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.

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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. 

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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. 

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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. 

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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.

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FDA announces emergency recall of oxygen concentrators after spontaneous fires

There have been no injuries. However, due to the serious risk of death, the devices manufactured by Jiangsu Jumao X-Care Medical Equipment must be removed from the market immediately. 

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Around the web

Radiology Business
Society of Interventional Radiology seeks AMA resolution urging payments on high-cost disposables

"The number of non-facility services reimbursed at less than direct costs grew 50% since 2024. The number of services under the MPFS for which reimbursement does not even cover cost likely is much higher than 300 services," the proposed AMA resolution states.

Cardiovascular Business
FDA wants new heart damage warnings added to COVID-19 vaccines

COVID-19 vaccines are associated with a very low risk of myocarditis and/or pericarditis, primarily in young adults. The long-term impact of this risk has been the subject of many studies and debates over the years. One side says that the benefits of vaccination far outweigh the risks, and the other side says that even the smallest risk of heart damage is too high.

Cardiovascular Business
Cardiology employment models undergoing a dramatic shift

Gerald G. Blackwell, MD, MBA, MedAxiom's president and CEO, examined how different cardiology employment models look today compared to even a decade ago.