The U.S. FDA’s CDRH has recently released a new International Harmonization Strategic Plan. This plan includes specific strategies to directly encourage harmonization, convergence, and reliance among medical device regulatory authorities.

After a three-year pilot, the U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) Program is converting to a permanent program. What should you expect? Learn more...

Is your local health system meeting a growing demand for home healthcare? Is your HTM department suddenly doing house calls? AAMI is seeking to survey HTM professionals regarding if and how they are approaching home healthcare and the maintenance of devices intended for a patient's home. Relevant organizations and professionals are welcome to participate in the ongoing survey.

The AAMI Foundation has awarded more than $45,000 in Kilmer grants to researchers focused on improving sterilization practices and patient safety. Discover who the deserving researchers are, and what they aim to accomplish...

When you clean a medical device, how do you know it’s truly clean? How do you know if your staff is trained effectively or if your cleaning tools are working as intended? Microbiology researcher and consultant Michelle Alfa joined AAMI during a special summit on cleaning verification to address these crucial questions and more.

A disaster strikes your hospital. A water line has broken. There’s flooding in the streets. You won’t have access to clean water for hours, if not days. As a sterile processing professional, what can you do to ensure medical devices stay clean and safe for patient use? Two SPD professionals shared stories, tips, and how a new AAMI standard can help.

With an eye on health equity, the FDA’s Center for Devices and Radiological Health (CDRH) has issued an update to the final guidance for the agency’s Breakthrough Devices Program.

Twice a year, the halls of AAMI HQ become filled with conversation, debate, and laughter as thought leaders from around the healthcare space come together for Sterilization Standards Week. But what is this event all about?

“We would encourage anyone in this community who has a global footprint to their medtech operations to look at attending." The 5th International Clinical Engineering & Health Technology Management Congress (ICEHTMC) will be held in Visakhapatnam, India from Nov 10-13, 2023. Hear from the event organizers to learn more...

"This marks an important step in our ongoing commitment to optimize the clarity, predictability, and consistency of the 510(k) Program as CDRH implements MDUFA V." The FDA has published three draft guidance documents proposing recommendations on best practices necessary in a 510(k) submission for increasingly complex medical devices.

How is the American Medical Association approaching artificial intelligence? We asked Jesse Ehrenfeld, president of AMA and AAMI AI co-chair, to explain just that and more in this exclusive Q&A.

AAMI is happy to announce the adoption of a new tranche of ISO guidance documents. Adopted periodically over the past fiscal year, these guidance documents address a range of issues, primarily hospital sterilization, industrial sterilization, and cardiovascular devices. 

During AAMI's inaugural Biologicial Evaluation Standards Week, U.S. FDA representatives offered an update on the agency’s actions and guidelines for manufacturers, including a discussion on conformity assessment of biocompatibility testing. Here's what they had to say...

“I’ll ask them if they’re into mechanical stuff, like tearing apart computers to see how they work. If they’re like, ‘Yeah, actually,’ those are the kids I want to talk to." As the HTM field struggles to fill open positions, we salute the AAMI members who are out in force, helping the next generation discover the crucial career path.

Do you have something to share with the people who use, maintain, and produce medical devices? If this describes you, the application to present at AAMI eXchange 2024 is currently open. Those interested in presenting on key issues in healthcare technology management are strongly encouraged to submit their proposals.

HTM innovation abroad! During a recent conference in Florence, Italy, Yadin David and Tom Judd, leadership from the Global Clinical Engineering Alliance, met with AAMI President and CEO Pamela Arora to talk about the 5th International Clinical Engineering & Health Technology Management Congress (ICEHTMC), scheduled to be held November 10-13, 2023 in Visakhapatnam, India. Find out why it can't be missed...

AAMI’s Technology Management Council is seeking examples of HTM initiatives that have enhanced patient safety, reduced costs, and/or improved hospital processes. The annual “Bright Ideas” program recognizes innovative healthcare technology management (HTM) departments that are implementing creative solutions to challenges.

While much of the world faces a dearth of healthcare technology management professionals, programs in Canada are cranking out newly minted technologists and biomedical equipment technicians faster than the Canadian healthcare industry can hire them.

Artificial intelligence technologies have the potential to profoundly benefit the healthcare industry... "but AI is not a silver bullet...” Open AI, Google, Microsoft, the National Academy of Medicine and even the American Medical Association, major stakeholders in the healthcare sector and beyond, are stepping up to mitigate risks.

Will you be in London for the 2023 International Standards & Regulation Conference? Co-hosted by BSI and AAMI, the hybrid, two-day event will address emerging issues related to medical devices and provide an update on the EU’s MDR transition proposal.