AAMI News February 2020

News in Brief

First AAMI Consensus Report Demystifies IEC 60601 Series

AAMI has published its first consensus report—a new kind of document developed to provide concise, prompt, and practical guidance on narrowly focused topics of high importance to the health technology community.

“The pace at which technology is evolving makes it difficult for traditional standards and technical information reports to keep up. AAMI members have voiced the need to have quicker guidance on issues where limited data exist, where there is variation in practice, or where there is confusion among stakeholders,” said Jen Padberg, AAMI senior vice president of standards program and policy. “To that end, the AAMI staff have, with consultation from members, developed a process by which much more rapid guidance can be provided in a new deliverable—an AAMI consensus report on emerging issues, or consensus report.”

 
AAMI CR500:2019, Basic Introduction to the IEC 60601 Series, is intended to clarify and to point out the importance of the IEC 60601 series of standards, as well as to provide guidance to understanding and to implementing the series. It is available in the AAMI Store at www.aami.org/store.


Fujifilm to Buy Hitachi Medical Imaging for $1.56B

Fujifilm entered into an agreement to buy Hitachi’s medical imaging business for about $1.56B. The deal would give Fujifilm an estimated 8.4% share of the global radiology device market, putting them in the same league as other global medical imaging companies like GE Healthcare, Philips, and Siemens, which hold over 20% of the market share, and Canon, which holds 9.5%. The deal is expected to close in July 2020.

“Fujifilm will further expand the business in the global market through cross-selling, utilizing the extensive sales channels of both companies,” said the company in a news release.

Hitachi’s current diagnostic imaging systems include computed tomography, magnetic resonance imaging, X-ray, and ultrasound. Fujifilm plans to incorporate its imaging processing and artificial intelligence technologies into new medical imaging solutions.


AAMI to Offer CBET Review Course in April

AAMI will again offer its popular review course to help biomedical equipment technicians (BMETs) prepare for the Certified Biomedical Equipment Technician (CBET) certification exam.

The eight-session CBET Study Course will be held every Monday and Wednesday evening, 7–9 p.m. starting Monday, April 6, and ending Wednesday, April 29. All sessions are recorded, so you can begin the study course at any time up until the end date.

These intensive online sessions cover each area of the CBET exam outline, including anatomy and physiology, public safety in the healthcare facility, fundamentals of electricity and electronics, health technology and function, health technology problem solving, and health information technology.

For more information and to register, visit www.aami.org/Certification.


FDA Final Rule on Submissions in Electronic Format

Medical device premarket submissions are now required to be sent in electronic format, according to a final rule issued by the Food and Drug Administration (FDA) on Dec. 16.

“We are taking this action to improve the efficiency of FDA’s premarket submission program for medical devices,” wrote the agency in a public notice, while adding that the new rule, which has been published in the Federal Register, would eliminate the need for multiple paper submissions.

In the final rule, the FDA wrote that the electronic submission requirement would “produce cost savings for firms without imposing any additional regulatory burdens for submissions or affecting the Agency’s ability to review submissions.” It estimated that the “final rule will result in annualized benefits of $1.76 million at a 3% discount rate and $1.76 million at a 7% discount rate, over 10 years.”


HTMLiveAAMI’s HTM Live! Webinar Series

AAMI has launched a new webinar series just for healthcare technology management professionals, called HTM Live! This series of free webinars connects HTM professionals from around the world with experts who will discuss many of the biggest issues facing the profession, from medical device cybersecurity to reducing alarm fatigue and utilizing analytics.

Visit www.aami.org/events for these webinars and other upcoming events from AAMI. Webinars are recorded and can be downloaded later. For more information, please email dmcgeary@aami.org.


ISMP Merges with ECRI for Improved Patient Safety

The Institute for Safe Medication Practices (ISMP) has become a subsidiary of the ECRI Institute, creating a broader patient safety advocacy organization.

“We’re leveraging both our expertise as well as our call points in the healthcare community,” said ECRI Institute President and CEO Marcus Schabacker in a press release. “Bringing these two entities together gives us very comprehensive coverage of the entire healthcare spectrum.”

“This affiliation is the natural evolution of a stronger partnership between two leading organizations dedicated to improving patient safety,” said ISMP President Michael Cohen in an ECRI press release. “We will now be able to work more closely together to share lifesaving information and further a vision where safe, high-quality healthcare is more readily available.”

Cohen will continue to lead the ISMP. Two ECRI executives will join the ISMP board of trustees.