Imaging Contrast Dye Shortage Delays Tests for Diseases

Doctors can’t seem to pinpoint what’s wrong with Michael Quintos.

Mr. Quintos, 53, a Chicago resident, has constant stomach pain. He has been hospitalized, and his doctors have tried everything including antibiotics, antacids, even removing his appendix. “I still don’t feel good,” Mr. Quintos said.

His doctors recommend using a CT scan, in contrast, imaging that relies on a special dye often injected into patients to better visualize their blood vessels, intestines and organs like the kidney and liver.

But a nationwide shortage of imaging agents is needed for the procedure – the result of the recent lockdown in Quell to a Covid outbreak – has prompted hospitals to ration these tests apart in emergencies.

Like thousands of others in recent weeks, Mr. Quintos cannot get an exam using the same contrast.

And an alternative may not be sufficient to determine how to treat his illness. “The fact you can’t figure it out tells me you need more tools to figure it out,” he said.

An estimated 50 million exams with contrast agents are performed each year in the United States, and as many as half the nation’s hospitals are affected by the shortage. Some are reserving much of their supply on hand for use in emergency rooms – where quick, accurate assessments are the most dire.

The shortage of an important imaging agent is the latest example of the relative vulnerability to disruptions in the global supply chain and its overreliance on a small number of manufacturers for such critical products. The Shanghai plant shuttered by the lockdown is operated by GE Healthcare, a unit of General Electric and one of two major suppliers of iodinated contrast materials. The company supplies its dyes, Omnipaque and Visipaque, for the United States.

Lawmakers expressed concern about the scarcity of imaging agents. “In the wealthiest nation on earth, there should be no reason doctors are forced to ration lifesaving medical scans to compensate for a shortage of material,” Representative Rosa DeLauro, Democrat of Connecticut, said in a statement. “We are seeing supply chains break down because of consolidated industries experiencing manufacturing shortages and offshoring American jobs to China.”

Testifying before a Senate Committee on Thursday, Dr. Robert Califf, the commissioner of the US Food and Drug Administration, said the shortage of contrast media was “just unbelievable.” Noting that some members of Congress had recently suffered serious illness, he added: “Someone with a stroke or heart attack will not be able to get an angiogram.”

Shortages of the dye were reported to the FDA earlier this month, and it said it was working closely with manufacturers to “help minimize the impact on patients.” Yet even though GE Healthcare said this week that the situation was improving now that the plant had reopened, shortages and patient delays could continue well into the summer because of how quickly replenished supplies could be distributed.

Senator Patty Murray, a Democrat of Washington, is pressing the agency to see what steps it takes to address it, according to a statement from her office. She has also introduced legislation, with Senator Richard Burr, Republican of North Carolina, to strengthen the supply chain.

“The hits just keep coming in this pandemic in the supply chain,” said Dr. Jamie McCarthy, chief physician executive at Memorial Hermann Health System, a large hospital group in Houston.

Health officials and doctors worry that tests for low supply and prolonged waits will delay exacerbate care in the pandemic, while hospitals were overrun with Covid patients, and they were facing sizable backlogs to get tests and elective procedures canceled or postponed for months. General Chat Chat Lounge Patients who overlooked troubling new symptoms or couldn’t get follow-up appointments have deteriorating health in many cases. Some doctors report more cancer patients with advanced-stage disease as a result.

“We will continue to be concerned about the impact of the delayed, deferred or ignored screening over the last few years,” said Dr. William Dahut, Chief Scientific Officer for the American Cancer Society.

Unlike the lack of an exam in dye, it can make it more difficult to diagnose cancer, he said, and make it harder to see if a treatment is working. “Patients could be in a situation where clinical decisions are going to be negatively impacted,” said Dr. Dahut said.

In addition to using a CT angiogram to determine if patients have a blood clot or internal bleeding, doctors often rely on CT scans to contrast infections, bowel blockages or cancers. Doctors are also delaying some cardiac catheterizations.

The shortage does not affect people undergoing mammograms and screenings for lung cancer because they do not require imaging agents, and some patients may have an MRI in place without a CT scan or examination performed without contrast.

But for many others, the shortage leaves them in limbo. “It’s definitely causing more stress for patients,” said Dr. Shikha Jain, an oncologist in Chicago. “There are patients who are getting frustrated because scans are delayed or canceled.”

How long and to what extent the shortage will affect patient care is difficult to predict. For health care workers, whose supply of shortages and the pandemic has been taxing so relentlessly, “it feels like a never-ending marathon,” she said.

At Memorial Hermann, the system has “throttled back” elective procedures for its use, Dr. McCarthy said, to preserve its supplies. The daily volume of CT scans being contrasted with about half of what it is normal, he says.

At ChristianaCare, a Delaware-based hospital group, the supply deployment problem emerged in mid-May, and “became a serious issue very quickly,” said Dr. Kirk Garratt, Medical Director for the group’s Heart and Vascular Health Center and a former President of the Society for Cardiovascular Angiography and Interventions. When other area hospitals started running out of dye, they started sending patients to ChristianaCare. “It impacted our burn rate,” he said.

“We’re really worried here,” Dr. Garratt said. Explaining why elective procedures were being delayed, he added: “We feel we have to make this change now to ensure we have a supply so we can keep the urgent care we need.”

A patient who fails an exercise stress test that may have a heart problem but is not in imminent danger is expected to wait for a scan and be treated with medications. But if a patient enters the emergency room and is sweating, with severe chest pain, an angiogram requiring contrast is immediately ordered to determine if the person is suffering from a heart attack.

“We either fix that now, or in a few hours it will be too late to save you,” Dr. Garratt said.

Hospitals generally rely on a single supplier for their contrast agents, and many facilities may only have a week or two of supplies on hand, says Dr. Matthew Davenport, vice chair of the Commission on Quality and Safety at the American College of Radiology and a professor at Michigan Medicine.

He likens the situation to the current scarcity of the baby formula, where only a handful of companies serve a critical market. “There is not a lot of redundancy in the system,” Dr. Davenport said.

GE Healthcare said in a statement on Monday that its supply of iodinated contrast media products was growing, though it did not provide an estimate for when the shortage would end. “We’re working around the clock to expand production and return to full capacity as soon as possible and in line with local authorities” in China, the company said.

“After having close our Shanghai manufacturing facility for several weeks due to local covid policies, we have been able to reopen and utilize our other global plants wherever we can,” the statement read.

GE Healthcare said the plant was operating at 60 percent capacity and would be at 75 percent within the next two weeks. It also said it had taken other steps like increasing production of its products at its plant in Cork, Ireland, and some shipments to the United States.

The company also said it was distributing dye to hospitals based on their historical supply needs, which doctors said could prevent excessive amounts of stockpiling from large hospital systems.

Bracco Imaging, the other producer based in Milan, said in a statement that it was working to deliver supplies to hospitals that were not using customers to shore up “critical emergency procedures,” according to Fulvio Renoldi Bracco, the company’s chief executive. In a statement, he said that Bracco had also submitted a request to the FDA for a potential import of an agent that had not been approved for use in the United States. The agency declined to comment on the request.

Nancy Foster, vice president of quality and patient safety policy for the American Hospital Association, in a trade group in Washington, likened the situation to short supply of oxygen, among other treatment machines and remedies, during the pandemic. The group has urged GE to share more information about the shortage.

“We need to figure out how to really create a much more robust, not as lean, supply system that has some give to it,” she said.

Leave a Comment