PORT WASHINGTON, N.Y., June 28, 2018 -- 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 US Food & Drug Administration (FDA) 510(k) clearance as a Class ll Medical Device.
The point-of-use (POU) QPoint Water Filter Capsules retain waterborne pathogens such as: bacteria, fungi and protozoa from in-premise drinking water systems. QPoint Filter Capsules deliver potable water suitable for cleaning superficial wounds, equipment used in medical procedures and washing surgeons' hands. This FDA 510(k) clearance ensures healthcare providers have a wide range of Pall POU water filters to support critical water hygiene control measures.
"Pall Medical products are designed using the latest technology to help prevent infection while also reducing healthcare costs. Our QPoint Filter Capsules reduce risk from in-premise waterborne pathogens by acting as a barrier at the point-of-use and protecting vulnerable patients" explained John Sweeny, General Manager, Pall Medica.
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 waterborne infections due pathogens frequently found in the drinking water systems. The threat from waterborne pathogens other than Legionella pneumophila is increasingly being recognized. Organisms such as Pseudomonas aeruginosa, non-tuberculous Mycobacteria, Stenotrophomonas maltophilia, Cryptosporidium parvum and Fusarium spp. also contribute to hospital-acquired infections. The Centers for Medicare & Medicaid Services expressed their concerns in a recent memorandum. 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.
As an effective waterborne infection control measure, QPoint Filter Capsules join the PallAquasafe™ Disposable Water Filter family as 510(k) cleared, Class II medical devices, thereby offering flexible logistics and coverage for patient protection. Pall water filters may be installed on sinks, showers, water fountains and ice machines within healthcare environments such as hospitals, nursing homes, health care facilities or clinical settings with immune-compromised patients. Pall POU water filters are made for long-term protection of high-risk patient groups, limited downtime periods during remediation and construction, validation, equipment failure, and for immediate control when monitored microbial conditions in the water drift outside the acceptable range. QPoint Filter Capsules are supplied sterile and 100 percent integrity tested. The robust sterilizing grade 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. Products covered under 510(k) Reference Number K163609 are available now.
"Pall-Aquasafe and QPoint water filter products are easy to install, require no additional plumbing and are available with service programs for change-outs. This makes the filters a simple and effective control measure as part of clinical care or as an immediate solution for protection where there are spikes in microbial contamination," said Vin Guercio, Senior Director, Global Marketing, Pall Medical.
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. For more information visit www.pall.com.
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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/