AAMI News December 2019

2019—The Year in Review

AAMI Exchange
The AAMI sign was a popular backdrop for photos and selfies at the AAMI Exchange.

AAMI ExchangeAAMI Exchange Reimagines the Annual Conference & Expo

This June, the AAMI Exchange rocked Cleveland, OH, and the health technology world. The Exchange reimagined the AAMI Annual Conference & Expo with new experiences and a fresh accent on innovation.

More than 80 education sessions featured future-focused tracks on healthcare technology management, cybersecurity, sterilization, regulations and accreditation, artificial intelligence (AI) and virtual reality, clinical engineering, data analytics, and global trends.

The Exchange included a dynamic IoT Experience and artificial/virtual reality theater, both new for 2019, as well as the inaugural AAMI Xcelerator Pitch Competition. Main-stage speakers included Toby Cosgrove, executive advisor for Google Cloud and former CEO and president of the Cleveland Clinic, who shared his insights about emerging opportunities, challenges, and trends in health technology, as well as award-winning author and futurist Nicholas Webb.

Change at FDAA Year of Change at the FDA

2019 began with Food and Drug Administration (FDA) employees facing the longest federal government shutdown in U.S. history, during which few could report to work (or draw a paycheck). Many device-related reviews ground to a halt. To keep the public informed, then–FDA Commissioner, Scott Gottlieb, took to Twitter to personally provide updates and
answer questions.

The shutdown ended in late January. Just over a month later, Gottlieb announced his departure from the FDA, a move that rattled the medical device industry. During his two-year tenure, Gottlieb was lauded for his work to streamline the regulation of medical devices, partnering with industry to help advance new technologies while maintaining patient safety.

In May, Norman Sharpless, director of the National Cancer Institute (NCI), took the reins as acting FDA commissioner. Because the acting position is limited to 210 days, Sharpless was followed by Brett Giroir, assistant secretary for health at the U.S. Department of Health and Human Services, who became acting commissioner in November.

The Trump administration has nominated Stephen Hahn, the chief medical executive of MD Anderson Cancer Center, to be the next permanent FDA commissioner.

Health TechnologiesThis Year’s Disruptive Health Technologies

According to Forbes, the top six digital transformation trends in healthcare for 2019 are:

  • Telemedicine
  • Artificial intelligence
  • Blockchain
  • Augmented reality and virtual reality
  • Digital twin
  • Wearables and the Internet of Things

510(k) ProgramFDA’s Moves to Modernize 510(k) Program

The Food and Drug Administration (FDA) issued several guidance documents intended to modernize and streamline the 510(k) premarket clearance program:

  • A final guidance established a framework for the agency’s Safety and Performance Based Pathway, which shifts away from predicate device comparisons to FDA-identified criteria, including consensus standards.
  • Four final guidances were designed to make the regulatory submission process more efficient for the agency and manufacturers: The Special 510(k) Program, Abbreviated 510(k) Program, Format for Traditional and Abbreviated 510(k)s, and Refuse to Accept Policy for 510(k)s.

The FDA named the publication of a final guidance document for its 510(k) Third Party Review Program an “A-list” priority for fiscal year 2020. The program is intended to speed up 510(k) decisions for certain low- to moderate-risk medical devices and allow the FDA to focus its resources on higher-risk devices.

Education LeaderTransformative Education Leader Joins AAMI

In February, AAMI named Robert Burroughs as the association’s senior vice president of education. Burroughs, who has more than 20 years experience in training and professional development, manages AAMI’s entire educational portfolio, which includes industry training courses for medical device manufacturers, certifications for healthcare technology management and sterilization professionals, and the AAMI Exchange, the association’s growing and revamped annual conference.

This past year, Burroughs and his team have expanded and launched new initiatives, including the Xcelerator Pitch Competition at the AAMI Exchange, the ACI 100% Team Certified Award that recognizes shops that value certification and make it a requirement for all eligible technicians, a growing list of course offerings in Europe, and an interactive online course to help biomedical equipment technicians study for the CBET certification exam.

CBET Study CourseAAMI Offers CBET Study Course

In August, AAMI announced that it would launch a Certified Biomedical Equipment Technician (CBET) Exam Preparation Program. The AAMI program is based on the Colorado Association of Biomedical Technicians (CABMET) program.

AAMI offered its first CBET Study Course in October, just in time for those planning to take their certification exam in November. The four-week online CBET Study Course covered all six areas of the CBET exam, providing participants with a highly respected instructor and the tools to help them succeed. Each module concluded with a practice exam to help familiarize participants with the exam format. AAMI plans to offer additional study courses in the future.

7The Joint Commission Appoints New Engineering Director

Herman McKenzie was named director of the department of engineering, standards interpretation group at The Joint Commission (TJC) in Chicago, IL. He now leads standards interpretation and customer support activities relative to Life Safety and Environment of Care standards. Previously, McKenzie held the roles of acting director of the department of engineering, senior engineer, and staff engineer at TJC.

In a recent Q&A with AAMI News, McKenzie said he is pleased to “have the opportunity to increase my knowledge so that I can help guide our customers through accreditation and compliance issues. I enjoy being able to teach and share information and I am looking forward to responding to customers seeking assistance in understanding codes and standards.”

CDRH ReorganizationCDRH Launches Reorganization Effort

The FDA’s Center for Devices and Radiological Health (CDRH) implemented a major reorganization in March to make the center more agile and focused on a total life cycle approach to managing medical devices. The long-planned reorganization combines several offices dedicated to the regulation of medical devices into one “super office” and establishes two new offices dedicated to policy innovation. The change was scheduled to be complete by September 30.

New offices within the revamped CDRH structure include the Office of Product Evaluation and Quality, Office of Policy, and Office of Strategic Partnerships and Technological Innovation. The Office of Communication and Education will remain. CDRH also is combining its internal and external communications staff into a Division of Communication with an Internal Communication Branch.

“After full implementation, the reorganization will integrate CDRH’s premarket and postmarket program functions along product lines, allow our experts to leverage their knowledge to optimize decision-making across the product life cycle,” the agency wrote. “This type of structure consolidates and integrates many of the current aspects of product review, quality, surveillance and enforcement into a new, team-based approach.”

AAMI FellowsAAMI Fellows Program Recognizes Health Technology Leaders

In June, AAMI launched the AAMI Fellows Program to celebrate leaders in the health technology and sterilization fields who have also distinguished themselves through their
contributions to the association.

The inaugural class, announced at the 2019 AAMI Exchange in Cleveland, OH, consists of 14 AAMI members who come from various backgrounds. What they share is a commitment to AAMI’s mission of leading global collaboration in the development, management, and use of safe and effective health technology.

AAMI recognizes fellows for the depth and breadth of their accomplishments in seven core areas: professional experience, education, technical contributions, presentations and publications, professional participation, certification, and awards and honors.

The next class of fellows will be announced in June and honored at the 2020 AAMI Exchange in New Orleans, LA, June 12–15.