Kimberly Redmond//December 1, 2023//
A health care worker holds syringes. - FDA
A health care worker holds syringes. - FDA
Kimberly Redmond//December 1, 2023//
After the U.S. Food and Drug Administration announced an investigation into reports of leaks, breakages and other quality issues with China-made plastic syringes, New Jersey-based medical technology companies are assuring the public that their devices are manufactured domestically and safe.
Following the Nov. 30 notice – in which the agency advised patients and health care providers to use syringes made outside of China until its review is complete – Franklin Lakes-headquartered medtech Becton, Dickinson and Co. (BD) and Parsippany-based global diabetes business Embecta Corp. (embecta) issued statements that they’re both ready to boost production to support those affected by the probe.
Eric Borin, president of BD Medication Delivery Solutions said, “Essentially all plastic syringes BD provides to the U.S. health care system are manufactured in the United States in Nebraska and Connecticut. 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.”
Borin added, “Ensuring the safety and quality of our products is the top priority at BD. We have been supporting health care needs with needles and syringes since the inception of our company in 1897 and have provided these products to the U.S. health care system through two world wars, the Polio vaccination trials and multiple pandemics – most recently manufacturing 2 billion additional syringes for COVID-19 vaccinations. BD stands ready to deploy our capacity to support the U.S. health care system and patients.”
Embecta – which is the world’s largest manufacturer of plastic insulin syringes and a former subsidiary of BD – produces all of its syringes at a facility in Holdrege, Neb., according to Shaun Curtis, senior vice president, Global Manufacturing & Supply Chain.
“In the coming year, embecta will mark 100 years since our predecessors developed the world’s first syringe dedicated to insulin delivery, and we are proud of our rich heritage of quality, reliability, and innovation that we have earned in the years since. Our skilled workforce in Nebraska, with its unmatched expertise in high volume syringe manufacturing, is prepared to support any healthcare customers who may be affected by the FDA’s safety communication,” he said.
According to the FDA, recent changes made to the plastic syringe dimensions during production at various manufacturing sites in China has led to quality issues, which may affect health providers’ ability to deliver the correct dose of medication when used alone or with other medical devices, like infusion pumps.
The agency says it is working with federal partners to further test syringes made in China as well as manufacturers “to ensure adequate corrective actions are taken,” but may prevent the devices from entering the U.S. market, if necessary.
The FDA is also recommending patients and providers check the manufacturing location of syringes by reviewing the labeling, outer packaging or contacting one’s supplier or group purchasing organization. If an individual only has syringes made in China, the FDA says they can be used “as needed until you are able to use alternative syringes and closely monitor for leaks, breakage, and other problems.”