AAMI News May 2018

News in Brief

France Invests $1.85B in AI Spending

After seeing France fall behind artificial intelligence (AI) leaders like the United States and China, French President Emmanuel Macron has announced that his country will invest $1.85 billion of public funding into AI pursuits over the next four years. The top driver of that investment? Using AI to spur better and more effective healthcare.

“Innovation that artificial intelligence brings into healthcare systems can totally change things: with new ways to treat people, to prevent various diseases, and a way—not to replace the doctors—but to reduce the potential risk,” Macron said in an interview with Wired magazine. “You can totally transform medical care, making it much more predictive and personalized, if you get access to a lot of data.”

To that end, Macron announced an effort to open public healthcare data for AI-based use, as well as change regulations to encourage French-trained scientists to gain employment closer to home, promoting greater collaboration between public and private researchers, and encouraging AI startup companies to take hold in France.

Foundation to Publish Alarm Management ‘Quick Guide’

The AAMI Foundation is set to publish the fourth installment in its series of infusion therapy “quick guides,” Managing Smart Pump Alarms: Reducing Alarm Fatigue, this summer. This free resource was developed by the National Coalition for Infusion Therapy Safety to help clinicians reduce the number of and improve the response to infusion pump alarms. Unchecked, these alarms can fatigue clinicians and adversely affect patient care.

This resource will complete the AAMI Foundation’s infusion therapy quick guide series, which was developed to help clinicians more effectively manage different aspects of infusion care. The other guides focus on multiple IV infusions, smart pump compliance and drug libraries, and optimizing patient outcomes.

“Our intent was to create a series of convenient, user-friendly guides for those who operate and manage infusion technology that provides them with guidance and best practices to help improve patient safety,” said Jim Piepenbrink, deputy executive director of the AAMI Foundation. “All of the resources produced by members of the Foundation’s National Coalition for Infusion Therapy Safety—the guides, seminars, and manuscripts—are the work of some very talented and dedicated volunteers, many of whom are in industry or are working in healthcare organizations. We couldn’t do this without their efforts and their willingness to share their stories and their lessons.”

To download the infusion therapy quick guide series, visit www.aami.org/infusiontherapysafety.

International Regulators Approve Clinical Evaluation Work Item

Regulators attending a March meeting of the International Medical Device Regulators Forum (IMDRF) in Shanghai, China, have agreed to conduct a global study on clinical evaluations of medical devices, a step forward in efforts to increase global harmonization of medical device regulations. The proposal was “unanimously supported by participating members,” said the China Food and Drug Administration (CFDA) in a statement.

The new work item proposal for the “clinical evaluation of medical devices,” which was developed by the CFDA in collaboration with industry trade association AdvaMed and the U.S. FDA, seeks to conduct international, collaborative research to determine basic requirements of clinical trial decision making and the acceptance of data from clinical trials conducted overseas, according to the CFDA.

This work will “provide guidance for regulators to determine when a clinical trial is needed and to allow for the use of foreign clinical data in submissions,” Greg Crist, executive vice president of public affairs at AdvaMed, told Regulatory Focus.

The new work item proposal was the first put forth by the CFDA, which is currently serving as the rotating chair for the IMDRF. The action marks a milestone for the CFDA as China moves from a participatory role to “a leader in the rulemaking of international standards recognition in the medical devices area,” the CFDA wrote.

The IMDRF meeting was attended by regulatory representatives from the United States, the European Union, Japan, and others.

Researchers Develop 3D-Printed Stethoscope

3D-stethoscope
The 3D-printed stethoscope

Why buy routine medical equipment when you can print it yourself? That’s what researchers at Western University’s School of Medicine & Dentistry in Canada have accomplished with a 3D-printed stethoscope made of the same plastic used in Legos.

The stethoscope, which was designed using open-source software and costs about $3 to make, was described by researcher Tarek Loubani as “the first open-source medical device that has been clinically validated and is widely available” in a press release. It is intended to be used in areas with limited access to medical supplies, such as warzones.

“We wanted physicians and allied healthcare professionals to be able to have something that was high quality,” said Loubani, who worked as an emergency physician in Gaza during wartime when medical supplies were often difficult to come by.

Based on the results of a clinical validation study published in the open-access journal PLOS One, the acoustic quality of the 3D-printed stethoscope was the same as that of a premium brand.