Health

Image Contrast Dye Delays in disease tests


Doctors can’t seem to pinpoint exactly what happened to Michael Quintos.

Mr. Quintos, 53, of Chicago, suffered from constant stomach pain. He was hospitalized, and the doctors tried everything, including antibiotics, antacids, even removing his appendix. “I still don’t feel good,” Mr. Quintos said.

His doctors recommend a contrast-enhanced CT scan, which relies on a special dye usually injected into a patient to better visualize blood vessels, intestines, and organs such as the kidneys. and their liver.

But a nationwide shortage of the imaging agents needed for the procedure – the result of a recent shutdown in Shanghai to quell a Covid-19 outbreak – has prompted hospitals to allocate tests. This is except for emergencies.

Like thousands of others in recent weeks, Mr. Quintos has been unable to see a doctor with 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 says.

An estimated 50 million tests with contrast are performed each year in the United States, and as many as half of hospitals nationwide are affected by drug shortages. Some are stockpiling most of their supplies for use in emergency rooms – where quick, accurate assessments are most severe.

The critical imaging agent shortage is the latest example of the country’s vulnerability to disruptions in global supply chains and over-compliance by a few manufacturers on such vital products. . The Shanghai plant that closed due to the closure is operated by GE Healthcare, a unit of General Electric and one of the two main suppliers of iodinated contrast material. The company supplies its dyes, Omnipaque and Visipaque, to the United States.

Lawmakers expressed concern about the scarcity of visual agents. Representative Rosa DeLauro, a Connecticut Democrat, said: “In the wealthiest country on Earth, there is no reason why doctors should be forced to ration medical CT scans to compensate for the loss of life. material shortage,” said Representative Rosa DeLauro, a Connecticut Democrat. “We are seeing supply chains break down as consolidated industries experience production shortages and shift American jobs to China.”

Testifying before a Senate committee on Thursday, Dr Robert Califf, commissioner of the US Food and Drug Administration, said the lack of contrast media coverage was “incredible” “. Noting that several members of Congress had recently become seriously ill, he added: “Someone who’s had a stroke or heart attack won’t be able to get an angiogram.”

Dye shortages were reported to the FDA earlier this month, and it said it is working closely with manufacturers to “help minimize the impact on patients.” However, although GE Healthcare said this week that the situation has improved as the plant has reopened, shortages and patient delays could extend into the summer due to delays. in the distribution of supplies are replenished rapidly.

Senator Patty Murray, a Democrat of 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 Senator Richard Burr, a Republican of North Carolina, to strengthen supply chains.

“The attacks just keep coming during this pandemic in the supply chain,” said Dr. Jamie McCarthy, chief physician officer at Memorial Hermann Health System, a large group of hospitals in Houston.

Health officials and doctors worry that low supplies and long wait times for testing will exacerbate delays in prior care caused by the pandemic, as hospitals are overwhelmed with Covid patients , they are facing a large backlog of testing and selection procedures that have been canceled or postponed for months. . Patients who ignore worrisome new symptoms or are unable to be re-examined have deteriorated in many cases. Some doctors say the result is more cancer patients with late-stage disease.

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

The lack of contrast, he said, could make it more difficult to diagnose cancer and could make treatment ineffective. “Patients may be in a situation where clinical decisions will be negatively impacted,” says Dr. Dahut.

In addition to using contrast with CT angiography to determine if a patient has a blood clot or internal bleeding, physicians often rely on contrast-enhanced CT to detect local infection, bowel obstruction, or cancer. Doctors are also delaying some cardiac catheterizations.

The shortfall doesn’t affect people who get mammograms and lung cancer screenings because they don’t require imaging agents and some patients may be able to get an MRI instead of a CT scan or have the test done. without contrast agent.

But for many others, the shortage leaves them in limbo. “It definitely causes more stress for patients,” said Dr. Shikha Jain, an oncologist in Chicago. “There are patients who feel frustrated because the scan is delayed or cancelled.”

How long and to what extent the shortage will affect patient care is difficult to predict. For health care workers, whose supply shortages and pandemic have been taxing consistently, “it feels like a never-ending marathon,” she said.

At Memorial Hermann, the system has “restricted” the use of contrast medium to elective procedures to preserve its supply, said Dr. McCarthy. The daily volume of CT scans performed with contrast medium, he said, is only half that of normal.

At ChristianaCare, a hospital group based in Delaware, the shortage issue emerged in mid-May and “became a serious problem very quickly,” said Dr. heart of the group and a past president of the Society of Cardiology and Interventional Cardiology. As other area hospitals started running out of dye, they started sending patients to ChristianaCare. “It affects our burn rate,” he said.

“We are really worried here,” Dr. Garratt said. Explaining why the election proceedings were delayed, he added: “We felt we had to make this change now to make sure we have the supplies so we can continue to do so. provide the urgent care we need.”

A patient who fails a stress test who may have a heart problem but is not of imminent danger may need to wait for a CT scan and be treated with medication. But if a patient comes into the emergency room and is sweating, accompanied by severe chest pain, then an angiogram that requires contrast is immediately indicated to determine if the person is having a myocardial infarction.

“We can fix that now, or in a few hours it will be too late to save you,” Dr.

Dr. Matthew Davenport, vice chair of the American College of Radiology’s committee on quality and safety and a professor at Michigan Medicine.

He likened the situation to the current shortage of infant formula, where only a handful of companies serve a critical market. “There is not much redundancy in the system,” says Dr. Davenport.

GE Healthcare said in a statement Monday that its supply of iodine-containing contrast media products is increasing, although it did not provide an estimate of when the shortages will end. stop. “We are working around the clock to expand production and return to full capacity as soon as possible and in accordance with local authorities” in China, the company said.

“After having to close our production facility in Shanghai for several weeks due to local Covid policies, we were able to reopen and are using our other global factories anywhere. possible,” the announcement read.

GE Healthcare says the plant is operating at 60% capacity and will be at 75% within the next two weeks. They also said they have taken other steps such as ramping up production of products at their plant in Cork, Ireland, and moving some shipments to the United States.

The company also said it is distributing the dye to hospitals based on their previous supply needs, which doctors say could prevent large hospital systems from stockpiling too much.

Bracco Imaging, another Milan-based manufacturer, said in a statement that it is working to make supplies available even to non-customer hospitals to use for “emergency procedures”. important level,” said Fulvio Renoldi Bracco, the company’s chief executive officer. In a statement, he said that Bracco had also filed a request with the FDA regarding the possibility of importing an unapproved equivalent for use in the United States. The agency declined to comment on the request.

Nancy Foster, vice president of quality and patient safety policy for the American Hospital Association, a trade group in Washington, likened the condition to hypoxia, among treatment machines. and other remedies, during the pandemic. The group called on GE to share more information about the shortage.

“We need to figure out how to actually create a more robust supply system, not a much leaner one,” she said.



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