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 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.

Federal judge sides with FTC; case against PBMs to move forward

A federal court dismissed a counterclaim from CVS, UnitedHealth and Cigna that sought to halt the case on constitutional grounds.

The flooded Baxter North Cove IV bag plant in North Carolina with its flags at half mast for the more than 250 people killed by Hurricane Helene, including at least one Baxter employee. Baxter photo

Baxter’s Asheville site now fully operational after damage from Helene

Hurricane Helene devastated the North Carolina manufacturing site, causing a nationwide shortage of IV solutions.

FDA announces recall of dangerous arterial catheters

While there have been no reported injuries, a manufacturing error involving debris contamination could potentially kill a patient.

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?