Your reprocessing staff often works in isolation from the surgical suite, their work — and the continued availability of sterile instruments — often taken for granted. But as an administrator, you play a role in their work, too. Here's a short course on what you should know about instrument sterilization.

The process
The work of central sterile involves two processes: disinfection and sterilization. Disinfection, the destruction of the most harmful (but not all) microorganisms on equipment and instruments, is carried out on a low, intermediate or high level depending on the microorganisms' resistance and a disinfecting product's concentration and contact time to counter it.

Sterilization, on the other hand, is the destruction of all microbial life through a prescribed procedure. There are several ways this can be accomplished. Steam sterilization is the most commonly used method for instruments that can withstand its high temperatures. Liquid sterilization involves the immersion of instruments, but unlike with steam, these instruments cannot be packaged before sterilization. Gas sterilization is a low-temperature option, but the process takes longer than steam or liquid and requires the exhaust of the fumes generated.

Whether an item is disinfected or sterilized is decided primarily by how likely that item, if contaminated, would cause infection in a patient. According to the Spaulding Classification System, items that will enter sterile tissue (such as implants) must be sterilized. Items that will be in contact with mucous membranes or non-intact skin (such as anesthesia equipment) should be sterilized or high-level disinfected. For items that come in contact with intact skin but not mucous membranes (such as blood pressure cuffs), low-level disinfection will suffice.

Policy and personnel
At the most basic level, it's important that you establish and enforce a policy governing your facility's reprocessing staff and procedure. This policy should be modeled on and guided by evidence-based recommendations, such as those issued by AORN, the CDC, the Association for the Advancement of Medical Instrumentation (AAMI) and the Association for Professionals in Infection Control and Epidemiology (APIC).

While outpatient surgery by its nature puts staffers under time pressure, and efficient solutions are often sought, the reprocessing policy you establish must be followed to the letter. Staff should under no circumstances skip steps, "doing what they think is right." If they don't follow the policy, they're not carrying out the task properly, putting the sterilization of your surgical tools in jeopardy.

It follows, then, that you'll need to hire skilled staff. They may not have to be formally certified. But they'll need to be knowledgeable in the ways of sterile processing, since they're the ones who know what needs to take place and they're the ones that guarantee the safety of the reprocessed instruments.

You'll need to keep them educated as well. If the individual central sterile personnel don't subscribe to AAMI's standards publication, then your facility should. The publication is the bible of sterilization standards. At our surgery center, we reference those recommendations whenever we have questions about the sterilization process.

Another educational source is free of charge. If your equipment manufacturers offer opportunities to meet with their product representatives, you should take advantage of the offer and schedule occasional in-services for your staff to learn firsthand how to reprocess their devices. Pre-cleaning and reprocessing by a manufacturer's written directions is of course standard practice, but given the complexity of many instruments — the numerous steps that go into cleaning an endoscope; the interior surfaces, particularly in cannulated instruments; how many ways the process could proceed less-than-effectively — hearing it directly from the source is almost essential. After all, they know the equipment inside and out.

Flashing cautions
While most aspects of reprocessing are straightforward and inarguable, flash sterilization remains controversial. Flashing, which offers a more rapid sterilization cycle for items that aren't wrapped or placed in a container, isn't recommended by AORN. In fact, the organization advises keeping the use of flashing to a minimum and avoiding the process except in emergency situations where time prohibits other options.

It should go without saying that a shortage of instruments doesn't necessarily constitute that kind of emergency. The regular use of flash sterilization to reprocess frequently used, frequently demanded items may highlight other areas that need to be dealt with.

When you think about it, the use of flash sterilization comes down to issues of cost and scheduling. How much can you spend on more instruments? Would it be cost-prohibitive to obtain replacements? Or would it be possible to schedule your cases more effectively to ensure that the instruments needed for each case will be able to make it through standard sterile processing and back to the OR on time?

If you must flash, however, infection control experts advise adding a closed container system to the process. The system, marketed under various names, involves a rigid tray with a lid, sealed with a valve on the top and the bottom. The valves open in the vacuum of the sterilization cycle, then seal shut afterwards. It provides a much more sterile option than open flash sterilization, in which the item itself is handled when removed from the chamber and exposed to the environment while transported to the OR, putting it at risk for recontamination.

Testing and follow-up
If your facility's reprocessing equipment isn't functioning correctly, your instruments won't be sterile. If your instruments aren't sterile, that's just about the worst nightmare your facility can have.

That's why it's critical that your central sterile staff monitor and regularly test the results of each piece of sterilizing equipment, according to each manufacturer's directions.

Some equipment employs chemical indicators, placed in with a sterilizer load, to verify that it's producing the correct amount of vacuum, steam, heat or other factors. Others use biological testing to ensure that, yes, they're actually killing the microorganisms on your instruments.

Each individual instrument pack put through the sterilization cycle should also include an indicator inside or as part of its packaging. Your OR staff should be aware of these indicators and remember to check them as they're setting up for a case.

In a related precaution, central sterile staff should also routinely keep inventories of what items were processed in each sterilizer load, recording items' serial numbers and even tagging the packaged post-cycle items, as a backup reference to assist in tracing and recalling affected items in the event that a test fails or an infectious outbreak is identified.

While it may be rare for an administrator to check up on the workings of the reprocessing room in person, your quality improvement coordinator should be your liaison to the department. Regular communication about sterile processing with your QI coordinator — as well as a QI coordinator who's regularly monitoring a reprocessing staff that's regularly testing the equipment and logging their throughput — is your ideal aim.

The instrument sterilization workroom is the backbone of operations at every surgical facility. Without it, everything — case flow, patient care, surgeons' techniques — grinds to a halt. It's clear any infection control protocol depends on the smooth management of central sterile.