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.

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.

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

Baxter closes largest IV solution factory, sparking fears of a shortage

Flood damage forced Baxter to close a facility that makes 60% of IV solutions in the U.S., a loss of 1.5 million bags per day.

FDA announces recall of Pfizer's fast-tracked sickle cell drug

The drugmaker is voluntarily withdrawing Oxbryta from the market due to a higher-than-acceptable risk of death.

FDA announces Class I recall for compounding inlets due to risk of death

Baxter’s disposable inlets for automated compounding systems could pose a serious risk to patients if not properly inspected before use.

FTC sues PBMs and GPOs for insulin price collusion

In a statement announcing its lawsuit, the FTC said Caremark, Optum RX and Express Scripts benefit from manufacturer rebates and ignore lower-costing drugs as a way to artificially increase prices.

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