Hospitals and imaging centers are monitoring patient safety as they deal with a global shortage of intravenous contrast fluids, a crisis that some experts say could be mitigated with advance notice.
The Food and Drug Administration on Tuesday reported shortages of iohexol and iodixanol, intravenous contrast media manufactured by GE Healthcare and used in computed tomography.
GE Healthcare, one of the top two suppliers of contrast agents in the U.S., first said it was rationing orders for iohexol products in an April letter to customers after the COVID-19 outbreak closed its Shanghai manufacturing facility for several weeks. The company has now said doctors should expect an 80% cut in supplies through June.
According to Nancy Foster, Vice President of Quality and Safety Policy for the Hospital Association.
“Many hospitals do CT scans with contrast for those who suspect they have a stroke, either a hemorrhagic stroke or a brain blockage,” Foster said. “Things like this can’t wait because if they do, it could result in death or serious injury to the patient. That’s why we’re so concerned about the shortage of contrast media right now.”
Health systems are working to ration their current stock of contrast material, she said, prioritizing which x-ray procedures need to be done urgently and postponing non-emergency, elective imaging.
In some cases, doctors may choose not to use a contrast agent for a CT scan, or alternatively may do an MRI if either would still work for the patient, Foster said.
“We are working around the clock to expand the capacity of our iodinated contrast agent products, including through our global manufacturing network,” GE Healthcare said in a statement. “For affected markets, we continue to keep our customers informed and work closely with them so they can plan accordingly.”
In addition to expanding production at its plant in Ireland, the company has focused on producing just three main contrast agent options and returning operators to the plant in controlled groups. GE Healthcare expects the capacity of its Shanghai site to increase to 50% by the end of the week.
Contrast fluids can also be used orally and for vascular imaging, such as for coronary angiography. evaluate the blood vessels surrounding the heart. Anesthetists may also use contrast dye for spinal surgery, said Matthew Davenport, vice chairman of the American College of Radiology’s Quality and Safety Commission.
The degree of accuracy required depends on the specific diagnosis and should be determined by the physician, Davenport said. For example, an aortic dissection is an operation that requires a contrast medium, in contrast to the assessment of appendicitis, where contrast may be helpful but not required.
Foster said that because of restrictions on contrast agents, the AHA has contacted insurers to let them know that hospitals and imaging centers can ask for approval for an MRI in a situation where they would normally opt for a CT scan as a less expensive option.
According to Dr. Bradley Delman, the hospital’s professor and director of radiology, at Mount Sinai Hospital in New York, there are only about two weeks of contrast material on hand at any given time. If a supplier is interrupted, the hospital does not have time to find other suppliers or restock.
“It’s really a cautionary tale that we’re relying on vendors to supply most or all of the product to the institution,” Delman said.
Healthcare providers who administer iohexol as a vascular contrast via an IV are under more stress than Mount Sinai, which uses the product as an oral contrast that patients take by mouth, he said.
Most healthcare systems in the US prefer to contract with suppliers and are generally required to order a minimum percentage of products from a single manufacturer, Davenport said.
“When GE crashed, everyone who had a privileged contract with GE suddenly had no contrast agent,” he said.
Usually buying from a single supplier means price incentives and stability, but in these circumstances it erodes reserves and reduces productivity, Delman said. This shortfall will likely result in a backlog of electoral cases at Mount Sinai that will stretch for several months.
Despite a disruption in the supply chain that began six weeks ago when Shanghai was shut down, healthcare systems were still caught off guard and forced to struggle amid recent news of shortages. If the industry had known about this earlier, healthcare systems could have been better prepared, Delman said.
“There is a possibility that if the supplier had previously notified the medical community about this process, some other suppliers could have improved performance,” he said.
Health systems should question whether this GE Healthcare incident is a one-time event or an indication that supply chain tuning is too risky, Davenport said.
“Should we endure this risk,” he said. “Or should we better understand where the supplies are coming from and how much risk there is in that supply chain when people enter into these contracts?”