PORT WASHINGTON, NY – September 26, 2017 - Pall Medical, a division of Pall Corporation – a global leader in filtration, separation and purification – is pleased to announce that its QPoint® Water Filter Capsules have received FDA 510(k) clearance as a Class ll Medical Device.
The sterilizing grade, point-of-use, QPoint Filter Capsules may aid in infection control by retaining waterborne bacteria, fungi and protozoa from in-premise drinking water systems. QPoint Filter Capsules produce water suitable for washing and drinking, superficial wound cleansing, the cleaning of equipment used in medical procedures and washing of surgeons’ hands. This FDA 510(k) clearance ensures healthcare providers have a wide range of Pall point-of-use (POU) water filters to support water hygiene control measures.
“Pall Medical products are designed using the latest technology to help prevent infection while also containing healthcare costs. Our QPoint Filter Capsules reduce risk from in-premise waterborne microorganisms by acting as a barrier at the point-of-use and protecting vulnerable users,” said Eric Garnier, General Manager, Pall Medical.
US Guidance for managing building water systems includes ANSI/ASHRAE Standard 188-2015 and the supporting Centers for Disease Control and Prevention toolkit. Both documents acknowledge that vulnerable users within healthcare facilities are susceptible to opportunistic pathogens populations frequently found in drinking water systems. Increasingly the threat from waterborne pathogens other than Legionella pneumophila is being recognized, with organisms such as Pseudomonas aeruginosa, Non-tuberculous Mycobacteria, Stenotrophomonas maltophilia, Cryptosporidium parvum, and Fusarium spp. also contributing to hospital-acquired infections. The Centers for Medicare & Medicaid Services expressed their concerns in a recent memorandum, and their expectations are that healthcare facilities and surveyors will conduct a risk assessment to identify where such opportunistic waterborne pathogens could grow and spread in the facility water system, and comply with requirements to protect the health and safety of its patients.
Limited treatment options and increasing resistance concerns with Pseudomonas aeruginosa and other Gram-negative pathogens have been recognized by the World Health Organization in its recent priority list of antibiotic resistant bacteria. The organization highlighted the urgent need to develop effective antibiotics and employ interventions that could significantly reduce the burden of infections. A recent publication by Cara Bicking Kinsey and colleagues, who conducted investigations into identifying risk factors for transmission of Pseudomonas aeruginosa following an outbreak in a US Neonatal Intensive Care Unit, found that “Residing in a room without a POU filter was the strongest risk factor for having a P. aeruginosa culture”.
As an effective control measure, QPoint Filter Capsules join the Pall-AquasafeÔ Disposable Water Filter family as 510(k) cleared Class II devices, thereby offering flexible logistics and coverage for patient protection. Pall point-of-use water filters may be installed for long-term protection of high-risk patient groups, and/or for more limited periods during remediation and construction, validation, equipment failure, and for immediate control when monitored microbial conditions drift outside the acceptable range.
“Pall-Aquasafe and QPoint water filter families are easy to install, require no additional plumbing, and are available with service programs for change-outs, making them a simple and effective control measure as part of clinical care, or as an immediate solution where there are spikes in microbial contamination,” said Vin Guercio, Senior Director, Global Marketing, Pall Medical QPoint Filter Capsules are supplied sterile and integrity tested. The robust Supor® membranes within the filter cartridge are rated and validated at 0.2 micron to remove bacteria, protozoa, fungi and particles in the water supply. They are intended to be used within healthcare environments such as hospitals, nursing homes, health care facilities or clinical settings where immune-compromised patients may be exposed to waterborne microorganisms originating from the water supply. Products covered under 510(k) Reference Number K163609 will be available late in 2017, and include:
- QJ212A – QPoint Filter Capsule – Jet Outlet (12 units per case)
- QJ22A – QPoint Filter Capsule – Jet Outlet (2 units per case)
- QR212A – QPoint Filter Capsule – Shower Rose Outlet (12 units per case)
- QR22A – QPoint Filter Capsule – Shower Rose Outlet (2 units per case)
Additional resources are below. If you have any questions, please contact us for support.
About Pall Corporation
Pall Corporation is a filtration, separation and purification leader providing solutions to meet the critical fluid management needs of customers across the broad spectrum of life sciences and industry. Pall works with customers to advance health, safety and environmentally responsible technologies. The Company’s engineered products enable process and product innovation and minimize emissions and waste. Pall Corporation serves customers worldwide.
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- CMS Memorandum. Department of Health & Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality/Survey & Certification Group. June 9 2017. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-17-30.pdf
- Bicking Kinsey, C., et al., (2017). Pseudomonas aeruginosa Outbreak in a Neonatal Intensive Care Unit Attributed to Hospital Tap Water. Infection Control & Hospital Epidemiology, 38 (7), 801-808. Doi:10.1017/ice.2017.87
- World Health Organization. Global priority list of antibiotic-resistance bacteria to guide research, discovery, and development of new antibiotics. February 2017. http://www.who.int/medicines/publications/WHO-PPL-Short_Summary_25Feb-ET_NM_WHO.pdf?ua=1
- ASHRAE 188 Legionellosis: Risk Management for Building Water Systems. June 26 2015. ASHRAE, Atlanta. www.ashrae.org
- Developing a Water Management Program to Reduce Legionella Growth & Spread in Buildings: A Practical Guide to Implementing Industry Standard. June 6 2016. Centres for Disease Control & Prevention. www.cdc.gov/legionella
- Water Safety in Buildings. World Health Organization 2011 ISBN 978 924 154 810 6. www.who.int/water_sanitation_health/publications/9789241548106/en/