The US Food and Drug Administration (FDA) published a safety communication on November 30, 2023, to inform consumers, healthcare providers, and healthcare facilities that the FDA is evaluating the potential for device failures (such as leaks, breakage, and other problems) with plastic syringes manufactured in China. The FDA is collecting and analyzing data to evaluate plastic syringes made in China used for injecting fluids into, or withdrawing fluids from, the body. At this time, the issue does not include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes.
The FDA received information about quality issues associated with several Chinese manufacturers of syringes.
At this time, while the FDA continues its evaluation of plastic syringes made in China, they recommend that consumers, healthcare providers, and facilities:
- Check the manufacturing location for syringes in use or in inventory by reviewing the labeling, outer packaging, or contacting the supplier or group purchasing organization.
- Consider using syringes not manufactured in China, if possible. At this time, glass syringes, pre-filled syringes, or syringes used for oral or topical purposes are not included.
- If they only have syringes manufactured in China, then they should continue to use them as needed until they are able to use alternative syringes and they should closely monitor for leaks, breakage, and other problems.
- Any issues with syringes should be reported to the FDA.
The FDA recommends reporting any problems with a syringe, or any medical device, through the MedWatch Voluntary Reporting Form. Healthcare personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
If you are experiencing supply issues for syringes, or other devices, you may contact the FDA about a medical device supply chain issue. Reporting supply chain issues to the FDA helps inform actions to prevent shortages and protect patient health.
The FDA safety communication can be accessed here.
Compliance Perspective
Issue
The FDA is aware of quality issues from recent syringe recalls, Medical Device Reports (MDRs), and additional complaints about syringes made at various manufacturing sites in China. Quality issues reported have included leaks, breakage, and other problems after manufacturers made changes to the syringe dimensions. These quality issues may 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.
Discussion Points
- Review policies and procedures that guide the purchasing of supplies to ensure they stipulate that syringes be purchased from locations other than China if possible. Update policies as needed.
- Train purchasing department personnel so that they are able to try to purchase syringes not manufactured in China if possible. Train healthcare workers to closely monitor syringes for leaks, breakage, and other problems; and on the steps they should take if they have any issues with syringes.
- Audit the manufacturing location for syringes by reviewing the labeling and outer packaging.
*This news alert has been prepared by Med-Net Concepts, LLC for informational purposes only and is not intended to provide legal advice.*
