This section highlights medical grade silver products, including those that have received FDA and/or EPA Approval for use in the medical field.
...Silver in the News...
The FDA has cleared another silver-based product. The AlphaSan® antimicrobial additive ( CAS Number: 265647-11-8 ) is a zirconian phosphate-based ceramic ion-exchane resin made with silver, and has been cleared by the FDA as an acceptable food contact polymer.
"On surfaces treated with AlphaSan antimicrobial, bacteria still find their way. However, they get an extra special dose of silver ions." - Milliken Corp.
Read more: FDA clears silver-based antimicrobial additive...
Medical Grade Silver Products & Laboratory Grade Colloidal Silver
Silverlon - Argentum Medical LLC, Dr. Bart Flick: FDA Approved Wound Care Dressings
Silverlon wound care dressings, FDA approved, are made by impregnating extremely minute particles of silver to polymeric substrates ( which comprise the actual dressing ). Silverlon works by slowly releasing silver ions into the tissues at the treatment site. The constant flow of bioactive silver is responsible for Silverlon's amazing antimicrobial properties.
Silverlon FDA 510(k) Clearances:
Silverlon® Wound Packing Strips Wound Contact Dressing - #K981
Reduces the potential disruption of the healing tissue during routine dressing changes, used for post surgical wounds, skin ulcers, partial thickness burns, skin grafts, pressure sores, dermal ulcers, vascular ulcers, and diabetic ulcers.
Silverlon® Wound Packing Strips - #K984210
A sterile, non adherent barrier dressing for infectious open wounds used to control bleeding and nasal hemmorhaging, to encourage draining, to assist in the removal of necrotic tissue, and used as an over the counter dressing for the local management of lacerations ( OTC ).
Silverlon® Island Wound Dressing - #K984208
A multi-layer barrier wound dressing used to treat vascular access or peripheral IV sites, orthopedic external pin sites, wound drain sites, surgical wounds such as skin donor sites, graft sites and incisions, and partial to full thickness dermal ulcers. OTC product used for local management of superficial wounds, minor burns, abrasions, and lacerations.
Silverlon® Adhesive Strip - #K984205
An adhesive antimicrobial barrier dressing used for wounds such as vascular access or peripheral IV sites, orthopedic external pin sites, wound drain sites, and surgical incisions.
More Information: Silverlon's Website
Argentyn 23 - Natural Immunogenics Colloidal Silver: Certified Endotoxin and Pyrogen Free
Argentyn 23 Colloidal Silver, available only to doctors, is the only colloidal silver product available in the United States certified as pyrogen free and containing no endotoxin. Natural Immunogenics' manufacturing process of Argentyn 23 ( an isolated silver product, or EIS ) produces a product unparalleled in purity, particle dispersion, particle sizing, and effectiveness ( as demonstrated in in-vitro comparison laboratory testing ). While Argentyn 23 is not FDA approved, it stands alone as a true medical grade colloidal silver.
Learn More at the company's website: Natural Immunogenics Colloidal Silver
Silvadene - Marion Laboratories: FDA Approved Silver Sulfadiazine Cream
Silvadene is an FDA approved topical cream used in over 70% of hospitals in the United States to prevent bacterial infections at burn sites, improve tissue healing, reduce scarring, and is often prescribed as a topical treatment for skin graft donor sites. This silver-rich cream ( a chemically produced silver salt compound ) is FDA approved as a topical antifungal and antibacterial for external use, and available on with a prescription. Silvadene has been proven effective against both gram-positive and gram-negative bacteria, including resistant strains.
Laboratory testing has demonstrated that Silvadene derives its antimicrobial properties from direct action on cell membranes and cell walls. One gram of Silver Sulfadiazine contains 10 milligrams of silver.
Silver Sulfadiazine was developed by Dr. Carl Moyer and Dr. Margraf under a grant obtained by Dr. Moyer, former chairman of Washington University's Department of Surgery.
Axenohl Silver Citrate Disinfectants: PURE Bioscience: EPA Registered Technical Grade
PURE Bioscience, a NASDAQ traded company, developed and patented a silver citrate molecule, and markets products generally ranging from 30 PPM to 2400 PPM. Axenohl surface disinfectant products are sold to control bacteria, mildew and fugus, and are marketed out of Costa Rica.
Axenohl Pro Disinfectant, 2400 PPM, has been documented to kill residual bacteria and virii 36 hours after a single application ( dilution 1:128 ).
Most of Axenohl products are currently not approved for industrial or clinical use in the United States. However, recent approval by the EPA for "Critical Care" ( a commercial disinfectant-fungicide-virucide ), marketed by EnvirOx, L.L.C. of Danville, Illinois, contains Axen 30, and has resulted in official approved uses in some US States.
PURE Bioscience, NASDAQ traded, has shared recent plans to sell their water purification technology and persue broader markets with their Axenohl product line, including seeking FDA approval through a partnership with Therapeutics, Inc., based out of La Jolla, California.
Learn More: Axenohl: Sistecam Laboratories
Innovative Medical Services
AgION - Antimicrobial Powder Coating: Steel Coated with Silver & Zeolite
AgION combines two key ingredients, silver ions and zeolite ( a clay ). The silver ions are responsible for the active antimicrobial properties, while the zeolite clay acts as a delivery mechanism, an ion pump, that delivers the silver ions into the environment in the presence of even a minute amount of moisture.
AgION is registered with the EPA ( for HVAC systems ), with the FDA ( for use as an additive in food contact polymers ), and the National Sanitation Foundation has certified AgION as safe and acceptable for product zone and food zone applications.
AgION is being used at The City of Hope's Helford Clinical Research Hospital, in Duarte, California, which is one of the most advanced state-of-the-art research hospitals in the United States, and houses the largest bone marrow transplant facility in the country ( the facility is scheduled for occupancy in 2004 ).
Learn More: AgION
Silver Impregnated Urinary Bladder Catheters
The use of silver to control infections in-vivo has been used in Europe at least since the mid 1990's. The use of silver coated catheters was shown to be both cost-effective and successful, according to a study done by Trenton Nauser, MD(*); Marcia Gilliland, RN; Timothy Williamson, MD and Steven Q Simpson, MD. Pulmonary Diseases and Critical Care Medicine and Infection Prevention & Control, Kansas University Medical Center, Kansas City, KS.
"During the control period, there were 15,935 inpatient days, compared with 16,089 during the study period. During the control period 29 patients experienced 33 infections that met criteria for CUTI. During the study period 18 patients experienced 22 infections. Institution of the silver impregnated catheter was associated with a 32% reduction in CUTI rate (1.37 vs. 2.07 per 1000 inpatient days, p [is less than] 0.001). Based upon our usage data for indwelling bladder catheters, we calculated an annual acquisition cost increase of $59,586. Using CDC data giving the average cost of nosocomial UTI, we calculated that annual treatment costs for CUTI will be reduced by $94,368. The institution should save $34,782 in annual overall costs by continuing to use the silver impregnated catheter."
More advanced technologies are available at this time, including silver impregnated catheters that release silver ions by electrolysis via a small electrical current ( very similiar to processes used to make colloidal silver ).
Read More: Silver Impregnated Catheters
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