Breathing System Filters for Critical Care
Pall is a leader in patient care and medical products. Our breathing system filters have an airborne bacterial and viral removal efficiency of at least 99.999% (when tested with Brevundimonas diminuta and MS2 Bacteriophage). Pall filters incorporate a proprietary pleated hydrophobic membrane, which is sealed into the filter housing using ultrasonic welding technology. Our filters play an important role in controlling the potential risk of cross-contamination and infection via breathing systems.
Pall’s breathing system filters can efficiently retain aerosols that are generated during mechanical ventilation procedures from a patient’s airway. During the 2002 SARS virus outbreak, our high-efficiency hydrophobic breathing filters were recommended by infection control organizations and researchers (data on file). We expect our breathing filters to provide high levels of retention for the SARS-CoV-2 if present in patient's airway secretions.
Here is a look at the three main categories of ventilation and breathing products, all of which help prevent the spread of infectious diseases in critical care settings:
Hospitals and healthcare providers rely on Pall’s Ultipor 25 patient side filter in combination with multiple-patient-use anesthesia circuits to protect patients and staff from risk of contamination during procedures requiring anesthesia ventilation.
Pall multiple-patient-use anesthesia circuits also allow hospitals and healthcare units to treat multiple patients over a 24-hour period with the same breathing circuit – as long as each patient receives a fresh Pall patient kit including a fresh Pall Ultipor® 25 filter. The Ultipor 25 filter protects the breathing circuit against airborne and liquid borne contamination, enabling extended use of the circuit for several patients within a period of 24h. Filter-protected multiple-patient-use circuits protect patients and staff while also helping to reduce patient time in the operating room and control costs of supplies and medical waste.
A typical patient kit includes a mask, an Ultipor® 25 heat and moisture exchange filter, and an elbow adapter.
The Pall BB50T filter is designed for use at machine-side in anesthesia and respiratory therapy for up to 24 hours. It protects the ventilator against patient contamination and the spread of any patient derived contamination into ambient air.
2. Respiratory Care
Pall’s Ultipor®100 breathing system filters are installed on breathing circuits for mechanical ventilation. The Ultipor® 100 can be used as a patient-side Heat and Moisture Exchange Filter (HMEF) in respiratory therapy for up to 48 hours if wet drug nebulization is not in use. The Pall BB50T is designed for use at machine-side in anesthesia and respiratory therapy for up to 24 hours.
Here are some reasons why Pall’s respiratory care filters are preferred in critical care settings:
- High degree of protection against contamination
- Reduced risk of spread of infection
- Physiological humidification of breathing gases
3. Pulmonary Function Testing
Pall’s Pro-Tec PF30S Pulmonary Function Testing (PFT) filters are designed for maximum protection and performance. With their 30mm female and male connectors Pall PFT filters can be used with a variety of pneumotachographs, valves and machinery. PFT filters reduce the risk of contamination. Transparent housings enable staff to monitor for visible contamination.
The key benefits of our PFT filters include:
- Minimal contamination of equipment
- Low risk of patient cross-contamination
- Minimal impact on test results
- Breathing system filters with validated superior retention efficiency - remove at least 99.999% of airborne viruses and bacteria and 100% of liquid-borne bacteria and viruses. (include HME?)
- Anesthesia circuits can be used for several patients on a surgical list within 24 hours, as long as each patient is provided with a fresh Pall patient kit (a mask, an Ultipor® 25 heat and moisture exchange filter, and an elbow adapter).
- Ultipor® 100 breathing filters with dual indication for anesthesia and respiratory therapy and extended use life – up to 48 hours
1. Ultipor® 25 Filter With Monitoring Port
High-efficiency, pleated, hydrophobic filter media
Airborne Bacterial/Viral Removal Efficiency
Liquid-borne Bacterial/Viral/Prion Protein Retention Efficiency
- Serratia marcescens (appx 0.45 µm)
- Brevundimonas diminuta (appx 0.30 µm)
- Mycobacterium tuberculosis
- Staphylococcus aureus
- Pseudomonas spec.
- MS-2 Bacteriophage (appx 0.02 µm)
- Human Immunodeficiency Virus
- Hepatitis C Virus
- Allergenic natural rubber latex proteins
- Abnormal prion proteins
Dry Filter: approximately 26 g
Transparent housing with a CO2 monitoring port and tethered port cap
Filter: 35 mL
Resistance to Airflow (ISO 9360)
Approximately 3.5 cm H2O @ 60 L/min
- Single patient use for a maximum of 24 hours in anesthesia
- Exchange if resistance exceeds safe levels
- Patient End: Coaxial 15 mm (female) x 22 mm (male)
- Circuit End: 15 mm (male) x 22 mm (female)
2. Multiple-Patient-Use Anesthesia Circuits
1. Pall Ultipor™ 100
Pleated hydrophobic membrane
Airborne Bacterial/Viral Removal Efficiency
Liquid-borne Bacterial/Viral Removal Efficiency
Water loss: 8 mg/L up to 800 mL tidal volume (ISO 9360: 1998 draft)
Resistance to Air Flow (ISO 9360)
Approximately 2 cm H2O at 60 L/min
- Tapered connectors (ISO 5356-1: 2015)
- Patient side: 15 mm (female) + 22 mm (male)
- Breathing system side: 22 mm (females)
Approximately 85 mL
Approximately 47 g
Change the filter after 24 hours. Use life may be extended to 48 hours if wet nebulization is not performed. Single use (change for each new patient). Use only at the patient end of the circuit.
2. Pall BB50T Breathing Circuit Filter
Pleated hydrophobic membrane
Liquid borne bacterial/viral removal efficiency
Airborne bacterial/viral removal efficiency
Resistance to Airflow at 60 L/min (ISO 9360)
Approx. 2.0 cm H20
Connections ISO tapers (ISO standard 5356-1)
- Patient side: 22 mm OD
- Breathing system side: 22 mm ID
Approx. 90 mL
Approx. 39 g
Machine side; 24 hours maximum
PULMONARY FUNCTION TESTING
1. Pall Pro-Tec® PF30S Filter for Pulmonary Function Testing
Contains no PVC or natural rubber latex
Pall ventilation and breathing products prevent cross-contamination and control the spread of viruses and bacteria, in the following applications:
Multi-patient-use anesthesia circuits for increased efficiency, reduced costs, and less generation of medical waste
- Respiratory ventilation in ICU that needs filters with extended use life.
Pulmonary Function Testing
- Lung function testing in healthcare units
1. Which problems do Ventilation and Breathing products address?
- Spread of viruses: The most important benefit of Pall’s ventilation and breathing filter products is that they are designed to prevent the spread of potentially pathogenic micro-organisms, including viruses. The bidirectional, hydrophobic medium provides an effective barrier against airborne bacteria and viruses with at least 99.999% and a liquid-borne efficiency of 100%. Pall Breathing System Filters also act as heat and moisture exchanger, if used at patient side.
- Circuit use life: Pall multi-use breathing circuits are designed to last longer than other similar products in the market. The extended circuit life means you can use the same circuit for up to 24 hours, if every patient receives a fresh Pall Ultipor®25.
- Costs: Pall’s breathing circuits are designed to work efficiently and minimize waste, and thus increase cost savings.
- Flow resistance: Our breathing filter products’ unique pleated hydrophobic membrane assures low air flow resistance in both dry and wet conditions.
2. Are Pall breathing filters equipped to prevent cross-contamination and keep Coronavirus at bay?
The novel Coronavirus outbreak that has affected the entire world is an airborne virus called SARS-CoV-2. During the 2002 SARS epidemic, many professional and infection control organizations recommended the usage of hydrophobic breathing system filters to prevent the spread of infection (data on file). Pall’s Breathing System Filters have shown a >99.999% retention efficiency, when tested with the H1N1 Influenza virus (size range 80 – 120 nm) which is similar in size to the SARS-CoV-2 (120 – 160 nm).
Extensive laboratory testing and several clinical studies validate the highest performance standards for Pall Breathing System Filters in the prevention of cross-contamination (data on file). While our filters are not yet validated against the novel Coronavirus, we expect them to provide high retention levels for the SARS-CoV-2 from the ventilated patient’s exhaled breath.
3. What are the advantages of using multi-use anesthesia circuits?
With a new Pall Ultipor 25 is used on every patient, Pall’s multi-use circuits offer the benefit of reduced costs and improved efficiency. Since our anesthesia circuits can be used on several patients in a 24-hour period, it means you can save on the costs related to buying circuits.
The fewer the number of circuits used, the less the money spent on them. Using the same circuit on multiple patients also means less medical waste is generated. Another key benefit of these circuits is that they help decrease time required for operating room turnover.
4. Can Pall Ultipor® 25 and Ultipor® 100 filters be used both at the patient side and the machine side?
Pall Ultipor® 25 and Ultipor 100® can only be used for patient-side applications. For machine-side applications, use the Pall BB50T.
5. Is it safe to clean and sterilize Pall breathing filters?
Pall breathing system filters must not be disinfected using liquid cleaning solutions. Doing so may have a detrimental effect on the integrity and functionality of the filter media. Using cleaning solutions may also lead to an unwanted increase in filter airflow resistance, making the filter unsuitable for subsequent usage on a patient. It is recommended that you do not soak, rinse, wash or sterilize Pall breathing system filters.
6. Are Pall breathing circuit filters HEPA grade?
Pall breathing circuit filters have not been tested to the technical standards for HEPA (High Efficiency Particle Absorber) - grade filters which are known to retain particles of 0.3 µm size with a minimum efficiency of 99.97%. However, Pall’s breathing filters are tested according to the ISO 23328-1:2003 standard, under which the filters are challenged with salt particles in the same range as HEPA grade filters and the penetration is recorded to measure filter efficiency (typical test results dry/ wet): BB100: 99.994%/ 99.992%; BB50T: 99.984%/ 99.9982%; BB25: 99.954%/ 99.977%).
Our products have undergone several laboratory airborne filtration efficiency tests with various virus and bacterial species, displaying efficiency levels of over 99.999%.
Pall products are known to retain Human Immunodeficiency Virus (HIV), Hepatitis C, Staphylococcus aureus and other viruses and bacteria in liquid-borne challenges with 100% efficiency (data on file).
7. Can drug nebulization be used in conjunction with Pall filters?
If proper ventilator pressure alarms are set and necessary precautions are taken to monitor sudden increases of filter resistance, you can use drug nebulization in conjunction with Pall breathing system filters. However, the compatibility of a filter with nebulization depends on the filter’s position in the breathing system in relation to the nebulizer’s position. The Pall Ultipor 100 can also be used in conjunction with metered dose inhalers. Product life under these conditions is up to 48h.
It is not recommended to use drug nebulization upstream of a patient side filter (e.g., in the inspiration limb), as the drug aerosol will be removed by the filter and will not reach the patient.
It is important to note that the Pall Ultipor® 25 is not indicated for use in conjunction with drug nebulization.
8. What are the most common types of breathing system filters used?
There are two basic types of breathing system filters.
- Electrostatic filters have an applied charge on the media that attracts aerosolized particles of the opposite charge and hold them to the media.
- Mechanical filters retain particles larger than small interstices in the filter media. Pall breathing filters have pleated filter membranes to increase the surface area and reduce resistance.
9. What are important factors to consider when selecting a breathing system filter?
- Has the product been validated to retain bacteria and viruses at high efficiency, using appropriate test organisms both for airborne and liquid borne route of contamination?
- The filter should comply with relevant standards in order to perfectly fit the machine to avoid the risk of breathing circuit disconnection, misconnection or obstruction.
10. Where should a breathing system filter be placed?
A filter should be placed upstream of any reusable component. The best strategy for protecting equipment and patients from contamination is to keep filters:
- Between the patient’s airway and the breathing circuit
- Between the expiratory limb and the machine
11. What quality assurance is provided for Pall breathing system filters?
Pall’s breathing system filters are individually tested during manufacture for:
- Filter Integrity – Assures filter housing and seal quality
- Filtration Efficiency – Assures the quality of the filter membrane using a non-destructive test.
12. How long can one filter be used?
Both the Ultipor® 100 and BB50T can be used for 24 hours. The Ultipor®100’s service life can be extended to 48 hours if wet nebulization is not performed.
13. How effective are Pall’s Breathing System Filters in retaining bacteria and viruses?
Pall’s Breathing System Filters are highly effective in retaining bacteria, viruses and particles. Their validation includes
- Airborne viruses and bacteria for example Influenza A Virus (H1N1) and MS2 bacteriophage as well as, Mycobacterium tuberculosis and Brevundimonas diminuta, have been tested with more than 99.999% filtration efficiency.
- Liquid-borne viruses and human pathogenic bacteria Hepatitis C and Human Immunodeficiency Virus have been tested at 100% efficiency.
Based on the physical properties, Pall Breathing System Filters are also expected to act as a highly effective barrier against various other similar organisms.
14. In case of an emergency, can the use of BB50T be extended?
Yes. In case of an emergency (like the SARS-CoV-2), the FDA has authorized and allowed the use of BB50T filter for an extended period of 168 hours (7 days), with its use in accordance to the instructions and recommendations provided by Pall Corporation. Please refer this note for end users about the extended use of BB50T breathing filter during COVID-19. The FDA has agreed to Pall’s marketing the filter for extended use under enforcement policy for the duration of the pandemic
15. What are the safety measures to be undertaken in case of an extended use of BB50T?
There are possibilities of risks arising when a filter is used beyond its normal life cycle, as it reduces the integrity of the filter. However, these risks are mitigated by ventilator alarms, adhering to hospital monitoring guidelines and thoroughly following the recommendations and safety procedures laid down for the extended use of a filter. In case of BB50T:
- Use an additional Heat and Moisture Exchanging (HME) filter (eg BB25 or Ultipor 100 in the patient side of the breathing circuit.
- Position the BB50T filter when active humidification is used, such that water build up can drain away from the patient side of the filter.
- When drug nebulization is applied, it should be between a Pall Ultipor 100 Heat and Moisture Exchanging (HME) Filter positioned at the Y-connection and the patient’s endotracheal tube.
Note: If drug nebulization is used outside the above Ultipor 100 application, for e.g. positioning the nebulizer in the inspiratory limb of the breathing circuit or at the patient’s endotracheal tube, then the service life of the BB50T cannot be extended.