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 recall of Medtronic brain surgery support systems

Medtronic has issued a recall affecting several versions of its StealthStation S8 due to a software error that puts patients at risk of serious injury or death.

FDA announces recall of Optum infusion pumps over risk of serious malfunctions

The Nimbus II Plus infusion pumps are being recalled due to multiple malfunctions that could put patients at risk.

M&A mergers and acquisitions business deal

Ecolab selling its surgical solutions business for $950M

Medline has entered into a “definitive agreement” to buy the surgical division, giving the company access to a variety of surgical supplies and equipment used by clinicians and patients.

FDA announces recall of SonarMed airway monitors after injury

Medtronic brand SonarMed airway monitors and acoustic sensors are being recalled due to a risk of breathing obstruction and lung tissue damage.

FDA announces recall of infusion pumps after thousands of complaints, 1 death

InfuTronix has received 3,698 complaints related to device failures of its Halo Ambulatory Infusion system and other Nimbus pumps.

FDA announces recall of more than 2 million catheter parts, citing serious health risks

Fresenius Medical Care is issuing a recall on 2,192,535 catheter extensions and adapters used in patients with acute and chronic kidney disease.

Joint replacements recalled after FDA safety warning

The FDA initially made the complaint in January. Exactech has agreed to recall products at risk of chemical oxidation as a result of faulty packaging.

Amazon brings shipping muscle to Lilly drug delivery

Amazon continues its march into healthcare as LillyDirect will begin working with Amazon Pharmacy to fill home delivery orders of certain diabetes, obesity and migraine medications.

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