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 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.

FDA issues Class I recall of brain fluid drain kits after 15 injuries

Two lines of Medtronic Neurosurgery EDMS kits are at risk of developing cracks that could expose patients to pathogens or cause cerebrospinal fluid to leak.

FDA greenlights first non-opioid treatment for severe pain in 20 years

Journavax was shown in clinical trials to be safe and effective, with no addictive potential.

DOJ settles $17M kickback case with catheter supplier

Liberator Medical Supply was accused of offering doctors kickbacks, such as discounted and free supplies, in exchange for filling prescriptions with its products.

FDA warns of risk of death associated with multiple sclerosis drugs

The agency found 82 cases of anaphylaxis associated with glatiramer acetate, sold under the brand names Copaxone and Glatopa, including 19 that emerged after patients had been taking these drugs for more than a year.

FDA issues warning on endoscopes after injuries, death from infections

All lots of Olympus-branded endoscopes are subject to an alert from the FDA, due to a sanitation issue associated with improper reprocessing.

FDA issues Class I recall on counterfeit infusion pump batteries

ICU Medical alerted customers to knockoff batteries being circulated by suppliers. Due to a risk of the batteries not holding a charge, the recall has been given the FDA’s most serious designation.

FDA issues alert on PCNL sheath safety after patient death

Trokamed sent a letter to customers warning them to never use its Mini PCNL Sheaths for suction and irrigation, due to a risk of kidney rupture.

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