Sen. Tom Cotton (R-AR) asked the Food and Drug Administration to tighten regulations on medical devices made in China to protect patient data and the integrity of hospitals after a series of incidents of cybersecurity breaches.
Cotton, the chairman of the Senate Intelligence Committee, asked acting FDA Commissioner Kyle Diamantas in a Tuesday letter to revise the agency’s standards for certifying medical devices by requiring older technology to undergo a cybersecurity clearance similar to that used for new devices.
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The FDA began requiring medical devices to demonstrate enhanced cybersecurity safeguards to receive FDA premarket clearance in March 2023, but older devices still on the market do not require the same type of testing.
Cotton said in the letter, also sent to the Cyber and Infrastructure Security Agency, that “more must be done to protect Americans from compromised medical devices.”
“American patients’ exposure to compromised Chinese-made medical devices poses a risk to both national security and public health,” Cotton wrote.
The letter comes following the FDA’s discovery last year that the device Contec CMS8000, a popular medical monitor that tracks patients’ vital signs, would automatically extract patients’ personally identifiable health information when connected to the internet.
Cotton said the data extraction from the device could leave patients open to “identity theft, insurance fraud, extortion and more sophisticated scams.”
He also said the device was “programmed to allow unverified users to remotely control the device,” thereby giving malignant actors in China the ability to “how the device operates and displays data, potentially leading to dangerous misdiagnoses of heart failure, arrhythmias, and hypertension.”
According to FDA records, roughly 7,000 monitors were recalled. They still remain in use in some hospitals, however, in part because there is no record of how many are in use nationwide.
A sizable percentage of U.S. hospitals depend on Chinese-made equipment, ranging from basic medical supplies such as syringes and gloves to computerized monitoring systems such as the recalled Contec CMS8000.
On the whole, 14% of all medical equipment in U.S. hospitals and more than 50% of basic medical supplies are made in China, according to a 2025 analysis of industry data from the journal American Affairs.
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As of 2024, China’s medical device industry was worth $84.55 billion worldwide, according to the China Chamber of Commerce for Import and Export of Medicines and Health Products.
Hospital diagnosis and treatment equipment, the largest category of China’s medical device exports, was valued at $22.26 billion in 2024.
