A sterilization labeling and logging solution

Before COVID-19 brought the hot-button issues related to contamination, sterilization, and the transfer of bacteria and other pathogens by aerosols from patient to patient or clinician to clinician, there had been a host of issues with dental instrument sterilization.

The HIV/AIDS epidemic that swept the United States in the 1980s and 1990s was a pivotal point for dentistry. The same year that Ronald Reagan signed a presidential executive order creating the first Presidential Commission on AIDS, a woman named Kimberly Bergalis had two molars removed by Dr. David J. Acer.^1,2 Later, Bergalis accused Acer of giving her HIV. Dental protocols for sterilization came into question when investigators struggled to figure out how not only Bergalis but five other patients also became infected with the AIDS virus.³

Similarly, in 2013, a Tulsa, Oklahoma-based dentist was accused of unsterile practices that led to a patient contracting hepatitis C.⁴ In 2019, a medical malpractice lawsuit was filed against a Virginia dental office after the family of a nine-year-old child was treated at the practice with unsterilized instruments.⁵ In this case, there were at least 50 patients who may have been affected by those unsafe practices. The same year in Seattle, some 1,250 children were treated with instruments that had not been sterilized.⁶

COVID-19 transmission brought many questions to dental practices regarding the safe processing of dental instruments. Dental providers do not set out to intentionally harm anyone, but clinicians have to be diligent not only in making sure the instruments they use are sterile but also that they have systems in place to test the efficacy of the sterilization equipment. There also must be fail-safes to prove that those systems have, in fact, been adequate in the sterilization process. In dentistry, we must be ahead of the curve, looking for potential hiccups in the system that could affect our patients’ safety and/or the safety of our dental practices’ against threats of litigation.

Thankfully, engineers and designers are always helping clinicians accomplish the task of sterilization more efficiently and effectively. There have been great gains in this area of the dental industry. The first autoclave was invented by Charles Chamberland in 1879,⁷ with a previous model called a steam digester created by Denis Papin in 1679.⁸ Instrument sterilization techniques have advanced over the years and created efficiencies for dental practices. Going back to the time when ethylene oxide gas was used to complete a sterilization cycle in 16 hours⁹ is a time we never want to repeat. The Centers for Disease Control and Prevention (CDC) has set forth many guidelines for sterilization techniques and monitoring device efficacy.¹⁰

In Canada, several events involving improper sterilization of dental instruments and monitoring precipitated Public Health Ontario to revise its Infection Prevention and Control (IPAC) checklist for dental practices. The checklist revision was completed and published in July 2019 in collaboration with the Royal College of Dental Surgeons of Ontario (RCDSO), the College of Dental Hygienists of Ontario, and the Ministry of Health and Long-Term Care.¹¹ This checklist for reprocessing dental and /medical equipment/devices is based on Public Health Ontario’s “Best Practices for Cleaning, Disinfection and Sterilization of Medical Equipment/Devices” from May 2013.¹² In addition, the RCDSO updated its standards of care for infection control and prevention, which addresses instrument reprocessing, sterilizer monitoring, and other elements of IPAC.¹³ Interestingly, the regulations in Ontario for dentists do not call for the sterilization package information to be recorded in patients’ charts as they do for hygienists.

In the United States, some states are considering following this protocol. Mandated or not, having proper controls and sterilization records not only will save time in the case of an audit but offer assurance that the sterilization process is being conducted properly. Time is of the essence when adding any new procedure to a dental workflow, and thankfully one company has created a solution that is efficient, cost-effective, automated, and reliable.

SteriLog is a patent-pending automated solution for labeling and logging instrument packages that also allows for certification of indicator test results. According to Dr. Sam Axelrod, vice president and codeveloper of SteriLog, this system meets and exceeds the demands of safety and compliance in instrument reprocessing tracking not only by labeling the packages and completing the logging, but also registering certification of the chemical indicator test results after the sterilization cycle is complete. SteriLog was developed by dental professionals and an IT specialist, and it has been tested in active dental facilities with more than four million packages reprocessed in the last two years.

The cost savings occurs in staff time and the added benefits of increased sterilization accuracy and compliance. The system records the date and maintains a complete automatic data backup that is searchable for specific criteria in the logs. The ability to print out either the entire data log or only selected portions and export to Excel increases efficiency.