Rapicide® OPA/28 has been validated for compatibility with the full line of MEDIVATORS® AERs supporting reusable chemistry. This includes the MEDIVATORS CER-1, CER-2, CER-OPTIMA, DSD-201 and SSD-102 models. Rapicide® OPA/28 is also available for manual High-Level Disinfection. For inquiries relating to the use of Rapicide® OPA/28 in other AER systems, please contact your AER manufacturer.
Yes. 24 hours is the final incubation period; however, growth of surviving spores has been documented in as little as 2 1/2 hours. We recommend checking for spore growth at regular intervals (i.e. 3, 5, 8 hours). If a failure is detected, there is no reason to further incubate the BI. A failed Test BI is reason for concern; however, the unprocessed Control BI should turn yellow, indicating spore growth.
Crosstex/SPSmedical incubators come with built in vial crushers, and/or we offer separate plastic vial crushers. After sterilization, the BI is properly “activated” when the inner media tube has been broken, allowing the media and spore strip to make contact. DO NOT CRUSH THE VIAL BEFORE PROCESSING THROUGH STERILIZER.
Instructions recommend disposing of BIs as normal waste when no growth is observed, e.g. passed test BI. When growth is observed in failed Test BI or unprocessed Control BI, these should be autoclaved at 250oF for 30 minutes prior to disposal as normal waste. Alternatively, a growth BI can be disposed of as biohazard waste without autoclaving.
Both the spores and the media are harmless, so there is no safety issue. There is, however, a concern as to the integrity of the product and therefore, it is recommended that a new test vial be run.
Media can evaporate or turn a brownish color if left in the incubator for periods beyond 48 hours. Media that has been incubated for 24 hours or less that starts to turn a brownish color, is usually an indication that the incubator temperature is operating too high. This “caramelizing” of the media does not necessary indicate a sterilization failure, but indicates the media has been exposed to heat for too long. Contact Crosstex/SPSmedical for further instructions if this happens.
A Control is an unprocessed BI. Each day the sterilizer is tested, an unprocessed BI should be activated and incubated for growth. The BI will grow and turn from purple to yellow which demonstrates the spores inside the BI were viable at time of use and that the incubator temperature is correct.
Check that the incubator is plugged in and that the green light on the incubator is on. Be sure the vial is properly activated using the built-in vial crusher or separate plastic vial crusher. Also be sure the BIs have been properly stored prior to use, e.g. room temperature, and not exposed to the Steam sterilization process.
The SporView Steam BI is for use with all types of Steam sterilizers and all cycles. It should not be used with other processes, such as EO gas, chemical vapor or dry heat.
Reusable chemistries are stressed and diluted by a number of factors that can cause the chemistry to quickly fall below the MRC, ultimately shortening the life of any reusable product. An important consideration in maximizing the reuse life of Rapicide OPA/28 for both manual and AER applications, is a thorough manual cleaning process aided by INTERCEPT Detergent. In AER application, it’s also important to have annual AER Preventative Maintenance and to maintain a consistent chemistry temperature in the reservoir and basin. Rapicide OPA/28 is reusable for up to 28 days provided the MRC is verified to be above 0.35%.
Pouches are designed for packaging single instruments or light weight items. Overloading pouches with too many items or a heavy item can cause them to burst during sterilization. A good rule of thumb is to not place items inside a pouch beyond 3/4 of the usable space. For heavy items, use a more appropriate package system, such as; sterilization wrap or a sterile container.
While steam sterilizers can and do mechanically fail, the most common reason for failure is operator error, e.g. running from a cold start, over loading the sterilizer and/or incorrect cycle parameters (time and temperature).
We have a Sterilization Classroom on our website where we post announcements, articles, free CE programs and even have an “Ask the Expert” section where users can receive answers to any questions regarding sterile processing. The website address is www.SPSmedical.com/education. We also offer a website dedicated to high-level disinfection (HLD) and that address is www.OPA28.com. Additionally, we provide free quarterly Webinars on hot topics and each Webinar is accredited for 1.0 CEU for Perioperative nurses and sterile processing personnel certified through IAHCSMM or CBSPD.
The pressure across the mask material. It is inversely related to breathability, but with greater mask efficiency, you may lose some breathability. The lower the Delta-P, the greater the breathability.
This scholarship covers all self-study certification materials and exam cost through IAHCSMM or CBSPD. To qualify, applicants must have a minimum of 6 months experience in the department and provide a letter of recommendation from a supervisor or manager.
BFE = Bacterial Filtration Efficiency; the % of bacteria filtered out at a pore size of 1-5 micron. PFE = Particle Filtration Efficiency; the % of particles filtered out at a pore size of 0.1 micron.
Best practice for manual rinsing would entail filling a basin with a large volume of fresh rinse water, and immersing the semi-critical device into the solution ensuring the inner channels and lumens of the instrument are thoroughly flushed with rinse water. The instrument should then be removed, and the basin emptied and refilled with fresh water. This process is repeated three times to ensure the OPA component is thoroughly removed from the device. It is not recommended to fill the basin with water while the instrument is present, as the splashing of the water as it hits the instrument could cause potentially harmful worker exposure.
When using Rapicide® OPA/28 for manual application, triple-rinse the disinfectant basin with clean water and wipe down the interior of the basin with a lint free cloth to remove residual precipitate. Triple-rinse the basin a second time prior to filling with Rapicide® OPA/28. For use with an AER, always refer to the manufacturer’s instructions for use when changing out HLD chemistries. The AER manufacturer will have specific instructions relating to any needed programming changes and proper chemistry change procedure. Thorough rinsing of reservoirs, basins, and AER disinfectant lines is encouraged to prevent any incompatibility between chemistries.
Check the sealing temperature of the heat sealer. Typical sealing temperatures are between 165-180°C (239-356°F). If the heat sealer can not be adjusted to provide a proper seal, then use indicator tape until the heat sealer can be repaired or replaced.