7.4 Sterilization, Disinfection, Hepatitis B & Biohazardous Waste
Key Takeaways
- Sterilization and disinfection are governed by Rule Chapter 64B5-25, F.A.C., and failure to follow those procedures violates s. 466.028(1)(u) and (x), F.S.
- Steam under pressure and chemical vapor sterilizers must be biologically monitored at least once every 40 hours (2,400 minutes) of use or once every thirty days, whichever comes first.
- Dry heat and ethylene oxide sterilizers must be biologically monitored every 120 hours of operation at sterilization parameters or every thirty days, whichever comes first.
- High speed handpieces, slow speed sleeves, contra-angles and prophy angles must be sterilized after each use by a heat, heat with pressure, or heat with chemical method.
- Oral prosthetic appliances received from a dental laboratory must be washed, rinsed, appropriately disinfected and rinsed again before placement in the patient's mouth.
Sterilization and Disinfection — Rule Chapter 64B5-25, F.A.C.
The chapter number matters. Infection control in Florida dentistry is Rule Chapter 64B5-25, Sterilization and Disinfection Procedures. Rule Chapter 64B5-9 is Prescriptions for Dental Hygiene Services and Certification of Dental Radiographers, and contains no sterilization rules. Study material citing "64B5-9.005" for spore testing is misattributed.
Purpose and the disciplinary hook — Rule 64B5-25.001
Failure to follow proper sterilization and disinfection procedures as set out in Rule 64B5-25.003 constitutes failure to provide reasonable sanitary facilities and conditions in violation of s. 466.028(1)(u), F.S., and constitutes negligence in the practice of dentistry in violation of s. 466.028(1)(x), F.S., as practice below the minimum standards of dentistry. An infection control lapse is therefore automatically two disciplinary grounds, without any separate finding of patient harm.
Definitions — Rule 64B5-25.002
- Sterilization: "the process by which all forms of microbial life within an environment are totally destroyed."
- Disinfection: "the destruction or inhibition of most pathogenic bacteria while they are in their active growth phase and the inactivation of some viruses." Disinfection allows the potential for viable pathogens to remain — the rule names tubercle bacilli and hepatitis A, B and C and non-A-non-B viruses as examples that may survive depending on the chemicals used.
- Infected with the Hepatitis B virus: the licensee is sero-positive for the Hepatitis B surface antigen and the Hepatitis B e-antigen. Both markers.
- CDC Guidelines: the CDC's Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, adopted and incorporated by reference.
- OSHA's Bloodborne Pathogen Standards: 29 CFR §1910.1030 (2012), adopted and incorporated by reference.
Permitted sterilization methods — Rule 64B5-25.003(1)
At least one of the following must be used: steam under pressure (autoclave); dry-heat; chemical vapor; ethylene oxide. Devices used to achieve sterilization must be FDA-approved for sterilization. EPA-approved disinfectant/sterilants or FDA-approved sterilants may be used, but are appropriate for sterilization only when used in the correct dilution and for the manufacturer's stated time periods, and only on non-heat-tolerant instruments which do not penetrate soft tissue.
Instrument categories — Rule 64B5-25.003(2)
| Category | Examples given by the rule | Requirement |
|---|---|---|
| Instruments that normally penetrate soft tissue or bone | Forceps, scalpels, bone chisels, scalers, surgical burs | Sterilized after each use |
| Instruments not intended to penetrate tissue or bone but that may contact oral tissues | High speed handpieces, contra-angles, prophy angles, amalgam condensers, plastic instruments, burs | Sterilized after each use according to the manufacturer's instructions |
| Handpieces specifically — 64B5-25.003(2)(d) | High speed handpieces, slow speed sleeves, contra-angles, prophy angles | Sterilized after each use using a heat, heat with pressure, or heat with chemical method capable of sterilization |
Where heat, steam under pressure, or chemical vapor sterilization is not technically feasible because of an instrument's size or composition, the instrument must undergo sterilization with a disinfectant/sterilant that destroys viruses and spores, EPA-registered as a disinfectant/sterilant, used per manufacturer's recommendations and the CDC Guidelines. Heat-sensitive instruments may require up to 10 hours of exposure in such an agent.
Pre-cleaning — 64B5-25.003(3): before sterilization, instruments must be cleaned to remove debris, by thorough scrubbing with soap or detergent and water, or by an FDA-approved mechanical device such as an ultrasonic cleaner or instrument washer, following the manufacturer's instructions.
Laboratory cases — 64B5-25.003(4): oral prosthetic appliances received from a dental laboratory must be washed with soap or detergent and water, rinsed well, appropriately disinfected, and rinsed well again before being placed in the patient's mouth.
Biological monitoring — Rule 64B5-25.003(9)
The procedures and equipment used for sterilization must have their efficacy tested periodically, and Florida sets two different intervals:
| Sterilizer type | Biological monitoring interval |
|---|---|
| Steam under pressure (autoclave) or chemical vapor | At least once every 40 hours (2,400 minutes) of use, or at least once every thirty days — whichever comes first |
| Dry heat and ethylene oxide | Every 120 hours of operation at sterilization parameters, or every thirty days — whichever comes first |
The rule explains how to compute use time: "Use time is determined by multiplying the number of cycles by the individual cycle time."
Disinfectant/sterilants used instead of heat sterilization must be used according to the manufacturer's recommended dilution and exposure time, and changed according to the manufacturer's recommendations.
The 120-hour dry-heat and ethylene oxide interval is routinely omitted from summaries that state only the 40-hour figure. Note also that Rule 64B5-25.003 imposes no fixed retention period for spore-test logs; any specific log-retention figure attributed to this chapter should be checked against the rule text.
Barriers and personal protective equipment — Rule 64B5-25.003(5)–(10)
- Gloves must be changed between patients, are never to be washed and reused, and must be removed and replaced immediately if punctured or torn, after rewashing the hands with soap and water.
- Hands shall be washed with soap and water and dried immediately after removing and prior to replacing gloves; a healthcare grade alcohol-based hand rub may also be used per the current CDC Guidelines.
- Protective eyewear must be worn by all dentists, dental hygienists and dental assistants while performing or assisting in any dental procedure, in accordance with OSHA's Bloodborne Pathogen Standard and the CDC Guidelines.
- At the completion of treatment, all surfaces that may have become contaminated with blood or other material must be cleaned and disinfected as the rule provides.
- All OSHA category 2 employees must be provided with, and must use, the barrier techniques required by the rule where they may be exposed to blood, saliva or other bodily fluids.
Hepatitis B — Rules 64B5-25.004 to .006 and s. 466.041, F.S.
The Board finds that licensees infected with the Hepatitis B virus present a grave danger by virtue of the communicability of the disease in a clinical setting, and that the rules "assure the ability of infected licensees to practise so long as adequate safeguards are maintained." The chapter provides for identification and monitoring of licensees infected with the Hepatitis B virus (Rule 64B5-25.005) and for emergency suspension of such licensees and initiation of complaints (Rule 64B5-25.006). Section 466.041, F.S., Hepatitis B carriers, is the statutory counterpart.
Biohazardous waste — Rule 64B5-25.007
Licensees who generate biohazardous waste shall comply with Rule Chapter 64E-16, F.A.C. (Biomedical Waste), which the Board incorporates by reference, in order to maintain minimum sanitary conditions required by s. 466.028(1)(u), F.S., and to meet minimum acceptable standards of dental treatment.
Extracted teeth get their own treatment:
- Teeth used for scientific, educational or testing purposes, or returned to the patient or the patient's legal guardian, should first be cleaned of adherent patient material, then decontaminated in accordance with Rule 64B5-25.003 and kept in a sealed, labelled, sterilized pouch.
- To render an extracted tooth non-biohazardous it must be decontaminated in accordance with Rule 64B5-25.003.
- Extracted teeth and tissue fragments not required for microscopic examination shall be discarded as the rule provides.
Rule 64B5-25.008 separately addresses shipment to dental laboratories.
Under Rule 64B5-25.003(9), F.A.C., how often must a dry heat sterilizer be biologically monitored?
What must a dentist do with an oral prosthetic appliance received from a dental laboratory before placing it in a patient's mouth?
Under Rule 64B5-25.001, F.A.C., what are the disciplinary consequences of failing to follow the required sterilization and disinfection procedures?