24 Del. Admin. Code § 1100-7.0
Current through Register Vol. 28, No. 5, November 1, 2024
Section 1100-7.0 - Anesthesia Regulations7.1 Definitions: The following definitions are taken from the Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry, American Dental Association, Council on Dental Education (July 1993). These terms refer to the extent of a drug's depressant effect upon the central nervous system and should not be confused with the route by which the drug is administered.
7.1.1 Analgesia -- the diminution or elimination of pain in the conscious patient.7.1.2 Local Anesthesia -- the elimination of sensations, especially pain, in one part of the body by the topical application or regional injection of a drug.7.1.3 Conscious Sedation -- a minimally depressed level of consciousness that retains the patient's ability to independently and continuously maintain an airway and respond appropriately to physical stimulation and verbal command and that is produced by a pharmacologic or non-pharmacologic method or a combination thereof. In accord with this definition, the conscious patient is also defined as "one who has intact protective reflexes, including the ability to maintain an airway, and who is capable of rational response to question or command." The drugs and techniques used should carry a margin of safety wide enough to render unintended loss of consciousness unlikely.
For purposes of these regulations, Conscious Sedation Permits shall be divided into two classifications:
Restricted and Unrestricted Permits -- Conscious Sedation induced by parenteral or enteral or rectal routes as well as nitrous oxide inhalation. This does not preclude the use of usual and customary pre-operative oral sedation.
Restricted Permit II -- Conscious Sedation induced by nitrous oxide inhalation only.
7.1.4 Deep Sedation -- is a controlled state of depressed consciousness accompanied by partial loss of protective reflexes, including the inability to continually maintain an airway independently and/or to respond purposefully to verbal command, and is produced by a pharmacologic or non-pharmacologic method or combination thereof.7.1.5 General Anesthesia -- is a controlled state of unconsciousness accompanied by partial or complete loss of protective reflexes, including inability to independently maintain an airway and respond purposefully to physical stimulation or verbal command, and is produced by a pharmacologic or non-pharmacologic method or a combination thereof. The same level of advanced training is necessary for the administration of both Deep Sedation and General Anesthesia.
7.1.6 Adverse Occurrences -- any mortality or other incident occurring in the out-patient facilities of such dentist which results in temporary or permanent physical or mental injury requiring hospitalization of said patient during, or as a direct result of, the conscious sedation, or deep sedation, or general anesthesia related thereto.7.2 Conscious Sedation: 7.2.1 No dentist shall employ or use Conscious Sedation, Restricted Permit I or Restricted Permit II, for dental patients unless such dentist possesses a permit of authorization issued by the Delaware State Board of Dentistry and Dental Hygiene. The dentist holding such a permit shall be subject to review and such permit must be renewed biennially.7.2.2 In order to receive such a permit, the dentist shall produce evidence showing that he or she: 7.2.2.1 For Restricted Permit I Conscious Sedation:7.2.2.1.1 Has completed a minimum of 60 hours of instruction, including management of at least 20 patients per participant (to achieve competency in this technique).7.2.2.1.2 Must be certified in CPR as documented by the American Heart Association or the American Red Cross. Advanced Cardiac Life Support Certification is encouraged.7.2.2.1.3 Must also have a properly equipped facility for the administration of Restricted Permit I Conscious Sedation, staffed with a supervised team of auxiliary personnel capable of reasonably handling procedures, problems and emergencies incident thereto. Adequacy of the facility and competence of the team is to be determined by the Anesthesia Advisory Consultants appointed by the Board. A certified registered nurse anesthetist may be utilized for Restricted Permit I Conscious Sedation only if the dentist also possesses such a permit.7.2.3 A list of emergency drugs and equipment that should be on hand would consist of the following: 7.2.3.1 Agents capable of treating: 7.2.3.1.1 hypotension and bradycardia7.2.3.1.2 allergy/bronchospasm7.2.3.1.4 narcotic-induced respiratory depression (e.g., narcotic antagonists)7.2.3.1.5 angina pectoris7.2.3.1.6 adrenal insufficiency (e.g., steroids)7.2.3.2 Equipment necessary to provide artificial respiration and assist in airway maintenance.7.2.3.3 Equipment necessary to establish an intravenous infusion and to inject medications.7.2.4 For Restricted Permit II Conscious Sedation: 7.2.4.1 Has completed a minimum of 14 instructional hours including supervised clinical experience in managing patients (in a course required to achieve competency in nitrous oxide inhalation sedation).7.2.4.2 Must also show certification in cardio-pulmonary resuscitation as certified by the American Heart Association or the American Red Cross.7.3 Deep Sedation and General Anesthesia (Unrestricted Permit- Individual): 7.3.1 No dentist shall administer deep sedation or general anesthesia for his/her dental patients unless such dentist possesses a permit of authorization issued from the Delaware State Board of Dentistry and Dental Hygiene. This permit also includes all Conscious Sedation techniques. The dentist holding such a permit shall be subject to review and such permit must be renewed biennially.7.3.2 In order to receive such a permit, the dentist must produce evidence showing that he/she: 7.3.2.1 Has completed a minimum of two years of advanced training in anesthesiology and related academic subjects (or its equivalent) beyond the undergraduate dental school level in a training program as described in Part II of the Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry or, is a Diplomat of the American Board of Oral and Maxillofacial Surgeons, or has satisfactorily completed a residency in Oral and Maxillofacial Surgery at an institution approved by the Council of Dental Education, American Dental Association, or is a fellow of the American Dental Society of Anesthesiology. A certified registered nurse anesthetist may be utilized for deep sedation or general anesthesia only if the dentist also possesses an Unrestricted Permit.7.3.2.2 Has a properly equipped facility for the administration of deep sedation and general anesthesia, staffed with a supervised team of auxiliary personnel capable of reasonably handling procedures, problems and emergencies incident thereto. Adequacy of the facility and competence of the anesthesia team is determined by the Anesthesia Advisory Committee Consultants appointed by Delaware State Board of Dentistry and Dental Hygiene.7.3.2.3 And is certified in Advanced Cardiac Life Support by the American Heart Association.7.4 Deep Sedation and General Anesthesia (Unrestricted Facility Permit): 7.4.1 General anesthesia, deep sedation, conscious sedation by means other than nitrous oxide, may be administered in a dental office that has these services provided by an individual meeting the requirements of 7.3.2.1 and 7.3.2.2 or employs or works in conjunction with a board certified anesthesiologist with an active Delaware license, provided that such anesthesiologist must remain on the premises of the dental facility until any patient given a general anesthetic or deep sedation regains consciousness. The requirements of regulations 7.4, 7.5 and 7.6 shall apply to the facility.7.4.2 Inspections: Prior to the issuance of a permit for Restricted Permit I (parenteral, enteral, or rectal Conscious Sedation) or an Unrestricted Permit (Deep Sedation or General Anesthesia), the Board shall require an on site inspection of the facility, equipment and personnel to determine if, in fact, the aforementioned requirements have been met. The evaluation shall be carried out in a manner described by the Board. The evaluation shall be carried out by the Anesthesia Advisory Consultants appointed by the Board. Each office that the dentist utilizes for Restricted Permit I Conscious Sedation or Deep Sedation or General Anesthesia requires individual inspection and must meet the requirements of that permit for which the dentist is applying.7.4.3 Anesthesia Advisory Consultants: 7.4.3.1 The Board of Dentistry and Dental Hygiene shall appoint a team of Advisory Consultants and alternates who will visit the facility concurrently to conduct the on-site inspection and evaluation of the facilities, equipment and personnel of a licensed dentist applying for written authorization to administer or to employ another to administer Restricted Permit I Conscious Sedation, or Deep Sedation or General Anesthesia (Unrestricted Permit). The Advisory Consultants shall also aid the Board in the adoption of criteria and standards relative to the regulation and control of Conscious Sedation, Deep Sedation and General Anesthesia. The Anesthesia Advisory Consultants shall utilize the "Guidelines for the use of conscious sedation, deep sedation and general anesthesia for Dentist", as approved by the American Dental Association in October 1996, or any current update thereof. If the applicant has been satisfactorily evaluated by another similar organization (e.g., the Delaware Society of Oral and Maxillofacial Surgeons which uses the AAOMS Office Anesthesia Evaluation Manual Standards), then the Board may accept this evaluation and not require additional on-site evaluation.7.4.3.2 If the results of the initial evaluation of an applicant are deemed unsatisfactory, upon written request of the applicant, a second evaluation shall be conducted by a different team of consultants.7.4.4 Re-evaluation: The Board may at any time re-evaluate credentials, facilities, equipment, personnel and procedures of a licensed dentist who has previously received a written authorization or permit from the Board to determine if he/she is still qualified to have such written authorization. If the Board determines that the licensed dentist is no longer qualified to have such written authorization, it may revoke or refuse to renew such authorization, after an opportunity for a hearing is given to the licensed dentist.7.5 Report of Adverse Occurrences: 7.5.1 All licensed dentists engaged in the practice of dentistry in the State of Delaware must submit a complete report within a period of thirty (30) days to the Delaware State Board of Dentistry and Dental Hygiene of any mortality or other incident occurring in the out-patient facilities of such dentist which results in temporary or permanent physical or mental injury requiring hospitalization of said patient during, or as a direct result of, the Conscious Sedation or Deep Sedation or General Anesthesia related thereto.7.5.2 Failure to comply with this rule when said occurrence is related to the use of Conscious Sedation or Deep Sedation or General Anesthesia may result in the loss of such permit described above, and will be considered unprofessional conduct.7.6 Applications and Reapplications: 7.6.1 A dentist who desires to obtain a permit to administer Conscious Sedation, Deep Sedation, or General Anesthesia or to maintain a facility where such services are provided shall submit an application on the form provided by the Board, pay the permit fee, and meet the requirements for the permit described herein.7.6.2 A dentist who desires to renew a permit shall submit a renewal application on the form provided by the Board and pay the permit renewal fee. Re-inspection of the facility, equipment, and staff shall not be necessary unless new techniques or criteria arise, as determined by the Board with the aid of the Anesthesia Advisory Committee.7.6.3 A permit issued by the Board under these regulations will expire at the same time as the permit holder's dental license and may be renewed biennially at the same time as the dental license is renewed.24 Del. Admin. Code § 1100-7.0
1 DE Reg. 852 (01/01/98)
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16 DE Reg. 880 (02/01/13)