This article closes our series on medical devices related to respiratory therapy, where we have covered topics like anesthesia circuits, oxygen masks, and breathing systems. Now, we’ll explore the regulatory process for registering humidifiers and heated wire breathing systems (HWBS) in Mexico.
What are Humidifiers and Heated Wire Breathing Systems?
- Humidifiers: medical devices designed to add moisture and, often, heat to the inspired gases delivered to patients undergoing respiratory support to mitigate risk of complications, particularly during prolonged ventilation.
- Heated Wire Breathing Systems (HWBS): specialized type of breathing circuits that incorporate heated wires within the tubing to maintain the temperature of the delivered gases, preventing condensation within the circuit.
These devices are used in conjunction with mechanical ventilators and various airway management devices (endotracheal tubes, laryngeal masks, face masks, etc.) in settings like surgery, emergency care, intensive care units (ICUs), and home healthcare.
What are the components of a Humidifier and its interaction with an HWBS?
Humidifiers and HWBS, while separate devices, work synergistically:
- Humidifier Components:
-
- Heating Element: Warms the water to create water vapor.
-
- Water Chamber: A reservoir holding sterile water. This can be a pre-filled, disposable chamber or a refillable chamber.
-
- Temperature Control System: Allows clinicians to adjust the temperature and, indirectly, the humidity level.
-
- Connection Ports: To connect to the breathing circuit (often the inspiratory limb).
- HWBS Components:
-
- Breathing Tubes: Flexible tubes connecting the patient’s airway to the oxygen source or ventilator.
-
- Heated Wires: Run along the inspiratory limb (and often the expiratory limb) of the breathing circuit.
-
- Temperature Sensors: Located within the circuit (often near the patient connection) to monitor gas temperature.
-
- Controller/Adapter: connects the heated wires to a power source from the ventilator, and transmits sensor data.
What types of Humidifiers are used with HWBS?
Humidifiers used with HWBS are primarily classified based on their heating method and water chamber type:
- Heated Humidifiers: These are the most common type, using a heating element to warm the water. They offer precise control over temperature and humidity.
-
- Pass-over Humidifiers: Gas flows over the surface of the heated water.
-
- Bubble Humidifiers: Gas is bubbled through the heated water (less common with ventilators, more common with lower-flow oxygen therapy).
- Water Chamber Types:
-
- Refillable Chambers: Require manual refilling with sterile water.
-
- Pre-filled, Disposable Chambers: Single-use chambers pre-filled with sterile water, reducing the risk of contamination.
-
- Auto-feed systems: The humidifier automatically refills from a larger sterile water source.
How are Humidifiers and HWBS Classified and Grouped in Mexico?
- Humidifiers: Generally fall under Class II medical devices, according to Rule 2 of the Mexican Pharmacopeia (FEUM) and “I. Medical Equipment” according to Article 262 of the General Health Law (LGS).
- Heated Wire Breathing Systems (HWBS): As discussed previously, these are Class II devices (Rule 2, FEUM) and “V. Surgical materials or wound care related devices” according to Article 262 of the General Health Law (LGS).
Grouping Strategy for Registration:
-
- Separate Registrations: Humidifiers and HWBS require separate registrations with COFEPRIS, even though they are often used together, they are distinct devices with different indications of use and classifications.
-
- Humidifier Grouping: Humidifiers with the same intended use, heating method, and similar materials can be grouped, even with variations in water chamber type (refillable vs. pre-filled), temperature control features.
-
- HWBS Grouping: Follows the guidelines outlined for regular Breathing Systems (similar materials, intended use, variations in length/connectors allowed).
Specific topics to consider:
-
- Performance Testing: Testing should be conducted with the humidifier and HWBS used together, demonstrating that the system delivers the intended temperature and humidity levels without issues.
-
- Instructions for Use: The instructions for both devices should clearly explain how to connect and use them together safely and effectively.
-
- Sterility: Sterility and re-sterilization information must be clearly defined for each grouped device (kit for HWBS).
-
- Technical documentation: Comprehensive technical information for all components must be included in the registration dossier.
-
- Components and accessories: Justification for the inclusion of the components and accessories of the system is necessary when they are not packaged together or are not for exclusive use with the circuits.
Conclusion
Humidifiers and HWBS are essential components of modern respiratory care. Understanding their distinct classifications, the interaction between them, and the specific grouping strategies for registration in Mexico is crucial for manufacturers to ensure successful market access.
Do you have questions about registering humidifiers, HWBS, or other related medical devices in Mexico? Contact us today for expert guidance and support throughout the regulatory process. Our team at Veraque is dedicated to helping you travel through the complex Mexican regulations.
