Sterilization Monitoring Service

Note: The SMS web portal is temporarily down for upgrades. To access reports or if you have questions, please call us at 317-274-5411 or email us at iusms@iu.edu

1. Fill out the form to create a new account.
2. After you submit the form, you will receive an email letting you know that your information is being reviewed.
3. After your account is confirmed, you will receive two emails: one with your profile username and one with your profile password.
4. After receiving your username and password, log into your account.
5. After logging in for the first time, you will receive a phone call in no more than two working days. During this phone call we will guide you through your initial account setup and give you your account number.
6. After you receive an account number for your sterilizer, you will be able to order test strips online.

If you have any questions or comments, contact us and we will get back to you in no more than two business days.

The SMS keeps a running list of available account numbers that we assign to sterilizers as clients join our service. Your account number is tied to an individual sterilizer and is stamped on each double-pocket envelope. Refer to it in all correspondence.

If your office is testing more than one sterilizer, each sterilizer must be assigned a different account number to ensure proper record keeping. If your office buys a new sterilizer, you must call us before using any spore tests so that we can assign your new sterilizer a different account number.

Sterilization procedures should be monitored through a combination of mechanical, chemical, and biological techniques designed to evaluate the sterilizing conditions and the procedure’s effectiveness.

Mechanical techniques

Mechanical techniques for monitoring sterilization include assessing the cycle time, temperature, and pressure of sterilization equipment by observing the gauges or displays on the sterilizer. Some tabletop sterilizers have recording devices that print out these parameters. Correct readings do not ensure sterilization, but incorrect readings could be the first indication that a problem has occurred with the sterilization cycle.

Chemical indicators

Internal and external chemical indicators use sensitive chemicals to assess physical conditions such as temperature during the sterilization process. Chemical indicators such as heat sensitive tape change color rapidly when a given parameter is reached.

An internal chemical indicator should be placed in every sterilization package to ensure the sterilization agent has penetrated the packaging material and actually reached the instruments inside. An external indicator should be used when the internal indicator cannot be seen from outside the package.

Single-parameter internal indicators provide information on only one sterilization parameter and are available for steam, dry heat, and unsaturated chemical vapor. Multiparameter internal indicators measure 2–3 parameters and can provide a more reliable indication that sterilization conditions have been met. Multiparameter internal indicators are available only for steam sterilizers (i.e., autoclaves). Refer to manufacturer instructions for proper use and placement of chemical indicators.

Indicator test results are shown immediately after the sterilization cycle is complete and could provide an early indication of a problem and where the problem occurred in the process. If the internal or external indicator suggests inadequate processing, the item that has been processed should not be used. Because chemical indicators do not prove sterilization has been achieved, a biological indicator (i.e., spore test) is required.

Biological indicators

Biological indicators (BIs) are the most accepted means of monitoring the sterilization process because they directly determine whether the most resistant microorganisms (e.g., Geobacillus or Bacillus species) are present rather than merely determining whether the physical and chemical conditions necessary for sterilization are met. Because spores used in BIs are more resistant and present in greater numbers than are the common microbial contaminants found on patient care equipment, an inactivated BI indicates that other potential pathogens in the load have also been killed.

Each double-pocket envelope is marked with an expiration date that allows ample time for routine monitoring. We cannot replace expired tests free of charge. Expired tests should be sterilized and discarded.

Store all double-pocket envelopes in a cool, dry place, away from your sterilizer or other heat sources.

1. Remove the two test strip packets from the TEST side of one double-pocket envelope and place them into an instrument pack or tray to be sterilized. Do not open the small packets containing the spore strips. Do not open the CONTROL side of the double-pocket envelope.
2. For dry heat sterilizers, place the spore test pack or tray on the top shelf in the center, or in the center of a single shelf unit. For all other types of sterilizers, place the test pack or tray in a central location among other packs or trays.
3. Process the pack or tray containing the spore packets through a normal sterilizer cycle.
4. After the cycle, place both spore strip packets back into the TEST side of the double-pocket envelope and seal the flap.
5. Complete the top half of the SMS report form on the reverse of the sheet of instructions that came with your test.
6. Place the sealed double-pocket envelope and the entire sheet into one prepaid mail envelope and mail. We will analyze the spore strips, complete our portion of the report form, and return it to you. If the spores on the test strips grow (suggesting sterilization failure), we’ll telephone you with the results and follow up with the report form.

The Indiana State Department of Health requires that all completed SMS report forms be kept for five years.

The spore strips should be processed with instruments during a normal load cycle.

The state of Indiana requires weekly testing of sterilizers. All other states should contact their local State Department of Health.

Correct functioning of sterilization cycles should be verified for each sterilizer by the periodic (at least weekly) use of biological indicators (BI). Follow the manufacturer’s directions concerning the appropriate placement of the BI in the sterilizer. A control BI (not processed through the sterilizer) from the same lot as the test indicator should be incubated with the test BI. The control BI should yield positive results for bacterial growth.

In addition to conducting routine biological monitoring, equipment users should perform biological monitoring:

• Whenever a new type of packaging material or tray is used
• After training new sterilization personnel
• After a sterilizer has been repaired
• After any change in the sterilizer loading procedures

Any load containing implantable devices should be monitored. Ideally, implantable items should not be used until the results of tests are known to be negative. As previously noted, the manufacturer’s directions concerning the appropriate placement of the biological indicator (BI) in the sterilizer must be followed. A control BI (not processed through the sterilizer) from the same lot as the test indicator should be incubated in the same manner as the test BI. The control biological indicator should yield positive results for bacterial growth.

If the mechanical (e.g., time, temperature, pressure) and chemical (internal or external) indicators suggest that the sterilizer is functioning properly, a single positive spore test result probably does not indicate sterilizer malfunction. Items other than implantable items do not necessarily need to be recalled; however, sterilizer operators should repeat the spore test immediately using the same cycle that produced the positive biological indicator (BI). The sterilizer should be removed from service and sterilization operating procedures reviewed to determine whether operator error could be responsible.

If the result of the repeat spore test is negative and operating procedures were correct, then the sterilizer can be returned to service. If the repeat spore test result is positive, do not use the sterilizer until it has been inspected or repaired and rechallenged with BI tests in three consecutive empty-chamber sterilization cycles. When possible, items from suspect loads dating back to the last negative BI should be recalled, rewrapped, and resterilized.

Results of biological monitoring and sterilization monitoring reports should be recorded.