Biologically Safe Water Filters

Under CMS’ new hospital inpatient prospective payment system, final rule for fiscal year 2011, hospitals must report central line associated bloodstream infections every 3 months.  The data will be posted on the Hospital Compare website.  Many states already require reporting (21 states).

The rules for financial penalties to hospitals with HAI problems are being developed.  The solution to HAI’s will require changes in operational protocols and the environments of care.  The continued over-use of antibiotics will not solve infection costs.  As HAI data is made public, patients will choose where to have surgery, etc.  Hospitals will have to solve this problem in the near future since they will have to pay for the costs associated with the infection. A recent article, One Superbug Infection Costs Hospital $60,000 pertains to surgical related infections.  Catheter related bloodstream infections (CRBSI) can go as high as $90,000 and are thought to be more prevalent than surgical related infections.

The Nephros Dual-Stage Ultrafilter has a .005 micron membrane which exceeds the CDC recommendations of .02 micron bacterial filtration. The DSU is a cost effective method of providing biologically pure water at the point of use.

AAMI microbiological standards for acute and home dialysis are changing.  The current standard is less than 2 EU/mL of endotoxin units and the proposed standard is less than 0.25 EU/mL with a proposed action level of less than 0.125 EU/mL.

The current standard for Coliform Forming Units is less than 200 CFU/mL and the proposed standard is less than 100 CFU/mL with a proposed action level of less than 50 CFU/mL.

The Nephros DSU will help achieve these lower levels.  The .005 micron pore size of the DSU wll provide up to 12 months of protection.  Use the DSU on water lines, prior to entering the dialysis machine.

This final filter can withstand multiple disinfection cycles.  The Nephros DSU can provide the protection needed on portable RO machiines that have bacteria build-up do to infrequent use.  The DSU also provides protection for RO water loops where bacteria/endotoxins can colonize in the water loop.

The Association for the Advancement of Medical Instrumentation (AAMI) Renal Disease and Detoxification Committee has approved the integration of Standard RD52 with the new ISO-23500 International Standard.

Many dialysis facilities that utilize portable RO’s will have to work harder to meet the new AAMI standards.  The new standard will lower the recommended tolerable endotoxin levels for water used to make dialysate.

The Nephros DSU is an ultrafilter (.005 micron) that provides additional filtration to meet the new AAMI standards.  The DSU can be installed on individual RO/DI machines - and also on central water and bicarb loops.

A number of dialysis clinics are developing high bacteria counts in their water for patient treatments.  Bacteria from the carbon tanks is mostly removed by the RO.  The RO is not 100% effective though, therefore; to protect the patient, all acute dialysis machines should have an ultrafilter.  An excellent discussion on this issue can be found on RenalWeb.  The Nephros DSU can provide the protection needed for portable RO machines in the acute and home hemo dialysis settings.

Water is the main source of contaminants in dialysate.  A presentation by Jo-Ann B. Maltais, Ph. D. at the NANT 27th Annual Symposium, March 3, 2010 discusses the contaminants in dialysis water.  Dr. Maltais highlights why we should use ultrapure dialysate and the long-term effects of chronic micro-inflammation on dialysis patients.  She gives evidence to support improved clinical outcomes using ultrapure dialysate.

The presentation also provides guidance for technicians regarding what systems can be used and how to validate them.  The Nephros DSU has an FDA 510K.  The .005 micron ultrafilter makes it a cost-effective component in the process to achieve ultrapure dialysis.

Water and dialysis fluid of high microbial purity reduce the inflammatory stimulus in patients.  This can result in improved responsiveness to erythropoietin (EPO).  The patient can then receive the same EPO benefits with less EPO.  See article.

Incorporating the Nephros DSU into the water and bicarb lines will allow dialysis providers to reduce endotoxin levels and treat their patients with ultrapure dialysate.  Significant savings in the use/cost of EPO can be achieved through the use of the Nephros DSU.

William Costerton, PhD, spoke at the 30th Annual Dialysis conference (ADC) in Seattle and provided an excellent site that highlights the problems of biofilm in medical water systems.

Dr. Costerton indicated that biofilms are present in 80% of infections.  Biofilms can cause infections in ICU’s, Burn Units, and Dialysis; plus, they can be found in dental unit water lines.  Biofilms have even been found attached to a patient’s pacemaker.

The Nephros DSU is a .005 micron filter - which can filter out these biofilms.  Expected life span is approximately 3 months on a standard faucet and 1 year when used post RO (reverse osmosis).

Hospital acquired infections killed 48,000 patients and cost $8.1 billion in 2006.  A study released by Resources for the Future focused on hospital-acquired pneumonia and sepsis. The study estimated that 1.7 million healthcare-associated infections (HAI) are diagnosed every year.According to the study a lapse in infection control can lead to extra days in the hospital and in some cases death.

Hospital water systems are often overlooked and can be the source for many of these infections. High risk areas such as ICU, transplant, oncology, hematology, burn unit, dialysis, etc. can benefit from the new Nephros Dual Stage Ultrafilter (DSU). The DSU filters to .005 microns which exceeds the CDC recommendations of .02 micron bacterial filtration. The DSU is a cost effective method of providing biologically pure water at the point of use.

The Nephros dual-stage ultrafilter (DSU) is a .005 micron ultrafilter for endotoxin control.  The filter will last about one year under normal conditions, post RO/DI, in a dialysis setting.  The DSU can be disinfected in place.  It can be part of a portable RO/DI or a final filter just before the dialysis machine (i.e. at wall box) or part of the RO water or bicarbonate loop.

Dialysis machine manufacturers include a .02 micron filter as part of their equipment.  Some of these filters degrade rapidly when exposed to disinfectants such as bleach and ultrafiltration is lost.

Most machine filters have to be changed every 2-3 months.  The yearly cost of multiple filters, plus the time to change them out along with the potential for failing the .02 micron filtration, adds up to more than the cost of using the Nephros DSU.

Ultrapure water/dialysate has multiple benefits for the dialysis patient, and used effectively, it can also lower overall costs for the dialysis facility.

Many acute dialysis units struggle to keep their portable RO/DI water supply for dialysis machines from exceeding the AAMI endotoxin standards.

Special considerations for acute hemodialysis have been issued.  You can find these standards at the following link ANSI/AAMI RD52:2004 Dialysate for hemodialyzers . The following are found under amendment 3 - Annex E.

E.2 Fluid Quality: suggests achieving higher fluid quality by passing final dialysate through a bacteria-and endotoxin-retentive filter.

E.3.7 Endotoxin-retentive filters: recommends in-line dialysate filters as a final barrier against contamination of the dialysate.

E.4 Microbial control strategies: “Consideration should be given to installing an in-line dialysate filter in the dialysis machine, if the machine manufacturer allows that option.”

The Nephros DSU contains a .005 micron membrane which eliminates bacteria, viral agents, cysts, fungi and biological endotoxins.  The DSU will produce ultrapure water when used post RO/DI.