BD to Increase Plastic Syringe Production After FDA Warns on Imports From China

In response to recommendations from the FDA that health care providers avoid using plastic syringes made in China, BD has announced it will ramp up US production of the drug delivery hardware.¹

Person holding syringe / Skylarov - stock.adobe.com

After warning health care providers against using plastic syringes from China late last November, the FDA doubled down on its recommendation last week. Initially, the guidance came after the agency collected reports of leaks, breakages, and other problems associated with the syringes; following recent facility inspections and product examinations, the FDA’s quality concerns have continued to mount.¹

“Our ongoing evaluation has confirmed that issues with the quality of plastic syringes made in China and their distribution in the US are more widespread than originally known,” said Jeff Shuren, MD, device center director at the FDA, in a news release.²

Since the FDA made its original recommendations in November, BD has upped its production of plastic syringes at sites in Nebraska and Connecticut. The company will remain committed to increasing production of the drug delivery hardware as the quality issues in China are resolved.

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“BD has the capacity to support additional syringe demand and is further increasing US production to help ensure continuity of patient care,” said Eric Borin, president of medication delivery solutions at BD.¹ “Over our more than 125-year history, we have served the health care system’s need for essential high-quality medical products, including manufacturing 2 billion additional syringes and needles to support the global pandemic response to COVID-19.”

On March 18, the agency sent warning letters to Jiangsu Shenli Medical Production Co. Ltd, a China-based syringe maker, and Medline and Sol-Millennium, 2 US-based companies that market plastic syringes made in China. According to Shuren, all 3 warning letters “describe violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for use in the US,” and “concern violations related to quality system regulations for syringe products.”¹

Voicing concerns about the plastic syringes’ ability to deliver correct doses either alone or paired with an infusion pump, the FDA urged providers to “immediately transition away” from all models of plastic syringes manufactured by Jiangsu Shenli and Jiangsu Caina Medical Co. Ltd, unless completely necessary.¹ The agency does not anticipate the shift to disrupt the supply of the essential drug delivery hardware.

“The FDA believes that the supply and manufacturing capacity of plastic syringes made in countries other than China, including domestic manufacturing, is adequate to support current health care demand. Therefore, the agency does not anticipate that a shift in the supply chain is likely to lead to a shortage of these products,” said Shuren.¹

READ MORE: FDA Updates

References

1. Hale C. BD boosts US production as FDA warns against using plastic syringes from China. Fierce Biotech. March 25, 2024. Accessed March 28, 2024. https://www.fiercebiotech.com/medtech/bd-boosts-us-production-fda-warns-against-using-plastic-syringes-china

2. FDA provides update on syringes made in China, issues warning letters related to violative products. News release. FDA. March 19, 2024. Accessed March 28, 2024. https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-provides-update-plastic-syringes-made-china-issues-warning-letters-related-violative-products