Summary: ECRI released a market analysis to aid healthcare providers in replacing malfunctioning plastic syringes from China, detailed in a report and an exclusive hazard notice. The FDA warns these syringes may cause patient harm due to leaks and breaks, posing significant supply chain challenges.

Key Takeaways:

  • Risk of Malfunction: Chinese-manufactured syringes are prone to defects like leaking and breaking, potentially causing incorrect medication dosages.
  • Supply Chain Concerns: The reliance on syringes imported from China creates substantial disruption risks within U.S. healthcare supply chains.
  • ECRI’s Guidance: ECRI provides ongoing support and recommendations to healthcare providers for identifying safe syringe alternatives and managing inventories effectively.

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.

FDA Warnings on Malfunctioning Syringes

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.

Challenges in Securing Safe Alternatives

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’s Proactive Measures

ECRI 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. ECRI said to contact vendors to request the original equipment manufacturer (OEM) identification, monitor recall notices to identify affected lots, and contact the organization for help identifying alternative products or to request lot-specific quality testing of their syringe inventory.