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The importance of biological monitoring

Oct. 1, 2020
How in-office monitoring in less than one hour could save you time and money.

The coronavirus outbreak has shone a spotlight on infection control (IC) and hygiene on a global scale. It is also making dental practices reevaluate their processes and focus more diligently on protecting clients and staff from disease and infection in general.1 One important part of a safety protocol in oral medicine is the cleaning and sterilization of dental instruments.2 The monitoring of instrument reprocessing continues to be a major part of safe patient care. This article explores the importance of using biological monitoring for the protection of patients. 

By investing in equipment and processes to maintain high levels of hygiene and safety, practices will protect themselves from shutdowns, lawsuits, and damaging reviews.3 While it may initially appear costly to implement thorough IC protocols and standard operating procedures (SOPs), the long-term benefits and protection afforded by such measures make it money well spent. 

The trifecta of monitoring

The Centers for Disease Control and Prevention (CDC) guidelines on infection control are clear in stating that all sterilizers should be subject to biological, chemical, and mechanical monitoring.4 In a recent survey conducted by Dental Economics, compliance in biological monitoring appeared widespread throughout dental offices. Unfortunately, the same was not true for chemical and mechanical monitoring. Using all three methods is essential because many practices complete biological tests only once a week. By failing to use chemical and mechanical monitoring every sterilization load, there is a risk that an inadequate process will not be detected.

Mechanically checking to ensure that all gauges are operating at optimum levels, examining printouts and/or downloads to ascertain compliance with the cycle parameters, and taking detailed recordings of information such as time and temperatures will go a long way toward safeguarding against equipment errors.2

With regard to chemical monitoring, a Type-5 chemical indicator in every sterilization load will demonstrate that time, temperature, and presence of saturated steam  have been reached for that cycle. Type-1 color changing strips or markings provide an instantaneous indication as to the status of the load items (processed versus unprocessed), but they easily change colors when introduced to heat and should not be the only chemical indicators used. Using both Type-5 and Type-1 indicators helps prevent the use of unsterilized instruments. As a best practice, each load item should have a Type 5 chemical indicator inside of the package and a Type 1 process indicator on the outside.

Performing spore testing or biological monitoring a minimum of once a week is vital to ensure that the sterilization equipment is performing correctly.4 The AAMI/ANSI ST79:2017, which is periodically updated and contains information crucial for the delivery of sterile health-care products, has more stringent guidelines. While many offices conduct biological indicator (BI) tests once a week, AAMI/ANSI ST79 recommends undertaking the process daily to help protect from using unsterilized instruments. 

BI testing checks for spores that have survived the sterilization process. It identifies any issues with the process and allows for adjustments to be made to prevent unsterilized instruments from being used.5 Many offices send their BI samples to external laboratories, and this slows the process and may lead to the use of insufficiently sterilized instruments. The benefit of mail-in BI tests is that there is third-party documentation for the practice’s records, but the delay in receiving the information may be an issue.

To avoid any delay and easily integrate daily BI testing into an office’s SOP, investment in an in-office incubation system may be the most prudent way forward. The speed of results—under one hour when using a 3M Attest biological indicator system—and not paying for the services of an external laboratory may save you money in the long run.6 

The ability to monitor results in less than one hour is key. Dental offices tend to cycle through instruments very quickly. As such, items don’t sit for long, making it vital to do regular testing to confirm the afternoon patients aren’t being exposed to the morning patients’ germs. If a breach occurs, you need to know as soon as possible to be able to protect patients. 

As patients learn about the higher standards and in-house monitoring, there may be an increase in the number of them coming to your practice. You will save time—no longer having to wait for reports from outside of your office, and avoiding the impact of any delays from using external services. 

As mentioned, one perceived advantage of using external laboratories is that they provide a record to show that the instruments have received adequate processing, should an issue arise. That said, the delay in receiving results, even of just one week, can impact the costs and productivity of a clinic. If your testing goes out on a Monday and you have to wait for the results for a week, you may have to reprocess a whole week’s worth of instruments if the sterilizer has failed. To do this, you will need to go through all instruments, examine the processing dates, repackage all affected instruments,  and then resterilize. This is time consuming and adds extra costs in supplies.7

With in-house testing capability, you will know much sooner that there has been a failure in the process, and you may be able to quickly remedy things by using an alternative sterilizer if you are lucky enough to have multiple sterilizers. Keeping your patients safe is priceless and being able to act immediately on failed tests provides an extra layer of protection for your customers and provides you confidence in knowing that your instruments are correctly sterilized. 

The importance of record keeping

It is essential to keep the records regarding sterilization monitoring up to date, and in order to maintain compliance, retention must be in line with local and state regulations. In the aforementioned Dental Economics survey, only 74% of respondents felt that the documentation of sterilization processes was sufficient in their offices. Some of these failings may be due to a lack of SOPs that define the processes required to correctly maintain documentation records.

The lack of proper record-keeping becomes a major issue when a sterilizer fails a spore test. The ramifications of using improperly maintained instruments and failing to produce records that procedures were followed can be devastating if a patient or staff member acquires an infection. Having comprehensive SOPs and monitoring logs helps guide team members should there be a positive spore test and will show them how to remedy the issue.8

The survey indicated that only 68% of clinics were prepared for failed spore tests. While many tests fail due to human error and a retest may indicate that the sterilizer is actually functioning properly, the lack of SOPs or documented procedural information may mean that in some cases, unsterilized instruments are used on patients. By implementing protocols to remove any instruments that have failed spore tests or questionable status, you will be able to provide your patients with more robust protection. 

Records should show the type of sterilizer and the cycle used, as well as the identification number and content of the load. Records should indicate the exposure parameters such as time and temperature, alongside the results of the other monitoring undertaken, such as mechanical, chemical, or biological. The test operator should initial and date all records to allow for follow-up queries. Recording this information allows for speedy identification of any instruments that may require reprocessing due to any of the three levels of test failure. 

The survey also indicated that many dental professionals do not feel that it is necessary to have specific readers for monitoring the IC process. However, as technology evolves and new issues arise, clinics must reevaluate their procedures and equipment. Doing so on an annual basis will help create a safer health-care environment and help ensure the well-being of patients and team. This is particularly true when it comes to infection control, and the sterilization of instruments plays a vital part in this process. A great example of reevaluating and improving BI testing in a practice is moving away from 24- to 48-hour spore testing results and mail-in testing, to receiving test results in less than one hour, such as with the 3M Attest biological monitoring system. 

Correctly processing instruments is one of the cornerstones of IC, and by implementing strict SOPs with regard to the procedures involved, there is a reduction in the risk of cross-contamination. To maintain your clinic’s standards on IC and sterilization, all three methods of monitoring the processing are vital. Having an in-office spore testing incubation system gives you extra reassurance that you are protecting your patients and team to the highest level possible.  


1. Bizzoca ME, Campisi G, Lo Muzio L. Covid-19 pandemic: What changes for dentists and oral medicine experts? 2020;17(5):3793. Int J Environ Res Public Health. doi:10.3390/ijerph17113793
2. Sterilization monitoring in dental offices. OSHA Review. February 15, 2018. Accessed July 14, 2020. https://oshareview.com/2018/02/sterilization-monitoring-in-dental-offices/ 
3. Carabash M. Infection control lawsuits: Getting sued for nervous shock. Oral Health Group. February 13, 2018. Accessed July 14, 2020. https://www.oralhealthgroup.com/features/infection-control-lawsuits-getting-sued-nervous-shock/ 
4. Sterilization: Monitoring. How is the sterilization process monitored? Centers for Disease Control and Prevention. Updated March 22, 2018. Accessed July 14, 2020. https://www.cdc.gov/oralhealth/infectioncontrol/faqs/monitoring.html 
5. Fluent MT. Sterilization monitoring with spore tests: Q&A with an infection control consultant. DentistryIQ. November 19, 2019. Accessed July 14, 2020. https://www.dentistryiq.com/dental-assisting/infection-control/article/14072263/sterilization-monitoring-with-spore-tests-qa-with-an-infection-control-coordinator
6. Biological indicators for equipment and load monitoring. 3M. Accessed July 14, 2020. https://www.3m.com/3M/en_US/company-us/all-3m-products/~/All-3M-Products/Health-Care/Medical/Sterilization-Monitoring/Biological-Indicators/?N=5002385+8707795+8707798+8711017+8711099+8753017+3294857497&rt=r3
7. Procedures to follow in the event of a positive spore test. DentalCare. Accessed July 14, 2020. https://www.dentalcare.com/en-us/professional-education/ce-courses/ce474/procedures-to-follow-in-the-event-of-a-positive-spore-test
8. Instrument processing protocol. California Dental Association. Updated March 2014. Accessed July 14, 2020. https://www.cda.org/Home/Practice/Practice-Support/Resource-Library/regulatory-compliance-infection-control-instrument-processing-protocol

MICHELLE STRANGE, MSDH, RDH, has been a dental clinician since 2000 and is currently a practicing hygienist, speaker, writer, content developer, consultant, and podcast cohost for A Tale of Two Hygienists. With a master’s in dental hygiene education and a belief in lifelong learning, she hopes to continue to learn and grow within the dental profession and one day see the gap bridged between medicine and dentistry.

Disclosure: This article was authored with financial support from 3M Oral Care.

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