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.

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.

New details emerge on looming medical isotope shortage

The supply of Mo-99 and Tc-99m—the most commonly utilized medical isotopes in the world—could be cut by as much as 40% until the reactor in the Netherlands is up and running again.

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.

The temporary rock bridge is now allowing access to the Baxter North Cove IV bag plant in North Carolina, which has enabled cleanup crews to begin work on the flooded plant that supplies 60% of U.S. IV bags.

Baxter works to get North Carolina IV plants back online as national shortages loom

Baxter's IV plant in North Carolina was flooded by Hurricane Helene. That plant provides 60% of the U.S. supply of IV bags.

Private equity firm buys controlling stake in Surescripts

TPG will not own a majority of the e-prescriber, with CVS Health and Express Scripts maintaining a minority stake.

The Texas State Capital building in Austin where 140 scope creep bills were defeated in 2024 by the Texas medical Association.

Texas sues PBMs and drug manufacturers for insulin price collusion

Two weeks ago, the FTC launched a similar antitrust suit. The pharmacy benefit managers and pharmaceutical companies are accused of artificially raising drug costs through rebates and kickbacks.

money court scale of justice ruling legal settlement

BD settles majority of 38,000 lawsuits over dangerous surgical mesh

Becton Dickinson & Co does not admit to wrongdoing and said the undisclosed settlement will not significantly impact its bottom line.

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