Building on our previous discussions about respiratory and anesthesia-related medical devices, this article delves deeper into the world of anesthesia systems. In earlier entries, we explored critical components such as anesthesia masks and circuits, which play vital roles in ensuring patient safety and effective care. Now, we turn our focus to the cornerstone of any anesthesia setup: the anesthesia machine.
We’ll explore its significance, functionality, and the essential steps for classifying and registering this device in Mexico. This guide will provide valuable insights into the regulatory landscape of this device in our country.
Understanding Anesthesia machines
An anesthesia machine is a medical device that delivers a controlled amount anesthetic agents and medical gases during surgical procedures. The anesthesia machine isn’t a single, monolithic device. It’s a carefully engineered system of interconnected components, each with a specific function. These components include:
- Gas Supply: This connects to the hospital’s central gas supply (oxygen, nitrous oxide, air) or to portable cylinders.
- Flowmeters: These precisely control the flow rate of each gas.
- Vaporizers: As mentioned above, these convert liquid anesthetics into inhalable vapors.
- Anesthesia Circuit / masks: This delivers the gas mixture to the patient and removes exhaled gases.
- Mechanical Ventilator: Provides mechanical breathing support.
- Monitoring System: Displays and records patient’s vital signs.
- Scavenging System: Removes exhaled anesthetic gases from the operating room to protect healthcare personnel.
- CO2 Absorbent: Removed exhaled CO2 from the system.
Classification and Grouping for anesthesia machines in Mexico
Anesthesia machines are classified as Class II medical devices under Rule 2 of the FEUM.
They fall under the category of “I. Medical Equipment” as per Article 262 of the LGS, reflecting their non-invasive nature and their main intended use to deliver gases to patients.
Grouping for Registration Purposes:
Anesthesia machines can be broadly grouped under a single registration if they meet the general criteria:
- Manufactured by the same company.
- Share the same brand name.
- Have the same intended use or indication.
- Utilize the same core technology.
Additionally, accessories that are part of a anesthesia circuits (e.g., adapters, tubing, flowmeters, replaceable parts) can often be included in the same registration.
However, standalone components may require separate registrations, as a summary:
- Gas Supply: Medical gases require sanitary license.
- Flowmeters: May be considered accessories.
- Vaporizers: As mentioned above, these convert liquid anesthetics into inhalable vapors.
- Anesthesia Circuit / masks: Usually requires separate registration, masks also require separate registration if does not come as a kit.
- Mechanical Ventilator: Requires separate registration.
- Monitoring System: Require separate registration (capnography, oximeter, etc.).
- Scavenging System: Depending on the system may require registration or not.
- CO2 Absorbent: Do not require sanitary registration if are part of the machine (exclusive use).
Since most current anesthesia machines are also classified as Medical Electrical Equipment, additional standards may need to be met for registration or import processes
Conclusion
Navigating the Mexican regulatory landscape can be challenging, but with the right knowledge and guidance, the process becomes manageable for complex devices such as anesthesia machines. Whether you’re looking to register the anesthesia machine, its components, or related accessories, reach out to regulatory Veraque experts who can provide tailored advice and support to streamline your registration process.
