Doctors can’t seem to determine what’s wrong with Michael Quintos.
Mr. Quintos, 53, a resident of Chicago, has constant stomach 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,” Mr. Quintos said.
Their doctors recommend using a contrast-enhanced CT scan, an image that relies on a special dye that is 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, as a result of Shanghai’s recent 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 is unable to have a contrast medium exam.
And an alternative may not be enough to determine how to treat your disease. “The fact that you can’t crack it tells me you need more tools to crack it,” she said.
An estimated 50 million exams with contrast agents are performed in the United States each year, and as many as half of the country’s hospitals are affected by shortages. Some are reserving much of their available supply for use in emergency rooms, where quick and accurate assessments are more dire.
The shortage of a vital imaging agent is the latest example of the country’s vulnerability to disruptions in the global supply chain and its overreliance on a small number of manufacturers for such critical products. The Shanghai plant closed by the lockdown is operated by GE Healthcare, a unit of General Electric and one of the two main suppliers of iodinated contrast materials. The company supplies its dyes, Omnipaque and Visipaque, to the United States.
Lawmakers raised concerns about a shortage of imaging agents. “In the richest nation on Earth, there should be no reason why doctors should be forced to ration life-saving medical scans to make up for material shortages,” Rep. Rosa DeLauro, D-Connecticut, said in a statement. a statement. “We are seeing supply chains unravel due to established industries experiencing manufacturing shortages and offshoring American jobs to China.”
Testifying before a Senate committee on Thursday, Dr. Robert Califf, commissioner of the US Food and Drug Administration, said the dye shortage was “just unbelievable.” Noting that some members of Congress had recently suffered serious illnesses, he added, “Someone with a stroke or heart attack wouldn’t be able to get an angiogram.”
The shortage of the dye was reported to the FDA earlier this month, and it said it was working closely with manufacturers “to help minimize the impact on patients.” However, while GE Healthcare said this week that the situation was improving now that the plant had reopened, patient shortages and delays could persist well into the summer due to a delay in how quickly supplies could be distributed. replenished supplies.
Sen. Patty Murray, a Democrat from Washington, is pressing the agency to see what steps it is taking to address the shortage, according to a statement from her office. She also introduced legislation, with Sen. Richard Burr, R-NC, to strengthen the supply chain.
“The hits keep coming in this supply chain pandemic,” 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 long waits for tests will exacerbate previous delays in care caused by the pandemic — when hospitals filled with Covid patients, they faced considerable delays in getting tests done. elective tests and procedures were canceled or postponed for months. . Patients who missed new worrisome symptoms or were unable to obtain follow-up appointments have suffered a decline in health in many cases. As a result, some doctors are reporting more cancer patients with advanced-stage disease.
“We remain concerned about the impact of delayed, deferred or ignored screening in recent years,” said Dr. William Dahut, 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 could find themselves in a situation where clinical decisions will be negatively affected,” 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 contrast-enhanced CT scans to detect infections, intestinal blockages, or cancers. Doctors are also delaying some cardiac catheterizations.
The shortage doesn’t affect people undergoing mammograms and lung cancer screenings because they don’t require the imaging agents, and some patients can have an MRI instead of a CT scan or have the exam 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 frustrated that scans are delayed or cancelled.”
It is difficult to predict how long and to what extent the shortage will affect patient care. For health workers, for whom supply shortages and the pandemic have been such an unrelenting burden, “it feels like an endless marathon,” he said.
At Memorial Hermann, the system has “reduced” contrast use for elective procedures, Dr. McCarthy said, to preserve its supplies. The daily volume of CT scans done with contrast is about half of normal, 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, medical director of the vascular health center. and heart group and past president of the Society for Cardiovascular Angiography and Interventions. When other hospitals in the area began to run out of dye, they began referring patients to ChristianaCare. “It affected our consumption rate,” he said.
“We are really worried here,” said Dr. Garratt. Explaining why elective procedures were delayed, he added, “We feel like we need to make this change now to make sure we have a supply so we can continue to provide the urgent care that we need.”
A patient who fails an exercise stress test that may indicate a heart problem but is not in imminent danger is likely to wait for an examination and treatment with medication. But if a patient comes into the ER and is sweating, with severe chest pain, an angiogram requiring contrast dye is immediately ordered to determine if the person is having a heart attack.
“Either we fix that now, or in a few hours it will be too late to save it,” 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 on hand, says Dr. Matthew Davenport, vice chairman of the American College of Radiology’s committee on quality and safety and a Michigan professor of medicine.
He compares the situation to the current shortage of baby formula, 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 its supply of iodinated contrast media products was increasing, though it did not provide an estimate of 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 line with local authorities” in China, the company said.
“After having to close our manufacturing plant in Shanghai for several weeks due to local Covid policies, we have been able to reopen and are utilizing our other global plants where we can,” the statement read.
GE Healthcare said the plant was operating at 60 percent capacity and would be at 75 percent in the next two weeks. It also said it had taken other steps, including ramping up production of the products at its plant in Cork, Ireland, and sending 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 said 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 clients to reinforce the use of “critical emergency procedures,” according to Fulvio Renoldi Bracco, the company’s chief executive. . In a statement, he said that Bracco had also submitted an application to the FDA for possible 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, vice president for patient safety and quality policy at the American Hospital Association, a trade group in Washington, likened the situation to a shortage of oxygen, among other treatment machines and medicines, 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 supply system, not so lean, that has something to give,” he said.