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use (IFU), is the equivalent of terminal sterilization, and is not IUSS if it includes use of a dry time and is packaged in a wrap or rigid sterilization container intended to be stored for later use.”(See Table 1.)


When should you choose a Short Cycle? s described by the S definition, the Short ycle is an accept- able practice for the steam sterilization of ophthalmic instruments and instrument sets. These sets should contain only lightweight metallic instrumentation. Lightweight metallic instruments heat quickly and produce less condensate, which allows faster drying during the drying phase of a steam sterilizer. This allows for shorter dry times and faster steam sterilization cycles. The Short Cycle can be used when the IFU of the instrument, containment device, and sterilizer all include the Short Cycle parameters. However, if any one of the above-mentioned IFU do not list the specific cycle parameters, it cannot be used. Furthermore, if the Short Cycle parameters are described as a flash or unwrapped steriliation cycle in any of those I, they are referring to an IUSS cycle and cannot be considered a Short Cycle. Table 2 illustrates some examples.


Short Cycle validation testing Its difficult to find matching I for Short ycles, especially when the sterilier dry times are based on the most difficultto dry items. Many ophthalmic facilities choose to test and validate a shorter dry time for their ophthalmic instruments so that they can shorten their set turnaround time.


Section 5.7 of ANSI/AAMI ST8 “Hospital Steam Sterilizers” describes a moisture retention test that can be used to validate the ability of a sterilizer to provide dry packs. Healthcare facilities wishing to validate a shorter dry time often refer to this standard. Hospitals choosing to use this standard as a reference should identify the worstcase load configuration for drying. This load will use the heaviest instrument sets within the containment device that is the hardest to dry. For example, a solid-bottomed container with 17 pounds of metal ophthalmic instrumentation would trap more steam condensate within it than a paper pouch with a single lightweight ophthalmic instrument. The former would be harder to dry and represent a worstcase configura- tion for drying. nce the worstcase load has been identified, the desired dry time is determined. The desired dry time is the shortest time that consistently results in dry sets. Often, facilities will run several different dry times to find the right one for their facility. What about the validation? All testing is done under a pro- tocol with clearly defined test sets and acceptance criteria. The


Instrument IFU


Vacuum assisted 270°F 4 min expo- sure with 20-minute dry time


Gravity 275°F 10 min with 16-min- ute dry time


Vacuum assisted 270°F 4 min expo- sure with 6-minute dry time


Prevac Instrument Cycle: 270°F 4 min exposure with 20-minute dry time


Gravity Wrapped Cycle: 275°F 10 min with 60 min air dry


Prevac Unwrapped Cycle: 270°F 4 min exposure with 1-minute dry time


SELF-STUDY SERIES


representative sets are prepared and weighed, and the sterilizer loaded. Immediately after the sterilization cycle, the sets are weighed, opened, and examined for residual moisture. There should be no visible moisture on the outside or inside of the containment devices. Additionally, if an absorbent wrapping material is used, it should not have increased in weight by more than 20% of its pre-sterilization weight. This procedure underscores the importance of knowing the weights of all your instrument sets.


The test is repeated two more times. All instruments and containment devices are cleaned, rinsed, and dried per the manufacturers’ written IFU, before assembling them for each test cycle. The test is successful when every device in the load for every cycle meets the moisture criteria (none present). Failure of even one pack means the test fails.


All test records, including the test criteria and test results,


must be maintained to support the use of the shortened dry- ing time. If changes are made to the containment device, load configuration or instruments in the set, validation testing must be repeated.


Quality assurance for Short Cycles Quality assurance is an essential part of sterilization. As with any steam sterilization cycle, Short Cycles use a combination of sterilization parameters, biological indicators and chemical indicators to evaluate the efficacy of the steriliation process. Short Cycles are held to the same testing standards as terminal cycles. Any time a failure occurs, it must be investigated and corrected per your facility’s policies and procedures. Let’s review the criteria necessary for quality assurance.


Sterilization parameters Sterilization parameters are checked every time a sterilization or test cycle is run on the sterilizer. The cycle printout, recording chart or electronic record is reviewed to ensure that the correct temperature was reached for the required amount of time, all vacuum cycles reached their vacuum point, and the dry time lasted the right amount of time. Any documented cycle alarms and aborts must be recorded, along with the correction for the problem that caused them.


Air removal test/Bowie Dick test


Air removal/Bowie Dick tests are required each day that a vacuum-assisted or prevac steam sterilizer is used. The test pack is the only item placed in the sterilizer, without any items to be sterilied or other test packs. The test finds air leaks and other Page 28


Table 2: IFU comparisons for appropriate use of a Short Cycle Steam Sterilizer IFU


Containment Device IFU


Sterilization Pouch / Prevac 270°F 4 min exposure with 20-minute dry time


Sterilization Wrap / Gravity 275°F 10 min with 16-minute dry


Container / Vacuum assisted 270°F 4 min exposure with 6-minute dry time


Conclusion


All IFU list a 20-minute dry time. The 20-minute dry time can be used.


The sterilizer IFU requires a longer dry time than the instrument and pouch IFU. The longest dry time (60 minutes) must be used.


The sterilizer IFU lists an Unwrapped Cycle, indicating that this is IUSS and can’t be used as a Short Cycle.


hpnonline.com • HEALTHCARE PURCHASING NEWS • May 2021 27


Self-Study Test Answers: 1. A, 2. C, 3. C, 4. B, 5. A, 6. A, 7. C, 8. D, 9. D, 10. A


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