The lack of contrast dyes for images delays testing for diseases
Doctors can’t pinpoint what’s wrong with Michael Quintos.
Mr. Quintos, 53, a Chicago resident, has constant stomach pain. He was hospitalized and his doctors tried everything, including antibiotics, antacids, even removing the appendix. “I’m still not feeling well,” Quintos said.
His doctors recommend using a CT scan with contrast, imaging that relies on a special dye often injected into patients to better visualize blood vessels, intestines, and organs such as the kidney and liver.
But a nationwide shortage of imaging agents needed for the procedure, the result of the recent confinement in Shanghai to quell a Covid outbreak – prompted hospitals to ration these tests except in emergencies.
Like thousands of others in the past few weeks, Mr. Quintos cannot take an exam using counterstain.
And one alternative may not be enough to determine how to treat your disease. “The fact that you can’t understand it tells me you need more tools to understand it,” she said.
It is estimated that 50 million tests with contrast agents are performed each year in the United States, and as many as half of the nation’s hospitals are affected by the shortage. Some are reserving much of their stash for use in emergency rooms, where quick and accurate assessments are most dire.
The shortage of a viable imaging agent is the latest example of the country’s vulnerability to disruptions in the global supply chain and its over-reliance on a small number of manufacturers for such critical products. Shanghai plans canceled by the blockade are managed 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 have expressed concern over the shortage of imaging agents. “In the richest nation on Earth, there should be no reason why doctors are forced to ration life-saving medical scans to make up for material shortages,” Connecticut Democrat representative Rosa DeLauro said in a statement. “We are seeing the disruption of supply chains due to established industries experiencing production shortages and the relocation of American jobs to China.”
The dye deficiency was reported to the US Food and Drug Administration earlier this month and the agency said it was working closely with manufacturers “to help minimize the impact on patients.” However, although GE Healthcare said this week that the situation is improving now that the facility has reopened, shortages and patient delays could persist into the summer due to a delay in the distribution of replenished supplies.
Senator Patty Murray, a Democrat from Washington, is lobbying the agency to see what steps it is taking to address the shortage, according to a statement from her office. She also presented legislation, with Senator Richard Burr, Republican of North Carolina, to strengthen the supply chain.
“The successes keep coming in this pandemic in the supply chain,” said Dr. Jamie McCarthy, medical director at Memorial Hermann Health System, a large hospital group in Houston.
Health officials and doctors fear that poor supply and long waits for tests will be exacerbated sooner delays in treatment caused by the pandemic, when hospitals were overrun with Covid patients, they faced considerable backlogs to get tests and elective procedures were canceled or postponed for months. Patients who overlooked new troubling symptoms or were unable to obtain follow-up appointments experienced deterioration in health in many cases. As a result, some doctors report more cancer patients with advanced disease.
“We continue to be concerned about the impact of delayed, deferred or ignored screening in recent years,” said Dr. William Dahut, scientific director of the American Cancer Society.
A lack of counterstain in an exam can make diagnosing cancer more difficult, he said, and can make it harder to see if a treatment is working. “Patients may find themselves in a situation where clinical decisions will have a negative impact,” said Dr. Dahut said.
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 CT scans to detect infections, intestinal blockages, or tumors. Doctors are also delaying some cardiac catheterizations.
The deficiency does not affect people undergoing mammograms and screening for lung cancer because they do not require imaging agents and some patients may be able to undergo an MRI instead of a CT scan or perform the examination without contrast .
But for many others, the deficiency leaves them in limbo. “It’s definitely causing patients more stress,” said Dr. Shikha Jain, oncologist from Chicago. “There are patients who get frustrated because scans are delayed or canceled.”
How long and to what extent the shortage will affect patient care is difficult to predict. For healthcare workers, for whom the supply shortages and the pandemic have been so relentlessly burdensome, “it feels like an endless marathon,” she said.
At the Hermann Memorial, the system “delayed” the use of contrast for elective procedures, said Dr. McCarthy said, to preserve his supplies. The daily volume of CT scans done with the contrast medium is about half of what it normally is, he says.
At ChristianaCare, a Delaware-based hospital group, the out-of-stock problem arose in mid-May and “became a serious problem very quickly,” said Dr. Kirk Garratt, medical director of the group’s heart and vascular health center and former president of the Society for Cardiovascular Angiography and Interventions. When other hospitals in the area started running out of tincture, they started sending patients to ChristianaCare. “It had an impact on our burning rate,” he said.
“We are really worried here,” said Dr. Garrat said. Explaining why the elective procedures have been delayed, she added: “We feel we need to make this change now to make sure we have a supply so that we can continue to provide the urgent care we need.”
A patient who fails an exercise test that could indicate a heart problem but is not in imminent danger is likely to await a scan and be treated with medication. But if a patient enters the emergency room and is sweating, with severe chest pain, an angiogram is immediately ordered which requires a contrast dye to determine if the person is suffering from a heart attack.
“Either we fix it now, or in a few hours it will be too late to save you,” said Dr. Garrat said.
Hospitals generally 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 president of the quality and safety committee of the American College of Radiology and a professor at Michigan Medicine.
He likes the situation for the current shortage of artificial milk, where only a handful of companies serve a critical market. “There isn’t much redundancy in the system,” said Dr. Davenport said.
GE Healthcare said in a declaration on Monday that his supply of iodinated contrast media was increasing, although he did not give 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 had to close our Shanghai manufacturing facility for several weeks due to local Covid policies, we have been able to reopen and are using our other global facilities wherever possible,” the statement read.
GE Healthcare said the plant was operating at 60% capacity and would hit 75% within the next two weeks. He also claimed to have taken other measures such as increasing production of the products at his Cork, Ireland plant, and transporting some shipments to the United States.
The company also said it was distributing the dye to hospitals based on their historic supply needs, which doctors say could prevent large hospital systems from accumulating excessive quantities.
Bracco Imaging, the other Milan-based manufacturer, said in a statement that it was working to provide supplies to hospitals that were not customers to support use for “critical emergency procedures,” according to Fulvio Renoldi Bracco, chief executive. of the company. In a statement, he said Bracco had also submitted an application to the FDA for the 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 quality and patient safety policy for the American Hospital Association, a Washington business group, compared the situation to oxygen shortages, among other machines and treatment remedies, during the pandemic. The group urged GE to share more information on the shortage.
“We need to figure out how to really create a much more robust, not that lean, power system that has something to offer,” he said.