As with personal protective equipment (PPE), infant formula, and toilet paper, the COVID-19 pandemic continues to cause supply chain disruptions—this time causing an Omnipaque shortage. The contrast dye shortage has resulted in reduction and/or delays of the availability of Omnipaque (Iohexol) and Visipague (Idixonal).
These contrast dyes are needed for some imaging tests, including computed tomography (CT scans), which are often used to help diagnose tumors, investigate internal bleeding, or check for other internal injuries or damage and computed tomography angiography (CTA scans), often used in emergency cases, including diagnosis of strokes, aneurysms, and for cardiovascular procedures. During imaging tests, the dyes create contrast in body parts and fluids, making it easier to read scans and diagnose illness and conditions.
The contrast dyes are produced primarily by GE Healthcare, which manufactures the majority of the market share. GE Healthcare said in April that it was rationing orders due to a COVID-19 shut down of its production facility located in Shanghai, China. That Shanghai plant is currently at 50 percent capacity. To address the Omnipaque shortage, some GE manufacturing had previously been moved to a plant located in County Cork, Ireland. While GE expects availability to improve somewhat by this week, a return to full stocking levels is not expected until at least July 2022.
ECRI recently produced an Alert with recommendations for managing the Omnipaque shortage and a list of vendors with functional equivalents.
“This ECRI Alert serves as a crucial piece of information that can help hospitals and other facilities better manage this latest supply chain crisis. And as always, ECRI is available to provide assistance to its members about their specific challenges related to the contrast dye shortages,” says Tim Browne, ECRI’s Vice President – Global Supply Chain Solutions.
ECRI suggests that facilities coordinate with GE Healthcare and wholesalers to ensure that the allocated quantity is accurate based on historical purchases. Facilities should also consult ECRI's complimentary Functional Equivalents Report that provides information about marketed contrast media and lists vendor product availability. The report can also be used to identify equivalent products to assist in navigating product shortages.
Among ECRI’s other recommendations are the suggestion to reserve the contrast dye for critical patients who require contrast-enhanced CT or cardiac catheterization procedures, and to reschedule non-urgent imaging studies until there is an adequate supply. And, If possible, use Iopamidol (Isovue) as an alternative contrast agent, or when possible, use other imaging modalities, such as MRI or ultrasound.
ECRI is also advising that organizations follow the May 12, 2022, Centers for Disease Control (CDC) guidance on how contents from unopened single-dose vials can be repackaged for multiple patients. Repackaging of the product should only be performed if done under ISO Class 5 conditions by qualified healthcare personnel in accordance with standards in the United States Pharmacopeia General Chapter <797> Pharmaceutical Compounding-Sterile Preparation. Additional information is available in the Alert.
The contrast shortage poses a serious threat to patient safety. Hospitals across the U.S. already have reported delaying or deferring imaging tests, or using tests that don’t require contrast, which could lead to delays in diagnosis and treatment of serious health problems and even misdiagnosis. As we know, early diagnosis and treatment are critical to producing better medical outcomes for patients.
In addition to being a patient safety issue, this shortage serves as another critical reminder that the medical community must work fervently to address supply chain issues, build a resilient supply chain support system within their organizations, and work to strengthen the global supply chain.
The last ten years have brought us several critical weather events, political turmoil, price increases, and of course, a world-wide pandemic. The supply chain has, and will continue to be greatly affected by things that are out of our control. But by working together, before and during such events, to create a resilient supply chain, we can prepare for disruptions and minimize harm to patients.
ECRI is prepared to partner with your organization to strengthen your supply chain. Contact us at clientservices@ecri.org.