Hospitals and imaging centers are monitoring patient safety concerns as they manage a global shortage of IV contrast fluids, a crisis some experts think might have been mitigated with earlier notice.
The Food and Drug Administration on Tuesday reported deficits of iohexol and iodixanol, intravenous contrast media products made by GE Healthcare and used in computed tomography imaging.
GE Healthcare, one of two major suppliers of contrast media in the U.S., first said it was rationing orders for iohexol products in an April letter to customers after a COVID-19 outbreak shut down its production facility in Shanghai for several weeks. Now, the company said doctors should expect an 80% reduction in supplies through June.
Out of the more than 75 million CT scans performed annually in the U.S., an estimated 40 million use a contrast medium which allows for better visibility of the organs and circulatory system, said Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association.
"Many hospitals will do a CT scan with contrast for someone they suspect is experiencing a stroke, either a hemorrhagic or a blockage in their brain," Foster said. "Those kinds of things can't wait because if they did, it could result in death or severe harm to the patient. And that's why we're so concerned about the shortage of contrast media right now."
Health systems are working on rationing their current stock of contrast, prioritizing which x-ray procedures need to be done urgently and postponing non-emergency, elective imaging, she said.
In some cases, physicians may not use contrast dye in a CT scan, or they might perform an MRI as an alternative, if either would still be effective for the patient, Foster said.
"We are working around the clock to expand capacity of our iodinated contrast media products, including drawing on our global manufacturing network," GE Healthcare said in a statement. "For impacted markets we continue to keep our customers informed and are working closely with them so they can plan accordingly."
In addition to expanding production at its Ireland manufacturing plant, the company is focusing on producing just three main variations of contrast products and bringing operators back to the plant in controlled groups. GE Healthcare expects its site capacity in Shanghai to increase to 50% by the end of the week.
Contrast fluids can also be used orally and for vascular imaging like coronary angiograms that assess blood vessels surrounding the heart. Anesthesiologists might also use contrast dye when working on spinal procedures, said Matthew Davenport, vice chair of the commission on quality and safety for the American College of Radiology.
The degree of accuracy needed depends on the specific diagnosis and must be determined by the physician, Davenport said. For example, an aortic dissection is an operation that would require contrast dye, versus an assessment for appendicitis, where contrast would be helpful but not necessary.
Because of the limits on contrast media, Foster said the AHA has contacted insurers to make them aware that hospitals and imaging centers may ask for an authorization for an MRI in a situation where they would normally choose the CT scan as a less expensive option.
At Mount Sinai Hospital in New York, the facility only has around two weeks of contrast media on hand at any given time, said Dr. Bradley Delman, the hospital's professor and site chair of radiology. If a supplier is disrupted, the hospital doesn't have much time to find other vendors or restock.
"It's really a cautionary tale of our reliance on vendors to supply most or all of a product to an institution," Delman said.
Providers that administer iohexol as vascular contrast through an IV are more severely strained than Mount Sinai, which uses the product as an oral contrast that patients ingest, he said.
Most health systems in the U.S. have preferred vendor contracting, Davenport said, and are typically obligated to order a minimum percentage of products from one manufacturer.
"When GE went down, anybody who had a preferred vendor contract with GE suddenly had no contrast media," he said.
Usually, buying from a single vendor means price incentives and stability, but in circumstances like this, it stresses reserves and makes productivity challenging, Delman said. This shortage will likely lead to a backlog of elective cases at Mount Sinai that spans several months.
Despite the supply chain disruption starting six weeks ago when Shanghai went into lockdown, health systems were still caught off guard and left scrambling amid recent news of the shortage. If the industry had known sooner, health systems may have been better able to prepare, Delman said.
"There is the possibility that if a vendor had notified the medical community earlier into this process, that some other vendors could have increased productivity," he said.
Health systems should be asking if this incident with GE Healthcare is just a one-off event or an indicator that the supply chain set-up is too risky, Davenport said.
"Should we tolerate that risk," he said. "Or should we have better awareness of where the supply is coming from and how much risk is inherent in that supply chain when people make these contracts?"
