Patient-administered nitrous oxide (N2O) delivery systems are quickly becoming a sought-after service for clinicians in various medical fields, from dentists to med spas. Nitrous oxide has effects of both analgesia (pain relief) and anxiolysis (anxiety relief), and self-administration systems enable patients to control their own pain and anxiety.
Before you add patient-administered nitrous oxide services to your practice, consult a healthcare attorney. As a medical gas, nitrous oxide is a “drug” within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This means that nitrous oxide systems must be administered in accordance with state and federal regulatory guidelines.
A healthcare attorney can advise you on the legal implications of adding nitrous oxide and review your policies and procedures for regulatory compliance.
Texas State Nitrous Oxide (N2o) Regulatory Requirements
Texas has different regulations regarding the administration of nitrous oxide, commonly known as “laughing gas”, depending on the type of professional license involved.
Texas Medical Board Rules
Physicians that want to administer nitrous oxide within an office-based setting must comply with Chapter 192 of the Texas Medical Board (TMB). The Texas Medical Board rules define four levels of office-based anesthesia services:
- Physicians who provide level II-IV anesthesia services in an outpatient setting, and physicians who perform procedures for which level II-IV anesthesia services are provided in an outpatient setting, must register and pay a fee to the Texas Medical Board.
- Physicians that provide only level I services do not need to register or pay a registration fee. Nitrous oxide fits within the definition of a level I anesthesia services when delivered by mouth in a low enough amount to allow the patient to remain ambulatory.
Physicians and physician staff must also comply with additional TMB requirements for office-based anesthesia services, including requirements for staffing, training, and equipment.
Texas State Board of Dental Examiners Rules
Dentists that desire to administer nitrous oxide inhalation sedation must comply with Chapter 110 of the Texas State Board of Dental Examiners (TSBDE). The rules of the State Board of Dental Examiners also define four levels of sedation. However, the rules place “nitrous oxide/oxygen inhalation sedation” in its own category of regulation below the four levels of sedation as set forth below:
- Nitrous Oxide/Oxygen Inhalation Sedation
- Level 1: Minimal Sedation
- Level 2: Moderate Enteral Sedation
- Level 3: Moderate Parenteral Sedation
- Level 4: Deep Sedation or General Anesthesia
A dentist must obtain a permit from the State Board of Dental Examiners before administering nitrous oxide within his or her office. A dentist who only holds a nitrous oxide/oxygen inhalation sedation may not intentionally provide minimal sedation, moderate sedation, deep sedation, or general anesthesia.
Dentists, dental hygienists, and registered dental assistants must also comply with TSBDE requirements for anesthesia training, equipment, and permitting.
American Dental Association Guidance on N2O Sedation
The American Dental Association (ADA) adopted sedation and anesthesia guidelines in 2016. According to those guidelines, nitrous oxide delivery systems should have safety features in place to help avoid adverse events:
“Practitioners should know how to maintain these features and to immediately remove the patient’s face mask to allow for breathing of room air when any of these safety features is suspected of failing.”
Additional dental best practices were developed by Council on Scientific Affairs (CSA) and the Council on Dental Practice (CDP) to reduce chronic occupational exposure in dental offices, such as equipping delivery systems with a scavenging system and venting fumes outside.
FDA & OSHA Nitrous Oxide Regulations
Nitrous oxide is not a controlled substance and consequently is not regulated by the DEA. However, N20 is regulated by the Food and Drug Administration (FDA) and the Occupational Safety and Health Administration (OSHA).
- FDA regulations: Nitrous oxide comes under the FDA’s FD&C Act definition of a medical gas. This means it must be prescribed by a qualified healthcare provider to be dispensed.
- OSHA Guidelines: While there is no specific OSHA standard for nitrous oxide or anesthetic gases, it is included in their “Anesthetic Gases: Guidelines for Workplace Exposures” guideline. This guideline covers the safe use of nitrous oxide and other anesthetic gases in a hospital-based or outpatient setting as well as workplace exposure monitoring and control. Since these guidelines set the standards for acceptable levels of workplace exposure to these gases, following them closely is essential to ensure workplace safety and avoiding citations.
Separate Anesthesia and/or Perioperative Pain Management (Analgesia) Consent Form
The Texas Medical Disclosure Panel (TMDP) recently published a standard disclosure form for the administration of Anesthesia and/or Perioperative Pain Management, effective September 1, 2023.
TMDP is required by law to determine which risks and hazards related to medical care and surgical procedures must be disclosed by healthcare providers to their patients, and to establish the general form for such disclosures.
TMDP has separate lists of medical treatments and surgical procedures that require disclosure of specific risks and hazards and those treatments and procedures that do not.
- List A sets out the treatments and procedures that require disclosure of specific risks and hazards;
- List B includes treatments and procedures that do not require disclosure of specific risks or hazards.
According to TMDP, nitrous oxide is considered a List A anesthesia that requires disclosure of specific risks and hazards when used in conjunction with other procedures.
A Texas healthcare attorney can advise you on the legal implications of adding N20 services and help you implement policies and procedures that keep your practice in compliance with all state and federal laws and regulations.
