This article continues our series on medical devices related to respiratory therapy, where we have covered topics like anesthesia circuits and oxygen masks. Now, we’ll explore the regulatory process for registering breathing systems in Mexico.
What is a Breathing System?
Breathing systems are commodity medical devices designed to deliver oxygen and/or air to patients requiring respiratory support. They are used in conjunction with various airway management devices such as endotracheal tubes, laryngeal masks, face masks, or nasal prongs. These systems are crucial in diverse healthcare settings, including surgery, emergency, intensive care units (ICUs) and home healthcare. Breathing systems ensure a continuous flow of gases, while also performing vital functions like CO2 removal and humidity and heat maintenance.
What are the components of a breathing system?
Breathing systems are intricate assemblies of various components working in harmony to ensure their intended use. Key components include:
- Breathing tubes: Flexible tubes connecting the patient’s airway to the oxygen source or ventilator.
- Reservoir bag: A flexible bag that acts as a temporary gas reservoir and aids in monitoring breathing patterns.
- Connectors and adapters: Various fittings that ensure proper connections between different parts of the system.
- Valves: One-way valves that control gas flow and prevent the rebreathing of exhaled carbon dioxide.
- Filters: Bacterial and viral filters that minimize the risk of infection and cross-contamination.
- CO2 absorber: (In closed and semi-closed systems) A canister containing chemicals that absorb carbon dioxide from exhaled breath.
- Heat and moisture exchangers (HMEs): Devices that conserve the patient’s exhaled heat and moisture, reducing the need for additional humidification.
- Flowmeters: Devices that precisely control the flow of gases into the circuit.
It’s important to note that while breathing systems are often used with ventilators, humidifiers, and monitors, these are considered separate medical devices with their own classifications and registration requirements.
What are the types of breathing systems?
Breathing systems are mostly classified based on how they manage gas flow and rebreathing:
- Open Breathing Systems: Fresh gas flows continuously from the source to the patient, and exhaled gas is released into the atmosphere. These are rarely used in modern healthcare due to inefficiency and infection control concerns.
- Semi-Closed Breathing Systems: These systems allow for partial rebreathing of exhaled gas after it passes through a CO2 absorber. Fresh gas is added to maintain adequate oxygen levels. This type is commonly used in anesthesia and short-term ventilation.
- Closed Breathing Systems: These systems re-breathe all exhaled gas after CO2 absorption, minimizing the need for fresh gas flow. They are often preferred for long-term ventilation in critical care settings.
Specialized Breathing Systems:
In addition to the main types, there are specialized breathing systems designed for specific applications:
- Pediatric circuits: Adapted for infants and children with smaller lung volumes and specific needs.
- Coaxial circuits: Employ a “tube within a tube” design for efficient gas flow and heat conservation.
- Continuous positive airway pressure (CPAP) circuits: Used to deliver continuous positive pressure to the airways, often for sleep apnea or respiratory distress.
- Heated wire breathing systems (HWBS): Incorporate heated wires within the circuit to maintain optimal humidity and temperature, reducing condensation and complications.
How are the Breathing Systems Classified and Grouped in Mexico?
Breathing systems fall under Class II medical devices as per Rule 2 of the Mexican Pharmacopeia (FEUM). They are categorized under “V. Surgical materials or wound care related devices” according to Article 262 of the General Health Law (LGS). This classification reflects their non-invasive nature and their function in conducting gases to a patient connected to a Class II active device (e.g., a ventilator).
Grouping Strategy for Registration:
Due to the wide variety of breathing systems available, grouping them for registration with COFEPRIS requires a strategic approach. Here are some important considerations:
- Similarities: Breathing systems with the same intended use and materials can be grouped under a single registration, even if they have variations in size (adult, pediatric, neonatal), tubing length, or the number and type of connectors and accessories.
- Types: Different types of breathing systems (e.g., CPAP, HWBS) can be grouped if they share similar materials and construction, even with specific components for each model.
- Sterility: While most breathing systems are provided non-sterile, sterility and re-sterilization information must be clearly defined for each grouped device.
- Technical documentation: Comprehensive technical information for all components, including those of the most complex system within the group, must be included in the registration dossier.
- Performance testing: Performance testing data must cover all models within the group for each component and accessory.
- Components and accessories: Filters, HMEs, CO2 absorbers, and other components may be considered medical devices themselves. Justification for their inclusion in the system is necessary when they are not packaged together or are not for exclusive use with the circuits.
Remember that ventilators, humidifiers, and monitors require separate registrations as they are independent medical devices, potentially falling under different classifications.
Conclusion
Breathing systems are critical medical devices that play a vital role in respiratory care across various healthcare settings. Understanding their classification, components, and grouping strategies is essential for successful registration in Mexico. By observing to COFEPRIS regulations and providing comprehensive technical information, manufacturers can ensure regulatory compliance to successfully enter to the Mexican Market.
Do you have questions about registering breathing systems or other 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.
