On March 19, 2024, the US Food and Drug Administration (FDA) provided an update about their ongoing evaluation of quality and performance issues related to plastic syringes made in China. The update also announced additional recommendations and actions the FDA are taking to address these issues, and steps for providers and facilities to take.
In November 2023, the FDA informed consumers, healthcare providers, and healthcare facilities that they were evaluating the potential for device failures (such as leaks, breakage, and other problems) with plastic syringes manufactured in China, that are used for injecting fluids into, or withdrawing fluids from, the body. They had received information about quality issues associated with several China-based manufacturers of syringes. The issue does not include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes.
On March 18, 2024, the FDA issued warning letters to three of the entities who either manufacture the plastic syringes or market and distribute them. The letters described 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 sale or distribution in the US, and also violations related to quality system regulations for syringe products.
The FDA said that they are concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance, and their evaluation is ongoing. According to the update, until further notice, providers should immediately transition away from using plastic syringes manufactured by Jiangsu Caina Medical Co Ltd, unless use of these syringes is absolutely necessary until the transition can be completed. Providers should also immediately transition away from using unauthorized plastic syringes manufactured by Jiangsu Shenli Medical Production Co Ltd, which includes all models other than the 5 mL luer lock syringe, unless use of these syringes is absolutely necessary until the transition can be completed.
The FDA issued additional recommendations in the safety communication update which can be viewed 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. F755 §483.45 Pharmacy Services states that the facility must ensure that medication is administered in the correct dose. Syringes that fail to meet FDA standards for performance should be removed from a facility’s inventory as soon as replacements are available.
Discussion Points
- Review policies and procedures that guide the purchasing of supplies to ensure they stipulate that syringes be purchased from approved sources. Update policies as needed.
- Train purchasing department personnel to obtain syringes from manufacturers other than those identified by the FDA as failing to meet safety standards. If the facility’s inventory includes syringes produced by the identified companies in China, ensure that purchasing personnel obtain replacement syringes as soon as 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 or any other equipment they use.
- Audit the manufacturing location for syringes by reviewing their labeling and outer packaging. Replace any syringes manufactured by the identified companies as soon as replacement syringes can be obtained. Monitor all syringes in use for their performance in meeting standards of practice for accurate administration of medications to ensure that dosages received by residents comply with physician orders. Immediately address any identified concerns.
*This news alert has been prepared by Med-Net Concepts, LLC for informational purposes only and is not intended to provide legal advice.*
