Imaging Contrast Dye Insufficient Delays Tests for Diseases

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

Mr. Quintos, a 53-year-old Chicago resident, has constant stomach pain. He was hospitalized and his doctors tried everything, including antibiotics, antacids, even removing his appendix. “I still don’t feel well,” said Mr. Quintos.

Doctors recommend using a contrast CT scan based on a special dye that is usually injected into patients to better visualize patients’ blood vessels, intestines, and organs such as kidneys and liver.

But the nationwide shortage of imaging agents required for the procedure is the result of recent results. quarantine To quell a Covid outbreak in Shanghai – it prompted hospitals to allocate these tests except in emergencies.

Like thousands of others in recent weeks, Mr. Quintos is unable to take an exam using contrast dye.

And an alternative may not be enough to determine how to treat his illness. “The fact that you haven’t been able to solve this tells me you need more tools to solve it,” he said.

About 50 million contrast-enhanced exams are performed each year in the United States, and half of the nation’s hospitals are affected by this deficiency. Some keep most of their stock for use in the emergency services – where quick and accurate assessments are most dire.

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

Lawmakers have expressed concern over the scarcity of imaging agents. “In the world’s wealthiest country, there should be no reason why doctors should be compelled to apportion life-saving medical screenings to make up for a shortage of supplies,” Connecticut Democratic Representative Rosa DeLauro said in a statement. We’re seeing supply chains disrupted by consolidated industries experiencing manufacturing shortages and transferring American jobs to China.”

Testifying before a Senate committee on Thursday, U.S. Food and Drug Administration commissioner Dr. Robert Califf said the contrast material shortage was “incredible”. “Someone who has had a stroke or heart attack can’t get an angiogram,” he added, noting that some members of Congress had recently suffered from serious illnesses.

There were paint deficiencies reported He told the FDA earlier this month that he was working closely with manufacturers “to help minimize the impact on patients.” Still, while GE Healthcare said this week that the situation has improved with the reopening of the facility, shortages and patient delays may continue into the summer due to the delay in how quickly replenished supplies can be distributed.

Washington Democratic Senator Patty Murray is pressuring the agency to see what steps it takes to address the famine, according to a statement from her office. He also introduced legislation, To strengthen the supply chain with Senator Richard Burr, Republican of North Carolina.

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

Health officials and doctors are concerned that the low supply and long waits for tests exacerbate earlier delays in care As hospitals caused by the pandemic flooded with Covid patients, they faced huge backlogs to get tests and elective procedures were canceled or delayed for months. Patients who missed new troublesome symptoms or were unable to get follow-up appointments often suffered from poor health. As a result, some doctors are reporting more cancer patients with advanced disease.

Chief scientific officer of the American Cancer Society, Dr. “We continue to be concerned about the impact of screening that has been delayed, delayed or ignored over the past few years,” said William Dahut.

He said a lack of contrast dye in an exam can make it harder to diagnose cancer and make it harder to see if a treatment is working. Dr. “Patients may be in a situation where clinical decisions are adversely affected,” Dahut said.

In addition to using contrast with a CT angiogram to determine if patients have blood clots or internal bleeding, doctors often rely on CT scans as opposed to point infections, intestinal obstructions or cancers. Doctors also delay some cardiac catheterizations.

This deficiency does not affect people undergoing mammograms and lung cancer screenings, as they do not need imaging agents, and some patients may have an MRI instead of a CT scan, or have the exam without contrast.

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

It is difficult to predict how long and to what extent a deficiency will affect patient care. “It feels like a never-ending marathon,” he said, for healthcare workers who are being relentlessly challenged by the shortage of supplies and the pandemic.

Dr. McCarthy said at Memorial Hermann that the system “throttles” the use of contrast for elective procedures to preserve their materials. The volume of daily CT scans performed with contrast is about half what is normally, he says.

At ChristianaCare, a Delaware-based hospital group, the problem of running out of supply emerged in mid-May, and Dr. “It very quickly became a serious problem,” said Kirk Garratt. President of the Society for Cardiovascular Angiography and Interventions. When the paint of other hospitals in the area started to run out, they started sending patients to ChristianaCare. “It affected our burning rate,” he said.

Dr. “We’re really worried here,” Garratt said. Explaining why elective procedures were delayed, he added: “We feel we need to make this change now to make sure we have a resource so we can continue to provide the emergency care we need.”

A patient who fails an exercise stress test that may indicate a heart problem but is not in imminent 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, which requires contrast dye, is ordered immediately to determine if the person is having a heart attack.

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

American College of Radiology vice chair of the quality and safety commission Dr. Matthew Davenport says hospitals often rely on a single supplier for contrast agents, and many facilities can only take a week or two to procure. Professor at Michigan Medicine.

He likens the situation to the current famine. infant formulawhere only a handful of companies serve a critical market. Dr. “There’s not much redundancy in the system,” Davenport said.

GE Healthcare said: an idiom He reported on Monday that the supply of iodinated contrast media has increased, although he did not make a forecast of when the shortage will 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,” the company said in China.

“After having to close our Shanghai production facility for several weeks due to local Covid policies, we were able to reopen and use our other global facilities wherever possible,” the statement said.

GE Healthcare said the facility is operating at 60 percent capacity and will be at 75 percent in the next two weeks. It also said it was taking other steps, such as increasing production of the products at its factory in Cork, Ireland, and sending some shipments to the United States.

The company also said it distributes the paint to hospitals based on past supply needs, which doctors say can prevent overstocking of large hospital systems.

Another Milan-based manufacturer, Bracco Imaging, said in a statement that it is trying to provide even non-customer hospitals with supplies to be used for “critical emergency procedures,” according to the company’s CEO, Fulvio Renoldi Bracco. In a statement, it said Bracco has also filed a request with the FDA for potential importation of an equivalent substance not 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 at the American Hospital Association, a Washington-based trade group, likened the situation to a lack of oxygen among other treatment machines and medications during the pandemic. The group urged GE to share more information about the famine.

“We need to figure out how to really build a much more robust supply system, not leaner, that does some work to it,” he said.

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