Following several patient deaths in connection with sedation procedures, the North Carolina State Board of Dental Examiners (“Dental Board”) in January 2022 published a series of proposed changes to its dental sedation regulations. But after a record amount of public feedback, the Dental Board voted at its September 9th meeting not to adopt the proposed rule changes as-is. Instead, the Dental Board voted to restart the formal rulemaking process with a revised set of proposed rule changes. The revised proposed rule changes are available for review on the Dental Board’s website.
As a result, the previously-published changes will not take effect; and until new proposed rule changes are formally adopted, the current dental sedation rules in 21 NCAC Subchapter 16Q remain unchanged.
The Dental Board currently plans a public hearing for comments on the revised proposed rule changes on November 17, 2022 The proposed effective date for the new proposed changes is February 1, 2023. The highlights of how the new changes differ from the previously published changes include the following:
General Requirements – Proposed Rule 16Q.0103
- Like the earlier proposed rule, the new proposed Rule .0103 contains a set of general requirements for all levels of anesthesia and moderate sedation, but does not include certain requirements that were deemed unnecessary for general anesthesia.
- All the equipment and drugs required by the rule must be “immediately available” and accessible from the operatory and recovery rooms.
- Clarifies that permit holders may, but are not required to, have an RN or BLS-certified auxiliary monitor and record sedation/anesthesia data; instead they may have an additional permit-holder dentist, an anesthesiologist, or a CRNA dedicated to anesthesia/sedation care and monitoring during the procedure.
- No longer references dental assistants with dental anesthesia assistant certifications, since North Carolina has no such certification programs.
- Generally requires capnography to monitor patients, but now allows an exception for patients whose behavior or conditions prevents the use of capnography, in which case the permit holder must document the clinical reasons(s) capnography is not used.
General Anesthesia Requirements – Proposed Rule 16Q.0202
- A paralytic/neuromuscular blocking agent must be “immediately available” as well as accessible from the operatory and recovery rooms.
Moderate Sedation Requirements – Proposed Rule 16Q.0302
- Muscle relaxant must be “immediately available” as well as accessible from the operatory and recovery rooms.
- Permit holder must document clinical reason to exceed manufacturer’s maximum recommended dosage of anesthetic or sedative.
Pediatric Moderate Sedation Requirements – Proposed Rule 16Q.0405
- Muscle relaxant must be “immediately available” as well as accessible from the operatory and recovery rooms.
- Permit holder must document clinical reason to exceed manufacturer’s maximum recommended dosage of anesthetic or sedative.
Tracking Adverse Events – Proposed Rule 16Q.0702
- The Dental Board has dropped proposed rule 16Q.0702, which would have required permit holders to maintain records of “adverse events” subject to inspection by the Dental Board.
Reporting Adverse Occurrences – Proposed Rule 16Q.0703
- Clarification that permit holders report “adverse occurrence” to the Dental Board if patient is admitted to a hospital as inpatient (no report required if patient is evaluated and released from emergency department without admission).
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