Doctors don’t seem to be able to determine what’s wrong with Michael Quintos.
Mr. Quintos, 53, a resident of Chicago, has constant abdominal pain. He has been hospitalized and his doctors have tried everything, including antibiotics, antacids and even removing his appendix. “I still don’t feel well,” said Mr. Quintos.
His doctors recommend using a contrast CT scan, imaging that relies on a special dye often injected into patients to better visualize their blood vessels, intestines, and organs such as the kidney and liver.
But a nationwide shortage of the imaging agents needed for the procedure — the result of the recent Shanghai lockdown to quell a Covid outbreak — has prompted hospitals to ration these tests except in emergencies.
Like thousands of others in recent weeks, Mr. Quintos can’t get an exam with the contrast dye.
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 contrast media studies are performed in the United States each year, and as many as half of the country’s hospitals are affected by the shortage. Some reserve a large portion of their inventory for use in emergency rooms – where quick, accurate assessments are most dire.
The shortage of an essential imaging agent is the most recent example of the country’s vulnerability to disruptions in the global supply chain and its over-reliance on a small number of manufacturers for such critical products. The Shanghai factory that has been closed by the lockdown is operated by GE Healthcare, a unit of General Electric and one of the two main suppliers of the iodized 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 richest country on Earth, there should be no reason why doctors are forced to ration life-saving medical scans to make up for a shortage of materials,” Connecticut Democrat Representative Rosa DeLauro said in a statement. “We are seeing supply chains break down as a result of consolidated industries facing manufacturing shortages and moving US jobs to China.”
dr. Robert Califf, the US Food and Drug Administration commissioner, testified before a Senate committee on Thursday, saying the contrast agent shortage was “just unbelievable.” Noting that some members of Congress had recently suffered from serious illnesses, he added, “A person having a stroke or heart attack would 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 minimize the impact on patients.” But while GE Healthcare said this week the situation was improving now that the plant has reopened, shortages and patient delays could continue well into the summer due to a slowdown in how quickly replenished supplies could be distributed.
Washington Democrat Senator Patty Murray is urging the agency to see what steps it is taking to address the shortfall, according to a statement from her office. Along with Senator Richard Burr, Republican from North Carolina, she also introduced legislation to strengthen the supply chain.
“The hits just keep coming in this supply chain pandemic,” said Dr. Jamie McCarthy, the chief physician of Memorial Hermann Health System, a large hospital group in Houston.
Health officials and doctors worry that the low supply and lengthy wait for tests will exacerbate previous delays in care due to the pandemic, as hospitals were overrun with Covid patients, they faced significant backlogs to get tests and elective procedures were canceled or postponed for months. Patients who overlooked troubling new symptoms or were unable to make follow-up appointments suffered from deteriorating health in many cases. Some doctors report more cancer patients with an advanced stage of the disease as a result.
“We remain concerned about the impact of delayed, delayed or ignored screening in recent years,” said Dr. William Dahut, the Chief Scientific Officer 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 may be in a situation where clinical decisions are negatively influenced,” said Dr. dahut.
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 for spot infections, intestinal blockages, or cancers. Doctors also delay some cardiac catheterizations.
The deficiency doesn’t affect people undergoing mammograms and screenings for lung cancer because they don’t need the imaging agents, and some patients may be able to get an MRI instead of a CT scan or have the exam done without contrast.
But for many others, the shortage leaves them in the dark. “It definitely causes more stress for patients,” says Dr. Shikha Jain, an oncologist in Chicago. “There are patients who get 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 professionals, for whom the supply shortage and pandemic are so brutally taxing, “it feels like a never-ending marathon,” she said.
At Memorial Hermann, the system has “nipped off” the use of contrast for elective procedures, said Dr. McCarthy, to keep his supplies. The daily number of CT scans performed with contrast is about half of what it normally is, he says.
At ChristianaCare, a Delaware-based hospital group, the inventory depletion issue emerged in mid-May and “became a serious problem very quickly,” said Dr. Kirk Garratt, the medical director of the group’s cardiovascular health center and a past president of the Society for Cardiovascular Angiography and Interventions. When other hospitals in the region ran out of dye, they started sending patients to ChristianaCare. “It affected our burn rate,” he said.
“We’re really concerned here,” Dr. Garratt said. Explaining why elective procedures were being delayed, he added: “We believe we need to make this change now to ensure we have stock so we can continue to provide the urgent care we need.”
A patient who fails an exercise stress test that may indicate a heart problem, but is not in immediate danger, will likely 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 is immediately ordered requiring contrast dye to determine if the person is suffering a heart attack.
“Either we fix that now, or in a few hours it will be too late to save you,” Dr. Garratt said.
Hospitals generally rely on one supplier for their contrast media, and many facilities may only have a week or two in stock, says Dr. Matthew Davenport, vice chair of the American College of Radiology’s Committee on Quality and Safety and a professor at Michigan Medicine.
He likens the situation to the current scarcity of baby food, where only a handful of companies serve a critical market. “There’s not a lot of redundancy in the system,” said Dr. Davenport.
GE Healthcare said in a statement Monday that the supply of iodinated contrast agent products was increasing, although it did not provide an estimate for when the shortage would end. “We are working around the clock to expand production and return to full capacity as soon as possible and in agreement with local authorities,” the company said.
“After closing our production facility in Shanghai for several weeks due to local Covid policies, we have been able to reopen and use our other global factories where we can,” the statement said.
GE Healthcare said the plant was operating at 60 percent capacity and would operate at 75 percent within the next two weeks. It also said it had taken other steps, such as increasing production of the products at its plant in Cork, Ireland, and flying some shipments to the United States.
The company also said it was distributing the dye to hospitals based on their historical supply needs, which doctors say could prevent large hospital systems from storing excessive amounts.
Bracco Imaging, the other Milan-based producer, said in a statement it was in the process of supplying supplies even to non-customer hospitals to bolster use for “critical emergency procedures,” said Fulvio Renodi Bracco, the CEO of the company. company. In a statement, he said Bracco had also filed a request with the FDA for the potential importation 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, the vice president of quality and patient safety policy for the American Hospital Association, a Washington trade group, compared the situation to the scarcity of oxygen, among other treatment machines and remedies, during the pandemic. The group has urged GE to share more information about the shortfall.
“We need to figure out how to really create a much more robust, not so lean, supply system that has something to do with it,” she said.