The Food and Drug Administration (FDA) has advised Americans to not use plastic syringes made in China, as further investigation shows that the products’ problem is “more widespread” than expected.
The FDA announced in November 2023 that it was looking into reports of leaks, breakages, changes of dimensions, and other quality problems with plastic syringes manufactured in China. The agency was conducting further investigations along with federal partners and “as necessary, may prevent syringes made in China from entering the United States.”
“Our ongoing evaluation has confirmed that issues with the quality of plastic syringes made in China and their distribution in the U.S. are more widespread than originally known,” he said.
The FDA recommends that patients, health care providers such as hospitals, and suppliers “immediately transition away” from using plastic syringes manufactured by Jiangsu Caina Medical and Jiangsu Shenli Medical Production, unless the use is “absolutely necessary.”
For other brands of syringes, the FDA suggests checking where the products are manufactured and, if possible, consider using products made outside of China.
The agency noted that the issues don’t extend to glass syringes, pre-filled syringes, or syringes used for oral or topical purposes.
The potential device failures could affect health providers’ ability to deliver the correct dose of medication when used alone or with other medical devices, such as infusion pumps, the health regulator stated, noting that it would work with manufacturers to ensure that corrective actions were taken.
Call for Boosting Domestic Medical Supply
Safety issues related to China-made syringes have led to a renewed call to increase domestic medical supplies.“In fact, the last time the agency inspected a Chinese hypodermic device manufacturing facility was in 2018. The FDA recently issued an advisory informing consumers of these potential syringe failures. While this is a good first step, we must do more to protect Americans’ health.”
The senators noted that four out of six needle and syringe manufacturing facilities in the United States shut down in 2023.
However, U.S. reliance on medical supplies from China and other countries has grown. According to the senators, 40 percent of syringes and needles used in the United States are imported, compared to 15 percent in 2018.
“Without a resilient domestic supply chain for medical supplies, we risk our nation’s crisis response, and the health of our citizens,” they wrote. “The most effective way to ensure the quality of these products is to manufacture them in the U.S.
“If we don’t change course soon, we risk losing the last of our syringe manufacturing facilities, which would make the United States largely reliant on China—a mistake we can’t afford to make.”
