According to the Food and Drug Administration (FDA), "device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more" [21 CFR 812.3(d)].

Sterilizing implantable devices:

Because of the potential for serious infections, flash sterilization is not recommended for implantable devices (i.e., devices placed into a surgically or naturally formed cavity of the human body); however, flash sterilization may be unavoidable for some devices (e.g., orthopedic screw, plates).  If flash sterilization of an implantable device is unavoidable, recordkeeping (i.e., load identification, patient’s name/hospital identifier, and biological indicator result) is essential for epidemiological tracking (e.g., of surgical site infection, tracing results of biological indicators to patients who received the item to document sterility), and for an assessment of the reliability of the sterilization process (e.g., evaluation of biological monitoring records and sterilization maintenance records noting preventive maintenance and repairs with dates).  See the complete recommendations on sterilizer and disinfection at www.cdc.gov “Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008”.

ATS, Inc. provides sterility assurance products for the healthcare industry – see Supplies.

DID YOU KNOW?

§    Autoclave Testing Service, Inc. is one of the first companies nationwide to offer a Mail-In sterilizer monitoring service using biological indicators.  Serving the healthcare industry throughout the United States and Canada since 1986, we have thousands of satisfied customers.

§   We have on-line test results allowing you to access your results at your convenience!  Your Sterilizer Test Report (STR) is posted on-line upon completion of culturing, offering minimum turn-around time.

§   We have 24-hour test results for Steam sterilizers!

§  We have a comprehensive Glossary of Terms related to the sterile processing area (scroll below to view the Glossary).  This is invaluable information, assisting you with this important area of your facility.

ATS, Inc. now stocks sterilization pouches, sterilizer cleaners, chemical indicator products, sterilizers (new and used), ultrasonic cleaners, water distillers, and more!  (see Supplies).