Supply Chain

Managing supplies is a crucial part of moving medical products from the manufacturer to patient’s bedside. Efficient supply chains can reduce healthcare costs and make medical devices more affordable for patients and health systems. This news page includes content on supply shortages, inventory management, and procurement practices.

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FDA issues Class I recall on insertion tubes after manufacturing error

Specific FHC-branded insertion tubes used in brain surgery are 20mm longer than expected and could pose a serious risk to patients. 

FDA recalls brain biopsy needles due to stainless steel debris

There have been no reported injuries. However, due to the risk of death or paralysis associated with metal debris entering brain tissue, the recall is designated Class I, the most serious of its type. 

FDA issues Class I alert on Philips ventilators after 4 injuries

All serial numbers and lots of several Philips ventilators are at risk for damaged airflow sensors if used with in-line nebulizers.

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FDA issues Class I recall of infusion pump batteries due to risk of burns

Rechargeable batteries used on CADD-Solis Li-ion infusion systems may short out if damaged, possibly causing the case to melt. No injuries have been reported.

Orano Med breaks ground on $265M thorium production site

The new 7,000-square-meter plant is located in France and will begin production of thorium-228, necessary for the development of isotopes used in cancer treatments. 

Main bridge access into the facility that was heavily damaged by the flooding. Photo by Aerial Lens.

Baxter reopens second production line at North Carolina IV solutions site

The plant is now operating at 50% of its pre-Hurricane Helene levels, as Baxter aims to reach full capacity by the end of the year.

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Medtronic sued by doctor for alleged patent infringement

Shirin Towfigh, MD, and her consultancy firm, Hexagon Health, claim Medtronic is selling patented surgical mesh with a novel fin-shaped design. 

phenylephrine FDA

FDA set to ban certain over-the-counter cold medications

Oral decongestants containing phenylephrine were found not to be effective. However, nasal sprays of the same drug are not subject to the FDA’s proposed order.

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Around the web

AI in Healthcare
4 ways HHS plans to help shape a national strategy for healthcare AI

HHS has thought through the ways AI can and should become an integral part of healthcare, human services and public health. Last Friday—possibly just days ahead of seating a new secretary—the agency released a detailed plan for getting there from here.

Cardiovascular Business
FDA announces recall after Philips heart monitor software failed to send alerts—multiple deaths reported

Philips is recalling the software associated with its Mobile Cardiac Outpatient Telemetry devices after certain high-risk ECG events were never routed to trained cardiology technicians as intended. The issue, which lasted for two years, has been linked to more than 100 injuries. 

Cardiovascular Business
Why electrophysiologists needed a champion in Washington

Heart Rhythm Society President Kenneth A. Ellenbogen, MD, detailed a new advocacy group focused on improving EP reimbursements, patient care and access. “If you’re not at the table, you’re on the menu," he said.