A dentist providing sedation services or an operating dentist
utilizing the services of a sedation provider as outlined in this chapter must
comply with the following:
A.
Patient Recovery. The operating dentist must ensure that the
sedation provider remains at the location where services were provided until
any patient given moderate or deep sedation/general anesthesia has been
assessed for discharge in accordance with this chapter and the ADA Sedation
guidelines. Patient assessment and discharge information such as level of
consciousness, oxygenation, ventilation, and circulation must be documented in
each patient record.
B.
Levels of Anesthesia. The dentist, the operating dentist and the
sedation provider must be prepared to manage deeper than intended levels of
anesthesia. If a patient enters a deeper level of sedation than the provider is
qualified to provide, then the dental procedure must stop until the patient
returns to the intended level of sedation.
C.
Equipment Required When
Administering Minimal Sedation, Moderate Sedation, Deep Sedation and/or General
Anesthesia. The dentist or operating dentist must ensure that that
following requirements are met as it relates to the delivery of sedation:
(1) A dentist whose practice includes the
administration of minimal sedation must provide the following equipment, which
is required to be functional at all times:
a.
Emergency equipment, including:
i. An
appropriate size bag-valve-mask apparatus or equivalent with an oxygen
hook-up.
ii. Oral and
nasopharyngeal airway device.
iii.
Appropriate emergency medications.
iv. An external defibrillator - manual or
automatic.
v. Broselow pediatric
measuring tape
b.
Equipment to monitor vital signs and oxygenation/ventilation, including:
i. A continuous pulse oximeter.
ii. A blood pressure cuff of appropriate size
and stethoscope, or equivalent blood pressure monitoring devices.
c. Oxygen, suction, and a pulse
oximeter must be immediately available during the recovery
period.
(2) A dentist or
operating dentist whose practice includes the administration of moderate
sedation must provide the following equipment, which is required to be
functional at all times:
a. Emergency
equipment, including:
i. An appropriate size
bag-valve-mask apparatus or equivalent with an oxygen hook-up.
ii. Oral and nasopharyngeal airway
device.
iii. Appropriate emergency
medications.
iv. An external
defibrillator - manual or automatic.
v. ACLS algorithms card
vi. Broselow pediatric measuring
tape.
b. Equipment to
monitor vital signs and oxygenation/ventilation, including:
i. A continuous pulse oximeter.
ii. A blood pressure cuff of appropriate size
and stethoscope, or equivalent blood pressure monitoring devices.
c. Oxygen, suction, and a pulse
oximeter must be immediately available during the recovery period.
d. Back-up suction equipment.
e. Back-up lighting system.
f. Equipment necessary to establish
intravenous (IV), intraosseous (IO), or sublingual (SL) access.
g. Electrocardiograph if providing sedation
services to patients with American Society of Anesthesiologists Physical Status
Classification of ASA III or higher.
h. Ventilation monitoring system (e.g. color
CO2, auscultation of breath sounds). Permit holders are required to obtain and
use an end-tidal carbon dioxide monitor (capnography).
(3) A dentist or operating dentist whose
practice includes the administration of deep sedation and/or general anesthesia
must provide the following and equipment, which is required to be functional at
all times:
a. Emergency equipment, including:
i. An appropriate size bag-valve-mask
apparatus or equivalent with an oxygen hook-up.
ii. Oral and nasopharyngeal
airways.
iii. Appropriate emergency
medications.
iv. An external
defibrillator - manual or automatic.
v. ACLS algorithms card
vi. Broselow pediatric measureing
tape.
b. Equipment to
monitor vital signs and oxygenation/ventilation, including:
i. A continuous pulse oximeter.
ii. A blood pressure cuff of appropriate size
and stethoscope, or equivalent blood pressure monitoring devices.
c. Oxygen, suction, and a pulse
oximeter must be immediately available during the recovery period.
d. Back-up suction equipment.
e. Back-up lighting system.
f. Equipment necessary to establish
intravenous (IV), intraosseous (IO) or sublingual (SL) access.
g. Electrocardiograph.
h. Ventilation monitoring system (e.g. color
CO2, auscultation of breath sounds). Permit holders are required to obtain and
use an end-tidal carbon dioxide monitor (capnography).
i. Additional emergency equipment to manage
difficult airways, including:
i. Laryngeal
mask airway, and/or endotracheal tubes and/or a LMA suitable for patients being
treated.
ii. Laryngoscope with
reserve batteries and bulbs.
iii.
Endotracheal tube forceps (e.g. Magill).
iv. At least one additional airway management
device.
v. Equipment to establish
surgical airway
(4)
Emergency Protocols: A
dentist or operating dentist whose practice includes the use of moderate
sedation or general anesthesia must have written emergency protocols, and must
provide training at least annually to familiarize office personnel in the
treatment of the following clinical emergencies:
a. Laryngospasm.
b. Bronchospasm.
c. Emesis and aspiration.
d. Airway blockage by foreign body.
e. Angina pectoris.
f. Myocardial infarction.
g. Hypertension/Hypotension.
h. Allergic and toxicity reactions.
i. Seizures.
j. Syncope.
k. Intra-arterial injection.
l.
Hyperventilation/Hypoventilation.
m. Cardiac arrest.
n. Cardiac arrhythmias.
A dentist or operating dentist must maintain for inspection
a permanent record, which reflects the date, time, duration, names of
attendees, and type of emergency protocol training provided.
D.
Drugs. A
dentist or operating dentist must have the following drugs and/or categories of
drugs with a current shelf life easily accessible from the operatory and
recovery room when providing the services below:
(1)
Moderate Sedation Services
a.
Level I (Enteral)
i.
Cardiac Drugs
1. Vasopressor (e.g. Epinephrine)
2. Nitroglycerin (spray or tablets)
3. Anticoagulant (aspirin)
4. Glucose (D50 or liquid glucose)
ii.
Reversal Agents
(required only for administration of benzodiazepines or narcotics)
1. Flumazenil (benzodiazepine reversal
agent)
2. Narcan (narcotic reversal
agent)
iii.
Other1. Antihistamine (e.g.
Benadryl IV or PO)
2.
Bronchodilator (e.g. Albuterol inhaler)
b.
Level II (Parenteral)
i.
Cardiac Drugs
1. Vasopressor (e.g. Epinephrine)
2. Nitroglycerin (spray or tablets)
3. Anticoagulant (aspirin)
4. Glucose (D50 or liquid glucose)
5. Lidocaine
6. Atropine
7. Adenosine
8. Diltiazem
9. Beta Blocker (e.g. Labetalol,
Esmolol)
ii.
Reversal Agents (required only for administration of
benzodiazepines, narcotics, or triggering agents of malignant hypothermia)
1. Flumazenil (benzodiazepine reversal
agent)
2. Narcan (narcotic reversal
agent)
3. Dantrolene, Ryanodex
(volatile gas reversal agent)
iii.
Other
1. Antihistamine (e.g. Benadryl IV or
PO)
2. Bronchodilator (e.g.
Albuterol inhaler)
3.
Corticosteroid (e.g. Solu-Medrol)
4. Muscle Relaxant (e.g.
Succinylcholine)
5. Narcotics (e.g.
morphine, fentanyl)
6.
Antihypertensive drugs (e.g. Propranolol, Verapamil)
(2)
Deep Sedation
and/or General Anesthesia Servicesa.
Cardiac Drugsi. Vasopressor
(e.g. Epinephrine)
ii.
Nitroglycerin (spray or tablets)
iii. Anticoagulant (aspirin)
iv. Glucose (D50 or liquid glucose)
v. Lidocaine
vi. Atropine
vii. Adenosine
viii. Diltiazem
ix. Beta Blocker (e.g. Labetalol,
Esmolol)
b.
Reversal Agents (required only for administration of
benzodiazepines, narcotics, or triggering agents of malignant hypothermia)
i. Flumazenil (benzodiazepine reversal
agent)
ii. Narcan (narcotic
reversal agent)
iii. Dantrolene,
Ryanodex (volatile gas reversal agent)
c.
Other
i. Antihistamine (e.g. Benadryl IV or
PO)
ii. Bronchodilator (e.g.
Albuterol inhaler)
iii.
Corticosteroid (e.g. Solu-Medrol)
iv. Muscle Relaxant (e.g.
Succinylcholine)
v. Narcotics (e.g.
morphine, fentanyl)
vi.
Antihypertensive drugs (e.g. Propranolol,
Verapamil)
E.
Anesthesia Gas Delivery Systems -
must include all of the following:
(1) Capability to deliver oxygen to a patient
under positive pressure, including a back-up oxygen system.
(2) Gas outlets that meet generally accepted
safety standards preventing accidental administration of inappropriate gases or
gas mixture.
(3) Fail-safe
mechanisms for inhalation of nitrous oxide analgesia.
(4) Inhalation equipment with an appropriate
scavenging system.
(5) Gas storage
facilities, which meet generally accepted safety standards.
(6) Engineering controls and maintenance
procedures to ensure safety of inhalation equipment.
F.
Patient Documentation - must
include, but is not limited to, all of the following:
(1) For administration of minimal sedation,
moderate sedation, deep sedation or general anesthesia -
a. Medical History - current and
comprehensive.
b. Height and
Weight.
c. American Society of
Anesthesiology (ASA) Classification.
d. Dental Procedure(s).
e. Informed Consent.
f. Time oriented anesthesia record, which
includes:
i. Parenteral access site and
method, if utilized.
ii.
Medication(s) administered - medication (including oxygen), dosage, route, and
time given.
iii. Vital signs before
and after anesthesia is utilized.
iv. Intravenous fluids, if
utilized.
v. Response to anesthesia
- including any complications
g. Condition of patient at discharge charted
with objective data or scale such as the Modified Aldrete scoring
system.
(2) In addition,
for administration of moderate sedation, deep sedation or general anesthesia -
a. Physical examination - airway assessment,
baseline heart rate, blood pressure, respiratory rate, and oxygen
saturation;
b. Time oriented
anesthesia record, which includes:
i. Time
anesthesia commenced and ended.
ii.
At least every 5 minutes record blood pressure, heart rate, oxygen saturation
(SpO2), and respiratory rate.
iii.
Continuous electrocardiograph (ECG) and documentation of changes in rhythm, if
clinically indicated by patient history, medical condition(s), or
age.
G.
Patient Monitoring - Must include,
but is not limited to the following:
(1) For the administration of Minimal
Sedation -
a. Continuous heart rate and
respiratory status;
b. Continuous
oxygen saturation (SpO2); and
c.
Pre and post procedure blood pressure.
(2) For the administrationof Moderate
Sedation -
a. Continuous heart rate,
respiratory status, and oxygen saturation;
b. Intermittent blood pressure, taken at
least every 5 minutes;
c.
Continuous electrocardiograph of patients with significant cardiovascular
disease;
d. End-tidal carbon
dioxide monitoring (capnography); and
e. Continuous monitoring of level of
consciousness
(3) For the
administration of Deep Sedation or General Anesthesia -
a. Continuous heart rate, respiratory status,
and oxygen saturation;
b.
Intermittent blood pressure, taken at least every 5 minutes;
c. Continuous electrocardiograph;
d. End-tidal carbon dioxide monitoring
(capnography); and
e. Continuous
monitoring of level of consciousness
(4) When the level of cooperation in a
pediatric or special needs patient does not reasonably allow for full
compliance with some monitoring requirements, the dentist must use professional
judgment regarding monitoring and must document the reasons preventing the
recommended management.
H.
Miscellaneous Requirements
(1)
Life Support
Certification(s)a. Dentists must
ensure that all dental personnel successfully complete Basic Life Support for
Healthcare Providers (BLS) certification and maintain current BLS certification
when utilizing, administering, or monitoring local anesthesia, nitrous oxide
analgesia, minimal sedation, moderate sedation, deep sedation, or general
anesthesia.
b. Any dentist who
files an application under this chapter for either a permit or a 14 Day
Notification to utilize the services of a sedation provider must obtain and
maintain life support certification in BLS and advanced life support
certification in Advanced Cardiac Life Support (ACLS). Advanced life support
certification in Pediatric Advanced Life Support (PALS) is required when
providing sedation services to pediatric patients and may be used in meeting
the ACLS advanced life support certification requirements of this
chapter.
c. Online life support
certification training and online advanced life support certification training
are not accepted unless hands-on participation with the instructor as a
component of the training is verified.
(2)
Personnel
a.
Minimal/Moderate Sedation -
When providing minimal or moderate sedation at a dental practice location, the
operating dentist and at least one other individual who is experienced in
patient monitoring and documentation, and trained to handle emergency
situations must be present.
b.
Deep sedation/general anesthesia - During the administration of
deep sedation or general anesthesia, the operating dentist and at least two
other individuals, one of whom is experienced in patient monitoring and
documentation, and trained to handle emergency situations, must be
present.
(3)
Monitoring and medication administration - The dentist retains
full accountability, but delegation as authorized by the
Maine Dental
Practice Act to dental personnel may occur under:
a. Direct supervision by the dentist when a
patient is being monitored, or
b.
Direct, continuous, and visual supervision by the dentist when medication,
excluding local anesthetic, is being administered to a patient.
(4)
Discharge -
Patient discharge after sedation and/or general anesthesia must be specifically
authorized by the dentist or sedation provider.