SurgiDat Serenity Audit and Recall: A simple solution designed to provide compliance.

CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Page 61

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).

Page 79

Sterilization records (mechanical, chemical, and biological) should be retained for a time period in compliance with standards (e.g., Joint Commission for the Accreditation of Healthcare Facilities requests 3 years) and state and federal regulations.

Page 79

Periodic infection control rounds to areas using sterilizers to standardize the sterilizer's use may identify correctable variances in operator competence; documentation of sterilization records, including chemical and biological indicator test results; sterilizer maintenance and wrapping; and load numbering of packs. These rounds also may identify improvement activities to ensure that operators are adhering to established standards989.

Page 92

Retain sterilization records (mechanical, chemical, and biological) for a time period that complies with standards (e.g., 3 years), statutes of limitations, and state and federal regulations. Statute of limitations is seven years.

For further information, please refer to the complete document at the CDC website.