IMDA eNews 020723

The latest news affecting you and your customers…

from the Independent Medical Specialty Dealers Association

Breakthroughs shrunk in 2022

The Food and Drug Administration reported a drop in use of its breakthrough device program in 2022, reports MedTech Dive. Last year, the FDA’s Center for Devices and Radiological Health granted breakthrough status to 135 devices, down from the 213 awarded in 2021. The number of devices with breakthrough status that received marketing authorization rose to 19 from 13. The annual number of breakthrough designations had climbed steadily in the early years of the program. The FDA reported a rise in the number of annual designations from 19 in 2017 to 206 in 2021. However, the figure fell to 164 in the FDA’s 2022 financial year, and was lower still for the 2022 calendar year. The Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program is intended to provide patients and healthcare providers with timely access to these medical devices by speeding up their development, assessment, and review.

Hospitals address ED violence

With roughly 85% of emergency physicians reporting in a recent survey that ED violence has increased over the past five years, health systems are taking action to protect providers and patients, according to a report in HealthLeaders. And while the most visible response is to increase security in the ED, some hospitals are using technology for a more proactive approach. At Sturdy Memorial Hospital in Attleboro, Massachusetts, for example, administrators are using the electronic health record platform to identify ED patients with a history of threatening behavior, which pushes out alerts to the care team. Those alerts not only give providers advance warning, but can allow them to call in behavioral healthcare specialists to help those patients.

‘Leave non-competes to the states:’ AHA and AdvaMed

About 100 organizations, including the American Hospital Association, urged the Federal Trade Commission to extend by 60 days the comment period for a proposed rule that would ban as an unfair method of competition contractual terms that prohibit workers from pursuing certain employment after their contract with an employer ends. Comments on the rule, which would not apply directly to not-for-profit entities, are currently due March 20. AHA believes that questions regarding noncompete agreements’ enforceability should continue to be left to the states. It plans to comment on the rule and work with the U.S. Chamber of Commerce, which intends to challenge the proposal. Also signing the Jan. 31 letter to the FTC was the Advanced Medical Technology Association (AdvaMed).

Vizient Innovative Technology Exchange in October

Vizient is accepting applications for its 2023 Innovative Technology Exchange and is encouraging suppliers of medical equipment and technology who want to showcase their products to healthcare decision-makers to participate. The event will take place Oct. 3 in Dallas and the deadline to apply is April 7. Applications can be submitted here. The annual Innovative Technology Exchange offers selected suppliers the opportunity to demonstrate their technologies to supply chain and clinical leaders from Vizient’s member hospitals and subject matter experts who serve on Vizient member councils. The event is part of a process that can earn candidates a Vizient Innovative Technology contract or designation for their product.