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.

Cardinal Health recalls some Monoject syringes

The company’s “Cardinal Health”-branded Monoject syringes, released in June 2023, were manufactured by a different contractor and differed slightly in dimensions from the “Covidien”-branded syringes, which could put patients at risk.

Amazon Pharmacy is now delivering medications by done

Amazon Pharmacy now delivering medications by drone, promising orders in 1 hour or less

The new service is now live in College Station, Texas. The drones use a series of sensors and cameras to remain stable and navigate around obstacles as needed.

Medtronic warns of unauthorized sale of dangerous products

Before they were stolen, the McGRATH MAC laryngoscopes in question were set to be destroyed.

Updated branding gives J&J 2 segments sharing 1 name

A healthcare logo familiar to Americans since the 1800s has gotten a makeover.

Governors urge Congress to act now on medication shortages, supply chain insecurities

Eleven GOP governors joined together to call for a more transparent drug manufacturing supply chain.

‘Gray market’ vendors hike up prices during drug shortages, leaving hospitals in a bind

Hospital executives find themselves in a challenging position—pay big bucks for hard-to-find medications or risk letting their patients down.

FDA warning letter details quality concerns, violations at Integra facility

The facility in question is responsible for producing collagen-based medical devices primarily used in wound care, soft tissue repair and complex reconstruction surgeries.

Pfizer facility on Wednesday, July 19, 2023, in Rocky Mount, North Carolina, after damage from severe weather. TRAVIS LONG/THE NEWS & OBSERVER VIA AP

Pfizer plant takes heavy tornado damage, loses approximately 50,000 pallets of sterile injectables

The Rocky Mount, North Carolina-based facility is said to be responsible for producing 25% of Pfizer’s sterile injectables used by hospitals in the U.S.

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