ALERT: Medication Vial Coring Poses Potential Fragmentation Risks

Two patient safety groups have issued an alert about the potential for injecting fragments of flexible stoppers on medication vials into patients.

“Coring” can take place when a piece of the stopper detaches during needle insertion, which could contaminate the medication, according to the April 4 alert from the Anesthesia Patient Safety Foundation (APSF) and ECRI/Institute for Safe Medication Practices (ISMP).

The groups have received several reports recently about such medication vial coring incidents.

“While no documented cases of patient harm have been reported to date, APSF and ECRI/ISMP believe there is a potential for significant risk if these fragments are inadvertently injected into patients,” states the alert.

The groups say that although coring incidents can occur with any needles used with vials that have flexible vial stoppers, blunt needles seem to pose the highest risk. While coring isn’t a new concern, guidance on how to prevent coring incidents is limited.

APSF and ECRI/ISMP are working to develop documented, evidence-based recommendations on the issue to add to their guidelines. In the meantime, they suggest adhering to the following interim recommendations in an effort to minimize occurrences.

• Use sharp needles, preferably with needle guard protection, and don’t use blunt needles unless there are specific recommendations from the manufacturer in the package to follow about how to access vials.
• Use the smaller 21-gauge needles over 18-gauge needles when possible.
• When using a sharp needle, use an angle that creates the least resistance to puncture.
• Puncture the vial stopper only once.
• If macroscopic coring is present, don’t administer its contents to a patient, secure the vial and drawn-up medication, and contact the pharmacy for help with reporting the incident and returning the vial to the manufacturer.
• Report the incident to ISMP at https://home.ecri.org/pages/ecri-ismp-error-reporting-system. Include the medication, manufacturer, vial lot number and photos of the coring. Also include the gauge of the needle used to access the vial and whether it was sharp or blunt. OSM