PLYMOUTH
MEETING, Pa., April 30,
2024 /PRNewswire/ -- 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. DOWNLOAD THE REPORT.
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.
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SOURCE ECRI