AAMI News September 2016

News in Brief

A Call for Papers

AAMI will devote the spring 2017 edition of its award-winning supplement Horizons to clinical alarm management.

Proposals are being accepted until Nov. 2. Those interested in submitting a research article, systematic review, case study, commentary, or other type of paper should email Senior Editor Gavin Stern at gstern@aami.org. Authors should specify in 200 words or less the topic of the proposed manuscript and describe how it will advance the literature on the subject.

Prior to publication, manuscripts will undergo peer review. The content of Horizons is indexed and searchable on various healthcare and scientific databases, including PubMed.

FDA Decides Against Regulating Fitness Trackers, Wellness Apps

WearablesThe Food and Drug Administration (FDA) confirmed it will not regulate low-risk general wellness products, such as exercise equipment, video games, and fitness trackers, in final guidance released this summer.

In the document, titled General Wellness: Policy for Low Risk Devices, the agency provides examples to help define whether a product is considered a “wellness device” or a “medical device” that falls under the FDA’s regulatory authority. The dividing line is whether the technology makes a medical claim, according to the agency.

Wellness products do things like promoting a healthy weight, managing stress, enhancing learning capacity, or improving mental acuity, the FDA said. They do not treat or diagnose a specific health condition, such as obesity or autism.

South Carolina Medical Association Partners with Analytics Firm

The South Carolina Medical Association (SCMA) has joined forces with KaMMCO Health Solutions (KHS) to build a statewide network that it says will help doctors share real-time patient data and other health information. The initiative is intended to improve clinical outcomes, reduce inefficiencies, and improve patient safety, SCMA said in a news release.

“SCMA members are continuously seeking opportunities to improve patient encounters and health outcomes. In keeping our priorities aligned, SCMA is positioned to help physicians across the state realize success,” SCMA President Alexander Ramsay, MD, said in a statement. “Partnering with KHS allows us to support the physicians of South Carolina with benefits unlike any other professional association when it comes to data analytics relevant to both patient care and the successful transition to alternative payment models. This is a win–win for all South Carolinians.”

KHS is a subsidiary of the Kansas Medical Mutual Insurance Company, a medical professional liability insurer affiliated with the Kansas Medical Society. The initiative is expected to launch sometime this fall.

Pediatric Medical Device Innovators Compete for Funds

Up to six medical device innovations that address a significant, yet unmet pediatric need will be awarded a maximum of $50,000 each following the “Make Your Medical Device Pitch for Kids!” competition on Oct. 8. In addition to the prize money, winners will receive consultation services from the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), an FDA-funded consortium, to assist in the development of a commercializable product.

Competition finalists will pitch their medical device ideas to a panel of judges at the fourth annual Pediatric Surgical Innovation Symposium, hosted by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System in Washington, D.C.

“This year, we are combining our annual FDA-funded consortium pitch competition with our Institute’s annual symposium to bring greater attention to promising devices and give competition participants more exposure to investors, policy makers, and children’s hospital executives that evaluate pediatric innovations,” said Kolaleh Eskandanian, PhD, executive director of the Sheikh Zayed Institute for Pediatric Surgical Innovation and NCC-PDI. “Our goal is to bring needed devices to children faster and to focus greater attention to helping bridge the gap that often follows the prototyping phase in the device development life cycle.