Description of Event or Problem · 1
LABS IN REGARDS TO A PRODUCT THE COMPANY MANUFACTURES. THE COMPANY SELLS PRODUCTS. THE ITEM IS REFERRED TO AS A SHIP-SHAW ROD WHICH IS SUPPLIED STERILE. REUSABLE SIZERS ARE USED PRIOR TO OPENING THE CORRECT IMPLANT. NEW SIZERS WERE ORDERED FROM SGARLATO LAST WEEK. I NOTICED THAT THE INSERTS PROVIDED WERE DIFFERENT. ONE OF THE SIZERS PACKAGING STATED THAT THE ITEM WAS STERILE IN THE PEEL PACK. THE PEEL PACK WAS WHITE ON ONE SIDE AND CLEAR ON THE OTHER. THERE WAS NO INFO ON THIS PEEL PACK TO STATE IT WAS STERILE. THE INSERT WITH THE OTHER SIZERS STATED THAT THE SIZERS WERE UNSTERILE AND NEEDED TO BE STERILIZED PRIOR TO USE. THE PEEL PACK WAS IDENTICAL. I DO NOT THINK THAT ANY OF THE SIZERS WERE STERILE. PT SAFETY COULD BE COMPROMISED BY THE WAY THIS COMPANY IS HANDLING THEIR INSERTS AND PRODUCT. THIS IS TO ALERT THE FDA OF A POTENTIAL PT SAFETY ISSUE WITH THIS PRODUCT. THE IMPLANT -SHAW ROD- IS PROVIDED STERILE. REUSABLE SIZERS ARE USED TO DETERMINE THE CORRECT SIZE IMPLANT. I RECENTLY PURCHASED NEW SIZERS. THE SIZERS COME INDIVIDUALLY PACKAGED ACCORDING TO SIZE. TWO OF THE SIZES COME IN NON-STERILE, THE OTHER STATED IT WAS STERILE AS LONG AS THE PACKAGE INTEGRITY WAS NOT COMPROMISED. UNFORTUNATELY ALL THE SIZERS ARE PACKAGED IN THE SAME WHITE AND PLASTIC PEEL PACKS. THERE IS NO INFO ON THE PEEL PACK. I DO NOT THINK THAT ANY OF THESE SIZERS WERE STERILE. I HAVE SPOKEN TO THIS COMPANY IN REGARDS TO OTHER ISSUES. MY FEELING IS THEY KNOW LITTLE ABOUT STERILIZATION PRACTICES. ON OTHER CONCERN, I HAVE IS IN REGARDS TO THE SIDE CUTTING BUR THAT IS ALSO USED WITH THESE RODS. I HAVE BEEN TOLD IT IS MULTIPLE USE BUR AND CAN BE RESTERILIZED, BUT IT IS NOT CLEARLY STATED IN THEIR PAPERWORK.