This article continues our series on anesthesia-related medical devices. Having previously covered anesthesia masks, endotracheal tubes, and laryngeal masks, we now turn our attention to the regulatory process for registering anesthesia circuits in Mexico.
What are Anesthesia Circuits?
Anesthesia circuits, also known as anesthesia breathing systems, are key medical devices used in anesthesia practice. They create a closed loop between the patient’s airway and the anesthesia machine, allowing for the controlled delivery of medical gases (oxygen, air, anesthetic vapors) and facilitate the removal of carbon dioxide and exhaled gases.
Components of Anesthesia Circuits
Anesthesia circuits are comprised of various components working together to achieve the intended use of the device:
- Breathing tubes: Connect the patient to the anesthesia machine.
- Reservoir bag: Temporary gas reservoir.
- Connectors and adapters: Communicating different parts of the circuit.
- Valves: Gas flow and prevent rebreathing of CO2.
Other components that can be considered optional or accessory to the circuits are:
- Filters: Infection and cross-contamination control.
- CO2 absorber: Absorb exhaled carbon dioxide in rebreathing circuits.
- Heat and moisture exchangers (HMEs): Conserve patient heat and moisture, particularly in longer procedures.
- Flowmeters: To control the flow of gases into the circuit.
- Vaporizers: Deliver precise concentrations of anesthetic vapors.
Types of Anesthesia Circuits
Anesthesia circuits are classified based on how they manage gas flow and rebreathing:
- Open Circuits: Fresh gas flows continuously, and exhaled gases are vented to the atmosphere. (Mapleson A)
- Semi-open Circuits: Partial rebreathing of exhaled gases occurs. (Mapleson B, C, D)
- Semi-closed Circuits: Controlled rebreathing with fresh gas flow and carbon dioxide absorption. (Circle system)
- Closed Circuits: Minimal fresh gas flow with complete rebreathing after carbon dioxide absorption.
Further sub-classifications exist, such as the Mapleson system and variations like the Bain circuit, parallel and specialized circuits like those used for nitrous oxide (N2O).
Reusable vs. Single-Use Circuits
While single-use anesthesia circuits are generally preferred due to their reduced risk of cross-contamination, reusable circuits are also available due cost-effectiveness and environmental impact.
Classification and Grouping in Mexico
In Mexico, anesthesia circuits are classified as Class II medical devices according to Rule 2 of the Mexican Pharmacopeia (FEUM). They are considered category of “V. Surgical materials or wound care related devices” as per Article 262 of the General Health Law (LGS). This classification reflects its non-invasive nature as an external communicating device and their short-term use.
Grouping Strategy for Registration:
Given the complexity and variety of anesthesia circuits, grouping for registration requires careful consideration. Here are some guiding principles:
- Variations within a System: Circuits with the same intended use and materials can be grouped under a single registration, even if they differ in size (adult, pediatric, neonatal), tubing length, or the number and type of connectors and accessories. This is in line with the “system” concept defined in the FEUM.
- Different Circuit Types: Different types of circuits (e.g., Mapleson A, Closed system) can be grouped together if they share the same general building materials, even if they have specific components for each model.
- Sterility: While most circuits are provided non-sterile, the sterility condition and re-sterilization characteristics (if applicable) must be considered during grouping.
- Technical Information: The registration submission must include comprehensive technical information for all components, including those of the most complex circuit within the group.
- Components and accessories: filters, HMEs, CO2 absorbers and other components can be considered medical devices by themselves. Justification of its presence in the system is mandatory when such components are not packed together or are not for exclusive use with the circuits.
- Performance Testing: Performance testing data must cover all models included in the registration for each component and accessory, if applicable.
Conclusion
Anesthesia circuits are essential medical devices with varying configurations and components. A thorough understanding of classification and grouping criteria is crucial for successful registration in Mexico. Each case should be evaluated individually to determine the optimal registration strategy.
Need expert guidance on registering your anesthesia circuits in Mexico?
Contact Veraque for a tailored solution to navigate the regulatory landscape and bring your products to market efficiently.
