AAMI Education Program Rethinks the Education Experience

April 1, 2020

Categories: AAMI News, Education & Academia, Government, Health Technology Management, HTM Professionals, Medical Device Manufacturers, Medical Device Manufacturing, Sterilization, Sterilization Professionals

What’s new in AAMI’s education department? A whole lot.

With a focus on delivering specific, practical topics for attendees, AAMI’s education suite is being reimagined to ensure participants who attend an AAMI training course, certification program, or webinar leave with practical knowledge that they can immediately apply to their professional lives.

“We’re evaluating all aspects of our education program to ensure we deliver the most effective and innovative experiences possible,” said MJ McLaughlin, AAMI’s director of education programming. “For example, we established a Faculty Advisory Group of respected experts in our core training suites of human factors, sterilization, software/cybersecurity, and quality systems/regulatory. They’ve been our eyes and ears to inform us on what’s going on in their fields. That’s crucial to helping us address the evolving needs of our members.”

For example, the Faculty Advisory Group’s input has led to the development of a lead auditor training program for the Medical Devices Single Audit Program, which is anticipated to begin in May. Additional offerings in the works include:

A Course to Help with 510(k) Premarket Submissions

Preparing your own 510(k) premarket submission to the Food and Drug Administration (FDA) can be a daunting task. That’s why AAMI worked with Rob Packard of the Medical Device Academy to develop a new training course, Navigating 510(k) & De Novo Requirements, designed for anyone responsible for preparing regulatory submissions to the FDA.

“One of the things that makes this course different from others on the market is its coverage of the De Novo submission process,” said Packard, who will be one of the instructors for the four-day course, first offered May 18–21. “Other courses don’t include this information because very few devices cleared by the FDA each year require a De Novo submission.” 

The first three days of the four-day course program will cover the 510(k) process. Content will be divided into 15 modules that follow the FDA’s requirements for 510(k) premarket submissions. The De Novo-specific sections of the premarket submission process will be discussed during the last (and optional) day. 

Attendees can expect to learn how to identify the appropriate U.S. regulatory pathway for their device, identify a predicate device, and create a testing plan for their premarket submission. Content for the course includes quality system requirements, design controls, and testing requirements for all types of devices.

To register for the 510(k) & De Novo Requirements course, visit the AAMI Store.

Recruiting and Training the Next Generation of HTM Professionals

The AAMI Credentials Institute is also offering up a new certification for people interested in starting a career in healthcare technology management (HTM) but don’t yet have experience. The new Certified Associate in Biomedical Technology (CABT) designation is aimed at high school graduates and adults looking to make a career change. The certification will demonstrate the foundational knowledge necessary to gain employment in the HTM field.

“CABT is a bridge certification,” said Danielle McGeary, AAMI’s vice president of HTM. “We want to help people who are interested in healthcare technology to obtain the work experience they need to enroll in HTM-related degree programs and reach that first rung in the ladder to other professional certifications, like CBET (Certified Biomedical Equipment Technician) and CHTM (Certified Healthcare Technology Manager).”

For the first year, the certification will be administered by approved testing centers and through remote proctoring. Once CABT is launched, AAMI plans to inform potential employers about how to use the certification to identify qualified and committed entry-level HTM employees.

 In Response to COVID-19, AAMI Education Goes Virtual

AAMI is transitioning all in-person courses scheduled through April 30, 2020, to a virtual format.

Our virtual option is robust and interactive. We will ship you the devices needed for hands-on learning during your course. You will also have easy access to course content, and you will be able to interact live with your fellow classmates and instructors. Curious about whether virtual will work for you? Test it out at zoom.us/test.

Existing registrants have four options:
  • Attend the class virtually.
  • Transfer your registration to a upcoming virtual or live class.
  • Choose to transfer your registration to a course yet to be scheduled.
  • Request a refund.
If you are currently registered for a course taking place prior to April 30, 2020, please contact education@aami.org to confirm your registration selection. If you are completing a new registration, you will be able to select either live or virtual attendance when you register.
Check www.aami.org/coronavirus for the latest updates.