DISPOSABLE VAGINAL SPECULUM

Description of Event or Problem

THE PACKAGE LABEL FOR TRINITY STERILE'S DISPOSABLE VAGINAL SPECULUM LARGE (ITEM NO. 22202) AND, PRESUMABLY, OTHER SIZES, GIVES THE IMPRESSION THAT THE PRODUCT IS STERILE WHEN IT IS NOT. THE WORD STERILE APPEARS IN VERY LARGE LETTERS AT THE TOP OF THE PACKAGE LABEL (AS PART OF THE BRAND NAME TRINITY STERILE), WHILE THE WORD NON-STERILE APPEARS ONLY IN MINUSCULE LETTERS OFF TO THE SIDE OF THE LABEL IN A TRIANGLE, NEXT TO THE "NO LATEX" AND "SINGLE USE ONLY" ICONS. I CAN TELL YOU THAT THE LABELING LED TO THE MISTAKEN IMPRESSION THAT THIS IS A STERILE SPECULUM, AND IT HAS BEEN USED UNDER THAT ASSUMPTION FOR SOME TIME ON OUR LABOR AND DELIVERY UNIT. WHILE I CANNOT POINT TO A SPECIFIC HARM THAT HAS REACHED A PATIENT, I CAN SAY THAT USING A NON-STERILE SPECULUM HAS THE POTENTIAL, UNDER SPECIFIC CIRCUMSTANCES, TO CAUSE HARM DURING A PREGNANCY, AS WITH PRETERM PREMATURE RUPTURE OF MEMBRANES. THE LABEL SHOULD CLEARLY STATE "NON-STERILE" IN VERY PROMINENT LETTERING, PROXIMATE TO AND MORE POMINENT THAN THE MISLEADING BRAND NAME "TRINITY STERILE," TO REMOVE ANY CONFUSION ABOUT THE STERILITY OF THIS SPECULUM.