Sterilizer Testing 101

Too often the practice’s sterilizer is seen as a household dishwasher or washing machine. Because its job is cleaning, it is taken for granted that it exists in a state of eternal cleanliness. But like household dishwashers and washing machines, sterilizers need to be cleaned—and their cleanliness needs to be tested.

The necessity for testing should go without saying. “Because you want to know whether the sterilizer works,” Lisa Kane, DMD, says. Dr Kane is the owner of Dental Office Compliance of New England LLC and an infection control consultant.“In order for instruments to be clean enough to be in someone’s mouth, they have to be sterilized. And the only way to tell whether your machine is working and doing what it’s supposed to be doing is if you test it. You have to test for biological indicators. You have to do a spore test, otherwise you don’t know whether it’s working.”

Linda M. Harvey, MS, RDH, LHRM, DFASHRM, likens the practice’s sterilization center to the heart of the practice. Harvey is the president and founder of The Linda Harvey Group, a health care compliance and risk management consulting company. “You have to keep that heart pumping well,” Harvey observes. “All the patient care systems are spokes of that hub, that heart—the sterilization center. Maintaining the efficacy of your sterilization units is done through weekly spore testing, which assures the instruments are indeed sterilized and able to be safely used on patients.”

Test Types
Different types of tests exist with the goal of making the sterilization process faster and more efficient. “There are different options,” Dr Kane observes. “There are in-office and mail-out tests. Double-check with your state and make sure they’re OK with in-office tests.”

Fortunately, the tests seem to be getting better and better. “The technology has changed in this arena,” Harvey says. “The technology is evolving everywhere in dentistry, not just with ‘dentistry in a day,’ artificial intelligence, or teledentistry. It’s also [affecting] our sterilization centers. And now there are rapid readout biological indicator tests, and you can get the results in 24 minutes in the office.”

In addition, practices must perform testing on a regular basis, at least weekly. “Someone or several team members should be assigned the task of weekly testing. If multiple team members will be conducting the spore testing, the tests must be standardized and ensure everyone is following the exact same process,”Harvey says. “That way, whether someone leaves the practice, [is] on vacation, or [is] out sick, it’s done. What’s exciting about this new technology is when you can have spore test results in 24 minutes, [it] enables you to immediately begin troubleshooting if you have a failed test [result]. Whereas with third-party testing, you may have to wait a week to get the results back. However, it’s important to know what the spore testing requirements are in your state or province. It’s wise to be familiar with your dental practice act.”

Worst Case Scenario
What should you do in the event of a failed spore test result? The answer, although inconvenient, is designed to minimize infection risk. “You’re supposed to take back everything from the last negative test [result], because you’ve labeled everything,” Dr Kane says. “You have to take it back and reprocess it. Ideally you have another autoclave you can use, but you [should] take the failed autoclave out of commission and retest it. If you get another failed test [result], you should probably research a little more, maybe call someone to fix it. A lot of times it fails because of user error. You don’t have to throw out your autoclave if it failed, but you do not want to use it again until you get a negative spore test [result].”

Redundancy steps and having a second sterilizer can help in the event of a failed test result. “Sometimes offices have multiple units,” Harvey observes. “They’ll have a traditional, typical-sized autoclave, and then [they’ll] have what’s called a STATIM, which holds a smaller capacity. Having a backup plan is important, because they [may be] faced with, ‘How do we go back and identify the instruments that have already been used on patients?’ Unless pouches and cassettes are properly labeled and dated, it can create confusion when trying to identify which instruments need to be resterilized.”

Best Practices
Although staffing redundancy in the sterilization center is an old idea, too many people can be counterproductive. “I recall working with one practice that was struggling with standardization. They had 4 people conducting spore testing, and they were getting failed test [results],” Harvey says. “In other words, they were [each] carrying out the spore testing differently, testing at different times of the day, or placing the test strips in different parts of the unit. Ultimately, we decided to pare it back and just keep 2 people involved who learned a standardized method. But typically, we need to have others who know how to properly test the autoclave.”

It is necessary to properly document that testing has occurred and passing results were achieved. “I’m always a big fan of taking pictures,” Dr Kane advises. “If you’re doing in-office tests, take pictures of the results as proof of the test [result]. It’s about the documentation. Most people, when they do spore tests, have a calendar; they literally put a check on that day or have a little notebook. But there’s a lot of information that needs to go in the spore test record. You need to make sure you’re in house, documenting it the right way and keeping track of everything. The problem with the out-of-office spore test is it takes a long time to get back. The in-office [test] is faster, but do whatever works best in your office.”

Do practices tend to properly document their sterilizer testing efforts? Regrettably, no. “Most people are not documenting correctly,” Dr Kane says. “We always go into offices and give everyone a new log. Most people are just documenting that they’re testing. Some people are taking pictures that they’re mailing off [to] test, and that’s their documentation. You need to have documentation of what’s in the load, what the parameters are, time, temperature, and pressure. What happens at the end of the load recording? What kind of load was run? And then you have to circle back and see whether the chemical indicator changed. Because if the chemical indicator didn’t change, your spore test [result] isn’t passing. There are probably 10 things that have to be recorded on the spore test log.”

As with so many products in the dental practice, following the manufacturer’s instructions for use is critical. “One of my top recommendations is that every practice have the manufacturer’s instructions handy,” Harvey says. “Whether they’re kept digitally or in paper format, have them accessible for onboarding new team members and [as a] ready reference when calibrating the team and checking periodically to ensure you’re still properly following those recommendations.”

The job of the sterilizer is to make sure instruments are ready for use on patients. Their job may be to provide safety, but they still need to be checked on a regular basis. Ensuring regular, accurate testing will help prevent infection control breaches.