FAQ


How does the service work?

1) Login to your account through the homepage. 

2) Fill out the information either using the online form, or by printing off the form and mailing. 

3) We will send you the non-pathogenic spore strips and simple instructions. 

4) Place the strips inside of the instrument bags or trays and process them through a normal sterilizer cycle (autoclave, dry heat oven, chemiclave, gas sterlizer). 

5) Mail the strips back to the school in the pre-paid mailer provided. 

6) We analyze the strips and send you a confidential report of the results. 

7) If sterilization did not occur, we will call you immediately and offer information on how to correct the problem.

Account Information

Account#

This number is stamped on each double pocket envelope. Refer to it in all correspondence. If you are testing more than one sterilizer, each will have a different number to assure proper record-keeping. If you buy a new sterilizer, call us before using any spore tests. Test Expiration Date: 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. Storage of Tests: Store all double pocket envelopes in a cool dry place away from your sterilizer or other heat sources.

Instructions for Creating an Account

The Sterilization Monitoring Service keeps a running list of available account numbers that we assign to sterilizers as clients join our service. If offices are testing more than one sterilizer, EACH STERILIZER will be assigned a DIFFERENT ACCOUNT NUMBER to assure proper recordkeeping. If offices buy a NEW STERILIZER, they must call us before using any of their other spore tests so that we can assign their NEW sterilizer a different account number.

Step 1: 
Go to sms.iusd.iupui.edu

Step 2:
Click on the "Create Account" button and fill out the form.

Step 3:
After you submit your information for your account you will receive and email letting you know that your information is being reviewed and that you will be receiving a confirmation email.

Step 4: 
You will then receive two emails, one with your profile username and one with your profile password.

Step 5:
After receiving your username and password, go back to the SMS homepage and click the Login button. sms.iusd.iupui.edu

Step 6:
After logging in you will receive a phone call in no more than 2 working days. During this phone call you will be guided through your initial account setup and will then receive your account number.

Step 7:
After receiving your account number you will be able to order strips through the SMS website by going to the Order Page link.

Step 8:
If you have any more questions or comments please fill out the contact form below and we will get back to you, in no more than 2 business days.

Spore Information

How to Use Spore Tests

1. Remove the two test strip packets from the TEST side of one double pocket envelope and place this 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 single shelf units. 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 reverse side of this sheet. 

6. Place the sealed double pocket envelope and this 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 5 YEARS.

How long should we keep test results? 
The Indiana State Department of Health requires that all completed SMS Report Forms be kept for 5 YEARS. 

When you process the spore strips, should they be processed in an empty autoclave or one with instruments? 
The spore strips should be processed with instruments during a normal load cycle. 

How often do we need to test? 
The state of Indiana requires WEEKLY testing of sterilizers. All other states should contact their local State Department of Health.

How is the sterilization process monitored? 

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 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, 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 only available 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 (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 determine 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.

If sterilizing an implantable device, should users perform biological monitoring (spore testing) more frequently? 

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 biologic 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.

How often should I perform biological monitoring (BI) (spore testing)? 

Correct functioning of sterilization cycles should be verified for each sterilizer by the periodic (at least weekly) use of BIs. Users should 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.

If sterilizing an implantable device, should users perform biological monitoring (spore testing) more frequently? 

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 biologic 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.

What should I do if a spore test result is positive? 

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 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.

Causes Potential Problem
Improper cleaning of instruments Protein and salt debris may insulate organisms from direct contact with the sterilizing agent and interfere with the efficacy of the sterilization agent.
Improper packaging Prevents penetration of the sterilizing agent; packaging material may melt. 
Wrong packaging material for the method of sterilization Retards penetration of the sterilizing agent.
Excessive packaging material

Improper loading of the sterilizer
Increases heat-up time and will retard penetration of the sterilizing agent to the center of the sterilizer load.
Overloading

No separation between packages or cassettes even without overloading
May prevent or retard thorough contact of the sterilizing agent with all items in the chamber.
Improper timing and temperature 

Incorrect operation of the sterilizer
Insufficient time at proper temperature to kill organisms.