AAMI Summer Learning Series: Regulatory/Accreditation Track
The AAMI Summer Learning Series is your opportunity to gain insights from leading health technology, regulatory, and sterilization experts in an interactive virtual format. Each custom track connects you with the content most relevant to success in your role. Registration includes live streaming access and recordings of the sessions. Each webinar can earn you from one (1) to four (4) CEU's towards your ACI certification. Learn when—and where—you want this summer at an incredible value!
–Registration includes all sessions in the track!–
Building a Globally Compliant Quality Management SystemFriday, July 10, 2:00 p.m. to 3:00 p.m. ET
Manufacturers must strategically utilize a variety of external standards to build out globular compliance for both regulatory affairs functions, as well as quality assurance functions within an ISO 134845:2016 compliant quality management system. Participants will learn global technical regulatory requirements, including the E.U.'s Medical Device Regulation and In Vitro Diagnostics Regulation, as well as U.S. FDA requirements and the use of harmonized or consensus standards to meet regulatory expectations.
- Kimberly Trautman, NSF International
HTM in the Ambulatory Surgical Center Environment of CareFriday, July 17, 2:00 p.m. to 3:00 p.m. ET
The Centers for Medicare & Medicaid Services' adoption of NFPA 99 2012 for ambulatory surgery centers (ASCs) seeking accreditation changed how the ASC market must address healthcare technology management within their environment of care. This session will discuss what these changes mean from a modern HTM perspective, as well as the challenges and business opportunities created by these changes.
- Ray Marden, Insight HTM, LLC
- Jared Wilson, Insight HTM, LLC
Electrical Safety Testing: Clearing Up Confusion, Keeping Patients SafeFriday, July 24, 2:00 p.m. to 3:00 p.m. ET
This moderated panel discussion will examine critical aspects of ensuring patient safety by testing to key electrical safety standards. Topics include: Why electrical safety testing is still important to the reduction of risk of injury or death for patients connected to electromedical devices, what has changed in IEC Electrical Safety Standards and the NFPA99 code, how to test medical devices and systems, electrical safety testing within isolated power environments, and more.
- Gerald Zion, Fluke Biomedical
Is Adopting a Quality Management System in Your Future?Friday, July 31, 2:00 p.m. to 3:00 p.m. ET
This session will discuss new market and regulatory pressures that may be driving healthcare technology management departments to formally adopt a quality management system (QMS). We will review current QMS options and discuss the pros and cons of taking on this new burden/opportunity. The core of this session will share the journey of an independent servicing organization (ISO) through its own QMS adoption. This will include commentary on how the ISO QMS experience can be applied in the hospital-based healthcare technology management setting. The session will wrap up with a discussion among session participants on how adopting QMS may—or may not—fit in their world.
- James Keller, Emergo by UL
- Richard Eliason, Crothall Healthcare