Section: UTMB On-line Documentation Subject: Healthcare Epidemiology Policies and Procedures Topic: Monitoring of Sterilizers

1.21 - Policy 2006 - Revised 1981 - Author

1.21 Monitoring of Sterilizers

Purpose	To assure the effectiveness of the sterilization process
Audience	Employees at UTMB hospitals and clinics, contract workers, volunteers, and students who use steam sterilizers, plasma gas, or peracetic acid to process patient care equipment
Documentation	For each sterilization cycle, the following information shall be recorded and maintained for three (3) years. - The lot/load number when applicable - The general contents of the load when applicable - The exposure time and temperature, if not provided on the sterilizer recording chart - The name or initials of the operator - The results of the biological test, when applicable - The response of the chemical indicator placed in the biological-indicator test packs, when applicable - The results of leak testing, when applicable - Any reports of inconclusive or non-responsive chemical indicators found later in the load
Sterilizer Malfunctions	• If the records indicate any malfunction or malfunction is suspected, the department head or designee shall be notified. After examination, if the malfunction cannot be corrected immediately, the cycle shall be terminated in accordance with the manufacturer’s instructions. The load shall be considered non-sterile, and the sterilizer shall be removed from service. The Physical Plant Department or qualified contract personnel shall then be notified and the sterilizer repaired.
Biological Monitors	• Biological indicator test packs shall be used during initial installation testing of steam sterilizers and after any major repairs of the sterilizer. Biological indicator test packs using Bacillus stearothermophilus shall be used routinely once each week and preferably once each day on all steam sterilizers (i.e., gravity-displacement, pre-vacuum and flash). Each load containing implantable devices shall be biologically monitored and, whenever possible, the implantable device quarantined until the results of the biological indicator test are available. • Test packs shall be constructed according to the type of sterilizer being challenged. These test packs shall be constructed in accordance with the most current standards of the Association for the Advancement of Medical Instrumentation. • The test pack is placed in the portion of the sterilizer where it is most difficult to sterilize items. For steam sterilizers, the “cold point” is usually on the bottom shelf of the sterilizer, directly above the chamber drain. Hydrogen Peroxide Plasma uses Bacillus subtilis as a biological indicator. Peracetic Acid sterilization uses Bacillus stearothermophilus as a biological indicator. See Sterile Processing policy for perioperative nursing: Monitoring to the Sterilization Process.
Actions for Positive Biological Test	• Positive biological indicator results (other than viability controls) shall be immediately reported by phone or messenger to the appropriate supervisor. This notification shall be followed by a written report. The report and notification shall include: • The time and date of the questionable sterilizer cycle. • A description of the sterilizer and load, with reference to the appropriate load control number. • The results of mechanical monitoring and of the internal chemical indicator test (if applicable) as obtained from the user department. • If the biological indicator is of the type that can be cultured it shall be sent to the microbiology laboratory for presumptive identification of the microorganism present on the positive biological indicator test. • The Program Manager of Sterile Processing with representation from the Physical Plant Department or qualified contract personnel shall attempt to determine the cause of sterilization failure and arrange for corrective action. • After the cause of the sterilization failure is determined and corrected, the sterilizer in question shall be immediately rechallenged with a biological indicator test pack. Until the results of retesting are satisfactory, the performance of the sterilizer shall be considered to be in question. • Sterilization failure shall be substantiated by laboratory confirmed positive biological indicator tests, verification of proper testing techniques by personnel, and confirmation by Physical Plant or qualified contract personnel that a mechanical failure did occur. At this time, materials processed in that sterilization cycle since the last negative biological indicator shall be considered non-sterile. These items shall be retrieved, if possible, and reprocessed.
	• Biological indicators shall be handled and used according to the manufacturer’s instructions and in accordance with the type of sterilizer being monitored. • Biological indicators that are positive shall be discarded as medical waste. • Any other information that may be useful in determining whether the report is valid or is questionable due to human error shall be documented.
General Information	• The Bowie-Dick test or a commercially available equivalent shall be carried out each day the high vacuum steam sterilizer is used before the first processed load. • Recall of processed supplies is at the discretion of the Hospital Epidemiologist or his designee. Whenever there is evidence of a sterilization failure, the Department of Healthcare Epidemiology shall be notified. • Equipment used for disinfection and sterilization shall be scheduled for cleaning and preventive maintenance routinely according to the manufacturer’s instructions. Documentation of the sterilizer(s) maintenance shall be kept by Physical Plant or by those in the clinic responsible for the sterilizer. See Sterile Processing policy for perioperative nursing: Cleaning of Autoclaves and the Sterrad.
References	1. National Standards and Recommended Practices for Sterilization. Association for the Advancement of Medical Instrumentation, Arlington, Virginia, Vol 1.1-1.2,1995. 2. Perkins, J.J., Principles and Methods of Sterilization in Health Science, 2nd Edition. Springfield, Illinois. Charles C. Scott, 1969. 3. CDC Guidelines for Handwashing and Hospital Environmental Control. U.S. Department of Health and Human Services. Atlanta, Georgia, 1985. 1. Training Manual for Central Service Technicians. American Society for Hospital Central Service Personnel of the American Hospital Association. Chicago, Illinois, 1986.