Modern patient monitoring systems provide a broad spectrum of healthcare solutions, ranging from clinical applications to personal use. As healthcare monitors continue to adapt to emerging needs, their fundamental design and components also evolve. This ongoing transformation frequently presents challenges in classifying and grouping them within the Costa Rican regulatory framework.
In this article, we will discuss what a patient monitoring system and its accessories constitute, as well as general guidelines on their classification and grouping in Costa Rica.
General characteristics of Patient Monitoring Systems
Patient monitoring systems can comprise diverse technical fields, extending from healthcare monitors to telemedicine systems, with an ample range of solutions and products. For this article, we will be focusing exclusively on the healthcare monitors generally used in clinical and healthcare settings.
A healthcare monitor is a device designed to continuously track and record vital health parameters, such as heart rate, blood pressure, oxygen saturation, and other relevant metrics. Standard healthcare monitors are compact, lightweight, and often equipped with sensors that can monitor basic patient parameters, such as ECG, heart rate (HR) oxygen saturation (SpO2) and non-invasive blood pressure (NIBP).
As the need for surveillance of more complicated or delicate parameters evolves, so does the technology of the healthcare monitor. Examples of this can be an MRI compatible healthcare monitor, or monitoring of central venous pressure (CVP).
Classification of Monitoring Systems in Costa Rica
As outlined in our Classification and Grouping Ultimate Guide, the initial step when classifying and grouping patient monitoring systems is to consider their intended use, and particularly for these medical devices, the accessories that come with them. Different intended uses can determine the classification of monitoring systems, and accessories, in specific cases, can modify the grouping of certain products or families of products.
Most patient monitoring systems fall under Class 2 medical devices by Rule 10. These types of systems often include the most basic healthcare environment solutions, such as a monitoring system of basic parameters, used as bedside or portable monitors.
Patient monitoring systems intended for use in situations where inaccurate patient parameter readings could pose an immediate danger are classified as Class 3 medical devices. This category includes, for example, monitoring systems utilized in Intensive Care Units (ICUs) and ambulance settings.
Modular healthcare monitors require distinct consideration. While they must adhere to previously mentioned classification guidelines, any additional modules not originally part of the main device variant must undergo separate analysis and registration. This approach stems from the principle that integrating a module into the core device expands its intended scope of use, effectively classifying the module as a medical device itself and needing individual sanitary registration.
Grouping of Patient Monitoring Systems
Regarding grouping criteria, different variants of the same device can be included in the same sanitary registration, as long as they satisfy the following criteria:
- Same manufacturer
- Same intended use
- More than one presentation can be included in the same registration, in which case all the presentations must be indicated in the application.
A rule of thumb is that different devices of the same family can be registered together, if they are commercialized as a different variant of the same device that offers “premium” or “basic” characteristics, such as:
- A different type of interface
- Touch screen
- Printing parameters availability
- Patient database
In respect of the accessories that can be included with the patient monitoring systems, a general recommendation is to perform a similar analysis of the intended use of the accessories by themselves, so as to rule them out of being medical devices. Most accessories are commonly ruled as non-medical devices, and examples of them include stands, power cords and printing paper.
If an accessory qualifies as a medical device, it must undergo individual case analysis. In many instances, multiple medical devices can be consolidated into a system, but such groupings demand thorough evaluation of specific details. Typically, accessories essential for the primary medical device’s intended function, and designed exclusively for its use, may be registered alongside the main device.
On the other hand, accessories that can be used with another type or brand of medical device are typically encouraged to be registered in their own sanitary registration. A common example of the latter situation is a pulse oximeter.
Conclusion
Classification and grouping of patient monitoring systems can become overwhelming when considering their different variants and included accessories. These guidelines can serve as a first approach when trying to discern between the many cases that can happen and help with a solid and simplified perspective.
If you have any inquiries about the registration of patient healthcare monitors or any other medical devices in the Costa Rican market, please feel free to contact us at contact@veraqueconsulting.com, or check our guidelines.
