4 Tips for Sterilizing Items That Can't Take the Heat

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Best practices to fine-tune your low-temperature sterilization protocols.


One of the biggest challenges of processing heat-sensitive critical devices is the fact that they typically have to be cleaned and disinfected manually. Just as they can't withstand the heat of your steam sterilizer, many of these devices can't withstand automatic washer/disinfectors that would otherwise make your job easier by flushing, rinsing and drying devices so they're ready to be prepped and packed. There are other challenges, too. Here's advice on overcoming them.

1 Create time for sterile processing
Educate your schedulers and surgical staff about which devices require low-temperature sterilization and what's involved in the process, so they know to build enough time into the schedule for effective cleaning, disinfection and sterilization between uses. One way to achieve this is by alternating between similar types of cases that use the same heat-sensitive instruments instead of placing them back-to-back on the schedule. The cycle times for sterilizers that use hydrogen peroxide gas plasma or vapor (28 to 55 minutes) and ozone (about 4 hours) are much shorter than the 12-hour-plus turnaround for ethylene oxide gas. That's certainly welcome news. But if your busy caseload makes it harder and harder to find time for sterile processing, consider purchasing more devices and instrument sets for high-volume cases to prevent backups.

2 Test SPD staff's competencies
The onus is on your staff to follow all manufacturers' directions for cleaning and disinfecting these items. Work with your sterilizer and device vendors to provide thorough training on the proper way to clean, prep, pack and sterilize every device, says Karen Owens, RN, sterile processing and OR distribution manager for Baptist Hospital East in Louisville, Ky. Perform regular competencies to ensure their skills remain sharp from year to year. All sterile processing department staff at Ms. Owens's facility are given competencies 90 days after initial hire and then once every year. "You've got to make sure they know how to run these machines," she says.

Have You Replaced Your Steris System 1 Yet?

With just 5 months to go until the FDA's August deadline for replacing the Steris System 1, many surgical facility leaders have told us that they've yet to find a replacement for the tabletop liquid chemical reprocessing system. The obvious choice would seem to be Steris's successor to the SS1, the System 1E. But the confusing nature of the FDA's approval of the device has left some unsettled. Consider:

  • Sterilizer or not? The FDA has labeled the 1E a "liquid chemical sterilant processing system," not a "sterilizer," but its clearance letter says that the system "provides processing for heat-sensitive semi-critical and critical medical devices." Critical devices, of course, must be sterilized.
  • Is the rinse water sterile? The original FDA letter stated that devices processed in the SS1E are rinsed with potable water that, despite going through a 3-step treatment process that involves filtration and exposure to ultraviolet rays, is not sterile. The FDA revised this language last month regarding the SS1E's rinse water treatment: "The treatment method eliminates bacteria/fungi/protozoa from the water. Studies with the test virus MS2 (EPA recommended surrogate for waterborne viruses) showed a 6-log reduction." The letter no longer states that devices processed in the SS1E "cannot be assured to be sterile," but it does state that devices processed in the SS1E, as with all liquid chemical sterilant processing systems, should be "used immediately or stored in a manner similar to that of high-level disinfected endoscopes."
  • Where's the biological indicator? Another concern has been the lack of an FDA-approved biological indicator for the SS1E. Steris is "still in discussion with the FDA on the clearance of" its biological indicator for the SS1E and "cannot provide any assurances to our customers that the FDA will clear the biological indicator," says Rosemary Niewolak, Steris's director of low-temperature sterilization. Steris notes that the FDA cleared the SS1E for usage without a biological indicator last April; biological indicators are not included in the FDA guidance on liquid chemical sterilants. The FDA requires several other steps to validate the efficacy of such systems, including chemical indicators, but not biological indicators. The FDA has cleared Steris's chemical indicators for the SS1E. "Since a biological indicator is not required for our customers to be able to utilize the processor," says Ms. Niewolak, and because the time period for SS1 users to transition to an alternative system is winding down, Steris is recommending that customers "move forward with the transition" rather than wait for the FDA to approve the biological indicator.

— Irene Tsikitas

3 Give staff the tools they need
In addition to education, give your staff the supplies needed to prep and pack heat-sensitive devices for sterilization. These may include:

  • Manufacturers' instructions. Make your staff's lives easier and keep your sterile processing department in compliance with regulatory and accrediting bodies by having all manufacturers' instructions for the cleaning, disinfection and sterilization of critical devices handy for staff to reference. This is becoming increasingly difficult as manufacturers' instructions grow more complex and varied, says Steve Johnson, AAS, sterile processing manager at Tacoma (Wash.) General Hospital. When there's confusion about how a particular device is to be sterilized, he suggests you consult with the manufacturer and, if necessary, with your infection preventionist to identify the best protocol for your facility. Online resources, such as www.onesourcedocs.com, are springing up to help you navigate the complex web of instructions pertaining to medical device processing.
  • Disinfection products. Finding the right disinfection product for her hospital's heat-sensitive devices was harder than expected, says Ms. Owens. She finally found a relatively simple solution that staff either spray onto an item or dip the item into, then let sit for 10 minutes. Having the right product — and an easy-to-use one — on hand helps to ensure this critical step is never missed.
  • Drying tools. If you're using hydrogen peroxide gas plasma or vapor, staff must remove any excess moisture before devices are packed and placed in the sterilizer, which can be a time-consuming process when you're not able to use automated washers. Ms. Owens has purchased several medical-grade compressed air hoses and cabinet-style instrument dryers, which she says can run from about $5,000 to $20,000, for both the decontamination room and prep-and-pack area to help her staff remove moisture from cleaned and disinfected items.

Failing to properly dry devices will almost certainly lead to a cancelled cycle in Advanced Sterilization Products' Sterrad line of gas plasma sterilizers. In addition to using air blowers and drying cabinets, use lint-free towels to assist with drying and, where possible, let instruments sit overnight to air dry, says Janet Moran, RN, MBA, CNOR, a senior clinical education consultant for ASP. Steris's Amsco V-Pro hydrogen peroxide vapor system uses a vacuum pump to remove excess moisture during the conditioning phase, which takes some, but not all, of the burden off your staff to ensure loads are dry.

4 Manage the schedule
This is all about sharing information about the upcoming day's schedule and instrument needs. At Tacoma General Hospital, Mr. Johnson worked with the IT department to create an automated report that pulls from the facility's surgical scheduling software and physician preference cards to give the SPD an accurate, up-to-date view of what instruments are needed for the following day. In the past, the sterile processing staff would rely on the written schedule — which would often change without SPD's knowledge — and would manually sift through preference cards to plan for the next day. "Being able to prioritize based on the actual surgery schedule — that's been a huge help for us," says Mr. Johnson.

At Porter Adventist Hospital in Denver, Colo., an SP/OR "rover" helps to bridge the communication divide by monitoring each day's surgical schedule and physicians' preference cards to identify heat-sensitive items that require quick turnovers and helping to fast-track them, says Mark Scofield, CRCST, CIS, sterile processing manager. The roving sterile processing tech gathers fast-tracked instruments as soon as they're finished being used and immediately starts the cleaning, decontamination and sterilization process. "Before, there were times when the OR wouldn't communicate that this set needs a quick turnaround," says Mr. Scofield. Now, the SP/OR rover ensures instrument sets are always ready for the next case.

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