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Monitoring the sterilization process: the whys and hows

October 27, 2020

For sterilization at a dental practice, the Centers for Disease Control guidelines recommend consistent monitoring and record-keeping of biological, physical/mechanical and chemical indicators for the type of sterilizer in use.

With some indicators, monitoring will occur with every load, and with others, only periodically.

· Biological indicators, or spore tests, offer the only definitive way to confirm a sterilizer is in working order, and effective in killing known highly-resistant microorganisms, such as Geobacillus or Bacillus species. Stringent challenge to the sterilizer exist to ensure microorganisms are killed. The CDC recommends biological indicator tests run at least once per week.

If the biological indicator fails, the CDC recommends running a second test. Until results are available (more on that later), the sterilizer should be considered non-functional, and any instruments from that batch quarantined. In the meantime, mechanical/physical and chemical monitoring should be completed with every load. Note: Mechanical/physical and chemical indicators do not guarantee sterilization. Rather, they detect malfunction of equipment or errors in the process.

· Physical/mechanical indicators provides vital clues in the sterilization process obtained by recording procedural and equipment data and checking for issues. If a failure occurs in the biological data, mechanical monitoring can help troubleshoot when an issue occurred, and which items to quarantine. Otherwise, the recommendation is to complete physical monitoring in every sterilization cycle.

While physical/mechanical indicator data is not legally required, documenting it is a really good idea. Think of it as an insurance policy, because it shows a sterilizer achieved the proper temperature for the correct amount of sterilization time gives the user a sense of how the sterilizer is functioning.

  1.  Manual record-keeping. At one time, a member of the team would track gauges and displays and record pressure, temperature and exposure time.
  2.  Printer or data logger. Today, a printer or data logger that houses valuable information for monitoring physical indicators can be incorporated in many sterilizers.

>> Insider tip: A dentist can improve the sterilization process.

Of hundreds of thousands of sterilizers out there, only a small percentage incorporate a data monitoring device, whether it be a printer or data logger. These present an opportunity to improve office sterilization with crucial information. Easy to obtain electronically or manually, this information provides confirmation the sterilizer is functioning properly and can help troubleshoot if it’s not.

Though typically completed by a team member, the process can benefit from an occasional analysis by the dentist.

· Chemical indicators can provide timely information about the sterilization cycle. Sensitive chemicals change color in relation to high temperatures and time. The results are monitored and required with every load.

Data is recorded manually, versus electronically, so a team member is required to verify that the chemical indicator passed, and either record details in a log or staple the indicator tape, strips or tabs into a notebook, and sign off.

If failure occurs, it’s an immediate signal of a problem with the sterilizer or that particular load.

Additional testing requirements

· Pre-vacuum sterilizers require additional testing, at least once per day. If a dental practice uses a pre-vacuum autoclave system, the team must confirm it is achieving the air removal level required for sterilization. The CDC recommends performing a Bowie-Dick test to detect air removal at least once per day, but tests can also be run with every load.

  •  If a sterilizer fails a Bowie-Dick test and is not achieving vacuum level, the sterilizer should not be used until it is serviced and passes inspection and a follow up test.

The biological indicator decision for dentist: Outsource or process in-house?

  1. Outsource. A testing strip or device is sent to an outside lab for processing. Office receives a pass/fail report.
  • PROS:
    Inexpensive.
    Minimal training or expertise required.
  • CON:
    Time delay with report, from 1-2 days, up to a week or longer.

2. In-office spore test. A device allows biological indicators to be tested on site, with an option of rapid results (a matter of hours) or overnight results after an incubation period occurs.

  • PRO:
    Immediate results.
    More control if a failure occurs.
  • CON:
    Training and expertise required.
    Cost of reader, reagents or devices to run it.

>>Insider tip: The type of practice can affect the number of biological indicators used. For instance, at a practice that offers implants, biological indicators must be run with each load that sterilizes an implant. All implants can be run in same load, but significant planning and scheduling is required.

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