The U.S. Food and Drug Administration has issued a safety notice to consumers, health care providers and facilities that it is evaluating plastic syringes made in China for potential device failures.
FDA is monitoring the reports of safety issues associated with "several Chinese manufacturers of syringes," the Nov. 30 notice said.
"The FDA continues to closely monitor all available sources of information related to this emerging safety issue," Kristina Wieghmink, communications officer for the center for devices and radiological health at the FDA, told Plastics News in an email.
"We are also working with federal partners to further test syringes manufactured in China, and plan to work with manufacturers to ensure adequate corrective actions are taken."
If necessary, FDA may prevent syringes made in China from entering the U.S., the notice said.
The administration "is aware of quality issues from recent syringe recalls, medical device reports and additional complaints about syringes made at various manufacturing sites in China," it said.
It would not disclose which Chinese manufacturing plants are associated with the faulty devices in response to inquiry from PN.
"Given the broad range of safety concerns reported, we believe it is important to make users aware of FDA's evaluation and actions at this early stage, to provide interim recommendations to reduce risks," Wieghmink said.
FDA encourages "users to report problems … to help inform our evaluation and continued actions. We will provide more information as it becomes available" she added.
The quality issues reported arose after manufacturers made changes to syringe dimensions, it said. The issues could affect the performance and safety of the syringes "including their ability to deliver the correct dose of medication when used alone or with other medical devices such as infusion pumps."
"The FDA is collecting and analyzing data to evaluate plastic syringes made in China that are used for injecting fluids into or withdrawing fluids from the body," the notice said. "At this time, the issue does not include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes."
Several syringe manufacturers, including Becton, Dickinson and Co. and diabetes business Embecta Corp., issued news releases that their plastic syringes are manufactured in the U.S. and not affected by FDA's safety notice.
"BD remains committed to supporting the U.S. health care system and is ready to increase production to help supply those providers who currently purchase syringes impacted by the FDA communication," Eric Borin, president of BD Medication Delivery Solutions said.
"Our skilled workforce in Nebraska, with its unmatched expertise in high volume syringe manufacturing, is prepared to support any health care customers who may be affected by the FDA's safety communication," Shaun Curtis, senior vice president of global manufacturing and supply chain at Embecta, said.
FDA recommends that while it continues evaluating China-made syringes, health care providers, facilities and consumers should check the manufacturing location of their syringe supply by reviewing labeling or outer packaging or contacting their supplier or group purchasing organization.
If users only have syringes manufactured in China, they can continue to use them until an alternative can be accessed while closely monitoring for leaks, breakage or other problems.