Scope of the COFEPRIS Guidance
The novel coronavirus demonstrates fast transmission capacity, which could impact significantly the operations of the healthcare services and cause a threat to public health. In order to mitigate a negative impact of the coronavirus disease, its complications, and respiratory illnesses associated thereto, COFEPRIS intends to implement special measures expanding the availability of the vitally important medical devices facing a significant increase in demand due to the pandemic. The present guidance, issued by the COFEPRIS in collaboration with several other state healthcare agencies, is dedicated to the ventilators, accessories associated thereto, and also the other respiratory devices to be placed on the Mexican medical devices market.
In particular, the document contains the minimum requirement the devices falling within its scope should meet in order to be allowed for marketing and use in Mexico.
According to the GMDN definition provided in the guidance, the ventilator is cyclical and automatic equipment, connected to the electrical network, intended to provide long-term alveolar ventilation support to patients, from infants to adults, in the intensive care units; using positive pressure to deliver gas to the lungs. The ventilator consists of a breathing circuit, a control system, monitors, and alarms.
The COFEPRIS states that healthcare institutions should use standard medical devices already approved by the authority. At the same time, the devices of this type have faced a significant increase in demand during the public health emergency. Thus, in order to expand the availability of the ventilators and other respiratory devices, the authority allows the importing and manufacturing of ventilators that meet the minimum requirements provided in the guidance. The classification of the devices covered by the scope of the present guidance is based on the Global Medical Devices Nomenclature (GMDN) and the Universal Medical Devices Nomenclature System (UMDNS).
According to the UMDNS, the guidance covers the following types of medical devices:
- Intensive care ventilators,
- Adult intensive care ventilators,
- Neonatal/pediatric intensive care ventilators,
- Transfer or transport fans,
- High-frequency fans,
- Portable and home use fans.
At the same time, according to the GMDN, the following classification categories should be used:
- General-purpose intensive care ventilators,
- Neonatal or pediatric intensive care ventilators,
- Intensive care ventilators,
- Transfer fans,
- High-frequency fans,
- Portable electric fans.
Minimum Requirements for Intensive Care Ventilators
As it was already mentioned before, the present COFEPRIS guidance provides minimum safety and performance requirements ventilators should meet. The document is addressed to medical device manufacturers and other parties involved in operations with medical devices, including healthcare professionals, medical device development centers, and other entities interested in importing, marketing or using ventilators and other respiratory devices in Mexico.
In order to meet the requirements set forth in the guidance, the ventilator shall have at least one of the ventilation modes described below:
- Controlled ventilation for deeply sedated or paralyzed patients, providing that the device has a pressure-regulated volume control.
- Optional support mode to be used for the patients that could breathe themselves (to a certain extent). When operating in this mode, the device identifies the moment when the patient begins to exhale and provides the expiratory pressure.
The guidance also provides a detailed list of requirements for numerous parameters of the ventilators, including, inter alia, the following ones:
- Tidal volume,
- Breathing frequency,
- Support pressure,
- Inspiratory flow,
- Inspiratory pressure,
- Ventilation modes,
- Pollution controls,
- Incoming gas supply,
- Electricity supply,
- Gas supply to the patient.
In accordance with the present COFEPRIS guidance on ventilators, the device should continuously monitor a specified set of parameters to ensure the device operates correctly. The ventilator should also have a built-in system of audible and visible alarms, properly notifying the healthcare professionals using the device on the following:
- High inspiratory pressure,
- Low Positive Pressure at the End of Inspiration (PEEP) or patient disconnect,
- A high and low minute or tidal volume,
- High and low respiratory rate,
- Inspired Fraction of Oxygen (FIO2) high and low,
- Low gas supply pressure,
- Low battery,
- Lack of power supply,
- Fan inoperative or fan failure,
- Silence alarm.
Safety and Performance Requirements
The document also contains the requirements on the biological safety of the device since ventilators include elements contacting the patient`s body. From the biological safety standpoint, the device should meet the requirements set forth in the standard ISO 18562-1:2017, providing that:
- The materials the device is being composed of should be pure and simple to the maximum extent possible,
- It is recommended to avoid using plasticizers for the elements that should be flexible,
- If the device contains polycarbonate, it should be used without additives, while it is allowed to use fiberglass,
- The manufacturer shall avoid using polyvinyl chloride.
The manufacturer can also make references to other related international standards, such as:
- ISO 80601-2-12:2020 Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators,
- IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
The software used to operate the device should meet the appropriate safety requirements. In particular, the manufacturer (developed) shall ensure the software code is free from any errors that could cause harm to the patient.
The guidance also provides a list of additional requirements the ventilators should meet, including the following ones:
- The device should be designed to operate at least for 14 days,
- The construction of the device should allow it to withstand from falling,
- The controls of the device should be designed in a way allowing healthcare professionals to use it easily,
- The instructions for use should be provided in Spanish,
- In case the device contains a battery, it should allow using the device for at least 7 hours. According to the present COFEPRIS guidance, the instructions for use accompanying the device should provide the users of the device with the all necessary information regarding the way the device operates and its characteristics, including:
- The description of the device`s performance, and also the indications of potential risks associated with the device,
- The instructions for use, including the recommendations on mitigating the identified risks.
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