Global patient safety nonprofit releases guidance for navigating supply chain disruptions caused by faulty syringes from China
The FDA has been warning healthcare providers and the public about malfunctioning plastic syringes made in China since November 2023. The affected syringes are leaking, cracking, and breaking – putting patients at risk of receiving incorrect doses of medication, risking serious injury or death. While the FDA advises against using syringes manufactured in China, healthcare providers are working to secure safe alternatives which is a time consuming process fraught with inefficiencies and delays. Since most of the syringes imported to the U.S. are made in China, this issue has the potential to cause serious supply chain disruptions.
ECRI – one of the nation’s largest patient safety nonprofits and the only independent evaluator of medical devices – has shared recommendations about mitigating the threat posed by these syringes since late last year. In an ECRI Exclusive Hazard Report from December 2023, ECRI advised its members to review their inventory of all plastic syringes to identify those made in China; contact vendors to request the original equipment manufacturer (OEM) identification; monitor recall notices to identify affected lots; and contact ECRI for help identifying alternative products or to request lot-specific quality testing of their syringe inventory.
ECRI recently released a comprehensive market analysis designed to help healthcare providers discontinue use of the affected syringes and secure safe alternatives. The report identifies the Key Performance Indicators (KPIs) of hundreds of comparable syringes to determine which are considered functionally equivalent.
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“Our global medical equipment supply chain crumbled under the weight of COVID four years ago,” said Marcus Schabacker, MD, PhD, President and CEO at ECRI. “I worry that the recent problems with syringes made in China reveal we’ve become too complacent about shoring up quality, safe products in our global and domestic supply chain since the pandemic... It's no secret that domestic manufacturers struggle to compete with less costly but less secure overseas alternatives. The appeal of cheaper products is understandable, but even though hospitals and health systems operate on tight margins, it’s critical for patients’ sake that they find ways to cut costs safely.”
About ECRI:
ECRI is the world’s only healthcare organization with the unique combination of capabilities including device evaluation in an independent testing lab; clinical safety expertise through the ECRI Patient Safety Office (PSO); alerts that track safety problems with medical devices long before they escalate to an FDA safety bulletin; and supply chain guidance for identifying functional equivalents in the marketplace.
For more information:
Contact Yvonne Rhodes, Associate Director of Strategic Communications, at YRhodes@ECRI.org