The U.S. Food and Drug Administration (FDA) classifies oxygen as a drug when provided to an injured or ill person. It requires specific labeling and product controls and must be individually prescribed to someone suffering from an ailment. When used incorrectly, oxygen can cause damage to someone’s health.
Oxygen administration, however, is the emergency standard of care for any in-water incident, including decompression sickness, arterial gas embolism, and near-drowning. The FDA recognizes a delay is not in the injured person’s best interest in situations of oxygen deficiency, so there is an exemption to the requirements for labeling and control of oxygen that allows administration without a prescription. The exemption requires that oxygen may be used only for una reanimación de emergencia cuando es administrado por personal debidamente capacitado..
Una vez que el proveedor ha recibido capacitación para el uso de oxígeno para emergencias, el paso siguiente es obtener acceso al equipo de oxígeno, pero tener cilindros llenos a menudo es un desafío. Las empresas de gas comercial que suministran productos de gas de uso médico deben seguir los requisitos de clasificación de medicamentos de la FDA y con frecuencia desconocen la exención de prescripción de la FDA, por lo que pueden mostrarse reacias a proporcionar cargas sin esa receta individual.
To help commercial gas companies, filling stations, and first aid providers, DAN prepared a document titled “FDA Prescription Exemption: Oxygen Fills for Emergency Use” and made it freely available. The DAN legal team reviewed it to ensure the exemption is correctly applied. The document explains how the exemption applies to diving first aid and ensures oxygen supply companies that they are not infringing on the FDA’s strict regulatory requirements.
A continuación se especifican los requisitos necesarios para llenar un cilindro de oxígeno sin una prescripción:
• The provider shall demonstrate they are properly trained to administer oxygen during an oxygen-deficient emergency. Completing courses such as DAN’s comprehensive Diving First Aid for Professional Divers or Emergency Oxygen for Scuba Diving Injuries constitutes proper training. The certification is usually considered current for two years. Be ready to present your valid training certification card.
• The oxygen equipment shall have a minimum capacity of 180 liters (6.4 cubic feet) of gas, the ability to deliver a minimum flow rate of 6 liters per minute for 15 minutes, a contents indicator (pressure gauge), and a means to administer oxygen to the patient (a suitable breathing device). DAN’s oxygen kits, among others, meet these requirements.
• The oxygen equipment and/or container shall be labeled “for emergency use by properly trained persons only.” Todos los equipos de oxígeno de DAN actualmente tienen estas etiquetas en cilindros, reguladores, válvulas y el estuche.
Otro error común es que el oxígeno de grado no médico de una estación de llenado no es adecuado para su uso en emergencias. Durante una emergencia se acepta el uso de cualquier tipo de oxígeno respirable.
Industrial gas-filling companies may maintain a policy to fill only with an appropriate prescription — and no regulation prevents them from doing so — but we hope this information about the exemption will help filling companies and providers maintain the availability of emergency oxygen.
Si usted o una empresa de llenado de oxígeno tiene preguntas o necesita una etiqueta adecuada para un kit de oxígeno de DAN, envíenos un mensaje de correo electrónico a oxygen@dan.org. .
© Alert Diver – Q3 2024