In preparation for 510(k) submission, Instructions for Use must be documented. Two topics important to orthopaedic manufacturers are ST79 and TIR30. ST79 Testing is described in ANSI/AAMI ST79, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. Manufacturers of medical device trays, instruments and rigid containers are responsible to demonstrate that these items can be cleaned and steam sterilized.
ST79 testing is performed and a validation report is written to support the manufacturer’s Instructions for Use. A typical protocol for ST79 testing is written to simulate worse case conditions. Specifically, 1) relatively resistant bacterial spores are inserted into the worse case instrument at locations judged to be most recalcitrant to penetration by steam, 2) half the anticipated sterilization exposure time is used to determine spore death and 3) maximum and minimum loads are separately sterilized. The proposed dry time for the tray is also validated.
TIR30 Testing is described in AAMI TIR30, a compendium of processes, materials, test methods and acceptance criteria for cleaning reusable medical devices. Manufacturers of reusable instruments are responsible to demonstrate that the instruments can be successfully cleaned according to Instructions for Use that will be submitted to FDA for a 510(k) clearance. The cleaning validation takes into account both manual and automatic instructions that hospitals must follow in order to adequately reprocess the instrument.
Jozef Mastej is Vice President of Operations at Gibraltar Laboratories, Inc. and has been with the company for 20 years. He received his degree from the University of Poland Jagiellonski Biology Program in Kracow, Poland. Mr. Mastej directs the Microbiology and Chemistry departments in respect to necessary equipment supplies and scheduling. He is a well-known professional in the field of steam sterilization, cleaning, microbiology and sterility, and has authored and co-authored numerous publications in the fields of microbiology and sterilization services. Mr. Mastej conducts seminars on steam sterilizations and cleaning validations through the Gibraltar Institute for Research and Testing (GIRT). He is also responsible for the company’s compliance with the controlled substance act and with GMP, GLP.