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 announces Class I recall of ventilators after 3 patient injuries

An unexpected nickel coating on the breathing circuits of Percussionaire Phasitron 5 ventilators is being blamed for the recall. The FDA is asking providers to stop using them immediately.

Helene damage to bridge Baxter North Cove facility in North Carolina.

Baxter producing IV solutions ahead of schedule at Asheville-area site

The company said its largest production line at its North Carolina plant is operational, accounting for 25% of total output. The site was damaged by flood waters from Hurricane Helene.

FDA issues Class I update on robotic arms due to risk of fire

A protective coating on Jaco Assistive Robotic Arms from Kinova could become damaged, leading to exposed metal causing an electrical fire when it comes into contact with a powered wheelchair.

Smith Medical FDA issues BLU tracheostomy tubes FDA recall

FDA issues Class I recall on tracheostomy tubes after 12 injuries

The Smiths Medical BLUSelect and related products have a manufacturing defect and must be removed from stocks immediately.

FDA approves first RSV vaccine for adults

Pfizer's Abrysvo vaccine can now be prescribed to all adults 18 and older at high risk for severe RSV complications, including pregnant women.

Wartime powers enacted to address nationwide IV fluid shortage

The Biden Administration has invoked parts of the Defense Production Act to address shortages that stem from Hurricane Helene damaging a Baxter production facility in North Carolina.

Employee parking lot is a sea of mud and storm debris at the the Baxter North Cove facility. Photo by Aerial Lens.

Baxter begins importing IV supplies as 86% of providers report shortages

Hurricane Helene severely damaged Baxter's plant near Asheville, North Carolina, leading to a nationwide shortage of IV fluid bags.

Teva settles with DOJ for $450M to resolve latest price fixing allegations

The world's largest generic drug manufacturer allegedly paid charities kickbacks to cover patient co-pays in an effort to inflate the price tag of its multiple sclerosis treatment.

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