Imaging contrast delays testing for short-term disease

Physicians can’t figure out what’s wrong with Michael Quintos.

Mr. Quintos, 53, a resident of Chicago, suffers from persistent abdominal pain. She has been hospitalized, and her doctors have tried everything, including antibiotics, antacids, and even appendix removal. “I still don’t feel well,” Mr Quintos said.

Her doctors recommend using a CT scan with contrast, imaging that relies on a special pigment to better visualize patients’ blood vessels, intestines, and organs such as the kidneys and liver.

But a nationwide shortage of imaging agents required for the procedure – the result of a recent lockdown in Shanghai due to the covidia outbreak – has prompted hospitals to ration these tests without an emergency.

Like thousands of others in recent weeks, Mr. Quintos will not be able to test using contrast dye.

And an alternative may not be enough to determine how to treat his illness. “You can’t get it out. It tells me you need more tools to get it out,” he said.

An estimated 50 million tests with contrast agents are performed each year in the United States, and about half of the country is affected by hospital deficits. Some are saving most of their supplies for use in emergency rooms – where quick, accurate assessments are most feared.

The shortage of a vital imaging agent is the latest example of the country’s weakness in disrupting the global supply chain and its over-reliance on a small number of manufacturers for such critical products. The Shanghai plant, which was shut down due to a lockdown, is operated by GE Healthcare, a unit of General Electric and one of the two main suppliers of iodized contrast materials. The company supplies its dyes, Omnipaque and Visipaque to the United States.

Lawmakers have expressed concern about the lack of imaging agents. “In the richest country in the world, there should be no reason to force doctors to perform life-saving medical scans to make up for the material deficiency,” said Rosa Delauro, a Democrat in Connecticut, in a statement. “We see the supply chain breaking down because the combined industries are experiencing production shortages and offshoring of American jobs in China.”

Testifying before a Senate committee on Thursday, Dr. Robert Calif, commissioner of the U.S. Food and Drug Administration, said the lack of contrast media was “simply unbelievable.” Noting that some members of Congress have been suffering from serious illness recently, he added: “No one will be able to have an angiogram, including a stroke or a heart attack.”

The FDA was informed of the dye shortage earlier this month and said it was working closely with manufacturers to “help reduce the impact on patients.” Yet even though GE Healthcare said this week that the situation is improving now that the plant has reopened, deficits and patient delays could go well in the summer as faster replenishment supplies can be delivered.

Senator Patty Murray, a Democrat in Washington, is pressuring the agency to see what steps it can take to address the deficit, according to a statement from her office. He has enacted legislation with North Carolina Republican Senator Richard Burr to strengthen the supply chain.

“The epidemic continues to hit the supply chain,” said Dr. Jamie McCarthy, chief medical officer of Memorial Herman Health System, a large hospital group in Houston.

Health officials and doctors worry that short supplies and prolonged waiting for tests will exacerbate pre-epidemic delays caused by the epidemic, when hospitals were overflowing with coward patients, faced large backlogs for testing and selection procedures were canceled or postponed for months. . . Patients who have ignored new symptoms or failed to get a follow-up appointment have in many cases suffered from poor health. Some doctors report more cancer patients with advanced-stage disease as a result.

Dr. William Dahut, chief scientific officer of the American Cancer Society, said, “For the past few years we have been concerned about the effects of delayed, delayed or neglected screening.

He said the lack of contrast dye in an experiment could make it more difficult to diagnose cancer, and make it harder to see if the treatment was working. “Patients may be in situations where clinical decisions are going to be negatively affected,” said Dr. Dahut.

In addition to using contrast with CT angiogram to determine if patients have blood clots or internal bleeding, doctors often rely on CT scans to rule out spot infections, bowel obstruction, or cancer. Physicians are also delaying some cardiac catheterization.

Lack of mammograms and screening for lung cancer does not affect people because they do not need imaging agents, and some patients may be able to have an MRI or contrast test instead of a CT scan.

But for many others, lack leaves them destitute. “It’s definitely putting more pressure on patients,” said Dr. Shikha Jain, a cancer specialist in Chicago. “There are patients who are frustrated because scans are being delayed or canceled.”

It is difficult to estimate how long and how much the deficit will affect patient care. For healthcare workers, whose supply shortages and epidemics are taxing so relentlessly, “it feels like a never-ending marathon,” he said.

At Memorial Harmony, the system has “throttle-backed” its contrasting use for alternative methods, Dr. McCarthy said, in order to preserve its supply. The daily volume of CT scans performed with contrast is usually about half that, he said.

At Delaware-based hospital group Christiancare, supply shortages occurred in mid-May and “quickly became a serious problem,” said Dr. Kirk Garrett, medical director of the group’s Heart and Vascular Health Center and a former president of the Society for Cardiovascular Angiography. . When hospitals in other areas began to run out of color, they began sending patients to Christian care. “It affects our burn rate,” he said.

“We’re really worried about here,” said Dr. Garrett. Explaining why electoral procedures are being delayed, he added: “We feel we need to make these changes now to make sure we have the supplies we need so that we can take the necessary emergency care.”

A patient who fails an exercise stress test that may indicate heart problems but is not in imminent danger will have to wait for a scan and be treated with medication. But if a patient enters the emergency room and continues to sweat with severe chest pain, an angiogram is immediately directed which requires a contrast dye to determine if the person has a heart attack.

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

Hospitals typically rely on a single supplier for their contrast agents and many facilities may have only one or two weeks of supply at hand, said Dr. Matthew Davenport, vice chairman of the American College of Radiology’s Quality and Safety Commission and a professor of Michigan medicine.

He compared the situation to the current lack of baby formula, where only a few companies serve a critical market. Dr Davenport said: “There is not much redundancy in the system.

GE Healthcare said in a statement on Monday that its supply of iodized contrast media products was increasing, although it did not provide an estimate of when the deficit would end. “We are working around the clock to expand production and return to full power as soon as possible and in coordination with local authorities,” the agency said.

“After closing our Shanghai manufacturing facility for several weeks due to local covid policy, we have been able to reopen and use our other global plants wherever possible,” the statement said.

GE Healthcare reports that the plant is operating at 60 percent capacity and will operate at 75 percent in the next two weeks. It added that it had taken other steps, such as increasing production at its plant in Cork, Ireland, and flying some shipments to the United States.

The agency also said it was distributing dyes to hospitals based on their historic supply demand, which doctors said could prevent large hospital systems from overstocking.

Braco Imaging, another producer based in Milan, said in a statement that it was also working to deliver supplies to hospitals that customers could not use for “critical emergency procedures”, according to Fulvio Reynolds Braco, the company’s chief executive. In a statement, he said Braco had also submitted a request to the FDA for possible 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 the American Hospitals Association’s Quality and Patient Safety Policy, a trade group in Washington, D.C., compared the situation with the short supply of oxygen to other treatment machines and remedies during the epidemic. The group has asked GE to share more information about the deficit.

“We need to figure out how to build a truly powerful, lean, supply system that can deliver something,” he said.

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