In medical settings, the quality of air is paramount. Contaminants can compromise patient safety, particularly in devices that deliver or manage respiratory care.
Rensa’s EFP Group* specializes in HEPA and ULPA filter design and manufacturing for medical devices such as ventilators, respirators, oxygenators, CPAP machines, smoke evacuators, and CO2 incubators.
* Rensa’s EFP Group is comprised of Custom Filter, APC Filtration, and RP Fedder Industrial
Understanding Air Filters
Air filters are essential components designed to remove particulate matter, microorganisms, and other pollutants from the air. Common types of air filters used in medical devices include:
- HEPA Filters: Capable of trapping 99.97% of particles larger than 0.3 microns, these filters are standard in environments requiring high levels of cleanliness.
- ULPA Filters: These filters offer even higher efficiency than HEPA filters, capturing 99.999% of particles, making them ideal for critical applications.
Our filtration engineers are skilled at helping OEMs select the right filter type for the medical device being designed, balancing functionality with cost effectiveness. In many instances, our team has helped OEM customers refine their equipment designs so they perform better in the field.
Types of Medical Device Air Filters
Rensa’s EFP Group has particular skill and experience designing air filters for:
Ventilators and Respirators
Air filters in ventilators and respirators are vital for preventing the transmission of airborne pathogens. They ensure that the air supplied to patients is free from contaminants. Compliance with standards set by the FDA and ISO is essential, as these devices often operate in environments with vulnerable populations.
Oxygenators
Oxygenators play a critical role in extracorporeal membrane oxygenation (ECMO) systems. Filters in these devices must effectively remove particulate matter to maintain the purity of the oxygen supply, thereby safeguarding patient health during critical care.
CPAP Machines
Continuous Positive Airway Pressure (CPAP) machines rely on air filters to function optimally. Clean filters enhance the effectiveness of the device and prolong its lifespan. Regular maintenance and replacement of filters are crucial to prevent respiratory infections in users.
Smoke Evacuators
In surgical settings, smoke evacuators are necessary for maintaining air quality. These devices filter out harmful smoke generated during procedures, protecting both patients and healthcare personnel from inhalation hazards.
CO2 Incubators
CO2 incubators are essential for cultivating cells and tissues. High-quality air filtration ensures a sterile environment, preventing contamination that could compromise research outcomes and patient treatments.
Innovations in Air Filtration Technology
Recent advancements in air filtration technology have led to improved materials and designs that enhance filter efficiency and lifespan. Innovations such as antimicrobial coatings, electrostatic filtration, and nanofiber technology are on the rise. These developments not only improve the effectiveness of air filters but also reduce the frequency of replacements, thus lowering operational costs for healthcare facilities.
Rensa’s EFP team has world class technical expertise having worked with the following:
- Filter Medias: membrane, glass media, synthetic media, high-loft, cellulose, and metal
- Filter Materials: carbon and other sorbents
- Framing Materials: stainless steel, aluminum, plastic, beverage board, PU foam
- Methodologies: spin sealing, spin casting, over molding, waterjet cutting, foam-in-place gasket, ultrasonic cutting and sealing
Regulatory Considerations
Manufacturers of medical devices must adhere to stringent regulations regarding air filters. Rensa offers best in class testing:
- Test Standards: IEST, ISO 29463, EN 1822 and NIOSH 42 CFP Part 8
- Approaches: leak tests, batch testing, 100% text, lot traceability
Testing and compliance aren’t just about meeting regulatory requirements. They are essential for ensuring the safety and efficacy of medical devices in protecting patients and healthcare workers alike.
Rensa’s EFP group makes a wide variety of filters for the most demanding OEM medical device filtration applications in the world. Start a conversation with us, and one of our specialists will reach out to get you heading in the right direction for your filter design journey.
