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.

FDA issues two serious patient safety alerts
The notices are unrelated, but both require that clinicians adhere to a set of updated use instructions. One patient died as a result of injury.
FDA announces Class I recall on defective ports used for vein access
There have been two reported injuries linked to the Smiths Medical ProPort Plastic Implantable Ports, many of which are subject to an immediate recall.
FDA issues Class I recall on newborn resuscitation devices
The recall impacts products from ROi, supplied by Mercury Medical. A defective spring can cause a controller to malfunction, resulting in poor ventilation.
FDA announces recall of endoscope sheaths after 26 injuries
While there have been no reported deaths, certain lots of Olympus single-use guide sheath kits are to be quarantined immediately.
FDA approves first therapy for very rare lipid storage disorder
Ctexli (chenodiol) can now be prescribed to patients with cerebrotendinous xanthomatosis, a condition caused by a genetic mutation that leads to cholesterol buildup around vital organs.

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.

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.

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.

Looming fear of more IV shortages as Hurricane Rafael gains strength

The IV solution supply chain is still recovering after Hurricane Helene damaged a manufacturing site in North Carolina.

Walgreens settles class-action fraud lawsuit for $100M

The pharmacy chain is accused of charging insurance more for generic drugs than uninsured customers of its Prescription Saving Club.

FDA recalls infant incubators due to risk of door falling off

A loose screw on the Giraffe OmniBed is to blame. With updated use instructions and repairs, the incubators are safe to use.

Around the web

Cardiovascular Business

ACC urges RFK Jr. to make Medicare reform a priority, warns against mass layoffs

The American College of Cardiology has sent a letter to HHS Secretary Robert F. Kennedy Jr. that outlines some of the organization’s central priorities and concerns.

Radiology Business

FDA announces recall of Medtronic interventional radiology devices after 17 injuries, 4 deaths

One product is being pulled from the market, and the other is receiving updated instructions for use.

AI in Healthcare

What federal regulators can learn from the states about AI oversight

If the Trump administration continues taking a laissez-faire stance toward AI—including AI used in healthcare—why not let the states go it alone on regulating the technology?

Supply Chain

FDA issues two serious patient safety alerts

FDA announces Class I recall on defective ports used for vein access

FDA issues Class I recall on newborn resuscitation devices

FDA announces recall of endoscope sheaths after 26 injuries

FDA approves first therapy for very rare lipid storage disorder

Around the web