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.

Contrast protocols based on lean body weight save supplies, reduce patient risk

Adjusting contrast dose based on a patient’s lean body weight provides the same image quality as other administration methods, new data show.

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.

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.

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