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 designates recall of Hamilton breathing circuits a Class I
Two lots of breathing circuits manufactured by Hamilton Medical have a defect that could cause the tubing to splinter. The affected devices must be quarantined, as they cannot be safely used on patients.
FDA announces recall of Integra applicators due to sanitation risk
Multiple lots of extended tip applicators from Integra LifeSciences could put patients at risk of serious infection, prompting the FDA to designate the recall as Class I.
B. Braun recalls IV solutions over serious patient safety risks
Two lots of IV solution bags from the company were found to contain particulate matter that could cause blockages in blood vessels, killing a patient. To date, no serious adverse events have been reported.
Error with Tandem insulin pumps causes 700 adverse events, 59 injuries
A malfunctioning speaker is being blamed for the error code, which effectively pauses infusions on t:slim X2 insulin pumps. Tandem Diabetes Care has promised to release a software patch to improve the safety of the devices.
FDA issues early alert on Baxter infusion pumps after 3 serious injuries
Some Baxter Novum IQ pumps have a software issue that can cause the “run” screen to go blank or trigger another system error, potentially resulting in inadequate infusion. The company has issued updated use instructions to ensure safe operation.

Wisconsin company to begin producing medical isotopes next year

The company’s CEO, Greg Piefer, detailed the plans at the Wisconsin Entrepreneurs’ Conference on June 2, stating that production would be achieved via small-scale nuclear transmutation.

An example of spectral cardiac CT being used to show iodine density in the myocardium to show perfusion deficits. Shown by Philips healthcare at ACC 2022.

VIDEO: Mitigating the contrast media shortage impact on CT imaging

Brian Ghoshhajra, MD, MBA, division chief, cardiovascular imaging, Massachusetts General Hospital and associate professor of radiology, Harvard Medical School, explains the impact of the iodine contrast shortage on computed tomography (CT) and cardiac imaging.

Contrast shortage update: GE expects supply to 'progressively recover' soon

Production at the facility in Shanghai is expected to be near 100% starting on June 6.

Iodine contrast being loaded into a contrast injector in preparation for a cardiac CT scan at Duly Health and Care in Lisle, Illinois. The contrast shortage is causing some healthcare organizations to postpone exams and procedures and ration contrast supplies. Photo by Dave Fornell

ACR working with FDA and HHS to help address imaging contrast shortage

The American College of Radiology (ACR) announced this week its government relations staff has been engaging federal agencies in an effort to improve product availability and hasten resolution of the ongoing iodine contrast shortage.

Eric Williamson, MD, MSCCT, the president of the Society of Cardiovascular Computed Tomography (SCCT) and professor of radiology at Mayo Clinic, explains how the iodine contrast shortage is causing issues for cardiac CT imaging. He discusses ways imagers can stretch they iodine contrast supplies and some technologies that might help conserve contrast. #contrastshortage

VIDEO: Contrast media shortage impacting cardiac CT imaging

Eric Williamson, MD, president of the Society of Cardiovascular Computed Tomography (SCCT) and professor of radiology at Mayo Clinic, explains how the iodine contrast shortage is causing issues for cardiac CT imaging and ways this can be mitigated.

FDA posts guidance on managing risk of drug shortages

The Food & Drug Administration has drafted guidelines to help U.S. healthcare better prepare for and respond to events associated with these situations.

A comparison between a traditional iodine contrast angiogram (left), and a gadolinium contrast angiogram (right). MRI gadolinium contrast is starting to be used in some interventional radiology procedures and is being considered in interventional cardiology due to the iodine contrast shortage.

Gadolinium can be used as substitute for iodine contrast in some interventional imaging procedures

Gadolinium might be an alternative, stop-gap solution for interventional procedures during the current iodine contrast shortage.

FDA asks drug makers to address shortages

Drug shortages have been impacted by COVID-19, with 95% of doctors believing the pandemic exposed weaknesses in the medicine supply chain.

Supply Chain

FDA designates recall of Hamilton breathing circuits a Class I

FDA announces recall of Integra applicators due to sanitation risk

B. Braun recalls IV solutions over serious patient safety risks

Error with Tandem insulin pumps causes 700 adverse events, 59 injuries

FDA issues early alert on Baxter infusion pumps after 3 serious injuries