IMDA eNews 091923

The latest news affecting you and your customers…

from the Independent Medical Specialty Dealers Association

FDA to clamp down on cybersecurity of medical devices

Beginning Oct. 1, manufacturers of medical devices must submit to the FDA their plans to monitor and patch post-market cybersecurity vulnerabilities, have a process in place for the secure design and development of devices, and provide a software bill of materials (SBOM), reports Dark Reading. The agency’s focus on medical-device cybersecurity stems from Congressional passage of an omnibus appropriations act in December 2022 that included a section requiring medical-device manufacturers to submit cybersecurity information to the FDA regarding any cyber device.

Best Buy, Geisinger team up for at-home program

A program for at-home chronic-care patients involving Best Buy Health and Geisinger has resulted in a 50% reduction in the time from admission into the program to the time home devices are set up. Patients receive devices—including blood pressure cuffs, body weight scales, thermometers and glucose meters—to monitor their health and transmit data to their Geisinger care team through Best Buy Health’s care-at-home platform, Current Health. Best Buy and Geisinger report a 19% improvement in how well patients follow their care plans by wearing and using their remote technology equipment, and an 18% reduction in technical issues reported.

Assault of hospital workers would be federal crime

Senate legislators introduced a bipartisan bill that would make assault or intimidation of hospital workers a federal crime, reports Fierce Healthcare. Anyone who “knowingly assaults” an individual employed by a hospital or by an entity contracting with a hospital or other medical facility and “interferes with the performance of the duties” of the worker would be subject to fines and up to 10 years imprisonment. Jail time would be increased to a maximum of 20 years should the attacker have used “a deadly or dangerous weapon,” inflicted “serious bodily injury” or committed the attack during a public emergency declaration, according to the text.

Manufacturers contest third-party litigation funding

The Advanced Medical Technology Association (AdvaMed) is asking for federal regulations to protect device manufacturers from lawsuits bankrolled by third-party funders, reports Medical Design & Outsourcing. In a letter, AdvaMed General Counsel and Chief Policy Officer Chris White wrote, “The influx of billions of dollars of third-party litigation funding has fundamentally changed the dynamics of mass tort litigation. They start by funding mass marketing campaigns … then leverage the sheer number of filings, regardless of the merit of each claim, into consolidated proceedings and pressure companies into mass ‘inventory settlements.’” Hernia mesh products were the most targeted medical devices in 2022, according to AdvaMed. CPAP machines were No. 2 due to the Philips Respironics recall.

Talk it up!

Be a hero. Tell your current and prospective manufacturer partners to make plans for the 2024 IMDA/HIRA Annual Conference and Manufacturers Forum, March 4-6, Rosen Shingle Creek in Orlando, Florida. Tell them it’s about exposure, networking, and learning about market trends affecting their business. Mention tee time Monday morning, March 4 – a great way to learn about specialty distribution and enjoy some sun. Then guide them to the IMDA website to learn more. We’ll see them – and you – on March 4th