A conversation with Emily Mengel, a clinical engineer with WakeMed Health & Hospitals in Raleigh, NC, who will be presenting at AAMI Exchange 2021 on using 3D printing/modeling within the hospital for COVID-19 response.

Becky Crossley, CBET, shares useful guidelines and troubleshooting tips of the trade for maintaining intravenous (IV) pumps.

Artificial intelligence and machine learning offer promising methods for handling the ever-growing amounts of “big data.” This is especially pertinent in the healthcare industry, which is experiencing a physician shortage.

A 2021 Bright Idea:  Beset by unexpected fiscal constraints, McLaren Health Care system HTM leaders devised a clever plan for replacing all their defibrillators across more than a dozen hospitals, even while reducing costs and labor.

Once again, the AAMI Foundation is accepting applications for a grant program supporting research that will enhance the safe adoption and use of health technology. Recipients of the Mary K. Logan Research Awards are eligible to receive up to $80,000 in funding for their projects.

The FDA’s Center for Devices and Radiological Health (CDRH) and its priorities were “overwhelmed” and “disrupted” by COVID-19 and the massive increase of work that resulted—but there is hope that the coming year will provide a “reset” for delayed work to begin while still managing the COVID-19 response.

This year has brought challenges that we never expected would happen. The changing environments and the speed of change has taken us to new levels of perseverance and resilience. Our workloads, dedication to our family and friends, and the communities we serve has shot up! On top of all these stresses, we’ve struggled with fear of illness, social isolation, economic insecurity, disruption of routine, and anxiety.

In November, the U.S. Food and Drug Administration (FDA) published final guidance that defines “microneedles” and clarifies when a microneedling product may be subject to device requirements.

Like all of us, AAMI member companies were blindsided by COVID-19. But they pivoted quickly from their business plans, collaborated with competitors, and mobilized to ramp up production of critically needed medical devices and supplies—all while keeping employees safe. Here are highlights of some member company efforts:

A widely used standard for steam sterilization has undergone an important update. Four new amendments to ANSI/AAMI ST79:2017, offer users new clarity and fresh guidance to stay in compliance with accrediting bodies

The US FDA has released a new action plan to advance the agency’s oversight of artificial intelligence and machine learning-based medical software. Participation in AAMI AI working groups is an important part of this new effort.

As part of a new direction for AAMI, AAMI AI is focused on guiding the design, use, and regulation of machine learning and artificial intelligence technologies for medical devices.

The decision making of artificial intelligence can oftentimes be ineffable. Experts recently argued that omitting explainability of AI in clinical decision support systems poses a threat to core ethical values in medicine and may have detrimental consequences for individual and public health.

A research team has developed vessels made from a biodegradable metal-polymer conductor membrane. This membrane mimics human blood vessels and can conduct electricity—opening the way to new treatment options inside the body. 

AAMI and the HTM community remember the late Louis Leibow, a generous colleague and a font of knowledge and advice for young healthcare technology professionals.

The FDA has developed a new regulatory framework for ensuring the safety and efficacy of AI-enabled medical device.

A team of researchers have developed an artificial intelligence solution to protect medical devices from malicious operating instructions in a cyberattack, as well as from human and system errors.

As of January 1, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) became responsible for the UK medical device market, leaving UK and EU medical device manufacturers and regulators in a compliance “scramble” with many open questions remaining.