US Food & Drug Administration 510(k) Clearance for Pall-Aquasafe™ Disposable Water Filters

Pall Medical is pleased to announce that Pall-Aquasafe Disposable Point-of-Use Water Filters have received FDA 510(k) clearance as a Class ll Medical Device.  The sterilizing grade water filters may aid in infection control by retaining waterborne bacteria.  Pall-Aquasafe produces water suitable for washing and drinking, superficial wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon's hands. 
 
“Pall Medical has a long history of working with healthcare professionals to design, validate, and produce a diverse range of filtration devices for critical contamination control.  Our products are a vital link in the chain of infection prevention and cost containment.   
Pall-Aquasafe Water Filters enable hospitals and other healthcare facilities to reduce risk from waterborne microorganisms by acting as a barrier to bacteria at the patient point-of-use.  said Eric Garnier, Vice President/General Manager, Pall Medical. 
 
In-building plumbing systems offer large surface areas for biofilm formation, and are susceptible to microbial colonization and growth.  Guidance for managing building water systems, and in particular Legionella, is available in the ANSI/ASHRAE Standard 188-2015 and a helpful implementation toolkit from the US Centers for Disease Control and Prevention.  Both these documents recognize that healthcare facilities contain more susceptible populations than the general public with regard to developing legionellosis, especially with high-risk patient groups such as burn, cancer, solid organ or bone marrow transplant, kidney disease, diabetes, chronic lung disease and intensive care.
 
As a control measure, Pall-Aquasafe Water Filters are effective for the continuous protection of high-risk patient groups, and can also be used more broadly to provide protection during periods of construction, validation, or equipment failure, and for immediate control when monitored microbial conditions drift outside the acceptable range. 
 
“Water Management Teams recognize that one of the most likely exposure routes to waterborne pathogens such as Legionella pneumophila, Pseudomonas aeruginosa, Non-tuberculous Mycobacteria, Stenotrophomonas maltophilia, Aspergillus fumigatus or Fusarium spp. is at the points-of-use.  Pall-Aquasafe filters provide a barrier to these pathogens at this critical point in the water network.  The filters are easy to install, require no additional plumbing and are available with service programs for changeouts, making them a simple and effective long term prophylactic for high-risk units, and as an immediate countermeasure for spikes in microbial contamination.” said Vincent Guercio, Senior Director, Global Marketing, Pall Medical.
 
Pall-Aquasafe Water Filters 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 the healthcare environment 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 K153434 include:
 

  • AQF4A - Pall-Aquasafe - Disposable Shower Head Filter (12 units per case)
  • AQ31F1SA - Pall-Aquasafe - Disposable Water Filter - Faucet (with smooth outlet)
    (12 units per case)
  • AQ31F1RA - Pall-Aquasafe - Disposable Water Filter - Faucet (with shower rose outlet) (12 units per case)
  • AQINA - Pall-Aquasafe - ln-Line Disposable Water Filter (12 units per case)

 
Additional resources regarding these products and general in-premise water hygiene information is below.  If you have any questions please contact us for further support.

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