IMDA eNews 112823

The latest news affecting you and your customers…

from the Independent Medical Specialty Dealers Association

Cybersecurity incident reported per new SEC rules

Henry Schein appears to be the first of the country’s largest medical device companies to disclose a cybersecurity incident since new Securities and Exchange Commission regulations took effect, reports Medical Design and Outsourcing. The new rules require all publicly traded companies registered with the SEC — not just developers and manufacturers of medical devices — to release details of a cyberattack within four days of determining that it has a material impact. Henry Schein announced the attack in an Oct. 15 news release, broadly describing the incident, precautionary actions and the involvement of law enforcement.

Not to worry?

Chinese health authorities have assured the World Health Organization that unusual or novel pathogens are not the cause of a recent increase in outpatient consultations and hospital admissions of children due to pneumonia, RSV and influenza. Chinese surveillance and hospital systems report that the clinical manifestations are caused by known pathogens in circulation.

Faster Medicare coverage for breakthrough devices

Medicare would cover medical devices approved under the FDA’s Breakthrough Device Designation for four years if the “Ensuring Patient Access to Critical Breakthroughs Product Act 2023 (HR 1691) ultimately becomes law, reports Medical Device and Diagnostic Industry. During the four-year period, the Centers for Medicare and Medicaid Services would be required to determine if the devices should be given permanent coverage under Medicare. The act has been passed by a House committee but would need to be passed by the House and then the Senate before being signed into law. The Breakthrough Devices Program is intended to provide patients and healthcare providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization.

More RSV vaccines on the way for infants

The CDC announced on Nov. 16 the release of more than 77,000 additional doses of Beyfortus™ (nirsevimab-alip (100 mg), a long-acting monoclonal antibody designed to protect infants against severe respiratory syncytial virus (RSV) disease. The additional doses will be distributed immediately to physicians and hospitals through the Vaccines for Children Program and commercial channels. CDC and FDA say they will continue to be in close contact with manufacturers to ensure the availability of additional doses through end of this year and for early 2024.

Fewer severe non-COVID respiratory illness among kids: study

Compared to the three years prior to the pandemic, children with medically complex conditions and otherwise healthy children saw decreases in severe non-COVID respiratory illnesses in 2020 and 2021, the authors of a study in JAMA Network Open, reports the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota. Previous studies have shown that the COVID-19 prevention strategies used by many countries were associated with substantial reductions in circulating levels of respiratory syncytial virus and influenza. This is one of the first studies, however, to examine severe respiratory illness occurrence among children with medical complexity and without medical complexity.

2024 Conference: Registration is open!

There’ll be plenty of learning inside and outside the meeting rooms at the 2024 IMDA/HIRA Conference in Orlando, Florida, March 4-6. In general sessions, you’ll receive updates on issues like how to deal with the threat of cyberattacks, how to navigate the world of contracts, and how to meet the clinical and financial needs of your customers. And outside the meeting rooms you’ll exchange ideas with peers during cocktails and shared meals, the Manufacturers Forum, and, of course, the golf course for those of that persuasion. Come to the 2024 IMDA/HIRA Conference. There’ll be a whole lot of learning going on. And it’s all for just $750 for IMDA members. Click here for registration information.