Fran Kritz

The Centers for Medicare and Medicaid Services (CMS) put a hold on implementing a final rule that would have provided immediate Medicare reimbursement for devices authorized through the Food and Drug Administration’s (FDA's) Breakthrough Devices Program.

Brian Stallard

AAMI will soon launch the latest installment in a growing collection of best practices and strategies for the sterilization of medical devices and tools. The new document, titled Industrial Sterilization: Challenging the Status Quo, Driving for Continuous Improvement, will a freely available and peer-reviewed supplement to AAMI’s journal, BI&T. The series represents a unique collaboration between medical industry leaders,

Randolph Fillmore

In an April 1 letter to health care providers, the U.S. Food and Drug Administration warned of possible patient infections from reprocessed urological endoscopes.

Brian Stallard

Changes to how the European Commission will use standards to support medical device regulation are leaving standards developers with concerns, questions, and uncertainty about the future of international standards harmonization.

Wava Truscott, PhD, MBA

Pieces of lint are thought of as fluffy, soft, flexible little things. What harm could they possibly do if left in a wound after an invasive procedure? The truth is that they can seriously affect patient quality of life and even threaten their mortality. A STERILIZATION CENTRAL feature.

Randolph Fillmore

The FDA’s Center for Devices and Radiological Health (CDRH) has affirmed the value of using Real World Evidence (RWE) in FDA regulatory decision making, offering a detailed series of examples in a report of RWE usage in premarket and postmarket decisions.

Herman McKenzie, MBA, CHSP, director of the Department of Engineering, Standards Interpretation Group, at The Joint Commission answers questions posed by AAMI members.

Chris Hayhurst

The good news for AAMI members with an eye toward education in 2021 is that despite the limitations imposed by the pandemic, the list of courses you can choose from is growing by the day.

Fran Kritz

A review by researchers at UCLA found that most methods used by healthcare systems to process N95 masks, intended for single use, are likely to do an adequate job of preparing the equipment for reuse.

Axel Wirth

A Cyber Insights post: Chief security strategist Axel Wirth analyzes how healthcare cybersecurity fared in 2020.

The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) is accepting applications through April 12, 2021, for its annual “Make Your Medical Device Pitch for Kids!” competition. This year’s competition focuses on innovations in pediatric devices that treat congenital heart disease.

AAMI recently announced that the annual AAMI eXchange is being redeveloped into a fully virtual event for 2021. Now, we are ready to share what’s in store for June 7 to 11 at the AAMI eXchange REWIRED.

The AAMI Board of Directors and Nominating Committee are welcoming two seasoned professionals: Ralph Basile, vice president of marketing and regulatory affairs for Healthmark; and Susumu Nozawa, head of regulatory affairs, North America, for Siemens Healthineers.

The AAMI standards community is mourning the passing of Jo-Ann Barbara Maltais, Ph.D., an experienced executive and advisor for medical device and drug development who led the design and implementation of several crucial AAMI standards.

Martha Vockley

Innovators in the health technology industry are powering through these issues to come up with crowdsourced, future-oriented solutions. Last fall, the U.S. Department of Human Services (HHS) challenged industry with a 10-day COVID-19 At-Anywhere Diagnostics Design-a-Thon to develop innovative health tools.

A fun Q and A with Fred Moxley, senior meetings manager at AAMI.

A fun Q and A with Sherrie Schulte, vice president of education at AAMI.

Chris Hayhurst

More than a year after COVID first hit, educators and education-program leaders all say the same thing: Nothing about the pandemic has been routine or expected, but the courses and the teaching and the learning all continue—health tech training has hardly missed a beat.

Brian Stallard

The AAMI Foundation is pleased to announce that Joyce Hansen, VP, Johnson & Johnson Microbiological Quality and Sterility Assurance, has been appointed to the AAMI Foundation board of directors.

A fun Q and A with Kasey Fuelling, director of training solutions at AAMI.