Shortage of imaging contrast dyes delays disease testing

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

Mr. Quintos, 53, a resident of Chicago, constantly suffers from stomach pain. He was hospitalized and his doctors tried everything including antibiotics, antacids and even removing his appendix. “I still don’t feel well,” Mr. Quintos said.

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

But a nationwide shortage of imaging agents needed for the procedure – the result of Shanghai’s recent lockdown to quell a Covid outbreak – prompted hospitals to ration such tests except in emergencies.

Like thousands of others over the past few weeks, Mr. Quintos cannot pass an exam using the contrast medium.

And an alternative may not be enough to determine how to treat his illness. “The fact that 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 up to half of the nation’s hospitals are affected by the shortage. Some reserve much of their supply for use in emergency rooms – where quick and accurate assessments are most disastrous.

The shortage of a vital imaging agent is the latest example of the country’s vulnerability to global supply chain disruptions and its overreliance on a small number of manufacturers for such critical products. The foreclosure-shut Shanghai plant is operated by GE Healthcare, a unit of General Electric and one of the two main suppliers of iodinated contrast media. The company supplies its colorants, Omnipaque and Visipaque, for the United States.

Lawmakers have expressed concern about the scarcity of imaging agents. “In the wealthiest nation on Earth, there should be no reason why doctors are forced to ration lifesaving medical tests to make up for a shortage of supplies,” Rep. Rosa DeLauro, Democrat of Connecticut, said in a statement. a statement. “We are seeing supply chains collapsing due to consolidated industries experiencing manufacturing shortages and shifting American jobs to China.”

Testifying before a Senate committee on Thursday, Dr. Robert Califf, the commissioner of the United States Food and Drug Administration, said the shortage of contrast media was “just unbelievable.” Noting that some members of Congress had recently suffered from serious illnesses, he added: “A person who had a stroke or a heart attack could not have an angiogram.”

Dye shortages 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 factory had reopened, shortages and patient delays could persist well into the summer due to a delay in the speed with which supplies could be replenished.

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

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

Health officials and doctors fear that low supply and prolonged waits for tests could worsen earlier delays in care caused by the pandemic, when hospitals were overwhelmed with Covid patients they faced significant backlogs to get tests and elective procedures have been canceled or postponed for months. Patients who overlooked troubling new symptoms or were unable to get follow-up appointments experienced deterioration in their health in many cases. As a result, some doctors are reporting more cancer patients with advanced disease.

“We continue to be concerned about the impact of delayed, delayed or ignored screening in recent years,” said Dr. William Dahut, scientific director of the American Cancer Society.

The lack of contrast dye in an exam can make it harder to diagnose cancer, he said, and can make it harder to see if a treatment is working. “Patients could find themselves in a situation where clinical decisions are going to be negatively affected,” Dr. Dahut said.

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

The shortage does not affect people undergoing mammograms and lung cancer screenings as they do not need imaging agents, and some patients may be able to have an MRI instead of a CT scan or undergo the examination without contrast.

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

It is difficult to predict how long and to what extent the shortage will affect patient care. For healthcare workers, for whom supply shortages and the pandemic have been so relentlessly taxing, “it feels like an endless marathon,” she said.

At Memorial Hermann, the system has “reduced” its use of contrast for elective procedures, Dr. McCarthy said, to preserve its supplies. The daily volume of CT scans done with contrast is about half of what it normally is, he says.

At ChristianaCare, a Delaware-based hospital group, the supply depletion issue surfaced in mid-May and “became a serious problem very quickly,” said Dr. Kirk Garratt, the health center’s medical director. heart and vascular group and former president of the Society of Angiography and Cardiovascular Procedures. When other hospitals in the area ran out of tincture, 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 have been delayed, he added: “We believe we need to make this change now to ensure we have a supply so we can continue to do the urgent care that we need.”

A patient who fails a stress test that may indicate a heart problem but is not in imminent danger will likely await analysis and be treated with medication. But if a patient walks into the emergency room and is sweating, with severe chest pain, an angiogram requiring contrast material is immediately ordered to determine if the person is suffering from a heart attack.

“Either we fix this now or in a few hours it will be too late to save you,” Dr. Garratt said.

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

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

GE Healthcare said in a statement Monday that its supply of iodinated contrast media was increasing, although it did not provide an estimate of when the shortage will end. “We are working around the clock to increase production and return to full capacity as soon as possible and in agreement with local authorities” in China, the company said.

“After having to close our Shanghai manufacturing facility for several weeks due to local Covid policies, we have been able to reopen and are using our other global factories wherever we can,” the statement said.

GE Healthcare said the plant was operating at 60% capacity and would reach 75% within the next two weeks. It also said it had taken other measures, such as increasing production of the products at its plant in Cork, Ireland, and stealing some shipments to the United States.

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

Bracco Imaging, the other Milan-based producer, said in a statement that it was working to deliver supplies even to hospitals that were not customers to reinforce the use of “critical emergency procedures”, according to Fulvio Renoldi Bracco, general manager of the company. In a statement, he said Bracco had also submitted a request to the FDA for the potential import of an equivalent 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, a professional group in Washington, likened the situation to the shortage of oxygen, among other treatment machines and remedies, during the pandemic. The group 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 something to do with it,” she said.

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