Thank you for the efforts to update the sedation and anesthesia guidelines for the Commonwealth of Virginia. Although I agree with a majority of the changes in the proposed text, there are some additional comments I wish the Board to consider.

First under the definitions in 18VAC60-21-10 I would ask that you consider the following changes:

1) Under section D, it may not be necessary to delete the definition of enteral.  Although moderate sedation is changing in order to not distinguish between enteral and parenteral routes of administration (and appropriately so), the definition of enteral may still come into play, especially when discussing maximum recommended doses in minimal sedation.

2) A point of clarification is that under Deep Sedation and General Anesthesia, the definitions mention "ventilator functions", this should state ventilatory function.  A ventilator is the mechanical machine that provides ventilatory support, the body has ventilatory and cardiovascular functions in these two definitions.

3) Please consider definining the "maximum recommended dose" as this will be a very debatable definition that practitioners will argue when defining the line between minimal and moderate sedation, as stated in 18VAC60-21-280 Section F 4. The ADA defines this in their guidelines as follows: "maximum FDA-recommended dose of a drug, as printed in FDA-approved labeling for unmonitored home use."  As a point of comment - this definition even by the ADA may be challenged by some providers as Xanax (alprazolam) allows for a higher FDA recommended maximum dose if titrated by the practitioner over time to the desired effect.  Some may choose to use the actual highest dosage allowed of 10mg per day, even though the FDA recommends dosing increases at intervals of 3-4 days and when increased should not be increased more than 1mg per day.

Under 18VAC60-21-260 General Provisions

1) Section K1 - it allows delegation of monitoring to " another dentists, anesthesiologists, or certified registered nurse anesthetist (CRNA)." In all other instances where a CRNA is mentioned, it is under the direction of the dentist, but in this single instance it is not.  According to the regulations, the CRNA must practice under the direction of a dentist with the appropriate level of sedation / anesthesia permit.  Therefore, a CRNA should also be under the direction of the dentist like the aforementioned assistant, hygienist, or nurse in this section.

2) Section M - Instead of "Special needs patients", this should read "Patients with Special Healthcare Needs". This is a matter of political correctness. In addition, the provisions here should also apply to pediatric patients that are uncooperative for IV placement prior to induction. Although this is mentioned in the section, the section heading makes it sound as if it only applies to Patients with Special Healthcare Needs.

18VAC60-21-279 Under section D - this section mentions the required equipment that shall be in working order and available, therefore item # 5 should not allow a pulse oximeter to not be available in the facility, therefore the section should simply read pulse oximeter.

18VAC60-21-290 Section 4.b - I would encourage the Board to consider changing the language of " at the timing that training occurred."  The ADA Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students have been developed to increase patient safety by ensuring that training and update / refresher courses meet the new standards, especially in terms of the competency in rescuing the airway and establishing parenteral access. The American Society of Anesthesiologists' 2018 Task Force on Procedural Sedation found that it was critical that a member of the team be competent in IV access. (http://anesthesiology.pubs.asahq.org/article.aspx?articleid=2670190) Practitioners should be held responsible for updating their training, especially in sedation and anesthesia as that person is responsible for the safety of the patient's life and the management of any complication that might arise.

Under 18VAC60-21-291

1) Section B.11 does not need to state parenteral administration any longer as this is all part of moderate sedation now and ECG should be required.

2) Section C - there is already a lot on input regarding this, but I would like the Board to consider verbiage such as this. " There shall be a two person team in the room with the patient at all times."  I believe the Board's intent was to ensure that two people were always present at the time, and as the AAPD and ADA guidelines state, the person monitoring the patient may have minor interruptible tasks. In many practices, this might include an immediately available third assistant to function as a "circulator" much like a circulating nurse in the OR.  Nevertheless, the established standard is a two person team. The only other explanation I have heard to justify this is the AAOMS Parameters of Care that state in Deep Sedation or GA that if the person monitoring the patient have no other responsibilities. However, this is Deep Sedation or GA.

Finally, it may be prudent for the Board to consider when a patient may be considered adequately recovered for these teams to leave the room with a designated staff member.  Unfortunately there have been numerous reports and associated morbidity and mortality when the sedation or anesthesia provider moves on to the next patient and leaves a patient with an "monitoring assistant." The ADA guidelines require that the patient return to a state of minimal sedation prior to leaving them with a dental assistant.  This may vary if the delegated individual were say an RN or a CRNA whom is licensed and has the adequate training to thoroughly monitor say the moderately sedated patient in recovery.

Thank you for your time and consideration of the above comments,

Jonathan L Wong, DMD, DADBA, DNDBA, FADSA

Diplomate, American Dental Board of Anesthesia *

Diplomate, National Dental Board of Anesthesia *

Fellow, American Dental Society of Anesthesiology *

*The ADA does not recognize Dentist Anesthesiologists as specialists, therefore anesthesiology services and expertise are rendered as a general dentist with a general anesthesia permit.