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Surgical Applications For NutraSilver

Surgical Applications For NutraSilver

What is the prognosis for expansion for disinfectants in the surgical market?

US demand is projected to increase 4% annually through 2011 and even great percentage in the global market.

US demand for infection prevention products and services is forecast to rise 4.0 percent annually to $15.6 billion in 2011. Mandatory state reporting requirements along with recommendations developed by the AORN, CDC, FDA, OSHA and JCAHO will lead to a widespread upgrading of infection prevention safeguards throughout the health care and life science sectors. Although long recognized as a problem, the transmission of disease-causing pathogens during patient procedures persists through the health care community. These failures are attributable directly to cost containment pressures that have discouraged facilities from elevating infection prevention to a major departmental function.

The goal prior to any invasive procedure is to rapidly kill bacteria at the site of the planned incision. No procedure, piece of equipment, or germicide alone can achieve that objective. According to work by Ruala (1990), alcohol is neither a sterilizing agent nor a high-level disinfectant. Although ethanol has been used historically for disinfection in a variety of species and situations, and in certain cases, may actually achieve the desired outcome, the effectiveness of ethanol is highly variable (dependent upon duration of contact time, agents being killed, and contamination present on the skin surface) and inconsistent (vegetative organisms are killed more quickly than spores). According to the Association for Professionals in Infection Control and Epidemiology, “ethyl alcohol and isopropyl alcohol are not effective in sterilizing instruments because they lack sporicidal activity and cannot penetrate protein rich materials and cannot kill hydrophilic viruses.”

INSTRUMENT PREPARATION: Alcohol is not acceptable for preparation of instruments to be used in any surgical activity. A variety of other sterilization methods exist that must be used for instrument preparation. Alcohol alone is not acceptable for skin disinfection. The utilization of an iodophor or chlorhexidiene detergent in combination with alcohol is required.

In considering methods for sterilization procedures, it is important to differentiate between sterilization and disinfection:
  • High pressure/temperature steam sterilization using an autoclave and appropriate monitoring systems (i.e,. spore strips, etc.) to assure sterility.
  • Gas sterilization with ethylene oxide using an approved gas sterilizer and appropriate monitoring systems to assure sterility and personnel safety.
  • Cold (chemical) sterilization used properly. Effective and proper use of cold sterilization is dependent on many factors including:
    The use of chemicals classified as “sterilants”. Those classified only as “disinfectants” are not adequate.
  • The physical properties of the item being sterilized. It must be relatively smooth, impervious to moisture, and be of a shape that permits all surfaces to be exposed to the sterilants.
  • Adequate exposure to all surfaces, both interior and exterior. Tubing must be completely filled and the materials to be sterilized must be clean and arranged in the sterilant to assure total immersion. The items being sterilized must be exposed to the sterilant for the prescribed period of time.
  • Use of efficacious solutions: The sterilant solution must be clean and fresh. Most sterilants come in solutions consisting of two parts that when added together form what is referred to as an “activated” solution. The shelf life of activated solutions is indicated in the instructions for commercial products. Generally, this is from one to four weeks.
  • Rinse instruments, implants, and tubing (both inside and out) should be rinsed with sterile saline or sterile water prior to use to avoid tissue damage.
    Approved Sterilization Products: There are many acceptable commercial sterilants available and their use is encouraged over preparing solutions from basic ingredients. Only products classified as sterilants are to be used for sterilizing instruments and implants for surgery and they must be used according to the manufacturer’s recommendations for sterilization. Following are examples of commercial products listed by brand names:
  • Heat (glass bead sterilizers) is effective at sterilizing materials that are not heat sensitive (metal instruments). These devices are very effective and convenient to use. Caution must be exercised to rinse the heated instruments in cool sterile saline BEFORE introducing the instruments into a body part.
  • Cidex: Active ingredient: 2% Glutaraldehyde. The manufacturer’s instructions indicate that a minimum of 10 hours is required for sterilization. Cidex comes in two formulations, Cidex and Cidex-7 (long-life). The shelf life of activated Cidex is 15 days and of activated Cidex-7 is 28 days.
  • Clidox: Active ingredient: Chlorine dioxide. 1:5 mixture must be mixed daily. 1:18 mixture is good for 14 days. 1:5 is a good sterilant; 1:18 is a disinfectant.
  • Alcide: Active ingredient: Sodium hypohlorite 1.37%. The manufacturer’s instructions indicate that a minimum of 6 hours is required for sterilization. The shelf life of the activated solution is 14 days.
  • Other acceptable sterilants are the following chemicals classified as sterilants by the Centers for Disease Control (CDC). These are the chemical ingredients of some of the commercial sterilants:
  • Glutaraldehyde (2%) for a minimum of 10 hours.
  • Formaldehyde (8%) / Alcohol (70%); minimum of 18 hours.
  • Stabilized hydrogen peroxide (6%) for a minimum of 6 hours.
  • Sterilization kills all viable microorganisms.
  • Disinfection only reduces the number of viable microorganisms.

    Currently approved sterilization procedures:

Life science, health care markets to see strong gains

Advances in biotechnology are boosting opportunities for infection prevention products and services in life science markets. Stringent safety and containment standards related to the handling and processing of genetically modified microorganisms and other biologicals are spurring demand for products in medical laboratories. The persisting threat of terrorism is also creating an emerging infection prevention market in the area of homeland security. Revenues for infection prevention products and services are also benefiting from expanding applications in the manufacturing and quality assurance of pharmaceuticals and medical devices. Although projected for expanded usage in health care and life science sectors, most infection prevention consumables and disposables will continue to lack pricing flexibility due to multiple supplier competition and limited opportunities for product differentiation. Bid contracts with centralized purchasing departments or buying groups will remain the primary method of sales to hospitals and other large customers. Surgical drapes and gowns, disinfectants, medical and laboratory gloves, face masks and sterilization supplies will continue to comprise the top selling groups of infection prevention consumables and disposables because of the critical nature of applications served. Revenues for contract sterilization and medical waste disposal services will also continue to expand favorably based on cost efficiency and convenience advantages offered to hospitals and medical product manufacturers, and upward trends in surgery and other direct contact medical and dental procedures.

The future looks bright for the surgical disinfectant industry. Product differentiation and cost considerations will be key factors in the choices purchasing departments will make. At this juncture, the opportunity is wide open for a new entrant; one that is broad-based, complete in its ability to disinfect and cost-effective. NutraSilver has demonstrated its efficacy as a broad-based disinfectant and is very inexpensive, allowing for greater profit margins. We welcome investors and distributor to investigate the opportunities to bring new, innovative products to the surgical disinfectant market by combining NutraSilver with other products in existing distribution streams.

Serious inquires from investors and distributors are welcome.