inforMED
MalfunctionLYV

INSTRUMENT IDENTIFICATION TAPE

Received Aug 26, 2019 · Event occurred Aug 6, 2019

Report MW5089320 · MDR key 8931838

Device

Generic name

Label Or Tag, Sterile

Manufacturer

Unk

Product problems

  • Product Quality Problem
  • Use of Device Problem

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

I WAS DOING AN INFECTION PREVENTION CONSULTATION VISIT AT A HOSP AND REVIEWING THEIR STERILIZED INSTRUMENTS, I NOTICED THE USE OF WHAT IS CALLED "INSTRUMENT IDENTIFICATION TAPE." I LOOKED UP SEVERAL BRANDS AND CONTACTED THE MFR FOR THE USE OF INSTRUCTION AND WHICH STATE THE PRODUCT CAN BE LEFT ON THE INSTRUMENTS FOR MULTIPLE CYCLES OF DECONTAMINATION AND STERILIZATION. HOW IS THIS ALLOWED WHEN THE PRODUCT ITSELF IS AN ADHESIVE? HOW ARE PROPER STERILIZATION METHODS ABLE TO BE ADHERED TO WHEN TAPE IS ALLOWED TO BE LEFT ON THE INSTRUMENT? PER THE CDC GUIDELINE FOR DISINFECTION AND STERILIZATION IN HEALTHCARE (2008) "CLEANING REMOVES THE BIOBURDEN AND REMOVES FOREIGN MATERIAL (I. E., ORGANIC RESIDUE AND INORGANIC SALTS) THAT INTERFERES WITH THE STERILIZATION PROCESS BY ACTING AS A BARRIER TO THE STERILIZATION AGENT." IF TAPE, AN ADHESIVE, IS LEFT ON AN ITEM, HOW DOES IT NOT ALLOW ORGANIC MATTER TO STICK TO THE INSTRUMENT? FDA SAFETY REPORT ID# (B)(4).