Sara Roncero-Menendez

What happens when a student of HTM professional wants to leverage their repair skills to design medical devices? At the University of Windsor in Ontario, Canada, a newly launched stream of courses is designed to do just that—to teach HTM students how to design new, innovative biomedical equipment.

Susan Klacik and Sarah Friedberg

AAMI's Sterilization Hospital Practices Working Group (WG 40) is known for developing the state-of-the-art standard for steam sterilization and sterility assurance in healthcare facilities, ANSI/AAMI ST79. But that's not all they've worked on! The WG 40 co-chairs provide a glimpse of what's on the horizon in this SETTING STANDARDS column.

Who are some of the hardest working folks in health standards development? This year's AAMI Awards in standards were defined by the passionate (and productive!) sterility assurance community who ensure the safety of patients and staff everywhere.

“We have such confidence in the processes that produce safe and sterile medical devices thanks to, in no small way, John’s work and leadership." The AAMI community and sterile processing professionals everywhere are mourning the passing of John Masefield, founder of Isomedix corporation.

AAMI members interested in giving back to the HTM field have the opportunity to join the association's Technology Management Council (TMC) and Healthcare Technology Leadership Committee (HTLC). Applications are due by April 16. 

Jennifer Peters

Cybersecurity concerns were front and center the Healthcare Information and Management Systems Society 2022 Global Health Conference & Exhibition (HIMSS22). And the frequency of incidents is increasing.

Maggie Berkey, CBET

Dread seeing the infamous "broken" note taped to a vital signs monitor? Don't panic! Senior BMET Maggie Berkey breaks down some easy steps for determining just what has gone wrong in AAMI's TROUBLESHOOT IT column. 

Eric Henry & Scott Thiel

Manufacturers of AI-enabled medical devices are faced with a dilemma: Push the boundaries of innovation or wait for regulatory legislation and guidance to catch up? In this COLLECTIVE LEARNING ON AI/ML column, two regulatory and compliance experts explore important considerations and a hypothetical case study for MDMs.

Ken Hoyme

The frequency of reported cybersecurity vulnerabilities that may affect medical devices has sped up during the past few years, with no sign of abating. Ken Hoyme, a senior fellow of global product cybersecurity at Boston Scientific, dives into what the problem is and what manufacturers need to understand to avoid them in this CYBERINSIGHTS column.

Fran Kritz

As Russia’s invasion of Ukraine continues, U.S. government agencies, industry associations, and private cybersecurity firms are urging hospitals to protect their medical data, devices, and equipment from potential cyberattacks.

Fran Kritz

Medical device cybersecurity has been a recent point of focus for the U.S. FDA's CDRH. AAMI news takes a closer look at some of the cyber-related  “programmatic accomplishments” the organization has outlined in a recent report.

Gavin Stern

The AAMI Nominating Committee has selected new leaders to serve on the AAMI Board of Directors, representing a significant change in the membership of the Board.

Brian Stallard

"Customers are looking for best practice for using these deeply customizable management systems, and now there is one.” A new white paper from the AAMI-sponsored CMMS Collaborative project has been published to create a standard categorization for all work activities carried out by HTM personnel.

Martha Vockley

It's a transition that will be "a major undertaking for manufacturers and it will have ramifications for healthcare systems, providers, and patients as well."  After issuing more than 900 EUAs for medical devices during COVID-19, the U.S. FDA is now accepting comments on its plan to transition to normal operations.

Randolph Fillmore

On March 8, the Cybersecurity and Infrastructure Security Agency (CISA) and Food and Drug Administration (FDA) published advisories describing vulnerabilities associated with the Axeda agent and Axeda Desktop Server. These web-based technologies, owned by the software company PTC, allow multiple people to view and operate the same remote desktop through the Internet.

Gavin Stern

In a meeting of the FDA’s Device Good Manufacturing Practice Advisory Committee on March 2, committee members and the public weighed in a proposed rule with far-reaching implications for the medical device industry—an alignment of the FDA’s Quality System Regulation (21 CFR 820) with the international consensus standard for devices, ISO 13485:2016.

Brian Stallard

Telemedicine has taken significant strides during COVID-19. But once the public health emergency declarations are over, will U.S. state and federal policy still allow innovative telehealth services? AAMI News explores.

On Wednesday April 13, don't miss MDM West 2022's hot topics in engineering quality Assurance. AAMI is sponsoring a track of sessions which delve into the FDA's pivot to ISO 13485, the rise in AI, evolving combination products, connected medical devices, and much more.

Martha Vockley

A shortage in ICU clinicians is driving demand for a technology once thought "novel" in healthcare systems: Virtual ICUs. The billion-dollar VICU market is rapidly growing. Here's how local hospitals are adopting this game-changing technology.

Susan Klacik, Clinical Educator, HSPA

The latest version of ST91 is introducing some big changes for flexible and semi-rigid endoscope processing in healthcare facilities, with special attention to staff and patient safety. Susan Klacik, clinical educator of HSPA, outlines some of what makes the newly published standard different.