department. This webinar will help you analyze the interdependency between the people you work with on a regular basis and help you improve your relationships at work.
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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?
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Packaging for Terminally Sterilized Medical Devices: How to Find Your Way in this Globally Regulated Industry

This two-part webinar identifies the purpose of sterile packages and packaging systems, packaging requirements sources, and shipping tests. The facilitators help attendees define the requirements of packaging standards and the types of packaging.
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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.
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Processing Flexible Endoscopes: Current Evidence-Based Guidelines

This 90-minute webinar covers the most current standards, guidelines and recommendations for reprocessing flexible endoscopes in healthcare facilities.
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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.
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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.
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Simulating Invasive Medical Procedures During Usability Tests

This webinar addresses the common need to simulate an invasive medical procedure during a usability test. It reviews the standard of care when conducting validation usability tests • enabling realistic tasks and the natural flow of one task into another. It introduces numerous techniques for simulating invasive procedures, such as placing a catheter into the spinal column, placing an implant in the eye, ablating heart tissue with a probe, and performing minimally invasive abdominal procedures. It showcases various materials that effectively simulate human tissue and how to set up test environments to effectively recreate the operating room, catheterization laboratory, intensive care unit, and physician’s exam room.
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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.
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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.
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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.
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Strategies to Conduct High-Integrity Validation Usability Tests

During this webinar, the presenters will review the myriad ways a validation test could be biased and ways to avoid it, thereby serving in the best interests of the manufacturer.
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Testing Training: Taking the Training Wheels Off

This webinar, referencing AAMI TIR49:2013, Design of training and instructional materials for medical devices used in non-clinical environments, will address ten of the most common questions related to training.
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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.
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The Future Direction of HFE in Medical Device Development

This presentation will consider how trends in industrial, scientific, business, and consumer product and development might drive the design of future medical products.
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Updates on AAMI ST79 and SPD Accreditation Surveys

This presentation is intended to help healthcare professionals prepare for a Joint Commission or Centers for Medicare and Medicaid Services survey as it relates to sterile processing of surgical instruments and other medical devices. We will discuss some of the recent updates to AAMI standards.
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Validation of a Medical Device Cleaning Process

There is increased focus by regulators around the world on medical device cleaning processes, and many medical device manufacturers find it a considerable challenge to plan and conduct a cleaning validation. The main challenges are an establishment of the cleanliness limits and an identification of the challenge conditions to be assessed during the process validation. This webinar describes logical and risk-based approaches to overcome these challenges.
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Warnings and Safety Information in Device Labeling

While most companies would readily acknowledge the importance of identifying and clearly communicating the potential hazards associated with their devices, oftentimes they are perplexed about the best methods for accomplishing it. Unfortunately, there is a dearth of actionable resources on how to design and develop warnings and safety information that stakeholders can readily access. This two-part series will address this gap.
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Webinar Recording: Maximizing the Value of ACI Certification and Understanding Recertification Requirements

Earning ACI's certifications can give professionals the career advancement they're looking for by validating their knowledge base, demonstrating their commitment to the field, and showcasing their devotion to continued education. Join this webinar, given by AAMI's Certification Manager, Martin McLaughlin, to learn how to maximize the benefits of certification within your organization and to better understand the process of maintaining your designation once it's earned.
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