IMDA eNews 080123

The latest news affecting you and your customers…

from the Independent Medical Specialty Dealers Association

Public companies must report cyberattacks

Publicly traded companies – including medical device manufacturers — must publicly disclose significant cyberattacks under new rules approved by the Securities and Exchange Commission, reports Medical Design & Outsourcing. The SEC rules require all publicly traded companies in the U.S. to release details of a cyberattack within four days of determining that it has a material impact. That determination comes down to whether “there is a substantial likelihood that a reasonable person would consider it important,” the SEC said. Companies would be able to delay disclosure if the U.S. attorney general determined the information’s release would create a significant national security or public safety risk.

Lung disease scanner funded by Australian government

The Australian government has granted US$740,000 to 4D Medical for the development of a new lung disease scanner. The company’s XV-Perfusion lung scanner measures both ventilation (air flow) and perfusion (blood flow) throughout a patient’s lungs during a breath. 4D Medical is developing the new generation scanner as part of the Australian Lung Health Initiative. The investment complements the government’s commitment to establish a new National Lung Cancer Screening Program, which will target heavy and/or long-term smokers aged 50 to 70 years who are not already showing symptoms of lung cancer. The screening program will use low dose computed tomography (LDCT) screening delivered in mobile clinics.

Vaporized hydrogen peroxide gets boost as EtO alternative

The U.S. Food and Drug Administration has adopted an international sterilization standard to give medical device manufacturers another alternative to ethylene oxide (EtO), reports MedTech Dive. Manufacturers can now make declarations of conformity to the International Organization for Standardization’s recommendations on low-temperature vaporized hydrogen peroxide in submissions to the FDA. The FDA framed the addition of the ISO test to its Recognized Consensus Standards database as a response to pressure to reduce EtO use and the need to support supply chain resiliency.

Three ventilation devices removed from shortage list

The FDA removed three ventilation-related devices from its medical device shortages list as supply chain issues from the pandemic continue to improve, reports Medical Design and Outsourcing. The devices are 1) non-continuous ventilators (product code: BZD), 2) non-life-supporting continuous ventilators (product code: MNS) and 3) continuous ventilators with minimal ventilatory support for facility use (product code: MNT). All had been in short supply due to the global semiconductor shortage and good manufacturing practices requirement compliance. Increase in demand was another factor specific to non-continuous ventilators, which had been in short supply since at least August 2020. The shortage of the two continuous ventilators started as early as September 2021.

Health system deploys gun detection video

Lubbock, Texas-based UMC Health announced it has deployed an AI gun-detection technology developed by ZeroEyes, Conshohocken, Pennsylvania. Gun images will instantly be shared with the ZeroEyes Operation Center, staffed 24/7/365, who will verify the threat and dispatch alerts, including visual description, gun type, and last known location, to local staff and UMC Police Force as fast as 3 to 5 seconds from detection. “When you study active shooter events, most of these events begin outside of the building,” said Jeff Hill, senior vice president of support services. “The idea with this type of surveillance is to identify these threats quicker so that we can intervene as soon as possible, resulting in saved lives.”