What is a Class Two Legionella or Pathogen Water Filter and When Should It Be Used?
Generally speaking, Class I Medical devices are considered low risk while Class II Medical Devices are considered medium risk and are required to undergo more stringent testing. These types of filters are often used as point of use (POU) filters to remove waterborne pathogens just prior to contact with patients or staff. If you aren’t sure if you need a class two Legionella filter, you should have a risk assessment performed.
More specifically, the FDA defines Class I devices as “not intended for use in supporting or sustaining life or of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury.”
The FDA defines Class II devices as “devices for which general controls are insufficient to provide reasonable assurance of the safety and effectiveness of the device.”
A Class II Legionella or pathogen water filter requires FDA approval because of its critical role in managing waterborne pathogens. These filters are designed to specifically address hazards like Legionella or NTM in water systems, making them essential in environments where water purity is crucial to health.
In 2023, ASHRAE Standard 514 emphasized the importance of integrating such filters into building water systems, particularly in settings where the risk of infection from pathogens needs to be rigorously managed, such as in healthcare facilities. This standard provides comprehensive guidelines for designing, maintaining, and operating water systems to prevent diseases caused by waterborne pathogens. In fact, Class II is mentioned 33 times in the ASHRAE 514 document.
Class II filters are particularly recommended for use in:
- Healthcare facilities: These settings house individuals who are more susceptible to infections, making effective water filtration critical to prevent diseases like Legionnaires’ disease, a severe pneumonia caused by Legionella bacteria.
- Complying with safety regulations: Utilizing Class II filters can help facilities adhere to strict health and safety regulations designed to control microbial hazards in water systems.
The implementation of Class II filters is a key component of a broader water management program as outlined by ASHRAE Standard 514, which should be tailored to the specific characteristics and vulnerabilities of your building and its occupants.
It is important to note that most filters are not Class II, but rather Class I, or they have no FDA clearance at all. As of recently, there was only one Class II and FDA-cleared 510k filter for sinks, showers, and ice machines in the marketplace.
Given that Class II Legionella or pathogen water filters are vital in environments where maintaining the integrity and safety of water systems is paramount, especially in healthcare settings, it is important that you not purchase just any filter. Contact the waterborne pathogen experts at Legionella Control System for guidance in the use of Legionella and pathogen water filters.
