Description of Event or Problem · 1
WE HAVE A MAJOR CONCERN WITH THE PACKAGING OF THE 1.9 FRENCH PICC FROM ARGON MEDICAL. THIS PICC LINE IS FREQUENTLY USED IN STERILE FIELDS IN THE NICU. THE PACKAGING IS LABELED AS STERILE, BUT IT IS IN A CLAM SHELL WHICH IS NOT SEALED AT THE SIDES. AIR AND BACTERIA CAN GET INTO THE CLAMSHELL IT EVEN THOUGH IT IS LABELED STERILE. WE OFTEN NEED TO MOVE THE DEVICE INTO THE STERILE FIELD FOR INSERTION DURING SURGERY AND THIS IS NON-INTUITIVE BECAUSE BOTH THE OUTSIDE OF THE CLAMSHELL, INSIDE OF THE CLAMSHELL, AND OUTSIDE OF THE WRAP ARE NOT IN FACT STERILE. IF THE PACKAGING IS DROPPED ONTO A STERILE FIELD, THE ENTIRE FIELD IS CONTAMINATED. WHILE PRACTICING IN THE NICU, ONE OF THE NICU NP'S EMPTIED THE CONTENTS OF THE PICC CLAM SHELL KIT ON A STERILE FIELD. WHEN THIS WAS BROUGHT TO THE NP'S ATTENTION, SHE POINTED OUT THAT THE PACKAGING IDENTIFIED THE CONTENTS AS STERILE. A HIGHLY QUALIFIED NURSE PRACTITIONER CONTAMINATED THE FIELD DUE TO AMBIGUOUS LABELING OF THE CLAM SHELL PACKAGING. OTHERS CAN MAKE THAT ERROR AS WELL BECAUSE THE PACKAGE IS LABELED "STERILE". MANUFACTURER RESPONSE FOR PICC LINE PACKAGING, FIRST PICC S/L (PER SITE REPORTER): ARGO IN A LETTER TO THE CLINICAL TEAM STATED THAT THIS HAS NEVER BEEN REPORTED AS AN ISSUE IN THE PAST. THEY HAVE OFFERED TO SUPPLY OUR FACILITY WITH THE STERILE PACKED ITEMS WITHIN THE CLAM SHELL WITHOUT THE CLAM SHELL, BUT DO NOT INTEND TO CONSIDER CHANGING THE LABEL ON THE OUTER SHELL INDICATING THE PACKAGE IS STERILE.