How Do You Know Instruments Are Sterile?


Proper training, standardized practices and regular audits bring peace of mind.

Instrument cleaning and sterilization is a complicated process rife with potential oversights and failures, so how can you be completely certain your facility’s tools are safe to use? “Trust, but verify,” says Hank Balch, CRCST, CER, CIS, CHL, founder and president of Beyond Clean, a sterile processing education, consulting and media firm headquartered in Lancaster, Pa. “The effectiveness of each step is dependent on the one before it, so you must create repeatable processes, and also use proven tools to verify the processes actually worked.”

Here’s what top sterile-processing professionals and teachers in the field have to say about making sure critical surgical tools are properly cleaned and sterilized before they’re brought to the bedside.

Engaged staff. Focus on providing consistent training for the surgical team members and reprocessing technicians who are charged with caring for instruments. “Ultimately, sterilization comes down to quality management, and that begins with the education and training of your staff,” says Alison Sonstelie, BS, CRCST, CHL, CIS, client success manager at Ascendco Health, a healthcare data, analytics and software company headquartered in Chicago.

She recommends designating a point person on staff to manage the quality monitoring of your sterilization processes. “That person can train staff on proper monitoring and cleaning techniques and keep tabs on problem events,” she says.

Mr. Balch urges facility leaders to put more of an emphasis on whom they hire to work in sterile processing. “You need a team of empowered and engaged technicians who are constantly looking at the process around them and asking, ‘Why?’” he says. “This kind of team doesn’t develop on its own. It must be recruited, cultivated and retained over time.”

Grassroots quality management happens when these critical thinkers are given the leadership support they need to identify, propose and implement changes to their department’s workflows. “That’s where the magic happens,” says Mr. Balch.

Standardized processes. When you break down the many steps of proper instrument care — from point-of-use treatments and decontamination to assembly and sterilization — you grasp the importance of standardizing the process. While your sterile processing staff must adhere to the steps outlined in the instructions for use (IFU) of devices and equipment, that doesn’t mean they can’t go beyond the bare minimum and create their own standardized workflow — coupled with easy-to-track metrics — to maximize the safety and efficiency of how they work in practice.

The best way to standardize instrument workflow is to collaborate with the techs who are doing the job day in and day out. “Listen to their suggestions and be willing to trial the ideas they come up with,” says Jig Patel, ST, CRCST, CHL, CIS, CER, sterile processing educator and quality manager at UCLA Health in Los Angeles. “The people who do the work constantly think about how things can be done better.”

If an instrument isn’t clean, it can never be sterile.
— Jig Patel

Spot audits. Even the most carefully planned procedures have occasional gaps and blind spots. “Monitoring is the most important step in the sterilization process,” says Ms. Sonstelie. “You need to track performance data for defects in the process because today’s instruments and devices are difficult to clean and sterilize, even for a fully trained staff who follow IFUs to the letter.”

Ms. Sonstelie believes performance monitoring must be objective and involve root cause analyses of the most critical trends identified. Otherwise, the entire tracking process becomes subjective. “This happens often,” she says. “Relatively minor issues like missing sterilization indicators are given the same importance as, say, not testing the insulation on laparoscopic instruments.”

It’s important to get out ahead of problem areas, set concrete audit goals and be proactive in the ways in which staff target problems, according to Ms. Sonstelie, who adds, “That said, facilities must begin with what they can handle.” She suggests starting small in developing specific audit goals based on the auditing practices recommended by instrument manufacturers.

Mr. Patel insists his staff spends quality time inspecting instruments to ensure they’ve been properly cared for before they’re returned to the ORs. “If an instrument isn’t clean, it can never be sterile,” he says. 

There’s no shortage of innovative technology on the market to supplement the manual cleaning efforts of your hardworking reprocessing techs (see “Real-Time Checks of Proper Instrument Care” below). Still, it’s important for surgical leaders to remember that the latest tools are meant to complement manual processes. “Facilities that don’t have solid, standardized practices in place rely on technology to replace manual cleaning,” says Ms. Sonstelie. “But solid manual processes are always superior to technology alone.” OSM

Real-Time Checks of Proper Instrument Care
INVALUABLE INSIGHT Borescopes enable staff to confirm the cleanliness of complex instrumentation.

Sterile processing department leaders are increasingly using the following technologies and devices to ensure instruments are clean and sterile.

Rigid containers provide a powerful defense against instrument contamination post-sterilization, says Hank Balch, CRCST, CER, CIS, CHL, founder and president of Beyond Clean. The containers also save space. “Most containers are validated to be stacked, which is helpful in facilities where storage is limited,” says Mr. Balch. 

Rigid containers can be heavy and cumbersome to move, require maintenance and must be cleaned between uses, which creates additional work for sterile processing techs and could cause delays if a facility doesn’t invest in enough containers to accommodate its instrument inventory, according to Jig Patel, ST, CRCST, CHL, CIS, CER, sterile processing educator and quality manager at UCLA Health in Los Angeles.

Biological indicators confirm conditions were met in a sterilizer load to kill the required number of microorganisms. “Biologicals are required by industry guidelines as a part of daily quality monitoring of sterilization equipment, as well as a means to verify sterility parameters on a load-by-load basis, as with the sterilization of surgical implants,” says Mr. Balch. 

Newer biological indicators can make life much easier for busy sterile processing techs. “With recent advancements, many of these products have gone from 24-hour read times to providing results in minutes, which significantly decreases the amount of time a sterilization load spends in quarantine,” says Mr. Balch.

Chemical indicators monitor whether the required parameters to achieve sterilization have been met for a specific process — such as hydrogen peroxide or steam sterilization. These indicators undergo a chemical or physical change that makes it easy for techs to see that the instruments were exposed to the proper temperature, time and sterilant. “This is a proven way to determine whether instrument sets have been through a proper sterilization process,” says Mr. Patel.

Borescopes let reprocessing techs inspect the insides of lumened instruments for bioburden and defects in a way that is impossible with the naked eye. Mr. Balch and Mr. Patel believe the devices are among the most helpful tools frontline sterile processing technicians have at their disposal. Some device IFUs even specify the need for inspection with a borescope at the decontamination or assembly stage of reprocessing. “As the complexity of medical device design continues to increase, the ability to visualize the cleanliness and functionality of internal channels is becoming more important,” says Mr. Balch.

He cautions leaders about the considerable training that goes into teaching technicians how to use the devices and advices documenting the findings of their inspections. He also points out that borescope use creates additional steps in the reprocessing workflow at the decontamination and assembly stages. That’s why Mr. Balch believes reprocessing techs must have leadership’s support to take full advantage of using borescopes to verify proper instrument care. “Otherwise, they just become expensive paperweights,” he says.

Jared Bilski

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