In the world of sterile processing, there can be a false sense of security when it comes to handling sterilants, Janet Prust, Global Standards Director for 3M Medical Solutions Division, warns.

“People just forget that they’re all hazardous,” Prust said in a recent Beyond Clean podcast entitled, “ANSI/AAMI: ST58 2013.” “Chemical sterilants are hazardous to microorganisms, and people are a big microorganism.”

As a participant on the committees that author standards including ST58 – the ANSI/AAMI document that guides use of chemical sterilants and high level disinfectants in healthcare settings, Prust knows a lot about such things.

That document is one of several serving as a Bible for sterile processors on how to use, care for and process a medical device or system to assure the delivery of safe, effective and high quality patient care.

If not handled properly, some of those chemicals used to clean medical devices can affect the eyes of the sterile processors who handle them, while others affect lungs or skin. Some have long-term effects. All should engender respect.

Sterilization is the process required to make an item free from all viable microorganisms necessary when devices will enter the patient’s sterile tissue, organs or systems or touch their bloodstream.

In contrast, high-level disinfection kills most organisms, but not all. For instance, it doesn’t kill bacterial spores, which are micro bacteria. Those bacteria are in a dormant and very resistant state, which makes them extremely hard to kill.

It is therefore possible that there can still be disease-causing organisms on devices that have been high-level disinfected (HLD). As long as that device only comes in contact with intact mucous membranes or skin, those layers will provide an adequate barrier, so the patient is not in danger.

“We know device manufacturers design an instrument for a specific use, but it’s where that device contacts the patient that determines the level of risk of infection for that patient,” Prust says.

It is that level of risk that then defines whether the device should be sterilized or high-level disinfection will be adequate, she says.

Making the distinction between sterilization and HLD more confusing, the U.S. Food and Drug Administration (FDA) labels chemicals that can be used in HLD as well as those for sterilization all as sterilants, she notes.

Essential to the job of handling chemicals, as sterile processors routinely do, is wearing PPE in the form of nitrile gloves and eye protection. Arms should be covered also, Prust says.

A recent post in Infection Control Today reminds readers that the place where those different forms of PPE intersect is potentially the most at risk, for instance the wrist where gloves meet gowns.

“This interface is considered one of the weakest areas because gaps can occur, allowing infectious fluids to seep through to the skin,” according to the CDC’s National Institute for Occupational Safety and Health (NIOSH) quoted in the Infection Control Today post.

Not only must staff protect themselves from splashes and platters, the use of chemical sterilants requires good air exchanges to ensure safe environmental conditions, Prust says. The number of air exchanges per hour is important because they help exhaust any residual chemical from the air.

More and more facilities are taking the extra precautionary step of installing environmental air monitoring systems. Although not required, they let staff know that the levels are safe, and when the air exceeds acceptable levels, action can be taken quickly.

Prust says that keeping people safe in a sterile processing environment requires:

  • Training staff
  • Having information available, including the ST58 document
  • Maintaining properly functioning equipment
  • Monitoring staff, process and environment

“With that approach, chemical sterilants can be used safely and effectively,” she says.

Sterile processors have found themselves in the spotlight during the global pandemic for their  expertise.

“We became a force multiplier in the hospital by the things we did,” Damien Berg, who is vice president for strategic initiatives at The International Association of Healthcare Central Service Materiel Management (IAHCSMM), said in an interview with Infection Control Today. “And we got known.”

Berg encouraged sterile processors to let their vital contribution of maintaining standards and innovating as needed in the face of the novel virus, sink in.

“Know that you do make a difference,” he said in the Infection Control Today post. “Everything you do touches a patient’s life, and thus the families and thus the surgeons and thus the hospital community.”

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