Health

Imaging Contrast Dye Shortage Delays Tests for Diseases

Doctors don’t seem to be able to pinpoint exactly what’s wrong with Michael Kintos.

Kintos, 53, who lives in Chicago, always has a stomachache. He was in the hospital and his doctor tried everything, including antibiotics, antacids, and even removal of the appendix. “I’m still sick,” Kintos said.

His doctor recommends using contrasting CT scans that rely on special dyes often infused into the patient to better visualize the patient’s blood vessels, intestines, kidneys, liver and other organs. I am.

However, a national shortage of contrast media required for this procedure (as a result of the recent blockade in Shanghai to suppress the outbreak of Covid) has led hospitals to distribute these tests except in emergencies. I did.

Like thousands of others in the last few weeks, Kintos cannot take tests with contrast media.

And alternatives may not be enough to determine how to treat his illness. “The fact that I can’t understand it tells me that I need more tools to understand it,” he said.

An estimated 50 million contrast media tests are performed each year in the United States, and half of US hospitals are affected by the shortage. Some have booked many of the supplies on hand for use in emergency rooms — quick and accurate assessments are the most disastrous.

The shortage of critical imaging agents is the latest example of a country’s vulnerability to global supply chain disruptions and its over-reliance on a small number of manufacturers for such critical products. The Shanghai plant, which was closed due to the blockade, is a unit of General Electric and is operated by GE Healthcare, one of the two major suppliers of iodinated contrast media. The company supplies the dyes Omnipaque and Visipaque for the United States.

Lawmakers expressed concern about the lack of contrast media. “In the wealthiest countries on the planet, there should be no reason for doctors to be forced to distribute life-saving medical scans to make up for material shortages,” Connecticut Democratic Party Rep. Rosa DeLauro said in a statement. Said. “We are seeing the supply chain collapsing due to a manufacturing shortage and an integrated industry experiencing offshoring of US employment to China.”

In a testimony in front of the Senate Committee on Thursday, Dr. Robert Caliph, Commissioner of Food and Drugs, said the shortage of contrast media was “incredible.” He added, noting that some members of Congress have recently suffered from a serious illness: “People with a stroke or heart attack will not be able to get angiography.”

The lack of dye report He submitted it to the FDA earlier this month, stating that he is working closely with the manufacturer “to minimize the impact on patients.” GE Healthcare said this week that the reopening of the factory has improved the situation, but delays in the rapid distribution of replenished supplies could lead to shortages and patient delays until summer. I have.

Senator Patty Murray, a Democrat in Washington, is pressing agents to see what steps they are taking to address the shortfall, according to a statement from her office. ..She introduced again legislation, We worked with Senator Richard Burr, a Republican in North Carolina, to strengthen our supply chain.

Dr. Jamie McCarthy, Principal Doctor of Memorial Hermann Health System, a large hospital group in Houston, said:

Health officials and doctors are worried about exacerbating the early delays in care caused by pandemics. When the hospital was flooded with Covid patients, they faced a significant backlog to take the test and the selective procedure was canceled or postponed for several months. Patients who overlook annoying new symptoms or miss follow-up appointments often suffer from poor health. As a result, some doctors report an increase in the number of advanced cancer patients.

“For the past few years, we continue to be concerned about the effects of screening delays, postponements, and neglects,” said Dr. William Dahat, director of the American Cancer Society.

A lack of contrast in the test can make it difficult to diagnose the cancer and to see if the treatment is working, he said. “Patients may be in a situation where their clinical decisions are adversely affected,” said Dr. Dahut.

In addition to using contrast with CT angiography to determine if a patient has a blood clot or internal bleeding, doctors rely on CT scans as opposed to spot infections, intestinal obstructions, or cancer. I often do. Doctors are also delaying some cardiac catheterizations.

People who are screened for mammograms or lung cancer do not need contrast media, so a shortage will not affect them. Some patients may be able to use an MRI instead of a CT scan or perform the test without a contrast agent.

But for many others, shortages confuse them. “It definitely causes more stress on the patient,” said Dr. Shikha Jain, an oncologist in Chicago. “Some patients are frustrated because scans are delayed or canceled.”

It is difficult to predict how long and to what extent a deficiency will affect patient care. “It feels like an endless marathon,” she said, to healthcare professionals, who are constantly burdened with supply shortages and pandemics.

At Memorial Hermann, Dr. McCarthy said the system “suppressed” the use of contrast for selective treatment in order to maintain its supply. He says that the daily amount of CT scans performed with contrast is about half the normal amount.

ChristianaCare, a hospital group based in Delaware, experienced a supply depletion problem in mid-May and “immediately became a serious problem,” said the group’s cardiovascular health center medical director and former cardiovascular. President of the Contrast and Intervention Society. When hospitals in other regions began to run out of dye, they began sending patients to Christiana Care. “It affected our burning rate,” he said.

“We are really worried here,” said Dr. Galat. He explained why the selective procedure was delayed and added, “I feel that we need to make this change now to secure supply so that we can continue the necessary emergency care.”

Patients who fail an exercise stress test that may indicate a heart problem but are not at imminent risk may be treated with medication awaiting a scan. However, if the patient enters the emergency room and sweats and has severe chest pain, an angiography that requires a contrast agent is immediately ordered to determine if he has a heart attack.

“We will be too late to fix it now or save you within a few hours,” Dr. Garat said.

Hospitals generally rely on a single supplier of contrast media, and many facilities may only be supplied for a week or two, said Vice-Chairman of the American College of Radiology Quality and Safety Commission. Says Dr. Matthew Davenport. Professor of Michigan Medicine.

He likens this situation to the current shortage of infant formula. There, only a handful of companies serve critical markets. “The system doesn’t have a lot of redundancy,” said Dr. Davenport.

GE Healthcare statement On Monday, it was said that the supply of iodinated contrast products was increasing, but no estimate was given as to when the shortage would end. “In China, we are working 24 hours a day in collaboration with local governments to expand production and bring it back to full capacity as soon as possible,” the company said.

“By local Covid policy, after having to close our manufacturing facility in Shanghai for a few weeks, we can reopen and use other global factories wherever possible,” the statement said. I am.

According to GE Healthcare, the plant is operating at 60% capacity and will reach 75% within the next two weeks. He added that he has taken other steps, such as increasing product production at his factory in Cork, Ireland, and part of shipments to the United States.

The company also said it distributes dyes to hospitals based on past supply needs. This can prevent large hospital systems from stockpiling excessive amounts, doctors said.

According to Fulvio Renordi Bracco’s CEO, another Milan-based producer, Bracco Imaging, is stepping up the use of “significant emergency measures” for non-customer hospitals as well. He said he was working to deliver supplies to do so. In a statement, he said Bracco also submitted a request to the FDA for a potential import of equivalent drugs not approved for use in the United States. The agency refused to comment on the request.

Nancy Foster, vice president of quality and patient safety policy at the American Hospital Association, a trading group in Washington, likened the situation to a shortage of oxygen during the pandemic, among other treatment devices and treatments. .. The group urged GE to share more information about the shortage.

“We need to understand how to actually create a much more robust supply system, not a lean supply system,” she said.

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