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Frequently Asked Questions

Q. How is SPSmedical different than other test laboratories?

A. There are numerous differences, including SPSmedical is a corporate member of both AAMI and CSA standards, where we contribute to writing sterilization standards. Upon request, SPSmedical provides a complimentary educational program, “Cleaning, Packaging and Sterilization of Instruments” which is based on sterilization best practices and is approved by IAHCSMM, CBSPD and DANBE for continuing education credit. SPSmedical provides three different mail-in spore testing products to choose from, including the PassPortPlus, which provides immediate information about the Steam sterilization cycle, allowing failures to be detected before the spore test results have been communicated by the test laboratory. Lastly, SPSmedical is used and recommended by leading sterilizer and instrument manufacturers.

Q. How often should sterilizers be spore tested?

A. According to the CDC, sterilizers should be tested at least weekly and every load that contains an implant. AAMI and AORN standards recommend steam sterilizers be spore tested at least weekly, preferably daily and every load that contains an implant. Low temperature sterilizers, i.e. EO gas and hydrogen peroxide processes, should be spore tested each load. Canadian Standards (CSA) say to test sterilizers the first load of the day and every load that contains an implant.

Q. Which is better, in office or mail in spore test systems?

A. Both systems should provide the same level of sterility assurance if performed correctly. While in office systems offer faster turnaround time of results, mail in systems are considered easier to use. For example, users selecting an in office system must purchase a different BI for each sterilization process and one or more preset incubators to process the Test and a Control BI each time. It is the responsibility of the facility to document the test results and retain the recordkeeping. However, the BI used in mail in systems is for multiple processes and incubation is performed by the test laboratory. The laboratory maintains the test results which are also reported back to the user by phone or fax. It is critical that the spore test results are documented appropriately with either system. SPSmedical is unique in that we manufacture both in-office and mail-in systems, dry block incubators and a full line of sterility assurance products including sterilization packaging (pouches, wraps, indicator tapes).

Q. Do I have to complete the information on each test envelope?

A. Yes, it is important that we have this information for proper documentation of your test results. Each test is considered a legal document and therefore all information should be filled out. We provide complimentary ID labels for all customers, that can simplify this process. Rather than hand writing all of your customer information, you simply apply a unique label that is specific to your account/sterilizer, and hand write information regarding that specific test such as the date the test was ran.

Q. What does the laboratory do when my test arrives?

A. The laboratory staff applies an identification sticker on the test envelope and corresponding tubes of media. Then the data is entered into the computer from the test envelope. The strips are transferred into sterile media and incubated for the appropriate period of time. All tests are checked daily for spore growth, and the results are recorded.

Q. Why do you incubate tests at different temperatures?

A. The G. stearothermophilus spores used to test Steam and Chemical Vapor sterilizers thrive at 56°C, while the B. atrophaeus spores used to test Dry Heat and EO gas require incubation at 37°C.

Q. How long does the spore test result take at your laboratory?

A. Once the test is received, the SPSmedical laboratory must incubate steam sterilizer tests for 24 hours before the final result can be documented. Chemical vapor results are available after 72 hours and EO Gas/Dry Heat both require 7 days incubation time. In the event that we identify a failure, no more incubation is required, and the customer is contacted the same day with CDC recommendations for a failed test result.

Q. What causes a sterilizer to fail?

A. While sterilizers can and do mechanically fail from time to time, i.e. worn door gasket, seals, pressure release value and/or heating coils, operator error is considered the leading cause of sterilizer failure. Users must be careful not to over load the sterilizer or run the sterilizer from a cold start. Improper packaging and/or selecting the wrong sterilizer cycle parameters can also lead to sterilizer failures. Staff should be trained on how to properly reprocess reusable devices and understand the importance of sterilization – including selecting the correct packaging system, chemical indicator, biological indicator, and running the appropriate sterilization cycle.

Q. How common is it for a sterilizer to fail the spore test?

A. Sterilizer failure is not common to users who follow best practices and MFG’s instructions for use. Operator error is the most common cause of sterilizer failure and if not corrected, will occur over and over again. Having regular maintenance performed on your sterilizer can also help prevent mechanical failures that will naturally occur over time.

Q. What should be done if a sterilizer fails the spore test?

A. According to the CDC, sterilizers that fail the spore test should be taken out of service and retested (after operator review of correct procedures). If the sterilizer fails a second spore test, the sterilizer should be professionally repaired and not used until it passes multiple spore tests.

Q. How do you determine a failed spore test?

A. A failed test result shows spore growth during incubation in our laboratory. This can be seen as turbidity and/or color change in the growth media caused by the presence of microorganisms. A Gram stain is performed to ensure the growth is in fact the test microorganism and not due to any outside contamination.

Q. If a spore test fails, how do you contact the customer?

A. SPSmedical will both contact you by phone, and send a physical lab report indicating a failure. We ensure that we talk to a live person and provide CDC recommendations for a failed test, as well as answer any other questions you may have.

Q. If I need to send a test in over-night, how do I proceed?

A. Rather than sending through the USPS, you can use UPS or FedEx and send the test envelope to: SPSmedical, Attn: Culture Laboratory @ 6789 W. Henrietta Road, Rush NY 14543.

Q. What can cause a spore test to be invalid?

A. A spore test is considered invalid whenever a critical procedure was not followed, i.e. no Control strip included, product used after the stated expiration date, Control strip processed, strips returned with different lot numbers, missing a control or test strip, etc. If you have an invalid test, we recommend you run another spore test immediately, ensuring the instructions for use are followed.

Q. What is a Class 5 integrator and does it replace the spore test?

A. A Class 5 integrator is a chemical indicator that reacts to all the critical sterilization parameters and mimics spore test results. While this is not a replacement for the spore test, a Class 5 integrator can provide immediate information about each sterilization cycle it is used in. The Class 5 integrator is often used more frequently than the spore test (due to the lower cost and immediate readout), allowing users to detect a sterilization failure quicker than relying on the spore test alone. As there are no bacterial spores in the Class 5 integrator, this product can NOT replace the use of the spore test, per the stated frequency of industry standards, but does allow for increased quality assurance when added to the sterility assurance program.

Q. Does it matter what type of water I use in my autoclave?

A. Yes. Only use the type of water specified by the sterilizer manufacturer, i.e. distilled or purified. Using tap water can cause mechanical failure and possibly void the sterilizer warranty.

Q. When is the best time of the day to spore test my sterilizer?

A. While you can run the spore test at any time during the day, being consistent with your testing can help prevent operator errors. It is considered routine to test the first load of the day, each day that you spore test your sterilizer(s). For sterilizers that have been turned off or not used in a long time, a warm up cycle is recommended prior to spore testing. CSA recommends testing the first load of the day.

Q. Should I run my spore test an empty sterilizer?

A. Sterilizers should be routinely tested with a load that is representative of the items the healthcare facility processes, i.e. instruments inside peel pouches or wrapped trays. You want the spore strip(s) to see the same conditions that your sterilized items do. For new sterilizer installation or those that have been repaired, three (3) consecutive empty sterilizer tests are recommended prior to placing the unit back into service.

Q. Can I check my test results at any time?

A. Yes, test results can be viewed at any time through our secure website: www.checkyourtest.com. Simply log in using your account number and password. All of your test results are available to review and print off as needed. Results can also be checked by calling the SPSmedical laboratory during normal business hours at (800)-722- 1529.

Q. How long should a facility keep the sterilizer spore test records?

A. Sterilizer records should be kept for a length of time required by your state health department which varies from state to state. SPSmedical mail-in customer spore test records are kept online for two years and archived thereafter.