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 issues recall on infusion pump parts due to risk of uncontrollable drug flow

Due to a risk of fatal overdose, the recall is labeled as the most serious of its type. While no patients have died, two have reportedly been injured.

FDA recalls Medtronic video laryngoscopes due to risk of explosion

One person has been reportedly injured and the recall has been labelled "most serious" by the FDA.

Baxter sells kidney care division to private equity firm for $3.8B

Carlyle Group will be the new owner of Vantive, once the sale finalizes in early 2025.

FDA recall on ventilators ranked ‘most serious’ after patient injury

Baxter is recalling its Life2000 Ventilator system due to a faulty battery charging dongle that could cause the systems to shut off during use.

FDA and Medtronic issue recall on endotracheal tubes due to risk of death

All Medtronic EMG Reinforced Endotracheal Tubes are being recalled due to a risk of collapse that could lead to serious injury or death.

In a national survey, 89% of cancer centers report drug shortages

Respondents said supply chain issues are running afoul of prior authorization requirements, leading to delays in patient care.

CVS Health announces $10.6B acquisition of Oak Street Health

CVS generic drugs twice as likely to be recalled over safety concerns, investigation finds

CVS generics have been linked to more than 15 manufacturers cited for producing allegedly contaminated drugs.

FDA announces recall of Medline endotracheal tubes after three injuries

The Medline Sub-G endotracheal tubes with subglottic suction are defective and known to tear, potentially leading to serious injury or death.

Around the web

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?

Cardiovascular Business

Boston Scientific enters renal denervation market with acquisition worth up to $540M

Boston Scientific has announced another significant M&A deal, scooping up an Israeli medtech company focused on RDN 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